BNT162b2 Vaccination With Two Doses in COVID-19 Negative Adult Volunteers and With a Single Dose in COVID-19 Positive Adult Volunteers

Summary

Participation Requirements

Description

This is a national open phase II trial, assessing the immunogenicity and safety of vaccine candidate Pfizer - BNT162b2 against SARS-CoV-2 in participants with no history of SARS-CoV-2 infection receiving two doses of vaccine and in participants with history SARS-CoV-2 infection of more than 6 months...

This is a national open phase II trial, assessing the immunogenicity and safety of vaccine candidate Pfizer - BNT162b2 against SARS-CoV-2 in participants with no history of SARS-CoV-2 infection receiving two doses of vaccine and in participants with history SARS-CoV-2 infection of more than 6 months and receiving only one dose of vaccine. A total of 300 volunteers will be included and vaccinated in 2 groups: Group 1: Adults with no history of COVID 19 (N=150) Sub-group 1A: 18 - 45 years old: 50 volunteers Sub-group 1B: 65 - 74 years old: 50 volunteers* (minimum of 45) Sub-group 1C: At least 75 years old: 50 volunteers* (minimum of 45) Group 2: Adults with history of COVID 19 of more than 6 months (N=150) Sub-group 2A: 18 - 45 years old: 50 volunteers Sub-group 2B: 65 - 74 years old: 50 volunteers* (minimum of 45) Sub-group 2C: At least 75 years old: 50 volunteers* (minimum of 45) Within each subgroup of the group 2, a distribution will be respected including: 1/3 volunteers with asymptomatic COVID-19 infection, 1/3 volunteers with mild COVID-19 infection (symptomatic but not hospitalized) and 1/3 volunteers with severe COVID-19 infection (hospitalization required). Participants within the group 1 will receive BNT162b2 (Comirnaty®) intramuscularly as a 2-dose series spaced 28 days apart at a dose of 30 µg each. Participants within the group 2 will receive BNT162b2 intramuscularly as a single dose of 30 µg. Analyses of humorale and saliva immune responses will be performed in differents centralized laboratories blinded for the trial group, by ELISA at Day -6/D0 (pre-vaccination sample), D29, D57, M6, M12, and M24. T and B cell analyses will be performed in a sub-group of participants Immunosenescence will be analysed in pre-vaccination samples.

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