CMV-MVA Triplex Vaccine for Cytomegalovirus

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 65 years old.

Exclusion Criteria

I have heart disease or diabetes.

I have active hepatitis B or C.

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

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

Participant Groups

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.

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.