Status:
UNKNOWN
Compare Immunological Efficacy of a Vaccine Regimen Combining Two Covid19 mRNA Vaccines (Pfizer-BioNTech and Moderna) With That of a Homologous Vaccination of Each Covid19 mRNA Vaccine
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
COVIREIVAC
Conditions:
Adult Who Received a First Dose of an mRNA Vaccine (Pfizer-BioNTech or Moderna) and Need to Receive a Second Dose
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
As part of the COVID 19 vaccine campaign, the two mRNA vaccines, BNT162b2 (COMIRNATY®) and mRNA-1273 COVID-19 vaccine Moderna, are administered in two doses in subjects without a history of SARS-CoV-2...
Detailed Description
Covid 19 has infected more than 132 million people around the world (https://covid19.who.int/, data from 04/07/21). In record time, effective vaccines were developed allowing the start of the vaccinat...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Having received a first dose of one of the two mRNA vaccines (Pfizer-BioNTech or Moderna) as recommended.
- For whom a 2nd dose of mRNA vaccine is planned within 4 to 6 weeks (according to the recommendations of the HAS and the ANSM).
- Without a history of SARS-CoV-2 infection (negative PCR, negative antigen test or negative chest CT or SARS-CoV-2 serology)
- Healthy or in stable health if pre-existing medical history. Stable health 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 neither a significant change in treatment or hospitalisation for worsening of the disease is envisaged in the near future
- Able to understand and comply with the research procedures as judged by the investigator
- Informed consent signed by the participant and the investigator.
- Person affiliated to a social security scheme.
Exclusion
- History of SARS-CoV-2 infection at the inclusion visit or between the 2 vaccine doses (documented by positive PCR, positive antigen test or positive chest CT or positive SARS-CoV-2 serology.
- Acute febrile infection (body temperature ≥ 38.0°C) within the previous 72 hours and/or with symptoms suggestive of COVID-19 or case contact within the last 14 days prior to the inclusion visit. Sick or febrile subjects may be re-invited for a new inclusion visit during the inclusion period when they no longer have these symptoms)
- Immunosuppressive medications 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 chemotherapy.
- Treatment with immunoglobulin or other blood product within 3 months prior to inclusion or with planned administration of immunoglobulin or blood product before the end of the study.
- Known HIV, HCV or HBV infection.
- Any immunosuppressive condition, such as cancer, that may reduce the immune response.
- The use of experimental Ig, experimental monoclonal antibodies or convalescent serum is not permitted during the study.
- Pregnant or breastfeeding.
- Participation in any other research involving humans (Jardé 1 or Jardé 2) within 4 weeks prior to the inclusion visit
- Person subject to a legal protection measure (guardianship, curatorship or safeguard measure).
- History of severe adverse reactions after vaccine administration including anaphylactic reaction and associated symptoms such as rash, difficulty breathing, angiodema and abdominal pain, or a history of allergic reaction that may be exacerbated by a component of the SARS-COV-2 vaccine at the time of the first vaccine injection
- Participant who has been vaccinated against BCG in the previous year.
- Having received a vaccination within 4 weeks prior to the first injection or scheduled to receive a licensed vaccine 4 weeks after the last injection.
- History of severe allergic manifestations
- Any bleeding disorder considered to be a contraindication to intramuscular injection or having had a phlebotomy
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT04900467
Start Date
May 28 2021
End Date
January 1 2022
Last Update
August 3 2021
Active Locations (1)
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1
CIC 1417 Cochin-Pasteur
Paris, France, 75679