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

  • STATUS
    Recruiting
  • End date
    May 2, 2023
  • participants needed
    43998
  • sponsor
    BioNTech SE
Updated on 2 September 2021
covid-19
SARS

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 g.

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 g 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 g or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 g (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 g.

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-nave (ie, BNT162b2-nave) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days.

Details
Condition *COVID-19, Covid-19, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS CoV 2 Infection
Treatment Placebo, BNT162a1, BNT162b1, BNT162b2, BNT162c2, BNT162b3, BNT162b2SA
Clinical Study IdentifierNCT04368728
SponsorBioNTech SE
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

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
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
upon study phase). For the boostability and protection-against-VOCs subset
Existing participants enrolled to receive a third dose of BNT162b2 at 30 g or
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
BNT162b2SA; male or female participants between the ages of 18 and 55 years
Capable of giving personal signed informed consent
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
g; male or female participants 18 years at rerandomization
Note that participants <18 years of age cannot be enrolled in the EU

Exclusion Criteria

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
Previous participation in other studies involving study intervention containing lipid nanoparticles
Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit
Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a Grade 1 abnormality
Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit
Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members
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
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