NCT05099965

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cytomegalovirus Infections
• HIV Infections
• Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	CMV-MVA Triplex	5 x 108 plaque-forming unit (pfu) ±0.5 x 108 pfu of MVA Vaccine
BIOLOGICAL	Placebo	7.5% Lactose in phosphate-buffered saline \[PBS\]

Timeline

• Start date: 2021-11-02
• Primary completion: 2024-11-08
• Completion: 2025-10-08
• First posted: 2021-10-29
• Last updated: 2025-11-12

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study