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Published on: October 18, 2012
The PEDVAC trial: preliminary data from the first therapeutic DNA vaccination in HIV-infected children
Paolo Palma1, Maria Luisa Romiti, Giuseppina Li Pira
1Chair of Pediatrics, University of Rome "Tor Vergata", Rome, Italy. paolo.palma@uniroma2.it
Insights
The PEDVAC study evaluated a novel therapeutic HIV DNA vaccine (HIVIS) in children. The vaccine demonstrated good safety and tolerance, with no severe adverse events or negative impacts on viral load or CD4 counts.
Area of Science:
- Immunology
- Vaccinology
- Pediatric Infectious Diseases
Background:
- Pediatric HIV-1 infection remains a global health challenge.
- Therapeutic vaccines aim to improve immune control in treated individuals.
- The PEDVAC study investigates a novel multiclade, multigene HIV DNA vaccine (HIVIS) for children.
Purpose of the Study:
- To assess the safety and immunogenicity of the HIVIS DNA vaccine in vertically HIV-1 infected children.
- To evaluate the vaccine's impact on immune responses in children on stable antiretroviral therapy.
- To determine if the therapeutic vaccine affects viral load or CD4+ T-cell counts.
Main Methods:
- A randomized controlled trial involving 20 HIV-1 infected children (6-16 years).
- Participants were on stable antiretroviral treatment (ART) with suppressed viral load and adequate CD4 counts.
- The vaccine group received intramuscular HIVIS DNA vaccine alongside ART; the control group received ART only. Immunizations occurred at weeks 0, 4, and 12.
Main Results:
- The HIVIS vaccine was well-tolerated, with only mild, self-limiting local skin reactions observed.
- No severe systemic adverse events were reported.
- No vaccinated children experienced a decrease in CD4+ T-cell counts or virological failure.
Conclusions:
- The HIVIS DNA vaccine shows a favorable safety profile in children with treated HIV-1 infection.
- Preliminary data suggest no detrimental effects on immune status or viral control.
- Further analysis of cellular immune responses will elucidate the vaccine's immunogenicity.
Abstract:
The PEDVAC study is the first trial designed to analyze safety and immunogenicity of a therapeutic vaccination with a multiclade multigene HIV DNA vaccine (HIVIS) in infected children. Twenty HIV-1 vertically infected children (6-16 years of age), on stable antiretroviral treatment for at least 6 months with HIV-1 RNA<50 copies/ml and stable CD4 counts (> 400 cells/mm³ or 25%) over 12 months of follow-up, were recruited into the study. Enrolled patients have been randomized into two arms: a control group of 10 children who continued previous antiretroviral treatment (HAART) (arm A) and a group of 10 children immunized intramuscularly with the HIVIS DNA vaccine in addition to previous HAART (arm B). Immunizations took place at week 0, 4, 12 and the boosting dose is planned at week 36. The 10 children in the vaccine group have received the first 3 priming doses of the HIVIS vaccine. Safety data showed good tolerance to the vaccination schedule. Mild cutaneous self-limeted reactions consisted of local irritation, usually itching or erythema +/- swelling at the injection site, were reported. No severe systemic adverse events have been observed. No vaccinated children had a decrease of CD4 T-cell counts from baseline. None experienced virological failure. Analysis of cellular immune responses was scheduled at week 0, 4, 12, 16, 20, 40, 60, 72 and 96 by standard lymphoproliferation assay, intracellular cytokine staining and cell-ELISA, a miniaturized assay to measure antigen-induced IFNγ secretion. Evaluation of these results is in progress and will provide key information on the status and changes of antigen specific immunity during HIV DNA immunization.
