MOVIE-TRACE Study: Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts
Conditions: Mpox (Monkeypox)
Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

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Project tittle: 
Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack 
Rate in Contacts 
 
Principal Investigador (PI):  
Professor Oriol Mitjà, Professor Hypolite Muhindo 
Date: 28/05/2025 
 
Version 1.1 
 
Note: This amendment (Version 1.1) includes administrative updates only to align dates and language with the 
ClinicalTrials.gov registration. No methodological changes have been introduced. 
 
List of participant institution 
Participant No. 
* 
Participant organisation name 
Country 
1 (Coordinator) 
University of Kinshasa (UNIKIN) 
DRC 
2 
Fundación Lucha contra el Sida, las Enfermedades 
Infecciosas y la Promoción de la Salud y la Ciencia 
(FLS) 
Spain 
3 
London School of Hygiene & Tropical Medicine 
(LSHTM) 
United Kingdom 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. BACKGROUND 
A mpox outbreak is currently ongoing in the Democratic Republic of Congo (DRC), involving 
primarily clade 1b, along with cases linked to other clades. Unlike previous outbreaks of clade 1, 
which were mostly associated with zoonotic transmission, this outbreak has demonstrated 
sustained human-to-human transmission, including direct and sexual contact in urban centers. 
Mpox is a zoonotic viral disease caused by the monkeypox virus (MPXV) that results in an illness 
and rash similar to that of smallpox. Based on clinical presentation and genomic sequencing 
results, MPXV isolates were classified into two clades: clade-I, predominant in Central Africa, 
with high fatality rates (1-12%), (1) (2) and clade-II, predominant in West Africa, with lower 
fatality rates (0.1%) unless the affected person is immunosuppressed. (3,4)  
In recent years, the Democratic Republic of Congo (DRC) has faced substantial outbreaks of 
clade-I MPXV. (5) Recurrent instances of Mpox outbreaks have affected the DRC, with the most 
recent occurring between 2023 and 2024. This 
outbreak has resulted in over 18,000 reported cases 
and approximately 1,000 fatalities as of May 2024, 
88% of deaths occurred in children under 15 years old, 
and the age group under 5 had a case fatality rate of 
over 10% (Fig. 1). In the DRC outbreak, MPXV is 
primarily thought to spread through respiratory 
droplets through coughs, sneezes or talks that 
facilitate the transfer of virus to others who are 
nearby.(6) Previous outbreaks, particularly among 
children in West and Central Africa, have 
demonstrated this mode of transmission. (7,8) Clade-
I MPXV outbreaks present significant challenges to 
public health, given this clade’ propensity for high 
transmission rates and severe clinical manifestations.  
In 2022, a global outbreak of clade-II MPXV, 
primarily linked to sexual transmission, affected 116 
countries, 
predominantly 
high-income 
nations. 
During this outbreak, there were more than 90,000 
cases, 
with 
about 
170 
deaths 
occurring 
in 
immunosuppressed adults. Our group published 
several landmark papers. The first provided a clinical 
description of cases, (9) showing that the clinical 
presentation was generally mild, with only a small proportion of people needing hospitalization 
due to local complications. The second focused on the presentation in women, (10) and a third 
study, demonstrated that people living with advanced HIV (CD4 count less than 200 cells/uL) 
had severe clinical manifestations and a case fatality rate of 15%. (11)  
The global clade-II MPXV outbreak highlighted the potential for transmission through intimate 
contact and sexual activity. (12) Our group also led key investigations shedding light on viral 
dynamics and transmission patterns, (13) as well as the accuracy of self-collected swabs for 
MPXV DNA detection. (14) In a longitudinal cohort study, we demonstrated a rapid decline of 
the viral load in blood compared to a more prolonged viral shedding from skin lesions. (13) 
Pharyngeal viral dynamics fell between these two groups. Time to clearance in 50% of patients 
(95% CI) was 1 (0-5) day in blood, 16 (13-23) days in oropharynx, and 25 (23-28) days in skin 
lesions (Fig. 2). Overall, our data suggested that, for clade-II MPXV, skin-to-skin contact was the 
predominant driver of transmission. 

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Firstly, efforts to control clade-I Mpox outbreaks rely heavily on public health interventions, 
particularly the identification and isolation of cases. However, there are no data regarding the 
dynamics of viral clearance in clade-I infection to determine the duration of isolation protocols. 
Understanding the kinetics of viral clearance is crucial for determining the appropriate duration 
of isolation and guiding clinical management practices. Moreover, understanding viral clearance 
may pave the way for future research because it will provide information of outcome 
measurement that can be used in future treatment efficacy RCTs.  
Moreover, understanding the Secondary Attack Rate (SAR) holds several important implications 
for managing and controlling the outbreak. By quantifying the risk of secondary transmission, 
SAR can guide decisions on the prioritization of contact tracing efforts, deployment of healthcare 
personnel, and distribution of medical supplies to mitigate further spread of the virus. SAR data 
can inform the development and adjustment of isolation and quarantine policies. High SAR values 
suggest a greater likelihood of secondary transmission, prompting stricter isolation measures and 
longer quarantine periods for contacts of Mpox cases. Conversely, low SAR values may indicate 
that existing control measures are effective, allowing for more targeted interventions. 
Importantly, SAR is instrumental in evaluating the effectiveness of vaccine efficacy trials and 
vaccination campaigns. SAR data can lay the groundwork for future trials on vaccine efficacy 
and effectiveness and can guide decisions on the deployment and prioritization of vaccines in 
Mpox-affected communities. 
To address these gaps, the ambition of this project is to provide crucial insights into the dynamics 
of MPXV clearance and person-to-person transmission in the DRC. By focusing on both the 
infected individuals and their contacts, the project aims to fill critical knowledge gaps that will 
inform effective public health interventions such as isolation and provide the basis for future trials 
on vaccine efficacy/effectiveness.  
 
1.1 OBJECTIVES 
This proposal outlines two linked epidemiological studies aimed at addressing the public health 
challenge of Mpox in the DRC provide insights into pathogenicity, clinical information on host 
susceptibility, and immune responses. The MOVIE study focuses on understanding the kinetics 
of viral elimination, shedding light on how MPXV interacts with host tissues and immune 
defences, and informing endpoint selection in therapeutic trials. The TRACE study aims to 
determine Secondary Attack Rate (SAR) in MPXV outbreaks, assessing host susceptibility within 

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specific populations, offering vital data to target interventions towards vulnerable groups and 
informing vaccine efforts by contributing to the assessment of vaccine efficacy endpoints. 
 
OBJECTIVE 1 (MOVIE Study):  Understanding MPXV Viral Clearance in Mpox Patients  
Rationale: Efforts to control Mpox outbreaks rely heavily on identifying and isolating cases. 
However, there is a critical gap in our understanding of the dynamics of viral clearance among 
clade-I MPXV infected individuals of all ages, particularly children and pregnant women. This 
knowledge gap hampers our ability to determine the optimal duration of isolation protocols and 
guide clinical management practices effectively. 
Objective: The MOVIE study aims to address this gap by describing the time to viral clearance 
in patients with PCR-confirmed Mpox infection in the DRC. By systematically collecting and 
analysing data on viral presence across different body compartments over a long period of time, 
the study seeks to provide essential insights into the kinetics of MPXV elimination and inform 
evidence-based strategies for isolation and clinical management. 
Feasibility and Measurability: The objectives of the MOVIE study are both measurable and 
verifiable. Time to viral clearance can be quantified through laboratory testing of patient samples, 
allowing for objective assessment of the effectiveness of interventions and the progression of 
infection. With access to appropriate resources and collaboration with local health authorities and 
research institutions, the study's objectives are realistically achievable within the proposed 
timeline. 
 
OBJECTIVE 2 (TRACE Study):  Evaluating Transmission Dynamics of MPXV in Mpox 
Cases and Contacts 
Rationale: In addition to understanding MPXV viral load, there is a pressing need to evaluate 
transmission dynamics of clade-I MPXV within Mpox-affected communities. Secondary 
transmission plays a significant role in sustaining outbreaks, yet the factors influencing 
transmission rates and the risk of infection among contacts of all ages remain poorly understood. 
This lack of knowledge hampers efforts to make decisions on contact tracing, healthcare 
personnel deployment, medical supply distribution, contact quarantine policies, and the 
assessment of effectiveness of vaccine trials or campaigns. 
Objective: The TRACE study aims to fill this knowledge gap by evaluating transmission 
dynamics of MPXV, including Secondary Attack Rate (SAR), in Mpox cases and their contacts. 
By systematically collecting data on contact exposure and subsequent transmission events, the 
study seeks to quantify the magnitude of transmission rate, identify risk factors associated with 
further transmission. 
Feasibility and Measurability: Like in MOVIE study, the objectives of the TRACE study are 
measurable and verifiable. Secondary Attack Rate (SAR) and transmission dynamics can be 
quantified through epidemiological analysis of contact tracing data and collection and testing of 
specimens from contacts. With appropriate resources and collaboration with local stakeholders, 
the study's objectives are realistically achievable within the proposed timeframe. 
 
1.2 INNOVATIVE APPROACH AND AMBITIOUS GOALS  

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The viral clearance and dynamics of transmission are likely to differ significantly in clade-II 
sexual transmission compared to clade-I droplet transmission in the current outbreak in DRC (Fig. 
3). (3) Sexual transmission of clade-II MPXV involves the virus infecting epithelial cells in the 
genital area,(15) resulting in low-level viremia and limited presence in respiratory excretions.(13) 
Prolonged viral clearance in skin lesions serves as a critical marker to determine isolation 
duration, and the Secondary Attack Rate (SAR) depends on subsequent sexual or intimate 
encounters. In clade-I respiratory transmission by droplets, the virus initially infects airway 
epithelial cells, then spreads to lymphatic vessels, spleen, and liver, triggering a significant 
viremia.(16–18) This dissemination facilitates widespread infection in various tissues, including 
the skin and distant organs, and the presence of viruses in respiratory excretions facilitates 
transmission to the next person. Our approach centers on investigating clade-I MPXV 
transmission in high-risk groups, with a focus on understanding viral replication in the respiratory 
tract compared to other body compartments. Additionally, we aim to assess the potential for higher 
Secondary Attack Rate (SAR) based on proximity for respiratory droplet transmission. 
 
 
Objective 1: MOVIE Study 
The MOVIE Study stands as a groundbreaking initiative in clade-I MPXV research, specifically 
aiming to explore the complex dynamics of clade-I MPXV viral load. Previous investigations in 
clade-I endemic regions have predominantly centered on the clinical manifestations of Mpox, 
owing partly to the limited access to laboratory facilities for conducting extensive virological 
analyses in Low- and Middle-Income Countries (LMIC) where the outbreaks occurred.(2,19,20) 
This gap in laboratory-based research has hindered a comprehensive understanding of the 
disease's pathogenesis in affected individuals. 
In contrast, some attention was devoted to studying the clade-II MPXV outbreak in 2022, 
particularly in high-income countries. At least three studies, characterized by their meticulous 
examination of viral detection and clearance dynamics, have significantly contributed to our 
understanding of clade-II MPXV infection transmitted sexually or by close direct 
contact.(13,21,22) However, it is imperative to recognize that the transmission patterns and viral 
clearance observed in the clade-II 2022 global outbreak, primarily driven by sexual transmission, 
may not necessarily mirror those of clade-I MPXV, which, as mentioned above, is predominantly 

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transmitted through respiratory dropplets. Thus, there remains a critical knowledge gap 
concerning the transmission dynamics of clade-I MPXV. 
The proposed work is ambitious in its scope and potential impact. By elucidating the kinetics of 
clade-I MPXV elimination in different body compartments, the MOVIE study aims to guide 
current approaches to Mpox management and prevention with the potential to inform evidence-
based strategies for isolation, treatment, and infection control, ultimately reducing morbidity and 
mortality associated with Mpox outbreaks.  
 
