Phase 2 Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults - Trial PACTR202308863634681

Timeline & Enrollment

Summary

Sudan Ebolavirus (SUDV) is a member of the Filoviridae family, which is known to induce viral hemorrhagic fever. SUDV has been associated with eight outbreaks, most recently in Uganda, and has a case fatality rate between 53-100%. There are no approved vaccines or therapeutics to treat individuals infected with SUDV. Building upon positive results of two phase I studies in Uganda and the United States respectively to evaluate the safety and immunogenicity of a single dose of the cAd3-EBO S vaccine, the vaccine is progressing into phase II trials. This is a multi-center, double-blinded, placebo-controlled, Phase II study to evaluate safety, tolerability, and immunogenicity of a single dose of cAd3-EBO S vaccine in healthy adults up to 70 years of age, in Uganda and Kenya. The study will enroll 125 eligible participants randomized 4:1 to receive the cAd3-EBO S vaccine at 1.0 × 10^11 PU dose or placebo (0.9% NaCl solution) at Day 1, intramuscularly in deltoid muscle. Participants will be screened for eligibility up to 28 days before enrollment. Enrollment will be staggered, starting with healthy adults 18 to 50 years of age (inclusive). Upon enrollment of minimum 25 younger adult participants (sentinel), the safety data up to 7 days post vaccination of these 25 sentinel participants will be reviewed by the independent DSMB. Progression to enrollment of the older adults (>50 to 70 years of age) will be dependent on the unblinded review of the DSMB. Safety and immunogenicity will be assessed at Days 1, 8, 15, 29, 85, 169, and will conclude at the end of study visit on Day 366. The primary objective is to evaluate the safety and tolerability of the cAd3-EBO S vaccine. The secondary objectives are to evaluate antibody responses (IgG) to cAd3-EBO S vaccine at Day 29 post-vaccination and across additional timepoints post-vaccination.

ICD-10 Classifications