Clinical trial NCT04368728: Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
Official title: A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS
Conditions: SARS-CoV-2 Infection
COVID-19
Summary: This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.
The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part.
The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate:
* As a 2-dose (separated by 21 days) schedule;
* At various different dose levels in Phase 1;
* As a booster;
* In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]).
The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg.
Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.
In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity.
The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg.
To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days.
To reflect current and anticipated recommendations for COVID 19 vaccine boosters, participants in C4591001 who meet specified recommendations and have not already received one, will be offered a third dose of BNT162b2 after their second dose of BNT162.
Interventions:
description: Intramuscular injection
name: BNT162b1
type: Biological
description: Intramuscular injection
name: BNT162b2
type: Biological
description: Intramuscular injection
name: Placebo
type: Other
description: Intramuscular injection
name: BNT162b2SA
type: Biological
Study arms:
design_group_title: 10 µg dose, 18-55 years of age (2 doses)
design_group_type: Experimental
design_group_title: 20 µg dose, 18-55 years of age (2 doses)
design_group_type: Experimental
design_group_title: 30 µg dose, 18-55 years of age (2 doses)
design_group_type: Experimental
design_group_title: 10 µg dose, 65-85 years of age (2 doses)
design_group_type: Experimental
design_group_title: 20 µg dose, 65-85 years of age (2 doses)
design_group_type: Experimental
design_group_title: 30 µg dose, 65-85 years of age (2 doses)
design_group_type: Experimental
design_group_title: 30 µg dose, ≥12 years of age (2 doses)
design_group_type: Experimental
design_group_title: Placebo, 18-55 years of age
design_group_type: Placebo Comparator
design_group_title: Placebo, 65-85 years of age
design_group_type: Placebo Comparator
design_group_title: Placebo, ≥12 years of age
design_group_type: Placebo Comparator
design_group_title: 100 µg dose, 18-55 years of age (2 doses)
design_group_type: Experimental
design_group_description: Participants ≥16 years of age who originally received placebo and are eligible for COVID-19 vaccination following any local or national recommendations will be offered the opportunity to receive BNT162b2 as part of the study.
design_group_title: Vaccination of Placebo recipients with BNT162b2 - Stage 1
design_group_type: Other
design_group_description: Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.
design_group_title: Vaccination of placebo recipients with BNT162b2 - Stage 2
design_group_type: Other
design_group_title: Booster vaccination of Phase 1 participants with BNT162b2 at a dose of 30 µg
design_group_type: Experimental
design_group_title: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 30 µg
design_group_type: Experimental
design_group_title: Booster vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg
design_group_type: Experimental
design_group_title: Vaccination of BNT162b2-naive participants with BNT162b2SA at a dose of 30 µg
design_group_type: Experimental
design_group_title: Booster and further vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg
design_group_type: Experimental
design_group_title: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 5 µg
design_group_type: Experimental
design_group_title: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 10 µg
design_group_type: Experimental
Sponsor: BioNTech SE
Collaborators: Pfizer Inc.
Drug name mappings:
name: 复必泰
lang: CN
name: Comirnaty-COVID-19 mRNA vaccine
lang: EN
name: トジナメラン
lang: JP
name: BNT-161b1
lang: EN