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

Must not have

Pre-existing cardiovascular disease or diabetes mellitus

Active hepatitis C or hepatitis B

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

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.

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.

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

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart disease or diabetes.

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I have active hepatitis B or C.

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I have not received an MVA-based vaccine in the last year.

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I am on blood thinners or have a bleeding disorder that prevents me from getting muscle injections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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.

0 / 5Eligibility criteria met