A Phase 1/2A, Randomized Study of a T Follicular Helper (TFH)-Targeting Genetic Vaccine Strategy Designed to Induce Broad, Durable Immune Responses
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Individuals 40 - 64 years of age 2. Received at least two doses of a COVID-19 mRNA vaccine (Moderna or Pfizer) \> 120 days before study entry 3. Nasal SARS-CoV-2 negative by molecular (polymerase chain reaction, PCR) testing at screening 4. The following laboratory criteria must be met at screening: 1. Total white blood cell (WBC) count \> 3500 cells/mm3 2. Absolute neutrophil count (ANC) \> 1500 cells/mm3 3. Hemoglobin \> 13.5 g/dL if male sex and \> 12.0 g/dL if female sex 4. Platelet count \> 140,000/uL 5. Estimated creatinine clearance (CrCl) \> 50 mL/min by Cockroft-Gault equation 6. Total bilirubin ≤ 1.1x upper limit of normal (ULN) 7. Aspartate aminotransferase (AST) ≤ 1.3x ULN 8. Alanine aminotransferase (ALT) ≤ 1.3x ULN 5. Individuals of reproductive potential must have a negative serum or urine beta-human chorionic gonadotropin (ß-HCG) test at screening and within 48 hours prior to entry. Reproductive potential is defined as: * Participants who have rea