Objective 2: TRACE Study 
This study also represents a unique opportunity to determine Secondary Attack Rate (SAR) in 
clade-I MPXV outbreaks. During the clade-II outbreak in 2022, the SAR could not be clearly 
defined due to challenges in reporting and identifying sexual contacts. The nature of sexual 
interactions often led to ambiguity or incomplete reporting, making it difficult to accurately assess 
transmission rates within this context. Previous experiences with clade-I MPXV outbreaks 
provided some insights into SAR, particularly in household transmission settings reporting values 
of up to 9% (23) or in congregate living situations (i.e., prisons, or healthcare facilities).(24,25) 
However, the evidence supporting SAR calculations for clade-I MPXV outbreaks is not strong 
due to methodological limitations in previous studies. SAR investigations were started based on 
suspected index cases rather than cases confirmed by positive PCR testing. Additionally, contact 
classification relied on symptoms without confirmation through PCR testing, and therefore 
missed a fraction of asymptomatic infections. The previously described approach introduces 
uncertainty into SAR estimations, as suspected cases may not always represent true infections, 
and symptom-based diagnoses of contacts may lack both sensitivity and specificity. Without 
confirmation through PCR testing, there is a risk of misclassification and overestimation or 
underestimation of SAR values. 
The TRACE study seeks to address these limitations by employing a rigorous methodology, 
including systematic PCR testing of all contacts at least at two different time points to confirm 
infections, and systematic symptom-based assessments, thus providing accurate and reliable data 
on SAR in clade-I MPXV transmission settings. 
 
2. METHODOLOGY 
This project will be delivered over 24 months and will be led by the Fight Infections Foundation 
(FLS, coordinator) along with the University of Kinshasa (UNIKIN, partner) and London School 
of Hygiene and Tropical Medicine (LSHTM, partner). Our consortium brings together partners 
in both Europe and the DRC with expertise in clinical, epidemiological and virological research 
into Mpox. Collectively, this consortium provides the breadth of experience needed to undertake 
our two proposed studies and deliver critical information to guide the response to the Mpox 
epidemic.  
Individual work packages are described in detail in Section 3. Below we outline the methodology 
for the two Scientific Work packages which are designed to provide critical data to inform the 
Mpox response in DRC. 
Ethics Approval 
Ethical approval will be obtained from the Observational Ethics Committee of HUGTiP (law 
14/2007 on Biomedical Research and Royal Decree 1716/2011 on Biobanks regulation) and from 
the DRC Ministry of Health National Ethics Committee (Comité National d’Éthique de la Santé, 
CNES). All participants will be asked to provide written informed consent. Where children are 

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enrolled, we will obtain assent from the child over 12 years old in addition to consent from a 
parent or guardian. 
Overall Design of the LLEGAT study 
The overall project design combines 1) identification and follow-up of Mpox index cases 
(MOVIE) to understand viral kinetics and duration of infectivity and 2) identification of close 
contacts of these index cases (TRACE) to understand Secondary Attack Rates (SAR) and 
determinants of transmission. A high-level scheme for the two studies is shown in Fig. 4. 
 
 
 
2.1 MOVIE study of MPXV Viral Kinetics (Work Package 5) 
Study sites: The main study site for participant recruitment will be in Èquateur, province. This 
site is well suited as i) it reports ongoing transmission of Mpox and ii) UNIKIN has been actively 
involved in research and epidemiological surveillance in the province of Équateur, where it has 
established a solid presence and collaborative networks in the field of infectious diseases. 
 
Design and population: The proposed design for our study is a prospective observational study, 
aimed at understanding the dynamics of MPXV infection in both children and adults. 
 
Sample Size: We plan to enrol approximately 50 cases of Mpox to ensure an adequate sample 
size for meaningful analysis. The study utilizes a convenience sample size, chosen to be within 
budget while still being sufficiently large for descriptive analyses. 
 
Inclusion and Exclusion criteria: Inclusion criteria for participation in the study include (1) 
individuals of any gender and age who (2) have been diagnosed with lesions suggestive of Mpox 
by a trained health worker; (3) have experienced symptom onset within the past 10 days prior to 
baseline assessment; (4) comply with the study protocol, and (5) be available for follow-up visits. 
(6) Informed consent will be obtained from all participants, or consent may be provided by a 

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legally authorized representative if non-adults or in case the individual is unable to provide it 
themselves, with assent from children of 12 years of age or older. Witnessed consent will be used 
for those who cannot read/write. 
Exclusion criteria include (1) cases of severe Mpox that necessitate hospital admission, (2) 
individuals with an alternative confirmed diagnosis explaining their illness, (3) prior vaccination 
against Mpox, (4) individuals over 40 years old who report having received smallpox vaccination 
during infancy. 
 
Case definitions and variables:   
‘Mpox case’ case definition: An Mpox case for MOVIE study will consist of an individual who 
exhibits symptoms suggestive of Mpox, such as characteristic skin lesions, symptom onset within 
10 days prior to baseline sample collection, meets the inclusion criteria for the study and tests 
positive for MPXV by PCR.  
 
Screening failure: Screening failure occurs when a suspected case, enrolled for participation, 
tests negative on a PCR test, leading to their exclusion from further procedures or participation. 
 
Severity Score: We will use a modified Mpox-Severity Score (Mpox-SS) to determine severity: 
The Mpox-SS has six main components: Rash extent and burden of lesions, secondary infections, 
mucosal areas affected, level of care, analgesia requirement. In addition to that we will consider 
additional components: Symptom assessment (fever), and internal organ involvement 
(respiratory, gastrointestinal, neurological symptoms). Each component will be graded from 0 to 
4, and the sum of scores will provide a total severity score. The Mpox severity score has been 
validated in adult individuals only, so this research provides an opportunity to validate the score 
in pediatric population (https://mpoxseverityscore.com/uploads/MPOX_SSS_V9.pdf). 
We will collect the following variables: 
 
Demographic variables: Age; Sex/Gender; Geographic location. 
 
Epidemiological and behavioral variables: Exposure history and contact with known or 
suspected Mpox cases, personal protective measures and hygiene practices; Occupation; 
Engagement in sex work; Involvement in sexual activity outside of the partnership; Engaging the 
services of sex workers in the past 2 weeks. 
 
Clinical variables: Comorbidities (measles, TB, malaria); HIV Status: HIV test results; Previous 
smallpox vaccination; Date of prodrome symptoms start; Date of vesicular rash start (date of the 
first vesicle); Approximately maximum number of concurrent skin lesions (e.g., 1, 30, 100); 
Distribution of lesions (face, scalp, trunk, arms, hands, legs, feet, soles, palms, penis, scrotum, 
labia majora, groin, buttocks); Distribution (localized to 1 region, 2 regions, more than 2 regions); 
Distribution in generalized rash (centrifugal, centripetal, even distribution); Development 
(monomorphic, pleomorphic); Duration of symptoms; Mpox Diagnosis: PCR test results; Mpox-
SS components (graded 0 to 4): Rash extent and burden of lesions, secondary infections, mucosal 
areas affected, level of care required, analgesia requirement, symptom assessment (fever, 
respiratory, gastrointestinal, neurological symptoms); Treatments received for Mpox.  
 
Photography of lesions 
 
Contact tracing information to identify secondary cases 
Laboratory variables: MPXV viral load measurements at skin lesions swabs, blood, 
oropharyngeal swabs, and urine at different time points; Viral culture: Presence of replication-
competent virus; Immunological Responses: MPXV-specific humoral and cellular responses. 

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Outcome variables: 
Primary endpoint: time to viral clearance for each body compartment, which is defined as the 
interval from the onset of symptoms to the first negative PCR result. This will be measured in 
skin lesions swabs, blood, oropharyngeal swabs, and first-void urine samples. 
Secondary outcomes: (1) Describing the viral load at each body compartment at different time 
points. (2) Exploring the association between severity of clinical features and the time to viral 
clearance. Severity of clinical features will be assessed using the mMpox-SS. (4) Investigating 
behavioural factors associated with Mpox acquisition by means of questionnaires. (5) Explore 
intrahost viral evolution in distinct compartments during infection evolution. 
 
Procedures:  
Baseline: The team in the field, through UNIKIN, will get notified about a case through the 
surveillance process after which the team will travel to the location and enroll the case. The 
screening and baseline visits will involve in-person interactions conducted either in a clinical 
setting, at participants' homes, or clubs, facilitated by a study investigator. During these visits, 
participants will receive detailed information about the study, and then informed consent will be 
obtained. Subsequently, a comprehensive interview will be conducted to gather demographic, 
epidemiological, and clinical data, including any relevant comorbidities and medical history. 
Photographs of lesions will be taken. The captured images will not only strengthen the dataset for 
this project but also hold potential for utilization in AI tools for diagnosis. Eligibility will then be 
verified based on predetermined inclusion and exclusion criteria, with ineligible participants 
being promptly informed and provided with necessary medical assistance.  
 
Sample collection: For eligible participants, one vesicle fluid sample will be collected and taken 
to Mbandaka laboratories for GeneXpert rapid within 48 hours to determine the continuation in 
the study. Additionally, a series of biological samples will be collected, including vesicle fluid 
from lesions or ulcers, blood for plasma collection, swabs, and first void urine samples and for 
storage at -80ºC for centralized shipment to Hospital Universitario Germans Trias I Pujol, 
Barcelona. To ensure sample integrity, swabs will be placed in 3 mL of viral transport medium, 
blood will be collected as dried blood spots (DBS) on filter paper and the urine is collected in a 
sterile 8ml tube. 
 
Follow-up visits: Follow-up visits will be conducted on days 0, 7, 14, 28, and 56, using the same 
baseline procedures for sample collection from skin lesions, blood and oropharynx and shipped 
to Barcelona for testing. 
 
Data source: Throughout the study, data will be sourced from patient medical health records and 
laboratory results, forming the primary basis for analysis and interpretation. 
 
 
2.2 TRACE Study of MPXV Transmission Dynamics (Work Package 6)  
Design and population: This will be an observational study evaluating transmission dynamics 
of MPXV within the context of the outbreak in the DRC The study population comprises 
individuals who have had close contact with PCR-confirmed Mpox cases within the outbreak 
setting. 
Sample Size: With an indicative sample size of 500 contacts, the study intends to recruit 
approximately 10 close contacts for each of the 50 Mpox cases identified.  This is a convenience 
sample that falls within the budgetary constraints but is deemed sufficient to determine the SAR. 

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Inclusion and exclusion criteria: Inclusion criteria include (1) individuals who report close 
physical contact with a PCR-confirmed Mpox case within 14 days from the onset of the index 
case's symptoms. Close physical contact is operationally defined as being within 2 meters of an 
infected person, particularly in enclosed spaces, for at least 5 minutes (CDC 2 meters rule for 
droplet transmission). (2) Willing to comply with the study protocol and be available for follow-
up assessments. (3) Informed consent is a prerequisite for participation, although consent can be 
provided by a legally authorized representative in case the individual is unable to provide it 
themselves. 
Exclusion criteria include (1) prior vaccination against Mpox, (2) individuals over 40 years old 
who report having received smallpox vaccination during infancy. 
 
