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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: Enrollment not started
 
Official Title
A 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
California - Northern
Pfizer / BioNTech
 
Acronym KP IRB No.
1607782
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Accepts Health Volunteers 18 years to 85 years
 
Purpose
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, and vaccine candidate-selection study in healthy adults. The study will evaluate the safety, tolerability, immunogenicity, and efficacy of 3 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.
 
Detailed Description
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: an efficacy stage.
 
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 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
  • 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
  • Sacramento Medical Center
  • Santa Clara Medical Center-Homestead
 
Clinical Area
  • Allergy and Immunology
  • Infectious Diseases


Principal Investigator:
Nicola Klein, MD
Contact Information:
- Vaccine Study Center KPNC
-vaccinestudycenter@kp.org
-Santa Clara Medical Center-Homestead


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