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

NCT05099965 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-05-14

Study results available
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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.

Conditions

  • Cytomegalovirus Infections
  • HIV Infections
  • Vaccine

Interventions

BIOLOGICAL

CMV-MVA Triplex

5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine

BIOLOGICAL

Placebo

7.5% lactose in phosphate-buffered saline

Sponsors & Collaborators

  • Beckman Research Institute

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sara Gianella, MD · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2024-11-08
Completion
2025-10-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05099965 on ClinicalTrials.gov