Contact definitions and variables:   
‘Mpox contact’ case definition for TRACE is an individual who reports having had close 
physical contact with a confirmed Mpox case (within 2 meters in the same enclosed space for at 
least 5 minutes [CDC, 2 meters rule for droplet transmission]) within 14 days from the symptom 
onset of the index case.  
Variables related to the case: Already described in before in MOVIE study section.  
Variables related to the contact:  
 
Demographic variables: Age, sex, geographic location. 
 
Epidemiological and behavioral variables: Exposure history and contact with other 
(non-index) known or suspected Mpox cases, personal protective measures and 
hygiene practices; Exposure setting (household, school, friends, intimate), Exposure 
risk factor (skin cuts, sores, ulcers before exposure, or none), Date of exposure (range 
will be acceptable); Occupation; Engagement in sex work; Involvement in sexual 
activity outside of the partnership; Engaging the services of sex workers in the past 2 
weeks.  
 
Clinical variables: Site, Location; Comorbidities (measles, TB, malaria); HIV Status: 
HIV test results; Previous smallpox vaccination. If a contact is confirmed to have 
Mpox through study procedures, we will collect the variables described for Mpox 
Case. 
 
Laboratory variables: Baseline MPXV serological result of the contact, MPXV DNA 
detected in the contact specimens (blood, oropharynx, anus), MPXV DNA detected in 
the index case specimens (i.e., lesion, blood, oropharynx, and urine). 
 
 
Endpoints:   
Primary endpoint:  
1)Secondary Attack Rate of Infection (SAR-i), the proportion of contacts who become 
infected with the pathogen (PCR positivity), regardless of whether they exhibit 
symptoms. 
2)Secondary Attack Rate of Disease (SAR-d), the proportion of contacts who develop 
symptomatic illness after exposure to the pathogen with PCR confirmation. 
In these attack ratios, the denominator includes all individuals who have had close contact with a 
confirmed case in the past 14 days since the symptom onset of the index case (i.e., higher end of 
the serial interval range). (26–28), while the numerator includes only those contacts from the 
denominator who subsequently become infected (SAR-i) or develop the disease (SAR-d). 

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• 
Contacts who test positive on PCR at baseline without symptoms will count as 
contacts. 
• 
Contacts who test positive on PCR at baseline and also exhibit symptoms will be 
considered as secondary contacts if the index case had symptoms of the disease at least 
5 days prior to the contact’s onset of symptoms (lower end of the of the serial interval 
range).(26) If the onset of symptoms was within less than 5 days, they may have been 
exposed to the same original source of infection and therefore be concomitant cases 
to the index rather than contacts. These cases will be analyzed separately in secondary 
analyses. 
We will confirm the viral genetic link between index cases and their contacts through genotyping 
analyses. We will conduct exploratory analysis to examine how the SAR varies by index case 
viral load, baseline characteristics of the contact and type of case-contact relationship (e.g., 
household vs. non-household contacts). 
Secondary endpoints: consist of factors of the case or the host associated with transmission, 
measured using all clusters of an index case and their corresponding contacts for which 
quantitative viral load is available for the index case. 
Procedures:  
Contact identification: A dedicated field team will be deployed to visit both confirmed Mpox 
cases and their contacts at their residences, or workplaces on two key days: day 0 (baseline) and 
day 14. Upon identifying an index case, the team will compile a comprehensive list of close 
contacts associated with each case in the past 2 weeks. 
 
Baseline visit: Each contact will be visited by the field team to gather essential demographic, 
epidemiological, co-morbidity, and clinical data at baseline (day 0). During these baseline visit, 
pertinent epidemiological information will be collected through structured interview. This data 
will include details such as the time of initial exposure to the index case, the location of contact, 
the degree of proximity, and the duration of contact.  
 
Sample collection: For eligible asymptomatic participants, a series of biological samples will be 
collected, including oropharyngeal and blood for PCR and serology testing and swab lesion (if 
there is). Samples will be collected from 10 contacts for each mpox case (500 contacts) at baseline 
and 14 days follow-up time points. To ensure sample integrity, swabs will be placed in 3 mL of 
viral transport medium, blood will be collected as dried blood spots (DBS) on filter paper. 
Samples will be storage at -80ºC for centralized shipment to Barcelona. 
 
Follow up: We will conduct a follow-up visit on day 14 with systematic swabbing for PCR 
testing. As part of this follow-up, oropharyngeal swabs and blood samples will be collected from 
everyone on day 14 for PCR and serological testing. 
 
Management of symptomatic cases: If participants exhibit symptoms indicative of Mpox within 
the 14 days following enrolment, they will undergo sample collection at the earliest opportunity. 
These symptomatic individuals will subsequently be enrolled into the MOVIE study for further 
investigation and will be added to the contact line-list for ongoing monitoring and analysis. This 
comprehensive approach ensures that all potential cases are thoroughly evaluated and included in 
the study's analysis, contributing to a more comprehensive understanding of Mpox transmission 
dynamics. 
 
Data source: Throughout the study, data will be sourced from patient medical health records and 
laboratory results, forming the primary basis for analysis and interpretation 
 

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2.3 Laboratory Assessments 
Samples will undergo molecular and genetic analysis in Germans Trias i Pujol Hospital, 
Barcelona: 
 
PCR testing: 
MPXV detection: MPXV GenExpert testing of samples collected from Mpox cases will be 
performed at a laboratory within the UNIKIN facility to confirm the case and move forward with 
further analysis. During transport, samples will be kept at 2-8°C; time from sample collection to 
laboratory receipt will be within 24 h; once received, samples will be processed immediately 
and/or stored at –80°C until processing. MPXV PCR testing from samples collected at specified 
time points will be conducted at the microbiology laboratory at the Germans Trias i Pujol 
Hospital. These samples will be stored at -80ºC at UNIKIN facilities until they are shipped to 
Barcelona in -20ºC boxes. All samples will be sent at the same time, once the sample collection 
is finished. All samples will be analyzed for the detection of MPXV DNA by qPCR. Copy number 
per mL will be determined using a linear dilution series of a quantified MPXV DNA standard. 
Viral loads from body fluids (i.e., blood and urine) will be expressed in DNA copies per mL, 
whereas the amount of virus in swab-collected samples (i.e., skin lesions, oropharynx) will be 
expressed as copies per mL of viral transport medium. 
 
Genotyping analysis 
MPXV clade typing: For samples analyzed at the Barcelona laboratory, only those that test 
positive for Monkeypox virus (MPXV) via quantitative PCR (qPCR) will proceed to clade typing. 
Clade differentiation is performed using a clade-specific PCR assay that targets genomic regions 
with known sequence divergence between MPXV clades. The protocol employs primers 
specifically designed to distinguish between Clade I (Congo Basin lineage, encompassing both 
Clade Ia and Clade Ib) and Clade II (West African lineage, including Clade IIa and Clade IIb). 
 
Viral Genome Sequencing: MPXV-positive samples with a cycle threshold (Ct) value of ≤25–
26 will be selected for whole genome sequencing (WGS) at the microbiology department of 
Hospital Universitari Germans Trias i Pujol (HUGTiP). High-quality viral DNA will be extracted 
and prepared for sequencing using Illumina platform. 
 
WGS allows for comprehensive analysis of the entire viral genome, enabling detailed 
investigation of genetic variation, including point mutations, insertions/deletions, and potential 
recombination events. This high-resolution genomic data will be used to determine phylogenetic 
relationships between strains, monitor viral evolution, and assess the emergence of new lineages.  
 
Phylogenetic Analysis: To investigate the evolutionary relationships among the detected MPXV 
strains, phylogenetic trees will be constructed using full-genome sequences obtained through 
WGS. Sequences will be aligned using MAFFT tools, and phylogenies will be inferred using 
Bayesian approaches. Reference genomes representing different MPXV clades (Clade I, IIa, IIb) 
will be included to contextualize the position of Congolese strains within the global MPXV 
diversity. 
 
This analysis will provide insights into the origin, diversification, and potential transmission 
pathways of MPXV in the study region. It will also allow identification of clusters and possible 
links between cases, contributing to both molecular epidemiology and outbreak control strategies. 
All phylogenetic outputs will be integrated with epidemiological and geographic metadata to 
enhance interpretation and guide public health response. 
 
 

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Data management:  
Results of laboratory analysis will be collected in a database by laboratory study-staff, with 
personal system of access by username and password. Clinical data will be collected in an 
independent database by the investigator or delegated study staff with a personal system of access 
by username and password. Based on the study ID, databases will be merged to create the final 
study database. A data management system will be set up and procedures will be implemented to 
warrant homogenization, traceability, and data quality. Quality control procedures will be put in 
place for data checking. Consistency checks will be created to reduce errors during data entry. 
 
The data management team and investigators will have access to the database. The backup of the 
data will be done on a timely basis. The final data for the analysis will not contain any personal 
identifiable data of the participating patients and those receiving the final data for analysis will 
not have access to any information that might help to physically identify patients.  
Each participant will be assigned a unique study identification number, and all data will be 
recorded and analyzed with this unique identification number. All information will be stored in a 
coded fashion in an encrypted password-protected database, using unique patient identifiers. All 
devices and servers that store protocol data with personal identifiable information will use full 
drive encryption, require OS-level and application-level authentication, field-level data 
encryption, and limit authenticated access with user profiles and groups. All transmitted data will 
be encrypted at source and decrypted at destination over secure channels.  
 
Statistical Methods:  
All analyses will be done with the R statistical package, version 4.1 or higher, under a significance 
level of 0.05.   
 
The demographic and clinical characteristics of study participants will be described using the 
median and IQR (defined by the 25th and 75th percentiles) or the number and percentage of 
available data. We will describe the viral load DNA from each ‘compartment’ (i.e., skin lesions, 
blood, oropharynx, and urine) using mean and standard deviation and/or median and interquartile 
range.  We will use a linear mixed effect models to describe the log viral load of individuals with 
Mpox and infer the time to viral clearance and describe the viral load over time. We will assume 
all bodily fluid compartments (i.e., skin lesions, blood, oropharynx, and urine) to be independent 
and will fit them separately. Values lower than the limit of detection of the assay will be 
considered right censored. Time to clearance between the different compartments will be 
compared with a log-rank test after estimating the Kaplan-Meier.  
In exploratory analyses we will evaluate variables associated with time to clearance including 
clinical features of the current illness (for example extent of skin lesions at enrolment, presence 
or absence of systemic features) and with demographic and co-morbidity data from participants 
(for example age and HIV status, co-infection with measles, TB or malaria). We will assess the 
extent to which clinical indicators of disease resolution (for example cessation of fever, re-
epithelization of skin) are associated with clearance of the virus. Associated factors to both 
acquisition and access to health care will be identify by descriptive statistical techniques including 
multiple regression analysis. All analyses will be done with the R statistical package, version 4.1 
or higher, under a significance level of 0.05. 
We will calculate the Secondary Attack Rate (SAR), including symptomatic and asymptomatic 
SAR. We will conduct exploratory analysis to examine how the SAR varies by increasing index 
case viral load, baseline characteristics of the contact and type of case-contact relationship. The 
relationship between characteristics of cases and viral load will be assessed by use of linear 
regression considering age (in years), sex, number of days from reported symptom onset, number 
of skin lesions and presence of systemic symptoms. To identify risk factors for transmission, we 
will use generalized mixed effect models for the risk of transmission to allow for within-cluster 
variation in the risk of transmission. Factors with potential influence on the risk of transmission 
include characteristics of the potential transmitter (i.e., age, sex, viral load, the number of skin 

PROTOCOL MOVIE-TRACE EQUATEUR 
 
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lesions, and the presence or absence of systemic symptoms, immunosuppression) and contacts 
(i.e., age, sex, and the type of contact they had with the index case, immunosuppression). 
 
