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Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
Overall Recruitment Status: Active, currently enrolling
 
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 INDIVIDUALS
 
Region Sponsors
California - Northern
Pfizer / BioNTech
 
Acronym KP IRB No.
1607782
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Healthy individuals who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. (Only enrolling 12-17 year old presently)
 
Purpose
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. 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: =12 years of age [stratified as 12-15, 16-55, or >55 years of age]). The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose).
 
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 12 - 17 years
 
Inclusion Criteria
  • Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive (Phase 1), or > 12 years (Phase 2/3), 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 (if required), 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 –(including but not limited to, use of mass transportation, relevant demographics, and frontline essential workers)
  • Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol
 
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
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s)
  • Receipt of medications intended to prevent COVID-19
  • Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19
  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination
  • 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
  • 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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