Clinical trial NCT05409300: Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea
Official title: Phase II Trial Evaluating the Immunogenicity and Safety of BBIBP-CorV Vaccine in Adults in Guinea
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: COVID-19
Vaccine Adverse Reaction
Sars-CoV-2 Infection
Healthy Volunteer
Keywords: BBIBP-CorV
Elderly
SARS CoV 2 infected participants
Safety and immunogenicity
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: CEPI
name: Alliance for International Medical Action
name: Centre National de Formation et de Recherche en Sante Rurale
name: Institut National de la Santé Et de la Recherche Médicale, France
name: APHP
name: Agence Nationale de Sécurité Sanitaire de la Guinée (ANSS Guinée)
name: Innovative clinical research network in vaccinology (IREIVAC)
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, single center national trial in Guinea, aimed to assess the humoral vaccine immune response induced by BBIBP-CorV vaccine in 200 adults aged between 18 and 45 years or 55 or older, one month after receiving the complete COVID-19 vaccination schedule.

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

200 participants will be included. 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.

Participants will receive two doses of BBIBP-CorV at 28 days interval. Vaccines will be administered intramuscular (0.5mL per injection)

Humoral vaccine immune responses, induced by BBIBP-CorV 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:

* Age between 46 and 54 years old
* Positive SARS-CoV-2 antigenic test
* Positive SARS-CoV-2 PCR results less than 48 hours old
* History of infection by COVID-19 confirmed within 3 months prior to inclusion
* Symptoms compatible with COVID-19: 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)
* Patient having received immunoglobulin or another blood product within 3 months prior to inclusion
* Previously received at least one injection of a SARS-CoV-2 vaccine
* 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 IgG level
timeFrame: 1 month after complete vaccination schema
Secondary outcomes:
measure: Anti-SARS-CoV-2 specific IgG level
timeFrame: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
measure: Anti-SARS-CoV-2 IgA and level
timeFrame: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
measure: Anti-SARS-CoV-2 IgM level
timeFrame: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
measure: Neutralizing antibody level for SARS-CoV-2
timeFrame: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
measure: Fluorospot tests (TH1, TH2, TH17, Cytotoxicity)
timeFrame: Day 0, Month 2, Month 6
measure: Mucosal SARS-CoV-2 specific antibody levels
timeFrame: Day 0, Month 1, Month 2, Month 6, Month 12
measure: Epitope profile
timeFrame: Day 0, Month 2
measure: B cell response to vaccine
timeFrame: Day 0, Month 2, Month 6
measure: Measurement of ultrasensitive IgA and mucosal IgA and IgM functionality
timeFrame: Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24
measure: Rate of adverse events
timeFrame: Month 1 until Month 24
measure: SARS-CoV-2 infection
timeFrame: Day 0 until Month 24
Other outcomes:
measure: Measurement of specific B memory cells
timeFrame: Day 0, Month 2, Month 6, Month 12
measure: Measurement of specific T cell response
timeFrame: Day 0, Month 12
measure: Identification of predictive determinants of vaccine response
timeFrame: Month 24
measure: Quantitative measures
timeFrame: Day 0 until Month 24
Locations:
city: Conakry
country: Guinea
facility: Centre de recherche de Landreah
city: Conakry
country: Guinea
facility: Palais du Peuple
Study officials:
affiliation: Innovative clinical research network in vaccinology (I-REIVAC)
name: Odile Launay
role: STUDY_CHAIR
affiliation: Centre National de Formation et de Recherche en Santé Rurale (CNFRSR)
name: Abdoul Habib Beavogui
role: PRINCIPAL_INVESTIGATOR
References: