Evaluation of the Immunogenicity and Safety of COVID-19 Vaccines (Ad26.COV2.S and NVX-CoV2373)

ABSTRACT

ConditionCOVID-19;Vaccine Reaction;SARS CoV 2 Infection;Vaccine Adverse Reaction

InterventionBiological Ad26.COV2.S;Biological NVX-CoV2373

Primary outcome:Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level

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