At a glance
ClinicalIndex Comparison Record- ✓HIV-1 infection documented by standard confirmatory testing (Western blot, second antibody test, or HIV-1 RNA assay).
- ✓Age 18–65 years.
- ✓Plasma HIV-1 RNA <50 copies/mL at 3 time points in prior 24 months with no consecutive RNA ≥50 copies/mL in past 24 months; also <50 at screening.
- ✓CD4+ cell count ≥350 cells/mm³ at screening.
- ✕HIV RNA ≥150 copies/mL at any point in the 6 months prior to screening.
- ✕Prior receipt of any HIV vaccine (prophylactic or therapeutic) or HIV immunotherapy.
- ✕Prior immunization with recombinant adenovirus or MVA vaccine, including adenovirus-vectored COVID-19 vaccines (Janssen, AstraZeneca).
- ✕Immunomodulatory, cytokine, or growth-stimulating factors (systemic chemotherapy, IL-2, interferon, methotrexate, GM-CSF, etc.) within 90 days prior to screening.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Pilot Study to Evaluate the Safety and Immunogenicity of the HIV-1 Vaccines MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) Given Alone or In Combination in HIV-1-Infected Adults Suppressed on Antiretroviral Therapy - The M&M Study
In Brief
A Phase 1 clinical trial evaluating MVA.tHIVconsv3, MVA.tHIVconsv4, and 1 other intervention for HIV-1 Infection. Completed, enrolled 26 participants across 1 site.
Detailed Summary
This is a double blind, randomized, placebo-controlled, parallel design, study in which 24 HIV-infected participants with durable viral suppression will be randomly assigned to receive vaccination with MVA.tHIVconsv3 (M3), MVA.tHIVconsv4 (M4), M3+M4 combined, or placebo. Participants will be randomized 7:7:7:3 to one of four study arms, and receive study treatment or placebo at Day 0. Each enrolled participant will complete the study in approximately 33.5 weeks (8.4 months). The purpose of this study is to find out: * If it is safe for people to receive injections of two investigational HIV vaccines, called MVAtHIVconsv3 and MVAtHIVconsv4 alone or in combination. * If giving participants these vaccine doses will increase their immune system's ability to kill HIV virus.
Study Details
Timeline
Interventions
viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1
viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1
The appropriate amount of Sodium Chloride for Injection USP, 0.9% will be drawn into a syringe.