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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368728
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Biontech SE

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.


Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection COVID-19 Biological: BNT162a1 Biological: BNT162b1 Biological: BNT162b2 Biological: BNT162c2 Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : August 11, 2021
Estimated Study Completion Date : March 8, 2023

Arm Intervention/treatment
Experimental: Low-dose, 18-55 years of age (Single dose) 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

Experimental: Mid-dose, 18-55 years of age (Single dose) 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

Experimental: High-dose, 18-55 years of age (Single dose) 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

Experimental: Low-dose, 65-85 years of age (Single dose) 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

Experimental: Mid-dose, 65-85 years of age (Single dose) 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

Experimental: High-dose, 65-85 years of age (Single dose) 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

Experimental: Low-dose, 18-55 years of age (2 doses) 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

Experimental: Mid-dose, 18-55 years of age (2 doses) 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

Experimental: High-dose, 18-55 years of age (2 doses) 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

Experimental: Low-dose, 65-85 years of age (2 doses) 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

Experimental: Mid-dose, 65-85 years of age (2 doses) 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

Experimental: High-dose, 65-85 years of age (2 doses) 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

Experimental: Low-dose, 18-85 years of age (Single dose) 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

Experimental: Mid-dose, 18-85 years of age (Single dose) 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

Experimental: High-dose, 18-85 years of age (Single dose) 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

Experimental: Low-dose, 18-85 years of age (2 doses) 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

Experimental: Mid-dose, 18-85 years of age (2 doses) 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

Experimental: High-dose, 18-85 years of age (2 doses) 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

Placebo Comparator: Placebo, 18-55 years of age Other: Placebo
0.5 mL Intramuscular injection

Placebo Comparator: Placebo, 65-85 years of age Other: Placebo
0.5 mL Intramuscular injection

Placebo Comparator: Placebo, 18-85 years of age Other: Placebo
0.5 mL Intramuscular injection




Primary Outcome Measures :
  1. Percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ]
    Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

  2. Percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ]
    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

  3. Percentage of participants reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ]
    As elicited by investigational site staff

  4. Percentage of participants reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ]
    As elicited by investigational site staff

  5. Percentage of sentinel cohort participants with abnormal hematology and chemistry laboratory values [ Time Frame: 1 day after dose 1 ]
    As measured at the central laboratory

  6. Percentage of sentinel cohort participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 1 ]
    As measured at the central laboratory

  7. Percentage of sentinel cohort participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 2 ]
    As measured at the central laboratory

  8. Percentage of sentinel cohort participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 1 day after dose 1 ]
    As measured at the central laboratory

  9. Percentage of sentinel cohort participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 7 days after dose 1 ]
    As measured at the central laboratory

  10. Percentage of sentinel cohort participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between before dose 2 and 7 days after dose 2 ]
    As measured at the central laboratory


Secondary Outcome Measures :
  1. SARS-CoV-2-specific WT serum neutralizing antibody levels, expressed as GMTs [ Time Frame: Through 2 years after the final dose ]
    As measured at the central laboratory

  2. GMFR in SARS-CoV-2-specific WT serum neutralizing titers from before vaccination to each subsequent time point [ Time Frame: Through 2 years after the final dose ]
    As measured at the central laboratory

  3. Proportion of participants achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific WT serum neutralizing antibody levels [ Time Frame: Through 2 years after the final dose ]
    As measured at the central laboratory

  4. SARS-CoV-2--spike protein-specific binding antibody levels and RBD-specific binding antibody levels, expressed as GMCs [ Time Frame: Through 2 years after the final dose ]
    As measured at the central laboratory

  5. Proportion of participants achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2--spike protein-specific binding antibody levels and RBD-specific binding antibody levels [ Time Frame: Through 2 years after the final dose ]
    As measured at the central laboratory

  6. GMFR in SARS-CoV-2-spike protein-specific binding antibody levels and RBD-specific binding antibody levels from before vaccination to each subsequent time point [ Time Frame: Through 2 years after the final dose ]
    As measured at the central laboratory

  7. GMR of the geometric mean of SARS-CoV-2-specific WT serum neutralizing titers to the geometric mean of SARS CoV 2 (spike protein and RBD) specific binding antibody levels [ Time Frame: Through 2 years after the final dose ]
    As measured at the central laboratory

  8. Confirmed COVID-19 incidence [ Time Frame: From the last dose of study intervention to the end of the study, up to 2 years ]
    Per 1000 person-years of follow-up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368728


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

Locations
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United States, Maryland
University of Maryland General Clinical Research Center Recruiting
Baltimore, Maryland, United States, 21201
University of Maryland Medical Center Investigational Drug Service Pharmacy Recruiting
Baltimore, Maryland, United States, 21201
University of Maryland, Center for Vaccine Development and Global Health Recruiting
Baltimore, Maryland, United States, 21201
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Rochester Regional Health/Rochester General Hospital Recruiting
Rochester, New York, United States, 14621
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45206
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
Biontech SE
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Biontech SE
ClinicalTrials.gov Identifier: NCT04368728    
Other Study ID Numbers: C4591001
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biontech SE:
COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine