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

  • End date
    Jan 27, 2023
  • participants needed
  • sponsor
    BioNTech SE
Updated on 18 January 2021
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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 2 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;
  • 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 evaluation in Phase 2/3 is BNT162b2 (mid-dose).

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.

Treatment Placebo, BNT162a1, BNT162b1, BNT162b2, BNT162c2, BNT162b3
Clinical Study IdentifierNCT04368728
SponsorBioNTech SE
Last Modified on18 January 2021

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Inclusion Criteria

Is your age greater than or equal to 12 yrs?
Gender: Male or Female
Do you have any of these conditions: Covid-19 or *COVID-19 or SARS-CoV-2 Infection?
Do you have any of these conditions: SARS-CoV-2 Infection or Covid-19 or *COVID-19?
Do you have any of these conditions: Covid-19 or SARS-CoV-2 Infection or *COVID-19?
Do you have any of these conditions: *COVID-19 or Covid-19 or SARS-CoV-2 Infection?
Do you have any of these conditions: *COVID-19 or Covid-19 or SARS-CoV-2 Infection?
Do you have any of these conditions: *COVID-19 or SARS-CoV-2 Infection or Covid-19?
Do you have any of these conditions: SARS-CoV-2 Infection or Covid-19 or *COVID-19?
Do you have any of these conditions: SARS-CoV-2 Infection or Covid-19 or *COVID-19?
Do you have any of these conditions: *COVID-19 or SARS-CoV-2 Infection or Covid-19?
Do you have any of these conditions: SARS-CoV-2 Infection or Covid-19 or *COVID-19?
Do you have any of these conditions: SARS-CoV-2 Infection or *COVID-19 or Covid-19?
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). 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
Capable of giving personal signed informed consent

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
Diabetes mellitus
Chronic pulmonary disease
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 and/or during study participation
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
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