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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: SARS-CoV-2 Infection, COVID-19

In brief

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.

Key facts

Study ID

NCT04368728

Run by

BioNTech SE

People needed

46969

Starts

2020-04-29

Expected to finish

2023-02-10

Last updated by the study team

2026-03-25

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Phases 1 and 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
• Receipt of medications intended to prevent COVID 19.
• Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19
• Phase 1 only: Individuals at high risk for severe COVID-19, including those with any of the following risk factors:
• Hypertension
• Diabetes mellitus
• Chronic pulmonary disease
• Asthma
• Current vaping or smoking
• History of chronic smoking within the prior year
• BMI >30 kg/m2
• Anticipating the need for immunosuppressive treatment within the next 6 months
• Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel).
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Women who are pregnant or breastfeeding.
• Previous vaccination with any coronavirus vaccine.
• Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
• Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids.
• Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
• Participation in other studies involving study intervention within 28 days prior to study entry through and including 6 months after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID 19, which are prohibited throughout study participation.
• Previous participation in other studies involving study intervention containing lipid nanoparticles.

Where it is running

• Birmingham Clinical Research Unit — Birmingham, Alabama, United States
• Medical Affiliated Research Center — Huntsville, Alabama, United States
• Optimal Research, LLC — Huntsville, Alabama, United States
• Alliance for Multispecialty Research, LLC — Mobile, Alabama, United States
• Chinle Comprehensive Health Care Facility — Chinle, Arizona, United States
• Johns Hopkins Center for American Indian Health — Chinle, Arizona, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• The Pain Center of Arizona — Phoenix, Arizona, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• Alliance for Multispecialty Research, LLC — Tempe, Arizona, United States
• Johns Hopkins Center for American Indian Health — Whiteriver, Arizona, United States
• Whiteriver Indian Hospital - Garrett Building — Whiteriver, Arizona, United States
• Whiteriver Indian Hospital — Whiteriver, Arizona, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Collaborative Neuroscience Research, LLC. - Investigator Site File Location — Garden Grove, California, United States
• Collaborative Neuroscience Research, LLC — Long Beach, California, United States
• Long Beach Clinical Trials Services Inc. — Long Beach, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• National Research Institute — Los Angeles, California, United States
• Velocity Clinical Research, North Hollywood — North Hollywood, California, United States
• Paradigm Clinical Research Center — Redding, California, United States
• Kaiser Permanente Sacramento — Sacramento, California, United States
• Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC) — Sacramento, California, United States
• University of California Davis Health — Sacramento, California, United States
• North Alabama Research Center, LLC — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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