Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children
Brief 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.