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Clinical Trial Summary

Participants will be 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. Vaccine Group: 60 participants will receive CMV-MVA Triplex® containing 5 x 10^8 plaque-forming unit (pfu) ±0.5 x 10^8 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections. Placebo Group: 30 participants will receive a volume of placebo (7.5% Lactose in phosphate-buffered saline [PBS]) that matches the volume of the active vaccine injection by IM deltoid injections.


Clinical Trial Description

A5355 is a phase II, double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of two injections of MVA Vaccine Encoding CMV antigens (Triplex®) in adults with both HIV and CMV. Participants will be 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 will have follow-up visits in person or by phone for 92 weeks after the second injection, for a total of 96 weeks of follow-up. During the study, participants will have blood, urine, genital secretions, and oral secretions collected. Enrollment will be stratified based on sex and use of gender-affirming hormones with at least 25% of participants being individuals assigned female sex at birth not on testosterone or individuals assigned male sex at birth on feminizing hormones. Special outreach to transgender and gender non-binary persons will be encouraged with exploratory stratified analysis conducted based on both gender and sex assigned at birth. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05099965
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 2, 2021
Completion date October 14, 2025

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