Limitations:  
Limited healthcare infrastructure and transportation challenges: In certain areas, the lack of 
adequate equipment for sample preservation and transportation may compromise their integrity 
before reaching Barcelona. Additionally, the international shipment of samples from the DRC to 
the laboratory in Barcelona can be complex, with potential delays or customs-related issues. 
 
Insufficient sample size: A small or unbalanced number of samples could reduce statistical power, 
increasing the risk of not detecting significant differences in viral excretion in different body 
compartments. This limitation may lead to inconclusive or less generalizable results. In addition, 
variability in the timing of sample collection and individual differences in immune response may 
further complicate the analysis, potentially affecting the reliability of comparisons between viral 
load in different compartments. 
 
Difficulty in contact tracing: Incomplete or inaccurate information regarding exposure history 
may lead to misclassification of cases and contacts, affecting the reliability of SAR estimations. 
Additionally, logistical challenges in tracking and following up with contacts over time may result 
in missing data, further limiting the accuracy and generalizability of the findings. 
 
Potential bias in epidemiological data collection and limited access to contacts: Incomplete or 
inaccurate self-reported data may lead to misclassification or underestimation of certain risk 
factors. Additionally, difficulties in reaching and enrolling contacts could result in selection bias, 
limiting the study’s ability to capture a comprehensive and representative overview of 
transmission dynamics.  
 
 
 
3. ETHICAL AND LEGAL ASPECTS 
3.1 Integration of national or international research activities into the project 
The success of the proposed project relies significantly on the integration of previously generated 
data and research outcomes from national and international activities. The collaborative efforts 
between the London School of Fight Infections Foundation (FLS), Hygiene & Tropical Medicine 
(LSHTM) and University of Kinshasa have yielded valuable insights into Mpox, which will serve 
as a foundation for the proposed research. Our team brings together leading UK, Spanish and 
African partners (FLS, LSHTM, UNIKIN) with expertise in clinical, epidemiological, and 
virological research focused on Mpox. Our network has previously undertaken pivotal work on 
Mpox including the first demonstration that the 2022 clade-II pandemic was due to sexual 
transmission, the first longitudinal study of viral kinetics of clade-II MPXV, and the largest study 
in people living with HIV during the 2022 pandemic demonstrating associations between CD4 
count and Mpox outcomes.  (9–11,13,29). 
Key Research Activities that will be integrated: 
 
Clinical Research Expertise: The FLS-LSHTM collaborative group on STIs and NTDs has a 
longstanding history of collaboration for more than 15 years, with substantial experience in Mpox 
clinical research over the 2022-2024 period. The University of Kinshasa serves as a key academic 
and technical partner in the mpox response in the DRC, bridging scientific research, public health 
training, and operational support to strengthen national outbreak control efforts. The FLS-
LSHTM collaboration includes the establishment of a network of clinicians spanning 19 
countries, enabling comprehensive data collection on the initial clinical presentation of Mpox, 
particularly 
its 
clade-II 
sexually 
transmitted 
form 
and 
severe 
manifestations 
in 

PROTOCOL MOVIE-TRACE EQUATEUR 
 
Page 15 of 37 
 
immunosuppressed patients. These studies have provided invaluable insights into disease 
epidemiology, risk factors, and clinical management. 
 
Trial Design and Conceptualization: The expertise gained from previous Mpox clinical 
research forms the cornerstone for trial design and conceptualization in the proposed project. 
Drawing upon insights from the diverse clinical presentations of Mpox and the nuances of 
epidemiological studies in different populations, the collaboration between institutes ensures that 
the upcoming trials are methodologically rigorous, ethically sound, and culturally sensitive. 
 
The integration of national and international research activities in the current proposal is 
established through regular communication, data sharing, and collaborative decision-making 
mechanisms to ensure coordination between consortium members. Joint workshops, training 
sessions, and research meetings are being held to foster knowledge exchange and mutual learning, 
further strengthening the linkages between national and international research efforts. 
 
3.2 Integration of Expertise and Methods from Different Disciplines  
In the context of the proposed work, an interdisciplinary approach is essential for achieving our 
objectives effectively.  
 
Clinical Epidemiology and Public Health experts will collaborate to design and implement the 
prospective observational studies, ensuring robust data collection and analysis. Clinicians and 
epidemiologists will collaborate to characterize the clinical spectrum of clade-I Mpox in DRC, 
identify risk factors for transmission, and assess disease outcomes. This interdisciplinary 
approach ensures that clinical observations are systematically analysed and translated into 
actionable public health recommendations. 
 
Laboratory Sciences and Molecular Biology: Laboratory scientists will employ PCR testing to 
conduct serial MPXV testing on samples collected from different body compartments of Mpox 
patients. In addition, viral culture, serology and genomic sequencing will be conducted by 
international partners to identify genetic variants and chains of transmission. By integrating 
laboratory findings with clinical data, we can elucidate the biological mechanisms underlying 
Mpox pathogenesis, time to viral clearance, and transmission dynamics between a case and its 
contacts. 
 
Data Science and Bioinformatics: Data scientists and biostatisticians will analyse the collected 
data using statistical methods to determine the time to viral clearance and assess transmission 
dynamics. They will identify associations between clinical, demographic, and epidemiological 
factors, providing valuable insights for optimizing Mpox control measures. 
 
3.3 Benefit-risk assessment for research subjects 
The studies proposed provide answers on pathogenicity and clinical information on host 
susceptibility and host immune responses.  
 
Objective 1 - MOVIE Study: by examining the kinetics of viral elimination, the MOVIE study 
will shed light on the pathogenic mechanisms of MPXV, identifying how the virus interacts with 
host tissues and immune defences. The study focuses on the kinetics of clade-I MPXV 
elimination, providing crucial epidemiological data on Mpox viral shedding and the duration of 
infectiousness. These dynamics are directly related to pathogenicity as they reveal the virus’s 
ability to replicate, persist, and cause damage within the host. Understanding the duration and 
levels of viral shedding helps in identifying how long and how intensely the virus can affect the 
host, which is essential for developing effective containment strategies and therapeutic 

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interventions. The MOVIE study could also contribute to pave the way for future research about 
clinical trials for therapeutics. It could potentially contribute to establishing a reduction in viral 
load as an endpoint in treatment RCTs for Mpox. 
 
Objective 2- TRACE Study: The TRACE study focuses on determining secondary attack rates 
in clade-I MPXV outbreaks. By analysing secondary attack rates, the study assesses host 
susceptibility within specific populations. Higher secondary attack rates suggest increased 
susceptibility among contacts, highlighting the vulnerability of certain groups to MPXV infection. 
This study will identify factors associated with increased susceptibility to MPXV, such as age, 
health status, and prior smallpox vaccination or natural immunity. This information is crucial for 
targeting interventions to the most vulnerable populations, including children who have been 
disproportionately affected. By providing data on host susceptibility, the study will inform public 
health strategies aimed at protecting high-risk groups and reducing Mpox-related morbidity and 
mortality. The TRACE study could contribute to provide insights on vaccine efforts as it 
contributes to assessment of vaccine efficacy endpoints. Phase 3 studies require researchers to 
assess the vaccine's effectiveness in reducing disease transmission and preventing secondary 
cases. 
 
Impact of the MOVIE study: 
 
Scientific Impact:  
a. Scientific advancement: The MOVIE study will significantly advance scientific 
knowledge by examining viral clearance and duration of infectiousness in various body 
compartments in people affected by clade-I MPXV. It also aims to elucidate factors 
influencing faster clearance and immunity related to rapid clearance.   
b. Therapeutic trials: Beyond its immediate impact on public health, the MOVIE study 
could also contribute to pave the way for future research studies and clinical trials focused 
on developing novel therapeutics for Mpox. It could potentially contribute to establishing 
a reduction in viral load as an endpoint in treatment RCTs for Mpox. Monitoring changes 
in viral load levels before and after treatment can provide valuable insights into the 
effectiveness of antiviral therapies and their impact on viral replication and disease 
progression. 
c. Biomarkers: Mpox viral kinetics and host factors associated with disease outcomes 
could provide valuable biomarkers for monitoring treatment response and predicting 
clinical prognosis. 
 
Societal Impact:  
a. Disease control strategies: By elucidating the time course of Mpox viral clearance in 
different body compartments, our aim is to generate new knowledge that can inform 
public health interventions. Understanding how long an infected individual remains 
contagious helps public health authorities implement appropriate control measures to 
prevent further transmission of the disease. For contagious diseases like Mpox, 
identifying and isolating infectious individuals can help contain outbreaks and reduce the 
spread of infection within communities. 
b. Reduced disease transmission through isolation: Knowledge of the duration of 
infectiousness informs decisions regarding the length of isolation for infected individuals. 
(30) Public health guidelines may recommend isolating individuals until they are no 
longer infectious to prevent them from spreading the disease to others. 
c. Contact Tracing and Surveillance: Duration of infectiousness data aids in contact 
tracing efforts, allowing public health authorities to identify and monitor individuals who 
may have been exposed to the disease. (31) Timely identification of contacts enables 
early intervention, including testing, quarantine, or isolation, to prevent further spread of 
infection. 

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d. Public Health Messaging: Communicating accurate information about the duration of 
infectiousness is essential for public health messaging campaigns. Clear guidance on how 
long individuals should isolate or avoid close contact with others helps promote 
compliance with preventive measures and reduces the risk of disease transmission in the 
community.  
e. Increased community resilience: By generating knowledge that can help mitigate the 
impact of Mpox outbreaks, MOVIE may contribute to building resilience within affected 
communities. This may involve empowering individuals with information on disease 
prevention measures and fostering community engagement in outbreak response efforts. 
f. Reduced morbidity and mortality: Through evidence-based insights into viral 
clearance dynamics, the study will inform the development of targeted interventions 
aimed at reducing Mpox transmission rates and improving infection control measures. 
This is anticipated to lead to tangible improvements in public health outcomes, including 
decreased Mpox morbidity and mortality rates in affected communities. 
g. Genomic Surveillance: Phylogenetic surveillance will help identify the different variants 
of the virus that may be circulating in the high-risk population. This can be important in 
distinguishing between local infections and emerging strains that may have different 
epidemiological behaviors. In addition, genomic data can help detect new waves of 
outbreaks or unexpected outbreaks by identifying common genetic patterns among cases 
of infection in different regions. 
 
Economic impact: 
a. Resource Allocation: By quantifying the risk of Mpox transmission within specific 
populations or settings, policymakers can make informed decisions regarding resource 
allocation, intervention strategies, and public health messaging. 
 
