At a glance
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Phase II, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®), in Adults With Both Human Immunodeficiency Virus (HIV)-1 and CMV Who Are on Potent Combination ART With Conserved Immune Function
In Brief
A Phase 2 clinical trial evaluating CMV-MVA Triplex and Placebo for Cytomegalovirus Infections and 2 related conditions. Completed, enrolled 94 participants across 12 sites.
Detailed 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.
Study Details
Timeline
Interventions
5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine
7.5% lactose in phosphate-buffered saline