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Virus Therapy

CMV-MVA Triplex Vaccine for Cytomegalovirus

Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 to ≤65 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 0 to weeks 12, 24, 48, 72
Awards & highlights

Study Summary

This trial will test a new vaccine for CMV. 60 people will get the vaccine and 30 will get a placebo. The vaccine will be given as two injections, four weeks apart.

Who is the study for?
Adults aged 18-65 with stable HIV on antiretroviral therapy (ART) for at least 48 weeks, a CD4+ count over 250 cells/μL, and an undetectable viral load. They must not be pregnant or breastfeeding, agree to use contraception, have no history of severe allergies to vaccine components or autoimmune disorders, and cannot be using certain medications like anticoagulants.Check my eligibility
What is being tested?
The trial is testing the safety and immune response to a CMV vaccine called Triplex® in people living with HIV. Participants are randomly assigned in a 2:1 ratio to receive either two doses of the Triplex® vaccine or a placebo via muscle injections four weeks apart.See study design
What are the potential side effects?
Potential side effects may include typical reactions at the injection site such as pain and swelling, flu-like symptoms including fever and fatigue, allergic reactions to ingredients in the vaccine, and possibly other immune-related responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 0 to weeks 12, 24, 48, 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 0 to weeks 12, 24, 48, 72 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
CMV DNA in PBMC
CMV DNA in urine
CMV DNA is genital secretion
+10 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Vaccine GroupActive Control1 Intervention
60 participants will receive CMV-MVA Triplex® containing 5 x 108 plaque-forming unit (pfu) ±0.5 x 108 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections.
Group II: Placebo GroupPlacebo Group1 Intervention
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.

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Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,261 Previous Clinical Trials
5,483,012 Total Patients Enrolled
Sara Gianella, MDStudy ChairAIDS Clinical Trials Group
1 Previous Clinical Trials
44 Total Patients Enrolled

Media Library

CMV-MVA Triplex® (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05099965 — Phase 2
Human Immunodeficiency Virus Infection Research Study Groups: Vaccine Group, Placebo Group
Human Immunodeficiency Virus Infection Clinical Trial 2023: CMV-MVA Triplex® Highlights & Side Effects. Trial Name: NCT05099965 — Phase 2
CMV-MVA Triplex® (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05099965 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the inclusion criteria for this study extend to individuals beyond 45 years of age?

"The guidelines for inclusion in this clinical trial necessitate that the age of participants must be between 18 and 65 years old."

Answered by AI

What is the upper limit for participants in this clinical research?

"Affirmative. Clinicaltrials.gov reports that this experiment is actively searching for participants, with the initial posting falling on November 2nd 2021 and the most recent update occurring June 20th 2022. The medical trial aims to enlist 90 individuals from 12 sites."

Answered by AI

What are the eligibility requirements to join this clinical experiment?

"This clinical trial is searching for 90 participants aged between 18 and 65 with a pre-existing HIV infection. These are the baseline requirements to be eligible for enrolment."

Answered by AI

Are there any vacancies left in this clinical research project?

"Affirmative. According to clinicaltrials.gov, this study is currently enrolling 90 patients from 12 different sites and has been accepting candidates since November 2nd 2021 with its most recent update on June 20th 2022."

Answered by AI

What additional experiments have been conducted concerning the Vaccine Group?

"Vaccine Group was initially studied in 2015 at Dana-Farber Cancer Institute. To date, 18378 trials have been completed and 16 studies are still ongoing - many of these being carried out from Los Angeles, California."

Answered by AI

What evidence is there that Vaccine Group provides a secure treatment option?

"The safety of Vaccine Group was rated a 2, since the Phase 2 trial only showed preliminary evidence for its safety but not efficacy."

Answered by AI

Are there multiple venues in Canada dispatching this research?

"This trial has 12 medical centres that are actively recruiting, with locations in Los Angeles, Boston and Aurora. For patient convenience, it is advised to select the closest participating site for minimal travel requirements when partaking in this study."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital CRS (MGH CRS)
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I thought I was just trying to do a good thing. I also thought these might be paid.
PatientReceived no prior treatments
~17 spots leftby Nov 2024