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Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults
Overall Recruitment Status: Active, enrollment completed
 
Official Title
PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY ADULTS
 
Region Sponsors
Northwest
BioNTech SE
Pfizer
 
Acronym KP IRB No.
20201000
 
Study Type Phase
Clinical Trial Phase IIA
 
Study Population Description
Healthy Individuals who are at risk for acquiring COVID-19, SARS-CoV-2 Infection
 
Purpose
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy adults. 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: 18 to 85 years of age [stratified as =/<55 or =/>55 years of age]). The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose).
 
Detailed Description
 
Gender Age Limit
Male & Female 18 - 85 years
 
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 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
  • 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
  • Please contact study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Coronavirus
  • SARS-CoV-2
  • COVID-19
  • Vaccine
  • RNA Vaccine
  • Infectious Diseases
 
KP Clinical Facility
  • Interstate Medical Office East
 
Clinical Area
  • Infectious Diseases


Principal Investigator:
Stephen Fortmann, MD
Contact Information:
- Madeline Peyton, MPH
-CHRCOVIDvaccinetrial@kpCHR.org
-Interstate Medical Office East


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