Evaluation of the Immunogenicity and Safety of Ad26.COV2.S's COVID-19 Vaccine (CoviComMali)

ANRS, Emerging Infectious Diseases

Status and phase

Active, not recruiting

Phase 2

Conditions

COVID-19

Vaccine Adverse Reaction

SARS CoV 2 Infection

Vaccine Reaction

Treatments

Biological: Ad26.COV2.S

Study type

Interventional

Funder types

Other

Identifiers

NCT05409261

ANRS0142S

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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