The goal of this clinical trial is to test two investigational COVID-19 booster vaccines, called CoTend-s3BXBB and CoTend-BXBB, in healthy volunteers ages 40-64. The CoTend-s3BXBB vaccine includes a component called "s3", which was designed to improve the body's response to the vaccine. CoTend-BXBB is the same vaccine without s3.
The main questions the study aims to answer are: 1) Is the investigational vaccine safe? 2) Does "s3" lead to bigger, broader, and longer-lasting responses to the vaccine?
5 different doses of the vaccines will be studied. Participants will receive a single dose of either CoTend-s3BXBB, CoTend-BXBB, or placebo. Participants will be monitored for side effects. Saliva, nasal, and blood samples will be collected and immune responses to the vaccine will be measured.
Individuals 40 - 64 years of age
Received at least two doses of a COVID-19 mRNA vaccine (Moderna or Pfizer) > 120 days before study entry
Nasal SARS-CoV-2 negative by molecular (polymerase chain reaction, PCR) testing at screening
Total white blood cell (WBC) count > 3500 cells/mm3
Pregnant or breastfeeding
Condoms (male or female) with or without a spermicidal agent
Diaphragm or cervical cap with spermicide
Intrauterine device (IUD)
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Treatment groupsSee each treatment group below.
Kara Chew
Lead sponsor
University of California, Los Angeles
Sponsor institution
University of California, San Francisco
Collaborator
University of California, Davis
Collaborator
Tendel Therapies, Inc.
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator