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
ARNCOMBI
Multicenter, Randomized, Open-label Trial Comparing the 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: Non-inferiority Trial
2 other identifiers
interventional
418
1 country
1
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 infection . In accordance with the marketing authorization for vaccines, HAS recommends that subjects who have received one dose of an mRNA vaccine receive a second dose of the same vaccine with an interval between the 2 doses of 4 to 6 weeks. These two vaccines are based on very similar technologies but were developed independently. Given the similarities between these two vaccines, the choice between the two, for the moment, is based solely on the availability of doses and on logistical constraints. Since April 14, the interval between the two doses of the mRNA vaccines is 42 days. WHO has announced that in the absence of available data, vaccine interchangeability cannot be recommended. However, to facilitate the organization of the vaccination campaign and allow faster vaccination of the population, it would be desirable to be able to use either one or the other mRNA vaccine for the 2nd dose. In order to be able to recommend the interchangeability of the 2 mRNA vaccines, it is proposed to evaluate the immunogenicity of a scheme combining the two Covid 19 mRNA vaccines (i.e. a 2nd dose of vaccine with the Moderna vaccine after a first dose of the Pfizer vaccine or 2nd dose of Pfizer vaccine after a first dose of Moderna vaccine) compared to that of a standard vaccination schedule with two doses of the same Covid 19 mRNA vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2021
CompletedFirst Posted
Study publicly available on registry
May 25, 2021
CompletedStudy Start
First participant enrolled
May 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedAugust 3, 2021
July 1, 2021
1 month
May 21, 2021
July 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-Spike IgG titer
Anti-Spike IgG titer measured by ELISA and neutralising antibodies to European SARS-CoV-2 and SARS-CoV-2 variants 28 days after the second injection.
28 days
Secondary Outcomes (1)
Adverse events
6 months
Study Arms (4)
Pfizer-Pfizer
ACTIVE COMPARATORPfizer-Pfizer Length of use : 1 day
Pfizer-Moderna
EXPERIMENTALPfizer-Moderna Length of use : 1 day
Moderna- Moderna
ACTIVE COMPARATORModerna- Moderna Length of use : 1 day
Moderna - Pfizer
EXPERIMENTALModerna - Pfizer Length of use : 1 day
Interventions
Eligibility Criteria
You may qualify if:
- 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)
- 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.
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- COVIREIVACcollaborator
Study Sites (1)
CIC 1417 Cochin-Pasteur
Paris, 75679, France
Related Publications (1)
Janssen C, Cachanado M, Ninove L, Lachatre M, Michon J, Epaulard O, Maakaroun-Vermesse Z, Chidiac C, Laviolle B, Aumaitre H, Assaf A, Lacombe K, Schmidt-Mutter C, Botelho-Nevers E, Briere M, Boisson T, Loubet P, Bienvenu B, Bouchaud O, Touati A, Pereira C, Rousseau A, Berard L, Montil M, de Lamballerie X, Simon T, Launay O; ARNCOMBI Study Group. Immunogenicity and reactogenicity of heterologous and homologous mRNA-1273 and BNT162b2 vaccination: A multicenter non-inferiority randomized trial. EClinicalMedicine. 2022 Jun;48:101444. doi: 10.1016/j.eclinm.2022.101444. Epub 2022 May 12.
PMID: 35582124DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Odile LAUNAY
Assistance Publique - Hôpitaux de Paris
- PRINCIPAL INVESTIGATOR
Cécile JANSSEN
Centre Hospitalier Annecy Genevois
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2021
First Posted
May 25, 2021
Study Start
May 28, 2021
Primary Completion
July 2, 2021
Study Completion
January 1, 2022
Last Updated
August 3, 2021
Record last verified: 2021-07