Impact of the TRACE study: 
 
Scientific impact: 
a. Scientific advancement: The study will provide data on secondary attack rates, host 
susceptibility, and host immune responses in household or school transmission settings. 
It will contribute to scientific advancements by addressing methodological limitations in 
previous studies and providing more accurate estimates of SAR in clade-I MPXV 
outbreaks.  
b. Vaccine efficacy endpoint measurement: SAR helps establish the baseline risk of 
disease transmission within specific populations or settings. This information is essential 
for determining the incidence and prevalence of the disease before vaccine intervention. 
Moreover, SAR serves as a key endpoint for evaluating vaccine efficacy. By comparing 
SAR between vaccinated and unvaccinated groups, researchers can assess the 
effectiveness of the vaccine in reducing disease transmission and preventing secondary 
cases. 
c. Vaccine efficacy sample size calculation: SAR data are used to calculate the sample 
size required for vaccine efficacy studies. Understanding the expected SAR in the target 
population allows researchers to determine the number of participants needed to detect a 
significant difference in disease transmission between vaccinated and unvaccinated 
groups. 
d. Vaccine real-world effectiveness: SAR data provide real-world evidence of vaccine 
impact on disease transmission in community settings. By measuring changes in SAR 
over time following vaccine implementation, researchers can evaluate the long-term 
effectiveness of the vaccine in reducing overall disease burden and interrupting 
transmission chains. 
 
Societal impact: 

PROTOCOL MOVIE-TRACE EQUATEUR 
 
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a. Policy Informing of at-risk populations: SAR measures the likelihood of an individual 
contracting Mpox from a known infected individual within a specific setting, such as a 
household or community. Understanding SAR helps policymakers and public health 
authorities assess the risk of Mpox transmission in different contexts, identify high-risk 
settings or populations, and tailor interventions accordingly. For example, if SAR is 
found to be higher in certain demographic groups or transmission settings, targeted 
preventive measures, such as vaccination campaigns or enhanced infection control 
protocols, can be implemented to reduce transmission rates and mitigate the spread of the 
disease. 
b. Quarantine Policies: Knowledge of the risk of infection acquisition informs decisions 
regarding the length of quarantine periods for close contacts. Public health guidelines 
may recommend quarantining individuals until they are no longer at risk of becoming 
infectious to prevent them from spreading the disease to others. 
c. Predictive value: SAR estimates provide valuable information for modelling the impact 
of different control measures and predicting the trajectory of Mpox outbreaks, thereby 
guiding the implementation of effective and timely response efforts. 
d. Increased community awareness: By raising awareness about Mpox transmission and 
prevention measures, TRACE may empower communities to take proactive steps to 
protect themselves and reduce the spread of the disease. 
 
Economic impact: 
a. Resource allocation: By quantifying the risk of Mpox transmission within specific 
populations or settings, policymakers can make informed decisions regarding resource 
allocation, intervention strategies, and public health messaging.  
b. Strengthened healthcare systems: By providing valuable data on Mpox transmission 
patterns, TRACE may contribute to the strengthening of healthcare systems preparedness 
in affected regions, improving their capacity to respond to infectious disease outbreaks 
in the future. 
 
 
3.4 Scale and significance of contribution 
The scale and significance of the MOVIE and TRACE studies' contributions to expected 
outcomes and impacts are enormous, given the magnitude of Mpox morbidity and mortality in 
affected regions like the Democratic Republic of Congo (DRC). Successful completion of these 
studies is expected to result in tangible improvements in public health outcomes, including 
decreased Mpox transmission rates, improved infection control measures, reduction of morbidity 
and reduction mortality. 
 
With Mpox outbreaks affecting thousands of individuals in the DRC, successful completion of 
the MOVIE and TRACE studies could have a considerable impact on reducing transmission rates 
and enhancing outbreak response.  
 
Given the high mortality rates associated with Mpox outbreaks, any interventions that reduce 
transmission (i.e., isolation, quarantine, contact tracing, identification of high-risk populations) 
and improve clinical management (i.e., prioritization of people at risk of severe infection, time of 
isolation) have significant implications for reducing both mortality and morbidity rates. These 
two studies could contribute to saving lives and reducing the burden of Mpox-related morbidity 
in affected populations. 
 
The disproportionate impact of Mpox outbreaks on children in the DRC underscores the relevance 
and significance of the studies potential impact on reducing morbidity and saving Disability-
Adjusted Life Years (DALYs). Given that Mpox outbreaks have resulted in a significant number 

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of fatalities, particularly among children under the age of 15, addressing the disease burden is of 
paramount importance. 
 
Another dimension of impact involves enhancing clinical outcomes for Mpox patients, 
particularly children and pregnant women by identifying factors associated with faster viral 
clearance. 
 
The information generated to guide future research and clinical trials focused on assessing 
therapeutics (i.e., time to viral clearance) and vaccines (i.e., SAR) for Mpox is indeed significant. 
For therapeutics, the study's findings on viral clearance dynamics, factors associated with faster 
clearance, and immunity related to faster clearance can help establish meaningful endpoints for 
treatment RCT. For vaccines, data on secondary attack rates, host susceptibility, and immune 
responses can contribute to assessing vaccine efficacy. 
 
3.5 Research data management 
We will develop a comprehensive set of study-specific data management documents. These will 
guide the processes across sub studies. For each sub-study this will include a study specific data 
management plan describing how data/research inputs will be set up to ensure compliance with 
good data management in line with the FAIR principles. A shared database will be set up 
including the development of electronic case report forms (eCRF), as well as the programming 
of edit checks and customised study specific reports. The database will be validated before 
deployment for use. Clinical, demographic, and linked laboratory data will be maintained within 
these databases. Data management activities will include data review and validation; managing 
and reconciling data from third parties; data exports to third parties; providing data listings, tables 
and patients profiles for the purpose of data review; and preparation and review of data before the 
database lock. 
 
Below, we outline our approach to data management and the management of other research 
outputs, specifically tailored to the needs and objectives of our project: 
Types of Data/Research Outputs and Estimated Size: Our project involves collecting various 
types of data, including clinical, demographic, and laboratory data. These datasets will comprise 
observational data, along with images, textual documentation, and laboratory results. The 
estimated size of these datasets will be substantial, given the comprehensive nature of our study 
involving 75 Mpox cases and 200 contacts. Careful consideration will be given to data storage 
and management infrastructure to accommodate the anticipated volume of data generated 
throughout the project. 
Findability of Data/Research Outputs: To enhance the findability of our data and research 
outputs, each dataset will be assigned persistent and unique identifiers, such as digital object 
identifiers (DOIs). These identifiers will facilitate the unambiguous identification and citation of 
our data. We will deposit our data in trusted repositories, ensuring that they are easily discoverable 
by researchers and stakeholders. 
Accessibility of Data/Research Outputs: We are committed to promoting open access to our 
data and research outputs wherever possible, in line with our commitment to transparency and 
scientific integrity. However, we recognize the need to balance openness with the protection of 
intellectual property rights (IPR) and participant confidentiality. We will provide clear guidelines 
on access to restricted data for verification purposes, ensuring that appropriate safeguards are in 
place to protect sensitive information. 
Interoperability of Data/Research Outputs: Standardization of data formats, metadata, and 
vocabularies will ensure interoperability and facilitate data integration and reuse. We will adhere 
to established standards and formats for data and metadata, ensuring compatibility with existing 
databases and analytical tools. 

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Reusability of Data/Research Outputs: We will apply appropriate licenses for data sharing and 
reuse, such as Creative Commons licenses or Open Data Commons licenses, to promote the 
ethical and responsible reuse of our data. Additionally, we will make available tools, software, 
and models developed during the project to facilitate data generation, validation, interpretation, 
and reuse by other researchers. 
Curation and Storage/Preservation Costs: We will allocate resources for the curation, storage, 
and preservation of our data and research outputs throughout the project lifecycle. This includes 
provisions for data backup, long-term preservation, and access to secure storage facilities. A 
dedicated person/team will be responsible for data management and quality assurance, ensuring 
that data integrity and compliance with FAIR principles are maintained.  
 
Community sensitization activities will be carried out in the target study areas, with subject 
screening for eligibility in the study conducted according to the protocol. Laboratory equipment 
will be calibrated in accordance with manufacturer’s recommendations and will undergo regular 
QC procedures. All laboratory testing will be performed in facilities implementing a laboratory 
quality system and following GCLP guidelines. Procedures for data sharing will be set out clearly 
in the participant information sheet, with current and potential future associated risks explained 
to research participants as part of the consent process. 
 
3.6 Implementation of Open Science Practices 
Open science practices play a pivotal role in ensuring the accessibility, transparency, and impact 
of our findings, particularly for regions with limited resources and infrastructure. Below, we 
outline how these practices are tailored to our project's objectives and the needs of LMICs: 
Early and Open Sharing of Research: We will adopt a proactive approach to sharing our 
research findings, recognizing the importance of timely dissemination for informing public health 
interventions in LMICs. Preliminary findings will be shared through pre-print repositories, 
allowing for rapid access and feedback from the global scientific community. 
Research Output Management: Robust data management protocols will be implemented to 
ensure the organization and documentation of research outputs. This includes the deposition of 
datasets in accessible repositories, accompanied by comprehensive metadata records to facilitate 
discovery and reuse. 
Ensuring Reproducibility of Research Outputs: Methodological transparency and 
reproducibility are paramount in our Mpox research. Detailed documentation of experimental 
procedures and analysis techniques will be provided to enable replication and verification, 
enhancing the reliability of our findings. 
Open Access to Research Outputs: Recognizing the limited access to scientific literature in 
LMICs, we are committed to making our research outputs freely available to researchers, 
healthcare professionals, and policymakers in these regions. Publications will be published in 
Gold Open Access journals ensuring unrestricted access to vital information. 
Participation in Open Peer-Review: We will actively engage in open peer-review processes to 
enhance the rigor and transparency of our research. By soliciting feedback from a diverse range 
of stakeholders, including researchers from LMICs, we aim to strengthen the validity and 
applicability of our findings. 
Involving Relevant Knowledge Actors: Engagement with relevant stakeholders, including 
community members, healthcare providers, and policymakers in the DRC, is integral to the 
success of our project. Through participatory approaches, we seek to co-create research agendas 
and solutions that address the specific needs and priorities of Mpox-affected communities in 
LMICs. 
FAIR Data Principles and Data Sharing: Adherence to the FAIR principles ensures that our 

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data are Findable, Accessible, Interoperable, and Reusable. Metadata-rich datasets will be 
deposited in accessible repositories, with a commitment to long-term preservation. Each output 
will be assigned a DOI for citation in reports and publications, promoting transparency and 
attribution. 
Pre-print Servers and Gold Open Access Publication: Manuscripts will be submitted to pre-
print servers to accelerate the dissemination of findings, particularly relevant for LMICs where 
access to subscription journals may be limited. Pursuing Gold Open Access publication ensures 
that our research outputs are freely available to all, facilitating knowledge exchange and capacity-
building in Mpox research globally, including in LMICs like the DRC. 
 
 
4. PLANS FOR DISSEMINATION AND COMMUNICATION OF 
RESULTS 
4.1 Strategic Communication Approach  
To maximize the impact of the MOVIE and TRACE studies, we will implement a comprehensive 
dissemination and exploitation plan, including strategic communication activities. We will 
develop a comprehensive communication strategy that includes clear objectives, dissemination 
and advocacy activities, type of outputs that are appropriate to audience and context.  
 
Objectives and Activities: 
Corporate Project Identity: We will develop a unified corporate identity for the project to ensure 
consistent public perception and recognition. 
Key Communication Tools: These will include policy briefs for policymakers, project meetings, 
and dissemination workshops for partner organizations and the national Mpox response program. 
Academic and policy audiences will be targeted through peer-reviewed publications and 
conference presentations, while other materials will be tailored for non-expert audiences.  
 
