Immunogenicity and reactogenicity following a booster dose of COVID-19 mRNA vaccine (Pfizer-BioNtech) and two adjuvanted sub-unit vaccines (SP/GSK) administered in adults who received 2 doses of Pfizer-BioNTech mRNA vaccine as a primary vaccination: A randomized, single-blinded multicenter clinical trial

Phase 1

• Conditions: COVID-19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-004550-33-FR
• Lead Sponsor: Assistance publique Hopitaux de Paris/ DRCI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-16
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.Age = 18 years
2.Adult in a healthy condition or with a stable health status if pre-existing medical history. Stable health status is defined as an existing disease that has not required a significant change in treatment or hospitalization for worsening in the 3 months before enrollment, and for which neither a significant change in treatment or hospitalization for worsening is expected in the near future
3.For women of childbearing age: a negative highly sensitive pregnancy urinary test during the inclusion visit AND use of an effective contraceptive method at least 4 weeks prior to vaccination and until at least 12 weeks after the vaccination
4.Who has received 2 doses of mRNA vaccine (Pfizer-BioNTech) with an interval of 3 to 6 weeks
5.Second dose of mRNA vaccine (Pfizer-BioNTech) administered at least 6 months before the booster dose
6.Understands and agrees to comply with the study procedures
7.Written informed consent signed by both the participant and the investigator
8.Subject affiliated to the French Social Security System

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1.Acute febrile infection (body temperature = 38.0°C) within the previous 72 hours and/or presenting symptoms suggestive of COVID-19 within the previous 28 days or having been in contact with an infected individual for the last 14 days before the inclusion visit;
2.Virologically documented history of COVID-19 (PCR or serology);
3.Immunosuppressive therapy such as corticosteroids > 10 mg prednisone equivalent/day (excluding topical preparations and inhalers) within 3 months prior to inclusion or within 6 months for chemotherapies;
4.Treatment with immunoglobulins or other blood derivatives within 3 months prior to inclusion or scheduled administration of immunoglobulins or blood derivatives before the end of the study;
5.Known HIV, HCV or HBV infection;
6.Any medical condition, such as cancer, that might impair the immune response;
7.Use of experimental immunoglobulins, experimental monoclonal antibodies or convalescent plasma is not permitted during the study;
8.Pregnancy or breastfeeding currently ongoing;
9.History of severe adverse events following vaccine administration including anaphylactic reaction and associated symptoms such as rash, breathing problems, angioedema, and abdominal pain, or a history of allergic reaction that could be triggered by a component of the SARS-COV-2 vaccine at the time of the first vaccine injection;
10.Participant who has received BCG (tuberculosis) vaccine within the previous year
11.Has received a vaccine within 4 weeks prior to the boost injection or is scheduled to receive a registered vaccine 4 weeks after the boost injection
12.Any bleeding disorder considered as a contraindication to an intramuscular injection, previous phlebotomy or receipt of anticoagulants
13.Participation in other research involving humans (French classification Jardé 1 or Jardé 2) within 4 weeks prior to the inclusion visit, or participation in any other vaccine trial
14.Subject under legal protection (e.g. guardianship, tutorship)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified