NCT04919109

Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Codagenix, Inc · Industry
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Accepted

Summary

This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety of and immune response to CodaVax-RSV in healthy children. They will be vaccinated in spring to early autumn 2023 and followed through the 2023-24 RSV season. 18 children aged 2 to 5 years who are RSV-seropositive (have antibodies to RSV) and 33 children aged 6 months to \< 2 years who are RSV-seronegative (do not have antibodies to RSV) will be enrolled in escalating-dose cohorts. A safety committee will review the safety profile of each dosing group before the next dose-escalation. Children will receive 2 doses of the vaccine at one of several dose levels or placebo (saline solution with no active ingredient) as nose drops; doses will be 28 days apart. A parent/guardian will record temperature and other conditions in a diary daily for 7 days after each dose. The parent/guardian will be contacted by telephone on the day after Dose 1 for safety assessment and review of the diary data. Children will return to the clinic 3, 7, 14, and 28 days after each dose. The parent/guardian will then be contacted by telephone monthly until 1 year after the second dose. Study procedures include physical examinations, vital signs, and collections of blood and nose/throat swab samples to look at safety of the vaccine and to analyze body's immune response.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	CodaVax-RSV	live attenuated vaccine against RSV
BIOLOGICAL	Normal Saline	Placebo comparator

Timeline

• Start date: 2023-03-28
• Primary completion: 2025-04-30
• Completion: 2025-08-27
• First posted: 2021-06-09
• Last updated: 2025-02-06

Locations

5 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated drug study