Target groups: 
Scientific Community: We will disseminate our research findings through peer-reviewed 
publications in high-impact scientific journals, conference presentations, and participation in 
relevant scientific events and workshops. Additionally, we will share preprints of our manuscripts 
on open-access repositories to facilitate early access to our research. 
Healthcare workers: We will engage with end users through targeted dissemination activities, 
including workshops, seminars, and webinars. These activities will provide opportunities for 
direct interaction and knowledge exchange between project researchers and stakeholders, 
ensuring that our findings are relevant and actionable. 
Policy Makers: We will produce concise and informative policy briefs summarizing key research 
findings, implications, and recommendations for policy makers. These briefs will be designed to 
present complex scientific information in a clear and actionable format, facilitating evidence-
based decision-making. 
Public at Large: We will employ various communication channels to reach the broader public, 
including press releases, social media campaigns, and multimedia content. These efforts will aim 
to raise awareness about the project, its objectives, and its potential benefits for society, 
emphasizing the importance of our research in addressing pressing health challenges. 
International Agencies: We will ensure results of the project are shared in real-time with the 
national Mpox response and with other key stakeholders such as the WHO and Africa CDC. 
Subasequrntly we will ensure data are presented at key academics such as the American Society 
of Tropical Medicine & Hygiene Meetings. 
 
Dissemination Models: 

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Innovative models: We will utilize webinars, video diaries, and multimedia outputs to engage 
diverse audiences.  
General Media: We will also engage with the broader community through social media including 
both institutional and investigator Twitter accounts and other social media platforms. By 
leveraging the power of social media, we will amplify the reach of our project, foster dialogue, 
and facilitate knowledge sharing among stakeholders. 
 
4.2 Exploitation measures for real-time data sharing 
Open access is vital to research uptake by decision makers and deepening international academic 
discourse, we will adopt an open access approach to data, research findings and training outputs. 
In line with EU’s Plan S, we will pursue Gold Open Access. All studies will be published in open 
access format to ensure maximal accessibility. All datasets will be made available, in anonymised 
form, via open-access repositories to facilitate secondary-analyses of data.  
 
4.3 Stakeholder and policy engagement 
Throughout the study, we will continue to meet with key stakeholders and also invite them to visit 
the study sites to see firsthand the study and the implementation of the interventions. As research 
is completed, a series of dissemination workshops will be held with local and national 
stakeholders. We will utilise a combination of strategies to engage with policy makers including: 
i) Policy briefs; ii) Breakfast meetings where findings and implications can be presented and 
discussed directly with key policy makers and programme staff; and iii) Stakeholder workshops 
at local level for government and health service officials and community members.  
 
Based on our experience in research and policy engagement in research and implementation we 
have identified several factors which increase the probability of translating research into policy 
and implementation, including: i) research of relevance to local needs in an area of public health 
importance; ii) delivery of visible health impact; iii) acceptable to local communities and health 
systems; iv) cost-effective and deliverable at scale; v) informed by and aligned with government 
policies and health systems. We believe our proposal meets these criteria. We have engaged with 
members of the Mpox response whilst developing this proposal to to ensure conceptual ‘buy-in’. 
Continuing engagement throughout will maximise the impact of our research.  
 
4.4 Feedback to Policy Measures 
We anticipate that the project's findings will contribute to designing, monitoring, reviewing, and 
rectifying existing policy and programmatic measures. By engaging with policymakers and 
providing evidence-based recommendations, we aim to support the implementation of new policy 
initiatives and decisions. The feedback from these studies will be crucial in refining the Mpox 
response framework, particularly in high-risk populations such as children and 
immunocompromised individuals. 
 
4.5 Intellectual property 
While the project is not expected to generate intellectual property requiring protection, our 
strategy will focus on ensuring open access to all data and findings. This approach is designed to 
maximize the dissemination and impact of the research outcomes, facilitating their uptake and 
application by various stakeholders. 
 
 

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5. SUMMARY  
KEY ELEMENT OF THE IMPACT SECTION 
SPECIFIC NEEDS 
 
EXPECTED RESULTS 
What are the specific needs that triggered this project? 
This project was triggered by needs of clade-I Mpox-
affected communities in LMICs.  
Firstly, there is an urgent need for comprehensive data 
on the pathogenicity of the Monkeypox virus (MPXV) 
to inform the appropriate duration of isolation and 
specific clinical management practices. Without this 
information, healthcare providers face challenges in 
implementing effective interventions.  
Secondly, 
there exists 
a 
significant 
gap 
in 
understanding the secondary attack rate (SAR) of 
MPXV, which is crucial for guiding disease control 
activities such as contact tracing, quarantine 
implementations, and targeted interventions for 
vulnerable populations (higher SAR). Accurate SAR 
data are also essential for evaluating the efficacy and 
effectiveness of vaccines, which is vital for the 
successful implementation of vaccination campaigns. 
 
What do you expect to generate by the end of the 
project? The project is expected to yield critical 
insights into the pathogenicity of the MPXV and its 
SAR in Mpox-affected communities within the DRC. 
These findings will inform the optimal duration of 
isolation and specific clinical management practices, 
enhancing patient care and public health responses. 
Additionally, the data on SAR will provide valuable 
guidance for disease control activities, such as contact 
tracing and targeted interventions to vulnerable 
populations and will be instrumental in assessing 
vaccine efficacy and effectiveness. Ultimately, the 
results will support the development of evidence-
based targeted interventions, improving health 
outcomes and resilience within these communities. 
 
 
 
 
 
D & E & C MEASURES 
 
TARGET GROUPS 
What dissemination, exploitation and communication 
measures will you apply to the results? The project 
aims to ensure that its findings reach and benefit 
diverse audiences, facilitating knowledge exchange 
and encouraging informed decision-making in the 
field of infectious disease management. We will 
develop a comprehensive strategy to maximize de 
impact of the project. 
Objectives and Activities: Corporate Project Identity 
to ensure consistent public perception and recognition 
and key Communication Tools including policy briefs, 
project meetings, dissemination workshops, peer-
reviewed publications, conference presentations, and 
engagement through social media channels.  
Dissemination Models: Innovative Models such as 
webinars, video diaries, and multimedia outputs to 
engage diverse audiences: dedicated Programme 
Website as the primary hub for communication and 
dissemination activities; dissemination on general 
Media by using institution and investigator social 
media profiles to engage with the broader community, 
amplifying the reach of the project and facilitating 
dialogue and knowledge sharing among stakeholders. 
 
Who will use or further up-take the results of the 
project? Who will benefit from the results of the 
project?  
Scientific Community: Publish in high-impact 
journals, present at conferences, and share preprints on 
open-access repositories. Beneficiaries: Researchers 
and scientists. 
Healthcare Workers: Conduct workshops, seminars, 
and webinars for direct interaction and knowledge 
exchange. Beneficiaries: Medical professionals and 
frontline healthcare workers. 
Policy Makers: Create concise policy briefs to support 
evidence-based 
decision-making. 
Beneficiaries: 
Government and health policy makers. 
Public at Large: Use press releases, social media, and 
multimedia to raise awareness and highlight the 
project's importance. Beneficiaries: General public 
and affected communities. 
International Agencies: Share results with national 
Mpox response teams, WHO, Africa CDC, and present 
at key academic events. Beneficiaries: Global health 
organizations and international health agencies. 

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OUTCOMES 
 
IMPACTS 
What change do you expect to see after successful 
dissemination and exploitation of project results to 
the target group(s)? We anticipate the following 
changes to each targeted group: 
Scientific Community:  Better understanding of 
MPXV pathogenicity and its SAR, leading to more 
informed and effective research in viral dynamics and 
epidemiology. 
Healthcare Workers: More informed isolation duration 
and improved clinical management strategies for 
Mpox. 
Policy Makers: Adoption of evidence-based policies 
and guidelines for Mpox surveillance, isolation 
protocols, and vaccination strategies.  
Public at Large: More informed communities that are 
better 
prepared 
to 
adhere 
to 
public 
health 
recommendations. This can result in reduced 
transmission and better community health outcomes. 
International Agencies: Strengthened global response 
to Mpox outbreaks, with coordinated efforts and 
strategies informed by robust data. Agencies like 
WHO and Africa CDC will have access to timely and 
relevant information to support international health 
initiatives and interventions. 
 
What are the expected wider scientific, economic and 
societal effects of the project contributing to the 
expected impacts outlined in the respective destination 
in the work programme? 
Scientific Impact: We will determine crucial aspects of 
clade-I MPXV, including viral clearance and duration 
of infectiousness in various body compartments, 
factors influencing faster clearance and immunity 
related to rapid clearance, the Secondary Attack Rate, 
host susceptibility, exposure risk factors and settings 
of risk (household or school transmission), and host 
immune responses. We will address methodological 
limitations in previous studies and provide more 
accurate estimates.  
Economic Impact: Help healthcare systems make 
informed decisions regarding resource allocation, 
intervention strategies and public health messaging, 
and plan accordingly.  
Societal Impact: Improved public health outcomes and 
increased community resilience.  
The project will empower communities with accurate 
public health messaging, increasing awareness and 
fostering community engagement and understanding 
of infectious diseases.  Results can lead to targeted 
interventions to reduce morbidity and mortality rates. 
 
 
6. QUALITY AND EFFICIENCY OF THE IMPLEMENTATION 
6.1 Work plan and resources 
Work will be delivered over a 24-month time frame and is divided into 6 inter-linked work 
packages (Fig. 5). The relationship between these work—packages is shown below. Detailed 
descriptions of the specific tasks, deliverables, milestones and risks are outlined below. 
 
WPs 1-4: Project Organisation. These three interlinked work packages provide the framework 
to support the overall delivery of our linked scientific work packages. They cover contractual and 
budgetary oversight, scientific leadership, and development of a dissemination plan. 

PROTOCOL MOVIE-TRACE EQUATEUR 
 
Page 25 of 37 
 
WP1 Coordination (Lead: FLS): 
Project 
coordination 
will 
be 
overseen by Professor Oriol Mitjà 
(FLS, SPAIN). This WP will 
oversee contractual and budgetary 
elements of the project and ensure 
the overall scientific work is 
delivered on time and budget. Along 
with the Scientific Lead (WP2), the 
Project Coordinator will direct the 
Project Steering Group. The Co-
ordinator will appoint a dedicated 
project administrator who facilitate 
contractual and financial elements 
of the project. 
 
WP2 Scientific Leadership (Lead: FLS/UNIKIN) Professor Hypolite Muhindo will provide 
scientific leadership across the consortium. This role will oversee overall coordination of 
scientific work packages and integration of capacity building across members of the overall 
consortium. Alongside the Project Coordinator (WP1), the Scientific Lead will direct the Project 
Steering Group.  
Project governance and steering will be performed synergically in both WP-1 and WP-2: The 
Project Steering Group lead by Professor Oriol Mità (WP1) and Professor Hypolite Muhindo 
(WP2) and members of all two consortium members (FLS, UNIKIN), including representatives 
of each work package with administrative support from each of the consortium members. This 
group will guarantee a rapid and effective decision making and efficient sharing of information 
across all relevant aspects of the project. Due to the emergency nature of the Mpox response this 
group will meet once a month and more frequently as required.  
WP3 Project Dissemination (Lead: FLS/LSHTM): This WP will oversee both internal 
communications within the consortium as well as the development and delivery of an external 
communication strategy and engagement with key stakeholders.  This will include knowledge 
dissemination strategies, ensuring data will be presented at international conferences and WHO 
meetings, through pre-prints and open access publications in line with the FAIR principles. 
WP-4 Capacity Building (Lead: FLS/LSHTM): We have sought input into our project proposal 
from co-applicants and through engagement with stakeholders involved in the Mpox response in 
DRC. Although the focus of the project is to support the emergency response to Mpox we aim to 
use this opportunity to still build critical research and epidemic response skills across the 
consortium. We will aim to build capacity within collaborating institutions through workshops 
led by the research team across a range of areas including study design, data collection, and the 
analysis of quantitative data. Where appropriate, we will provide funds for team members to 
attend training courses. 
Work Packages 5-6: Scientific Work Packages (Lead: UNIKIN): We will deliver two inter-
linked scientific studies to address critical questions about transmission of Mpox in the 
Democratic Republic of Congo. Central to this approach will be the identification of index cases 
who will be recruited into a longitudinal study of viral shedding and period of infectiousness, and 
their contacts who will be recruited into an observational study focused on the secondary attack 
both studies are provided in Section 2 (above) with specific tasks and deliverables outlined below 
(Section 3).  
 
