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

A5355 was a phase II, double-blind, randomized, placebo-controlled, multicenter trial to evaluate the safety and immunogenicity of two injections of MVA-based anti-CMV Vaccine (Triplex®) in adults with both HIV and CMV. Participants were randomized in a 2:1 ratio to receive either two injections of CMV-MVA Triplex® or placebo administered at study Entry/Day 0 and week 4. Participants were followed for 92 weeks after the last scheduled vaccination at week 4, for a total study duration of 96 weeks. During the study, participants had blood, urine, genital secretions, and oral secretions collected. Enrollment was stratified based on sex and use of gender-affirming hormones. The target sample size was 90 participants (of whom at least 25% were to be female participants not on testosterone or male participants on feminizing hormones).