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

Summary

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

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.

Sponsors & Collaborators

• Johns Hopkins University

  collaborator OTHER

• University of Miami

  collaborator OTHER

• Leidos Biomedical Research, Inc.

  collaborator INDUSTRY

• Bambino Gesù Hospital and Research Institute

  collaborator OTHER

• PENTA Foundation

  collaborator NETWORK

• Case Western Reserve University

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Walter Reed Army Institute of Research (WRAIR)

  collaborator FED

• Armed Forces Research Institute of Medical Sciences, Thailand

  collaborator OTHER_GOV

• University of Padova

  collaborator OTHER

• Chulalongkorn University

  collaborator OTHER

• Henry M. Jackson Foundation for the Advancement of Military Medicine

  lead OTHER

Principal Investigators

• Merlin Robb, MD · Henry M. Jackson Foundation for the Advancement of Military Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-18

Primary Completion

2023-10-16

Completion

2023-10-16

Countries

• South Africa

Study Locations