Clinical trial NCT05409261: Evaluation of the Immunogenicity and Safety of Ad26.COV2.S's COVID-19 Vaccine
Official title: Phase II Trial Evaluating the Immunogenicity and Safety of Ad26.COV2.S Vaccine in Adult Participants in Mali
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: COVID-19
Vaccine Reaction
SARS CoV 2 Infection
Vaccine Adverse Reaction
Keywords: Ad26.COV2.S
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: CEPI
name: Innovative clinical research network in vaccinology (IREIVAC)
name: Institut National de la Santé Et de la Recherche Médicale, France
name: APHP
name: Center for Vaccine Development - Mali
First posted: 2022-06-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Phase II, non-randomized, open-label, comparative, national, multicenter trial in Mali, aimed to assess the humoral vaccine immune response induced by Ad26.COV2.S vaccine in 200 adults one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.

Detailed description: The main objective of this phase II trial is to evaluate the humoral immune response induced by the Ad26.COV2.S vaccine in adults one month after complete vaccination regimen against SARS-CoV-2, compared younger (up to 45 years old) and elderly (55+ years old) populations.

200 participants will be included, 200 participants for each vacine. The age categories are 18 - 45 years, 55 - 64 years and 65+ years. The number of participants per age group will be distributed as follows 1:1:0,5. There will be no comparison between population on different vaccines.

Ad26.COV2 vaccine (200 participants) 18-45 years old, 80 participants 55-64 years old, 80 participants 65 years old or older, 40 participants

Participants in Ad26.COV2 arm receive intramuscularly as a single dose of 0.5mL.

Humoral vaccine immune responses, induced by Ad26.COV2.S vaccine, will be measured by ELISA at D0, M1, M2, M6, M12 and M24.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 45 years old or 55 years and older
* Be eligible to receive one of the study vaccines as part of the trial
* Understand and agree to comply with study procedures (visits, telephone calls)
* Agree not to participate in any other vaccine study during the time of the study
* Give written informed consent prior to any examination performed as part of the trial

Exclusion Criteria:

* Positive SARS-CoV-2 antigenic test
* Positive SARS-CoV-2 polymerase chain reaction (PCR) results less than 48 hours old
* History of infection by SARS-CoV-2 confirmed by antigenic test or PCR within 3 months prior to inclusion
* Symptoms compatible with infection to SARS-CoV-2: sick or febrile participants (body temperature ≥ 38.0°C)
* Pregnant or breastfeeding woman
* Known chronic disease impacting the participant's immune response (uncured cancer, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection)
* Anti-coagulant treatment
* Immunosuppressive treatment
* Contraindication to the proposed vaccine (according to RCP)
* Previously received at least one injection of a SARS-CoV-2 vaccine
* Patient having received immunoglobulin or another blood product within 3 months prior to inclusion
* A history of serious adverse vaccine reactions (anaphylaxis and associated symptoms such as rash, breathing difficulties, laryngeal edema, or a history of allergic reaction that may be exacerbated by a component of the SARS-CoV-2 vaccine)
* Any condition that, in the opinion of the investigator, may adversely affect the well-being of the participant and interfere with the purpose of the study

Primary outcomes:
measure: Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level
timeFrame: One month after complete vaccination schema
Secondary outcomes:
measure: Anti-SARS-CoV-2 Spike IgG level
timeFrame: At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion
measure: Anti-SARS-CoV-2 immunoglobulin M (IgM) level
timeFrame: At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion
measure: Neutralizing antibody level for SARS-CoV-2
timeFrame: Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion
measure: Fluorospot tests (type 1,2, and 17 helper T cell (TH1, TH2, TH17), Cytotoxicity)
timeFrame: Inclusion (Day 0) and then 2 and 6 months after inclusion
measure: Mucosal SARS-CoV-2 specific antibody levels
timeFrame: Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion
measure: Determination of Epitope profile
timeFrame: Day 0 and Month 2
measure: B cell response to vaccine
timeFrame: Day 0, Month 2, Month 6
measure: Measurement of ultrasensitive immunoglobulin A (IgA) and mucosal IgA and IgM functionality
timeFrame: Day 0 and then 1, 2, 6, 12, and 24 months after inclusion
measure: Rate of adverse events
timeFrame: Between month 1 and month 24 after inclusion
measure: SARS-CoV-2 infection
timeFrame: Date of inclusion until 24 months
Other outcomes:
measure: Measurement of specific B memory cells and T cell response
timeFrame: B memory cells: Day 0 and then 2,6, and 12 months after inclusion., T cell : Inclusion (D0) and then at 12 months after inclusion
measure: Identification of predictive determinants of vaccine response
timeFrame: Day 0 until 24 months
Locations:
city: Bamako
country: Mali
facility: CVD-MALI
Study officials:
affiliation: Innovative clinical research network in vaccinology (I-REIVAC)
name: Odile Launay
role: STUDY_CHAIR
affiliation: Center for Vaccine Development-Mali (CVD-Mali)
name: Samba Sow
role: PRINCIPAL_INVESTIGATOR
References: