HIV Vaccine to Reduce Reservoir in Children & Adolescents Network

Protocol Title: Phase I, Proof of Concept, Open-Label, Randomized Clinical Trial to Evaluate the Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens with or without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth

The first pilot clinical trial to evaluate therapeutic modalities to limit or reduce HIV reservoirs in children. In particular, the effect of vaccination with HIVIS DNA and MVA-CMDR on HIV reservoir markers as a result of vaccine-induced immune responses will be studied.

Rationale for the study: HIVIS DNA and MVA-CMDR vaccines induce immune responses important for clearing infected cells: broad HIV-specific CD8+ cytotoxic T cells, potent antibody dependent, cellular cytotoxicity (ADCC), and binding antibody (Ab) and neutralizing antibody (NAb). We include early treated children because of their healthy immunity and small HIV reservoirs. Giving licensed vaccine, CervarixR, against human papilloma virus (HPV) that contains toll-like receptor (TLR) 4 agonist with HIVIS DNA could increase DNA antigen loading on dendritic cells and promote adaptive immune responses to the HIV vaccine.

Study Design: The study will include a total of 25 children who are virally suppressed and youth aged ≥ 9 years old with perinatally acquired HIV to investigate the effects of HIVIS DNA / MVA-CMDR + Cervarix.

The participants will be enrolled and randomized to 3 arms:
Arm 2: HIVIS DNA/MVA-CMDR+Cervarix
Arm 3: Cervarix only.

Specific aims: HVRRICANE has two main aims; to quantitate and characterize the HIV reservoirs before and after HIVIS DNA ± Cervarix and MVA-CMDR vaccination and to characterize HIV-specific cellular and humoral immune responses before and after vaccination and assess their relationship to the HIV reservoir endpoints.

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