The PEDVAC trial: Preliminary data from the first therapeutic DNA vaccination in HIV-infected children

Paolo Palma, Maria Luisa Romiti, Giuseppina Li Pira, Carla Montesano, Nadia Mora, Angela Aquilani, Veronica Santilli, Hyppolite K. Tchidjou, Federico Ivaldi, Luigi Giovannelli, Giuseppe Pontrelli, Giada Borra, Pontus Blomberg, Lindvi Gudmundsdotter, Andreas Bråve, Marco Montano, Stefania Bernardi, Fabrizio Manca, Britta Wahren, Paolo Rossi

Research output: Contribution to journalArticle

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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 RNA400cells/mm 3 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.

Original languageEnglish
Pages (from-to)6810-6816
Number of pages7
JournalVaccine
Volume29
Issue number39
DOIs
Publication statusPublished - Sep 9 2011

Fingerprint

Vaccination
vaccination
HIV
therapeutics
DNA
DNA Vaccines
Highly Active Antiretroviral Therapy
recombinant vaccines
Human immunodeficiency virus 1
HIV-1
Immunization
immunization
Therapeutics
Vaccines
vaccines
antigens
Safety
Antigens
AIDS Vaccines
erythema

Keywords

  • Children
  • HIV
  • Multigene HIV DNA vaccine
  • Therapeutic vaccine

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)
  • Molecular Medicine

Cite this

The PEDVAC trial : Preliminary data from the first therapeutic DNA vaccination in HIV-infected children. / Palma, Paolo; Romiti, Maria Luisa; Li Pira, Giuseppina; Montesano, Carla; Mora, Nadia; Aquilani, Angela; Santilli, Veronica; Tchidjou, Hyppolite K.; Ivaldi, Federico; Giovannelli, Luigi; Pontrelli, Giuseppe; Borra, Giada; Blomberg, Pontus; Gudmundsdotter, Lindvi; Bråve, Andreas; Montano, Marco; Bernardi, Stefania; Manca, Fabrizio; Wahren, Britta; Rossi, Paolo.

In: Vaccine, Vol. 29, No. 39, 09.09.2011, p. 6810-6816.

Research output: Contribution to journalArticle

Palma, P, Romiti, ML, Li Pira, G, Montesano, C, Mora, N, Aquilani, A, Santilli, V, Tchidjou, HK, Ivaldi, F, Giovannelli, L, Pontrelli, G, Borra, G, Blomberg, P, Gudmundsdotter, L, Bråve, A, Montano, M, Bernardi, S, Manca, F, Wahren, B & Rossi, P 2011, 'The PEDVAC trial: Preliminary data from the first therapeutic DNA vaccination in HIV-infected children', Vaccine, vol. 29, no. 39, pp. 6810-6816. https://doi.org/10.1016/j.vaccine.2010.12.058
Palma, Paolo ; Romiti, Maria Luisa ; Li Pira, Giuseppina ; Montesano, Carla ; Mora, Nadia ; Aquilani, Angela ; Santilli, Veronica ; Tchidjou, Hyppolite K. ; Ivaldi, Federico ; Giovannelli, Luigi ; Pontrelli, Giuseppe ; Borra, Giada ; Blomberg, Pontus ; Gudmundsdotter, Lindvi ; Bråve, Andreas ; Montano, Marco ; Bernardi, Stefania ; Manca, Fabrizio ; Wahren, Britta ; Rossi, Paolo. / The PEDVAC trial : Preliminary data from the first therapeutic DNA vaccination in HIV-infected children. In: Vaccine. 2011 ; Vol. 29, No. 39. pp. 6810-6816.
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