Project Timeline. We have allowed 24 months for the overall project. Broadly this includes 8 
months for study setup, 8 months for recruitment and 8 months for finalizing laboratory work and 

PROTOCOL MOVIE-TRACE EQUATEUR 
 
Page 26 of 37 
 
analysis (Fig. 6). Given the emergency nature of the call, we anticipate sharing interim results in 
real-time with the Ministry of Health MPOX response team and other key stakeholders such as 
WHO and Africa CDC. 

PROTOCOL MOVIE-TRACE EQUATEUR 
 
Page 27 of 37 
 
 
Project Month 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 19 
20 
21 
22 
23 24 
Workpackage 
Outcome 
Success 
Measure 
Activity 
 
 
 
 
 
 
WP1 
Project 
Co-
Ordination 
Project 
delivered 
on time 
and 
budget 
Contracts 
signed, 
Financial and 
Technical 
Reporting 
Completed 
Contract Signed 
 
 
 
 
 
 
 
 
 
 
Staff Appointed 
 
 
 
 
 
 
Project 
Steering 
Group Meetings 
 
 
 
 
 
 
WP2 
Scientific 
Leadership 
Scientific 
Studies 
Complete
d 
Ethical 
approval 
obtained, 
scientific 
studies 
completed and 
results 
translated into 
policy 
Project 
Steering 
Group Meetings 
 
 
 
 
 
 
Protocol 
Finalisation 
 
 
 
 
 
 
Ethics Approval 
 
 
 
 
 
 
Study Training 
 
 
 
 
 
 
Study Monitoring 
 
 
 
 
 
 
WP3 
Dissemination, 
Policy Impact 
and 
Community 
Engagement 
Uptake of 
Results 
into 
Policy 
Change in 
National & 
Regional 
Policy  
Development of a 
project 
dissemination plan 
 
 
 
 
 
 
Project Website 
 
 
 
 
 
 
Data Sharing with 
MOH 
mpox 
response team 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Deposit 
 
 
 
 
 
 
Scientific 
Publications 
 
 
 
 
 
 
WP4 Capacity 
Building 
Staff 
Trained in 
Research 
Staff trained in 
GCP, 
GCLP 
and 
Researc 
Staff Training & 
Mentorship 
 
 
 
 
 
 

PROTOCOL MOVIE-TRACE EQUATEUR 
 
Page 28 of 37 
 
and 
Laborator
y Methods 
Methodologies.  
Enhanced 
laboratory 
capacity 
for 
mpox research 
 
 
 
 
 
 
 
 
WP5 and WP6 
Study 
 
Data 
on 
the 
viral 
load 
of 
MPOX 
Clade 1 in 
different 
body 
tissues. 
50 patients and 
enrolled 
to 
analyze 
viral 
load in different 
biological 
compartments. 
Staff training 
 
 
 
 
 
 
Participant 
recruitment 
and 
Follow-Up 
 
 
 
 
 
 
Laboratory Work 
 
 
 
 
 
 
Analysis 
 
 
 
 
 
 
Data 
on 
secondary 
attack rate 
of MPOX 
virus and 
determina
nts 
of 
transmissi
on 
500 
contacts 
enrolled 
and 
completed 
follow-up with 
calculation 
of 
symptomatic 
and 
asymptomatic 
secondary 
attack rate 
Staff training 
 
 
 
 
 
 
Participant 
recruitment 
and 
Follow-Up 
 
 
 
 
 
 
Laboratory Work 
 
 
 
 
 
 
Analysis 
 
 
 
 
 
 

PROTOCOL MOVIE-TRACE EQUATEUR 
 
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6.2 Capacity of participants  
6.2.1 Consortium Composition and Objectives Alignment 
Our consortium brings together three leading institutions: the Fight Infections Foundation (FLS, 
Spain), the London School of Hygiene & Tropical Medicine (LSHTM, UK) and University of 
Kinshasa (UNIKIN, DRC). We have assembled an inter-disciplinary network of investigators 
with leading expertise and skills in their relative fields and who have access to the infrastructure 
and skills required to deliver each of our work packages and c conduct this research project.  
This consortium is designed to match the project’s objectives by integrating diverse disciplinary 
and interdisciplinary knowledge essential for addressing global public health challenges. FLS 
brings its strengths in clinical research in infectious diseases and specially its expertise in 
dermatology and venereology having conducted extensive research on infections of the skins and 
sexually transmitted infections. LSHTM contributes its extensive expertise in global health and 
epidemiology ensuring a holistic approach to research challenges related to the current proposal. 
UNIKIN offers significant capabilities in community-based epidemiological research and 
laboratory research. The consortium emphasizes open science practices, community-engaged 
research, and incorporates gender aspects in research and innovation (R&I). This alignment 
ensures that the research is scientifically robust, culturally relevant, and actionable, involving 
affiliated entities and associated partners for comprehensive coverage. 
 
6.2.2 Individual Contributions and Roles: 
1- Professor Hypolite Muhindo Mavoko (UNIKIN), a physician specialized in tropical 
medicine and full professor at UNIKIN. Since 2013, he has directed numerous clinical trials 
and observational studies on malaria, Ebola, Covid-19, and Mpox—particularly in resource-
constrained settings and among vulnerable populations. He has published extensively on 
diagnostics, vaccine acceptance, and public health ethics. Professor Muhindo currently leads 
multiple Mpox research projects, focusing on transmission and vaccination, and actively 
collaborates with international consortia to build local capacity and reinforce global health 
preparedness. 
2- Professor Oriol Mitjà (FLS), is an infectious diseases physician and clinical researcher with 
significant contributions to science on Neglected Tropical Diseases (NTDs) of the skin 
including yaws, Haemophilus ducreyi, and syphilis.  His team was the first to describe the 
clinical and virological characteristics of Mpox (The Lancet 2022, Lancet Infectious Diseases 
2023); provided a detailed description of the disease presentation in women (The Lancet 
2023) and identified an association with a fulminant form of Mpox in individuals with 
advanced HIV (The Lancet 2023). 
3- Dr Sara Buezo (FLS), has extensive experience in field research and training in Central 
Africa in the field of epidemiology of infectious disease transmission. 
4- Dr Camila González-Beiras (FLS), has extensive experience in conducting field research, 
training, and capacity building in Papua New Guinea and Western Africa in the field of skin 
NTDs, including the implementation of large-scale community-based randomized clinical 
trials on yaws (NEJM 2022), development of point-of-care tools for tropical ulcer conditions 
(i.e., LAMP test). 
5- Professor Placide Mbala Kingebeni (IRNB), is an Associate Professor at the University of 
Kinshasa, School of Medicine; he is the Head of the Epidemiology and Global Health 
Division and Director of the Clinical Research Center at the National Institute of Biomedical 
Research (INRB in French) in the Democratic Republic of the Congo (DRC). Dr. Mbala has 
extensive experience in medical biology, with specific training and expertise in microbiology, 
virology, and outbreak investigations. His research focuses on viral zoonoses with risk factors 

PROTOCOL MOVIE-TRACE EQUATEUR 
 
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for human contamination. As PI and co-investigator for several university and US-funded 
grants, Dr. Mbala laid the groundwork for his research projects in very remote areas of the 
DRC where most outbreaks occur. 
6- Professor Michael Marks (LSHTM), is an Infectious Diseases clinician and epidemiologist 
with extensive expertise in managing large multinational projects in Africa and the Pacific. 
He is widely recognized as a world-class scientist in the field of Sexually Transmitted 
Infections (STIs) and Neglected Tropical Diseases (NTDs), and he serves as an advisor to 
international institutions and donors in these areas.  
 
 
6.3 Work package description 
Work package number  
1 
Work package title 
Project Co-ordination and Management 
Time span 
Month 1 to Month 24 
WP leader 
FLS 
Participants 
ALL 
 
Objectives  
The objective of the Project Co-ordination work package is to ensure effective and appropriate 
overall leadership of the project to facilitate achievement of the project goals.  
Specific objectives are: 
1. Implement an organizational structure that will co-ordinate and guide the activities of the 
project. 
2. Coordinate and obtain all ethical and regulatory approvals required from local research ethics 
committees (RECs). 
3. Establish agreements between the sponsor (FLS) and the study sites, including material and 
data transfer agreements 
Description of work  
Task 1.1: Project management and coordination, including the establishment of a Project 
Steering Group (Months 1 to Month 24).  
The Co-ordinator (PI), Professor Oriol Mitjà (FLS) will work with the Scientific Leadership team 
(WP2) and have overall oversight of project activities. The PI will work with the work-package 
leads to co-ordinate all field and laboratory work and data analysis. Work at each partner sites 
will be overseen by the relevant PI. The project administrator will assist the project co-ordinator 
with all administrative tasks including creation and management of project records, organization 
and minutes for meetings and preparation of reports. 
The PI, the work package leaders and the members of the Scientific Steering Committee will 
constitute the Project Steering Group (PSG). Thus, there will be a bi-directional transfer of 
information between the PSG and the researchers at each consortium partner. Given the 
imperative for rapid progress, the PSG will meet weekly initially for evaluation of progress, 
resolution of problems, negotiating hurdles etc. As the project becomes more established this may 
move to fortnightly or monthly as required. 
The PI and a designated financial administrator at HUGTiP will monitor financial management 
of the project and regular transfer of funds to the partners. This will be tied into achieving project 

PROTOCOL MOVIE-TRACE EQUATEUR 
 
Page 31 of 37 
 
milestones and achievement of key deliverables.  
Task 1.2: Regulatory issues coordination and clinical research operational design (Month 1 
to Month 8) 
The PI, in coordination with the Scientific Leadership team will oversight regulatory issues, 
including the submission of ethics applications at HUGTiP and in DRC, as well as, to register the 
study on an appropriate study database. 
Again, in coordination with the Scientific Leadership, the senior researchers of this study will 
collaborate to define the overall design of operational clinical procedures on the field seamless 
adapted to the local surveillance activities ongoing in the outbreak areas. 
Task 1.3 Data management (Month 1 to Month 24) 
We will develop a comprehensive data management plan (DMP) outlining how data will be 
transferred between partners, outlining the access rights of consortium partners, and defining the 
procedures to follow to guarantee Open Data Access without trespassing the GRDP Data transfer 
agreements will be put in place as appropriate. 
Task 1.4: Material and Data Transfer Agreements (Month 4 to Month 8) 
The Principal Investigator will coordinate material and data transfer agreements to cover the 
movement of samples and data between countries and collaborating partners. These agreements 
will include obtaining, where needed, appropriate national approvals as well as policies on safe 
transfer and storage of study data. 
 
