Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)

Summary

A5355 was a randomized, placebo-controlled study conducted at US sites to evaluate the safety and immunogenicity of two injections of the study drug Modified Vaccinia Ankara (MVA)-based anti-Cytomegalovirus (CMV) Vaccine (Triplex®) in adults with both HIV and CMV. Participants were randomly assigned to receive either two injections of Triplex® or placebo at Entry/Day 0 and week 4. The primary hypotheses of this study were: 1. two injections of Triplex® administered according to a 4-week, two-injection schedule would be safe over 48 weeks, and 2. blood plasma levels of soluble receptors for tumor necrosis factor type II (sTNFRII) would decrease over the first 48 weeks in participants receiving the active vaccine compared to placebo.

Timeline

Start

2021-11-02

Primary completion

2024-11-08

Completion

2025-10-08

Drugs

Indications