Evaluation of the Immunogenicity and Safety of Ad26.COV2.S's COVID-19 Vaccine (NCT05409261) | Clinical Trial Compass
UnknownPhase 2
Evaluation of the Immunogenicity and Safety of Ad26.COV2.S's COVID-19 Vaccine
Mali200 participantsStarted 2022-06-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 v…
What they're measuring
1
Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level
Timeframe: One month after complete vaccination schema