 
Work package number  
2 
Work package title 
Scientific Leadership  
Time span 
Month 1 to Month 24 
WP leader 
FLS/UNIKIN 
Participants 
ALL 
 
Objectives  
The objective of the Scientific Leadership work package is to ensure effective and appropriate 
overall scientific oversight of the project and ensure scientific goals are achieved.  
Specific objectives are: 
1. Co-ordinate protocol development 
2. With project Co-ordinator (WP1) coordinate and obtain all ethical and regulatory approvals 
required from local research ethics committees (RECs). 
3. Oversee work conducted in WP3 & 4 for delivery of the scientific outputs of the study 
 
Description of work  
Task 2.1: Scientific steering and coordination of the project (Month 1 to Month 24) 
The Scientific Leadership team (WP) will work with the Co-ordinator (WP1 - Professor Oriol 
Mitjà) and have overall oversight of project activities. They will work with the work-package 
leads to co-ordinate all field and laboratory work and data analysis. Work at each partner sites 
will be overseen by the relevant PI.  

PROTOCOL MOVIE-TRACE EQUATEUR 
 
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The Scientific Leadership team and Co-ordinator in collaboration with the work package leads 
will constitute a Project Steering Group (PSG). Thus, there will be a bi-directional transfer of 
information between the PSG and the researchers at each consortium partner. Given the 
imperative for rapid progress, the PSG will meet weekly initially for evaluation of progress, 
resolution of problems, negotiating hurdles etc. As the project becomes more established this may 
move to fortnightly or monthly as required. 
Task 2.2: Clinical protocols, ethical clearances, and scientific procedures (Month 1 to Month 
8) 
The Scientific Leadership Team, in coordination with the Coordinator will be responsible for 
drafting of clinical trial protocols, the submission of ethics applications and the granting of ethical 
clearances as well as to draft the standard operational procedures that will rule the homogeneous 
implementation of the scientific activities of the project  
Task 2.3 Scientific Oversight (Month 1 to Month 24) 
The Scientific Leadership team will be responsible for overseeing implementation of WPs 3&4. 
This will include i) training of study teams in relevant processes such as consent, participant 
recruitment in compliance with Good Clinical Practices (GCP), ii) oversight and conduct of 
laboratory testing including ensuring compliance with GCLP and maintenance of laboratory 
record, iii) liaison with field sites, the Ministry of Health and other partners and iv) overseeing 
integrated analysis of study findings. 
 
Work package number  
3 
Work package title 
Dissemination 
Time span 
Month 1 to Month 18 
WP leader 
FLS/LSHTM 
Participants 
ALL 
 
Objectives  
The objective of the Dissemination work package is to ensure results arising from the project are 
disseminated rapidly to all relevant stakeholders (patients, communities, Ministries of Health) 
through a variety of mechanisms and that data underpinning these findings are made available to 
the research and public health community in keeping with FAIR principles. 1) Develop a 
comprehensive plan for dissemination and exploitation of the project results; 2) Develop a 
comprehensive plan for sharing of study data and code; 3) Implement the data management and 
publications plans to ensure timely analysis and reporting of results. 
Description of work  
Task 3.1 Development of a project dissemination and exploitation plan (Month 1 to Month 
2) 
We will develop a comprehensive plan for the dissemination and exploitation of both data and 
results emerging from the project. This plan will include a clear timeline for each dissemination 
strategy (local and international meetings, publications) and guidance to ensure that all 
dissemination is in line with Plan-S policies on Open-Access and FAIR guidance on availability 
of data. The dissemination plan will include clear guidance on recognition of all collaborators to 
ensure that fair benefit sharing between partners occurs and that study output authorship is 
representative of the role of all partners in the project. 
Task 3.2 Stakeholders meetings (Month 3 to Month 24) 
We will hold regular meetings throughout the project where we will bring together academic, 

PROTOCOL MOVIE-TRACE EQUATEUR 
 
Page 33 of 37 
 
community and ministry of health stakeholders. They will facilitate rapid and regular 
dissemination of results and ongoing engagement with key stakeholders to ensure study results 
are utilized to inform national, regional and international guidance on the control Mpox 
Stakeholders and when leading to changes in the project implementation as decided by the Project 
Steering Group. 
Task 3.3: Academic Publications and presentation at academic conferences (Month 13 to 
Month 24) 
Outputs from the study will be submitted to high-impact open access medical journals to ensure 
maximum reach within the academic community. 
Task 3.4: Data Deposit in an Open Access Repository (Month 16 to Month 18) 
We will deposit relevant study data into open access repositories in real-time and in accordance 
with FAIR principles to ensure that data generated in the study is available to the wider research 
community to maximise impact of the work. 
 
Work package number  
4 
Work package title 
Capacity Building 
Time span 
Month 2 to Month 18 
WP leader 
FLS/LSHTM 
Participants 
ALL 
 
Objectives  
The main objective of this work package is to build capacity in research institutions in DRC to 
respond to future Mpox outbreaks. This will include strengthening laboratory molecular capacity 
and training in the delivery of epidemic response studies.  
 
Description of work  
Task 4.1: Laboratory strengthening (Month 2 to Month 18) 
Training will include hands-on in the molecular amplification assays. In addition, the laboratory 
teams will be trained in GCLP guidelines (WHO, 2009, ISBN 978 92 4 159785 2). The GCLP 
guidelines are recommended by the WHO’s special programme for research and training in 
tropical diseases diagnostic evaluation expert panel as the standard for clinical laboratories 
involved in the evaluation of diagnostics for infectious diseases. The training session will include 
exercises on the application of GCLP in this study and laboratory standard of procedures (SOPs) 
including SOPs for sampling handling and testing, study relevant documents such as a study 
analytical plan, and forms to document traceability, transparency and validity of results will be 
developed. The trained laboratory staff will be assessed at the end of the training to document 
their competency in performing the assays and training certificates will be provided. 
Task 4.2: Research Team Training (Month 4 to Month 12) 
The training will cover research methodologies, GCP, GCLP, the study protocol and procedures.  
This will include approaches to community entry, consent, GCP, sample collection and study 
documentation. Study staff attending the training sessions will receive training certificates. 
Following central training site visits will be performed to ensure study procedures are being 
followed appropriately. 
 

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Work package number  
5 
Work package title 
MOVIE Study 
Time span 
Month 4 to Month 24 
WP leader 
UNIKIN 
Participants 
ALL 
 
Objectives  
The main objective of this work package is to deliver a longitudinal cohort study to understand 
the viral load of different body fluids amongst patients with Clade I- MPXV in the context of the 
current outbreak in the Democratic Republic of Congo.  
 
Description of work  
Task 5.1 Protocol Finalization (Month 4 to Month 6) 
A comprehensive protocol including all components of the study including recruitment 
methodology, case record forms, sample tracking documentation and standard operating 
procedures will be developed. This protocol will form the basis of an ethics submission in both 
DRC and the EU. 
Task 5.2 Study Training (Month 7 to Month 8) 
Staff will receive study specific training sessions covering GCP, the study protocol and 
procedures.  This will include approaches to community entry, consent, GCP, ethics, sample 
collection and study documentation. Study staff attending the training sessions will receive 
training certificates.  
Task 5.3 Participant Recruitment (Month 8 to Month 18) 
UNIKIN will identify ~50 patients with PCR-confirmed Mpox. Patients and contacts will undergo 
serial study visits with specimen collection as outlined elsewhere. 
Task 5.4 Laboratory Work (Month 9 to Month 24) 
Samples will be stored in the field and transported to Barcelona when the collection of all samples 
is complete. Quantitative real-time PCR will be performed to measure MPXV viral load in 
different body tissues. MPXV positive samples will be typed and sequenced for phylogenetic 
studies. Samples will be stored to allow additional experiments. 
Task 5.5 Analysis (Month 20 to Month 24) 
Integrated analysis combining clinical meta-data and laboratory analysis. This will result in a 
detailed report for the Ministry of Health and partners which will provide critical data to define 
the duration of infectivity of different body tissues and help guide contact tracing and infection 
control practices.  
 
 
Work package number  
6 
Work package title 
TRACE Study 
Time span 
Month 4 to Month 24 
WP leader 
UNIKIN 
Participants 
ALL 

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Page 35 of 37 
 
 
Objectives  
The main objective of this work package is to deliver a contact tracing study to understand i) the 
secondary attack rate of MPXV ii) the proportion of secondary infections that are symptomatic 
and asymptomatic and iii) determinants of onward transmission from index cases to their contacts 
of Clade I. MPXV in the context of the current outbreak in the Democratic Republic of Congo. 
 
Description of work  
Task 6.1 Protocol Finalization (Month 4 to Month 6) 
A comprehensive protocol including all components of the study including recruitment 
methodology, case record forms, sample tracking documentation and standard operating 
procedures will be developed. This protocol will form the basis of an ethics submission in both 
DRC and the EU. 
Task 6.2 Study Training (Month 7 to Month 8) 
Staff will receive study specific training sessions covering GCP, the study protocol and 
procedures.  This will include approaches to community entry, consent, GCP, sample collection 
and study documentation. Study staff attending the training sessions will receive training 
certificates.  
Task 6.3 Participant Recruitment (Month 8 to Month 18) 
Using patients identified in WP5 we will generate a line list of contacts for PCR confirmed Mpox 
patients. We anticipate recruiting ~10 close contacts per patient. Each patient will receive a 
baseline visit and sample collection followed by two weeks of surveillance and repeat sample 
collection. If any patients develop Mpox they will be offered recruitment into the case study 
(WP5) and the contact tracing process repeated.  
Task 6.4 Laboratory Work (Month 9 to Month 24) 
Samples will be stored in the field and transported to Barcelona when the collection of all samples 
is complete. Quantitative real-time PCR will be performed to measure MPXV viral load in 
different body tissues. MPXV positive samples will be typed and sequenced for phylogenetic 
studies. Samples will be stored to allow additional experiments including serological assessment 
for both vaccinia and MPXV antibodies.  
Task 6.5 Analysis (Month 20 to Month 24) 
Integrated analysis combining clinical meta-data and laboratory analysis. This will result in a 
detailed report for the Ministry of Health and partners which will provide critical data to define 
the secondary attack rate of Clade I-MPXV, the proportion of secondary infection that are 
symptomatic and asymptomatic and the determinants of transmission. 
  
 
7. BIBLIOGRAPHY 
1. 
https://www.cdc.gov/poxvirus/mpox/outbreak/2023-drc.html [Internet]. 2024. 2023 
Outbreak in Democratic Republic of the Congo.  
2. 
Jezek Z, Szczeniowski M, Paluku KM, Mutombo M. Human Monkeypox: Clinical 
Features of 282 Patients. Journal of Infectious Diseases. 1987 Aug;156(2):293– 
3. 
Mitjà O, Ogoina D, Titanji BK, Galvan C, Muyembe JJ, Marks M, et al. Monkeypox. Vol. 
401, The Lancet. Elsevier B.V.; 2023. p. 60–74.  

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4. 
Ogoina D, Iroezindu M, James HI, Oladokun R, Yinka-Ogunleye A, Wakama P, et al. 
Clinical Course and Outcome of Human Monkeypox in Nigeria. Clinical Infectious Diseases. 
2020 Oct 15;71(8):E210–4.  
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