Status:
UNKNOWN
Randomized, Single-blinded, Multicenter Trial Comparing the Immune Response to a 2nd Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNTech) or Sanofi /GSK B.1.351 Adjuvanted Vaccine in Adults
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
IREIVAC/COVIREIVAC Network
Conditions:
COVID-19 Vaccines
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
The effectiveness of COVID-19 vaccines in reducing the risk of severe COVID-19 is currently demonstrated. In France, since the beginning of the vaccination campaign, 54,266,859 people have received at...
Detailed Description
The data currently available on the persistence of immunity on the one hand, and the appearance of viral variants with reduced sensitivity to vaccine immunity on the other, suggest the need to adminis...
Eligibility Criteria
Inclusion
- Age ≥ 60 years.
- Adult in good health 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 hospitalisation for worsening in the 3 months prior to inclusion, and for which no significant change in treatment or hospitalisation for worsening of the disease is envisaged in the near future.
- For participants over 60 years of age who participated in Coviboost, to have received a booster dose of mRNA vaccine (Pfizer-BioNTech) administered at least 6 months before the 2nd booster dose
- Not included in Coviboost (new participants to be recruited) and having received 2 doses of mRNA vaccine (Pfizer-BioNTech) with an interval of 3 to 6 weeks and a 1st booster dose of mRNA vaccine (Pfizer-BioNTech) or Moderna administered at least 6 months before the 2nd booster dose
- Understands and agrees to comply with the study procedures.
- Written informed consent signed by the participant and the investigator.
- Person affiliated to a social security scheme.
Exclusion
- Acute febrile infection (body Acute febrile infection (body temperature ≥ 38.0°C) within the previous 72 hours and/or had symptoms suggestive of COVID-19 within the last 28 days or had case contact within the last 10 days before the inclusion visit.
- Virologically documented (PCR or serology) history of COVID 19.
- Immunosuppressive drugs such as corticosteroids at a dosage \> 10 mg prednisone equivalent/day (excluding topical preparations and inhalers) within 3 months prior to inclusion or within 6 months for chemotherapies.
- Treated with immunoglobulin or other blood product within 3 months prior to inclusion or scheduled for administration of immunoglobulin or blood product before the end of the study.
- Known HIV, HCV or HBV infection.
- Any condition, such as cancer, that may reduce the immune response.
- Use of experimental Ig, experimental monoclonal antibodies or convalescent serum is not allowed during the study.
- History of severe adverse reactions after vaccine administration including anaphylactic reaction and associated symptoms such as rash, difficulty breathing, angioedema and abdominal pain, or a history of an allergic reaction that may be exacerbated by a component of the SARS-COV-2 vaccine during the first vaccine injection.
- Participant having been vaccinated against BCG in the previous year.
- Having received a vaccination within 2 weeks prior to the 2nd booster dose or scheduled to receive a licensed vaccine 2 weeks after the 2nd booster dose.
- Any bleeding disorder considered as a contraindication to an intramuscular injection, previous phlebotomy or receipt of anticoagulants.
- 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.
- Subject under legal protection (e.g. guardianship, tutorship).
Key Trial Info
Start Date :
June 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT05405283
Start Date
June 8 2022
End Date
July 1 2023
Last Update
July 3 2023
Active Locations (1)
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1
GH Broca-Cochin-Hôtel-Dieu CIC 1417 Cochin-Pasteur
Paris, France, 75004