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)
Parallel
CoTend-BXBB (SARS2-30404)
Biological/VaccineAd35-vectored SARS-CoV-2 RBD (XBB.1.5) vaccine
CoTend-s3BXBB (SARS2-17032)
Biological/VaccineAd35-vectored s3-SARS-CoV-2 RBD (XBB.1.5) vaccine
Placebo
Biological/VaccineSterile sodium chloride 0.9% for injection, preservative free
16
Treatment groupsSee each treatment group below.
Frequency of solicited local reactogenicity adverse events (AEs) within 7 days after dosing.
Number of participants with solicited local reactogenicity AEs (injection site pain, erythema, or swelling) within 7 days after dosing. An AE is any untoward medical occurrence in a clinical investigation of a patient administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment.
Frequency of solicited systemic reactogenicity AEs within 7 days after dosing.
Number of participants with solicited systemic reactogenicity AEs (malaise, participant-measured body temperature, fatigue, headache, chills, nausea, muscle aches/pain, joint pain) within 7 days after dosing.
Frequency of unsolicited AEs within 28 days after dosing.
Number of participants with unsolicited AEs within 28 days after dosing. Unsolicited AEs are AEs that were not pre-defined as solicited.
Frequency of serious adverse events (SAEs) within 28 days after dosing.
Number of participants with an SAE within 28 days after dosing. An SAE is defined as any adverse event that results in any of the following outcomes: death during a period of surveillance defined by the protocol, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. The following are also considered SAEs for this study: severe COVID-19, defined as COVID-19 requiring hospitalization or supplemental oxygen, myocarditis or pericarditis within 6 weeks of study vaccination, and acute or new onset thrombosis or thromboembolism within 60 days of vaccination.
Serum anti-D614G NAb GMTs through week 8.
Serum anti-D614G NAb GMTs
Serum anti-JN.1* NAb GMTs through week 8.
Serum anti-JN.1\* NAb GMTs (\*the most relevant SARS-CoV-2 variant at the time of analysis will be evaluated)
Proportion of participants achieving anti-D614G NAb titers of 1:250 or better through week 8.
Proportion of participants achieving anti-D614G NAb titers of 1:250 or better
Proportion of participants achieving anti-JN.1* NAb titers of 1:250 or better through week 8.
Proportion of participants achieving serum anti-JN.1\* NAb GMTs of 1:250 or better (\*the most relevant SARS-CoV-2 variant at the time of analysis will be evaluated).
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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
