Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-31 @ 6:52 PM
Study NCT ID:
NCT04900467
Status:
UNKNOWN
Last Update Posted:
2021-08-03
First Post:
2021-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARNCOMBI
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.
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.
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 vaccination campaign less than a year after the outbreak was declared by WHO.
To date, more than 604 million vaccine doses have been administered worldwide (https://covid19.who.int/, data from 04/07/21).
On December 21, 2020, the first mRNA vaccine developed by Pfizer and BioNTech obtained a marketing authorization (conditional AMM) in Europe for the active immunization of people 16 years of age and over to prevent Covid-19 due to SARS -CoV-2. Then, on January 6, 2021 Moderna in turn obtained a conditional Marketing Authorization for the indication of active immunization to prevent Covid-19 due to SARS-CoV-2 in subjects 18 years of age and over.
In France, more than 7 million injections have been performed with the Pfizer / BioNTech vaccine and more than 617,000 doses of the Moderna vaccine.
The two mRNA vaccines, BNT162b2 (COMIRNATY®) from Pfizer / BioNTech and mRNA-1273 COVID-19 vaccine Moderna, are given on a two-dose schedule in subjects without a history of SARS-CoV-2 infection. In accordance with the AMM for vaccines, HAS recommends that subjects who have received one dose of an mRNA vaccine receive a second dose of the same vaccine. The recommended interval between the 2 doses is 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 14 April, the interval between the two doses of mRNA vaccines is 42 days. In order to facilitate the organisation of the vaccination campaign and to enable the population to be vaccinated more quickly, it would seem desirable to be able to use either COVID 19 RNA vaccine for the 2nd vaccine dose. However, the WHO has announced that, in the absence of available data, the interchangeability of vaccines cannot be recommended.
In order to be able to recommend the interchangeability of the 2 mRNA vaccines, the ARN Combi trial aims to compare the immunogenicity of a standard vaccine regimen (second dose of the same Covid 19 mRNA vaccine) to that of a regimen combining the two Covid 19 mRNA vaccines (i.e. either a 2nd dose of vaccine with Moderna vaccine after a first dose of Pfizer vaccine or a 2nd dose of Pfizer vaccine after a first dose of Moderna vaccine)
To date, more than 604 million vaccine doses have been administered worldwide (https://covid19.who.int/, data from 04/07/21).
On December 21, 2020, the first mRNA vaccine developed by Pfizer and BioNTech obtained a marketing authorization (conditional AMM) in Europe for the active immunization of people 16 years of age and over to prevent Covid-19 due to SARS -CoV-2. Then, on January 6, 2021 Moderna in turn obtained a conditional Marketing Authorization for the indication of active immunization to prevent Covid-19 due to SARS-CoV-2 in subjects 18 years of age and over.
In France, more than 7 million injections have been performed with the Pfizer / BioNTech vaccine and more than 617,000 doses of the Moderna vaccine.
The two mRNA vaccines, BNT162b2 (COMIRNATY®) from Pfizer / BioNTech and mRNA-1273 COVID-19 vaccine Moderna, are given on a two-dose schedule in subjects without a history of SARS-CoV-2 infection. In accordance with the AMM for vaccines, HAS recommends that subjects who have received one dose of an mRNA vaccine receive a second dose of the same vaccine. The recommended interval between the 2 doses is 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 14 April, the interval between the two doses of mRNA vaccines is 42 days. In order to facilitate the organisation of the vaccination campaign and to enable the population to be vaccinated more quickly, it would seem desirable to be able to use either COVID 19 RNA vaccine for the 2nd vaccine dose. However, the WHO has announced that, in the absence of available data, the interchangeability of vaccines cannot be recommended.
In order to be able to recommend the interchangeability of the 2 mRNA vaccines, the ARN Combi trial aims to compare the immunogenicity of a standard vaccine regimen (second dose of the same Covid 19 mRNA vaccine) to that of a regimen combining the two Covid 19 mRNA vaccines (i.e. either a 2nd dose of vaccine with Moderna vaccine after a first dose of Pfizer vaccine or a 2nd dose of Pfizer vaccine after a first dose of Moderna vaccine)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-002174-52 | EUDRACT_NUMBER | None | View |