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History of Changes for Study: NCT04368728
Study to Describe the Safety, Tolerability, Immunogenicity, and Potential Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults
Latest version (submitted August 25, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 29, 2020 None (earliest Version on record)
2 May 4, 2020 Recruitment Status, Study Status, Study Design, References, Contacts/Locations and Oversight
3 May 5, 2020 Study Design and Study Status
4 May 13, 2020 Study Status and Contacts/Locations
5 June 4, 2020 Study Status, Contacts/Locations, Study Design and Study Identification
6 June 26, 2020 Contacts/Locations, Study Design and Study Status
7 July 15, 2020 Recruitment Status, Arms and Interventions, Outcome Measures, Study Status, Contacts/Locations, Eligibility, Study Design, Study Description and Study Identification
8 July 21, 2020 Contacts/Locations, Study Design, Study Status and Study Identification
9 July 27, 2020 IPDSharing, References, Contacts/Locations, Study Design, Study Status and Study Identification
10 July 30, 2020 Recruitment Status, Study Status and Contacts/Locations
11 July 31, 2020 Arms and Interventions, Outcome Measures, Study Status, References, Contacts/Locations, Eligibility, Study Design and Study Description
12 August 6, 2020 Contacts/Locations and Study Status
13 August 17, 2020 Contacts/Locations and Study Status
14 September 3, 2020 Contacts/Locations and Study Status
15 September 25, 2020 Contacts/Locations, Eligibility, Study Status, Arms and Interventions, Study Identification, Study Design and Study Description
16 October 14, 2020 Contacts/Locations, Study Status and Eligibility
17 October 23, 2020 Outcome Measures, Contacts/Locations, Arms and Interventions, Eligibility, Study Description and Study Status
18 October 30, 2020 Contacts/Locations and Study Status
19 November 11, 2020 Study Status, Contacts/Locations and Outcome Measures
20 November 20, 2020 Study Status and Contacts/Locations
21 December 15, 2020 Study Status and Contacts/Locations
22 December 22, 2020 Arms and Interventions, Study Description and Study Status
23 January 8, 2021 Study Status, Contacts/Locations and Study Design
24 January 20, 2021 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Study Design
25 February 9, 2021 Study Status
26 March 17, 2021 Contacts/Locations, Arms and Interventions, Study Status and Study Description
27 March 30, 2021 Contacts/Locations, Arms and Interventions, Study Status, Outcome Measures, Eligibility and Study Description
28 April 9, 2021 Recruitment Status, Study Status and Contacts/Locations
29 April 29, 2021 Arms and Interventions, Outcome Measures, Contacts/Locations, Eligibility, Study Design, Study Description and Study Status
30 May 28, 2021 Study Status, Contacts/Locations and Study Design
31 July 21, 2021 Study Status, Contacts/Locations and Eligibility
32 August 4, 2021 Study Status and Contacts/Locations
33 August 25, 2021 Contacts/Locations and Study Status
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Study NCT04368728
Submitted Date:  April 29, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: C4591001
Brief Title: Study to Describe the Safety, Tolerability, Immunogenicity, and Potential Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2020
Overall Status: Not yet recruiting
Study Start: April 28, 2020
Primary Completion: January 27, 2023 [Anticipated]
Study Completion: January 27, 2023 [Anticipated]
First Submitted: April 27, 2020
First Submitted that
Met QC Criteria:
April 29, 2020
First Posted: April 30, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 29, 2020
Last Update Posted: April 30, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: BioNTech SE
Responsible Party: Sponsor
Collaborators: Pfizer
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: SARS-CoV-2 Infection
COVID-19
Keywords: COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 21
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 8640 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Low dose, 18-55 years of age (Single dose)
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
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)
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
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)
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
Experimental: High-dose, 18-55 years of age (2 doses) 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)
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
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)
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
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)
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
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
Placebo
0.5 mL Intramuscular injection
Placebo Comparator: Placebo, 65-85 years of age
Placebo
0.5 mL Intramuscular injection
Placebo Comparator: Placebo, 18-85 years of age
Placebo
0.5 mL Intramuscular injection
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Pfizer CT.gov Call Center
Telephone: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
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.
Open or close this module References
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services