Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05099965 · ClinicalTrials.gov registry record · Phase 2
Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)
A Phase 2 study of HIV Infections and Cytomegalovirus Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 12
- Study locations
NCT05099965 is a Phase 2 study of HIV Infections and Cytomegalovirus Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 90 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (80% lower). The trial reports 12 study locations across 9 states.
The verdict
NCT05099965, a Phase 2 study of HIV Infections and Cytomegalovirus Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 12
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL CMV-MVA Triplex
Study Locations (12)
California
- UCLA CARE Center CRS - Los Angeles
- UCSD Antiviral Research Center - San Diego
- Ucsf Hiv/Aids Crs - San Francisco
Pennsylvania
- Penn Therapeutics, CRS - Philadelphia
- University of Pittsburgh CRS - Pittsburgh
Alabama
- Alabama CRS - Birmingham
Colorado
- University of Colorado Hospital CRS - Aurora
Massachusetts
- Massachusetts General Hospital CRS (MGH CRS) - Boston
Missouri
- Washington University Therapeutics (WT) CRS - St Louis
North Carolina
- Chapel Hill CRS - Chapel Hill
Ohio
- Case Clinical Research Site - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2021-11-02 |
| Est. Completion | 2025-10-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05099965
The ClinicalTrials.gov registry entry for NCT05099965 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (80% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05099965 reports 12 study locations spanning 9 distinct geographic areas - top geographies include California, Pennsylvania, Alabama.
Frequently Asked Questions
What is clinical trial NCT05099965 about?
NCT05099965 is a clinical study titled "Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)". 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 En...
What is the current status of trial NCT05099965?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2021-11-02. Estimated completion is 2025-10-08.
What conditions does trial NCT05099965 study?
This clinical trial studies the following conditions: HIV Infections, Cytomegalovirus Infections, Vaccine.
What interventions are being tested in trial NCT05099965?
The interventions under investigation include: Placebo (BIOLOGICAL), CMV-MVA Triplex (BIOLOGICAL).
Who is sponsoring clinical trial NCT05099965?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05099965 being conducted?
This trial has 12 study locations across Alabama, California, Colorado, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
RECRUITING · Phase 2
-
Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT
RECRUITING · Phase 2
-
Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
RECRUITING · Phase 2
-
Imaging Immune Activation in HIV by PET-MR
RECRUITING · Phase 2
-
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)
ACTIVE NOT RECRUITING · Phase 2
-
A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)
ACTIVE NOT RECRUITING · Phase 2
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.