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

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

February 18, 2022

Primary Completion Date

October 16, 2023

Study Completion Date

October 16, 2023

Conditions
HIV Infections
Interventions
BIOLOGICAL

HIVIS DNA/MVA-CMDR

HIVIS DNA IM by needle-free injection at weeks 0 and 4 followed by intramuscular (IM) needle injection of 1 X 108 IU/mL (1ml) MVA-CMDR at weeks 24 and 36 in the same arm as HIVIS DNA.

BIOLOGICAL

HIVIS DNA + Cervarix and MVA-CMDR

Cervarix IM by needle injection followed by 1500 micrograms (0.5ml) per injection of HIVIS DNA IM by a needle-free injection device in the skin above (proximal to) the Cervarix injection (within 1.5 cm). They will receive 1 X 108 IU/mL (1ml) MVA-CMDR IM by needle injection at weeks 24 and 36 in the same arm as HIVIS DNA. They will also receive 0.5 ml Cervarix at the time of the first MVACMDR injection in the opposite arm from the MVA injection at week 24.

BIOLOGICAL

Cervarix

Cervarix by IM needle injection at weeks 0, 4 and 24.

Trial Locations (1)

7505

Stellenbosch University, Tygerberg Hills

Sponsors
All Listed Sponsors
collaborator

Bambino Gesù Hospital and Research Institute

OTHER

collaborator

PENTA Foundation

NETWORK

collaborator

Johns Hopkins University

OTHER

collaborator

University of Miami

OTHER

collaborator

Leidos Biomedical Research, Inc.

INDUSTRY

collaborator

Case Western Reserve University

OTHER

collaborator

Karolinska Institutet

OTHER

collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

collaborator

Armed Forces Research Institute of Medical Sciences, Thailand

OTHER_GOV

collaborator

University of Padova

OTHER

collaborator

Chulalongkorn University

OTHER

lead

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

NCT04301154 - 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 | Biotech Hunter | Biotech Hunter