Purpose

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: ≥16 years of age [stratified as ≤55 or >55 years of age]). The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose).

Conditions

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥16 years, inclusive, at randomization (dependent upon study phase).
  • 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 or microbiological 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 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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Low dose, 18-55 years of age (2 doses)
  • Biological: BNT162b1
    Intramuscular injection
  • Biological: BNT162b2
    Intramuscular injection
Experimental
Low-mid dose, 18-55 years of age (2 doses)
  • Biological: BNT162b1
    Intramuscular injection
  • Biological: BNT162b2
    Intramuscular injection
Experimental
Mid dose, 18-55 years of age (2 doses)
  • Biological: BNT162b1
    Intramuscular injection
  • Biological: BNT162b2
    Intramuscular injection
Experimental
Low dose, 65-85 years of age (2 doses)
  • Biological: BNT162b1
    Intramuscular injection
  • Biological: BNT162b2
    Intramuscular injection
Experimental
Low-mid dose, 65-85 years of age (2 doses)
  • Biological: BNT162b1
    Intramuscular injection
  • Biological: BNT162b2
    Intramuscular injection
Experimental
Mid dose, 65-85 years of age (2 doses)
  • Biological: BNT162b1
    Intramuscular injection
  • Biological: BNT162b2
    Intramuscular injection
Experimental
Mid dose, ≥16 years of age (2 doses)
  • Biological: BNT162b2
    Intramuscular injection
Placebo Comparator
Placebo, 18-55 years of age
  • Other: Placebo
    Intramuscular injection
Placebo Comparator
Placebo, 65-85 years of age
  • Other: Placebo
    Intramuscular injection
Placebo Comparator
Placebo, ≥16 years of age
  • Other: Placebo
    Intramuscular injection
Experimental
High dose, 18-55 years of age (2 doses)
  • Biological: BNT162b1
    Intramuscular injection

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555

More Details

Status
Recruiting
Sponsor
BioNTech SE

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.