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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: Completed Phase 2 study of HIV Infections and Cytomegalovirus Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Higher scores/grades mean a worse outcome.
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 |
What the finished NCT05099965 record still lists
NCT05099965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (80% lower).
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 lists 12 locations in 9 states (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.
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