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

NCT04368728

Last updated date
Study Location
University of Maryland General Clinical Research Center
Baltimore, Maryland, 21201, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
SARS-CoV-2 Infection, COVID-19
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study stage).

- 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.

- Capable of giving personal signed informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.


- 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.


- Stages 1 and 2 only: Previous clinical or microbiological diagnosis of COVID 19.


- Sentinel participants in Stage 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


- Sentinel participants in Stage 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.


- 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.


- 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.


- Sentinel participants in Stage 1 only: Positive serological test for SARS-CoV-2 IgM
and/or IgG antibodies at the screening visit.


- Sentinel participants in Stage 1 only: Any screening hematology and/or blood chemistry
laboratory value that meets the definition of a ≥ Grade 1 abnormality.


- Sentinel participants in Stage 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.


- Sentinel participants in Stage 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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SARS-CoV-2 Infection, COVID-19Study to Describe the Safety, Tolerability, Immunogenicity, and Potential Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults NCT04368728
  1. Baltimore, Maryland
  2. Baltimore, Maryland
  3. Baltimore, Maryland
  4. New York, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Describe the Safety, Tolerability, Immunogenicity, and Potential Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults
Official Title  ICMJE A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND POTENTIAL EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY ADULTS
Brief Summary

This is a Phase 1/2, randomized, placebo-controlled, observer-blind, dose-finding, and vaccine candidate-selection study in healthy adults.

The study will evaluate the safety, tolerability, immunogenicity, and potential efficacy of up to 4 different SARS-CoV-2 RNA vaccine candidates against COVID-19:

  • As a 2-dose or single-dose schedule
  • At up to 3 different dose levels
  • In 3 age groups (18 to 55 years of age, 65 to 85 years of age, and 18 to 85 years of age

The study consists of 3 stages. Stage 1: to identify preferred vaccine candidate(s), dose level(s), number of doses, and schedule of administration (with the first 15 participants at each dose level of each vaccine candidate comprising a sentinel cohort); Stage 2: an expanded-cohort stage; and Stage 3; a final candidate/dose large-scale stage.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • SARS-CoV-2 Infection
  • COVID-19
Intervention  ICMJE
  • Biological: BNT162a1
    0.5 mL intramuscular injection
  • Biological: BNT162b1
    0.5 mL intramuscular injection
  • Biological: BNT162b2
    0.5 mL intramuscular injection
  • Biological: BNT162c2
    0.5 mL intramuscular injection
  • Other: Placebo
    0.5 mL Intramuscular injection
Study Arms  ICMJE
  • Experimental: Low-dose, 18-55 years of age (Single dose)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: Mid-dose, 18-55 years of age (Single dose)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: High-dose, 18-55 years of age (Single dose)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: Low-dose, 65-85 years of age (Single dose)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: Mid-dose, 65-85 years of age (Single dose)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: High-dose, 65-85 years of age (Single dose)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: Low-dose, 18-55 years of age (2 doses)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: Mid-dose, 18-55 years of age (2 doses)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: High-dose, 18-55 years of age (2 doses)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: Low-dose, 65-85 years of age (2 doses)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: Mid-dose, 65-85 years of age (2 doses)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: High-dose, 65-85 years of age (2 doses)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: Low-dose, 18-85 years of age (Single dose)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: Mid-dose, 18-85 years of age (Single dose)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: High-dose, 18-85 years of age (Single dose)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: Low-dose, 18-85 years of age (2 doses)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: Mid-dose, 18-85 years of age (2 doses)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Experimental: High-dose, 18-85 years of age (2 doses)
    Interventions:
    • Biological: BNT162a1
    • Biological: BNT162b1
    • Biological: BNT162b2
    • Biological: BNT162c2
  • Placebo Comparator: Placebo, 18-55 years of age
    Intervention: Other: Placebo
  • Placebo Comparator: Placebo, 65-85 years of age
    Intervention: Other: Placebo
  • Placebo Comparator: Placebo, 18-85 years of age
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2020)
7600
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2020)
8640
Estimated Study Completion Date  ICMJE March 8, 2023
Estimated Primary Completion Date August 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study stage).
  • 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.
  • 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.
  • 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.
  • Stages 1 and 2 only: Previous clinical or microbiological diagnosis of COVID 19.
  • Sentinel participants in Stage 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
  • Sentinel participants in Stage 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.
  • 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.
  • 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.
  • Sentinel participants in Stage 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit.
  • Sentinel participants in Stage 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ? Grade 1 abnormality.
  • Sentinel participants in Stage 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.
  • Sentinel participants in Stage 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04368728
Other Study ID Numbers  ICMJE C4591001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Biontech SE
Study Sponsor  ICMJE Biontech SE
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Biontech SE
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP