A Phase 1/2A, Randomized Study of a T Follicular Helper (TFH)-Targeting Genetic Vaccine Strategy Designed to Induce Broad, Durable Immune Responses (CONTENDER)

NCT06810934 Phase 1/Phase 2 RECRUITING

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.

Details

Lead sponsor	Kara Chew
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	80
Start date	2025-10-21
Completion	2029-10

Conditions

• COVID-19
• SARS-CoV-2 Infection

Interventions

• CoTend-BXBB (SARS2-30404)
• CoTend-s3BXBB (SARS2-17032)
• Placebo

Primary outcomes

• Frequency of solicited local reactogenicity adverse events (AEs) within 7 days after dosing. — 7 days
  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. — 7 days
  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. — 28 days
  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. — 28 days
  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.
• Frequency of adverse events of special interest (AESIs) within 28 days after dosing. — 28 days
  Number of participants with AESIs. AESIs defined as: thrombotic or thromboembolic events, thrombosis with thrombocytopenia syndrome, immune thrombocytopenia, or capillary leak syndrome occurring within 60 days; new thrombocytopenia \<150 x 10\^9/L or below the lower laboratory limit of normal or worsening in grade of thrombocytopenia within 60 days after study vaccination; new D-dimer elevation \>2000 ng/mL within 60 days; laryngospasm, bronchospasm, or anaphylaxis assessed as at least possibly related; generalized urticaria assessed as related; any other grade allergic/ hypersensitivity reaction within 7 days; any ulceration, abscess, or necrosis at injection site assessed as possibly related; myocarditis or pericarditis occurring within 6 weeks; new diagnosis of Guillain-Barré syndrome occurring within 60 days; any new or worsened immune mediated medical condition; grade 3+ lab abnormality for which there is a reasonable possibility of causal relationship to study treatment.
• Frequency of medically attended adverse events (MAAEs) within 28 days after dosing. — 28 days
  Number of participants with MAAEs (MAAE defined as an AE resulting in a hospitalization, emergency room visit, or otherwise unscheduled visit with medical personnel for any reason) within 28 days after dosing.

Countries

United States