CompletedPhase 2/3

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

United States46,969 participantsStarted 2020-04-29

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: • Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase). For the boostability and protection-against-VOCs subset: Existing participants enrolled to receive a third dose of BNT162b2 at 30 µg or BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at rerandomization. Newly enrolled participants enrolled to receive 2 doses of BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at enrollment. Existing participants enrolled to receive a third dose of BNT162b2 at 5 or 10 µg; male or female participants ≥18 years at rerandomization. Note that participants \<18 years of age cannot be enrolled in the EU. * Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. * Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. * Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19. * Boostability and protection-against-VOCs existing participant subset only: Participants who provided a serum sample at Visit 3, with Visit 3 occurring within the protocol-specified window. * Capable of giving personal signed informed consent Exclus…

What they're measuring

Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 1

Timeframe: Within 7 days after Dose 1

Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 1

Timeframe: Within 7 days after Dose 2

Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 1

Timeframe: Within 7 days after Dose 1

Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 1

Timeframe: Within 7 days after Dose 2

Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 1

Timeframe: From Dose 1 to 1 Month After Dose 2

Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 1

Timeframe: From Dose 1 to 6 Months After Dose 2

Percentage of Participants With Abnormalities in Hematology Parameters 1 Day After Dose 1: Phase 1

Timeframe: 1 Day After Dose 1

Trial details

NCT IDNCT04368728

SponsorBioNTech SE

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-10

Results submitted2024-02-09

View on ClinicalTrials.gov More SARS-CoV-2 Infection trials

Plain-language summary

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 1

Timeframe: Within 7 days after Dose 1

Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 1

Timeframe: Within 7 days after Dose 2

Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 1

Timeframe: Within 7 days after Dose 1

Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 1

Timeframe: Within 7 days after Dose 2

Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 1

Timeframe: From Dose 1 to 1 Month After Dose 2

Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 1

Timeframe: From Dose 1 to 6 Months After Dose 2

Percentage of Participants With Abnormalities in Hematology Parameters 1 Day After Dose 1: Phase 1

Timeframe: 1 Day After Dose 1