Therapeutic DNA vaccination of vertically HIV-infected children: report of the first pediatric randomised trial (PEDVAC).

<h4>Subjects</h4>Twenty vertically HIV-infected children, 6-16 years of age, with stable viral load control and CD4+ values above 400 cells/mm(3).<h4>Intervention</h4>Ten subjects continued their ongoing antiretroviral treatment (ART, Group A) and 10 were immunized with a HIV...

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Autores principales:	Paolo Palma, Maria Luisa Romiti, Carla Montesano, Veronica Santilli, Nadia Mora, Angela Aquilani, Stefania Dispinseri, Hyppolite K Tchidjou, Marco Montano, Lars E Eriksson, Stefania Baldassari, Stefania Bernardi, Gabriella Scarlatti, Britta Wahren, Paolo Rossi
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2013
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/2fae08b895b048feaa4b1ba130fb66aa
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spelling	oai:doaj.org-article:2fae08b895b048feaa4b1ba130fb66aa2021-11-18T08:44:19ZTherapeutic DNA vaccination of vertically HIV-infected children: report of the first pediatric randomised trial (PEDVAC).1932-620310.1371/journal.pone.0079957https://doaj.org/article/2fae08b895b048feaa4b1ba130fb66aa2013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24312194/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Subjects</h4>Twenty vertically HIV-infected children, 6-16 years of age, with stable viral load control and CD4+ values above 400 cells/mm(3).<h4>Intervention</h4>Ten subjects continued their ongoing antiretroviral treatment (ART, Group A) and 10 were immunized with a HIV-DNA vaccine in addition to their previous therapy (ART and vaccine, Group B). The genetic vaccine represented HIV-1 subtypes A, B and C, encoded Env, Rev, Gag and RT and had no additional adjuvant. Immunizations took place at weeks 0, 4 and 12, with a boosting dose at week 36. Monitoring was performed until week 60 and extended to week 96.<h4>Results</h4>Safety data showed good tolerance of the vaccine. Adherence to ART remained high and persistent during the study and did not differ significantly between controls and vaccinees. Neither group experienced either virological failure or a decline of CD4+ counts from baseline. Higher HIV-specific cellular immune responses were noted transiently to Gag but not to other components of the vaccine. Lymphoproliferative responses to a virion antigen HIV-1 MN were higher in the vaccinees than in the controls (p = 0.047), whereas differences in reactivity to clade-specific Gag p24, RT or Env did not reach significance. Compared to baseline, the percentage of HIV-specific CD8+ lymphocytes releasing perforin in the Group B was higher after the vaccination schedule had been completed (p = 0.031). No increased CD8+ perforin levels were observed in control Group A.<h4>Conclusions</h4>The present study demonstrates the feasibility, safety and moderate immunogenicity of genetic vaccination in vertically HIV-infected children, paving the way for amplified immunotherapeutic approaches in the pediatric population.<h4>Trial registration</h4>clinicaltrialsregister.eu _2007-002359-18IT.Paolo PalmaMaria Luisa RomitiCarla MontesanoVeronica SantilliNadia MoraAngela AquilaniStefania DispinseriHyppolite K TchidjouMarco MontanoLars E ErikssonStefania BaldassariStefania BernardiGabriella ScarlattiBritta WahrenPaolo RossiPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 11, p e79957 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Paolo Palma Maria Luisa Romiti Carla Montesano Veronica Santilli Nadia Mora Angela Aquilani Stefania Dispinseri Hyppolite K Tchidjou Marco Montano Lars E Eriksson Stefania Baldassari Stefania Bernardi Gabriella Scarlatti Britta Wahren Paolo Rossi Therapeutic DNA vaccination of vertically HIV-infected children: report of the first pediatric randomised trial (PEDVAC).
description	<h4>Subjects</h4>Twenty vertically HIV-infected children, 6-16 years of age, with stable viral load control and CD4+ values above 400 cells/mm(3).<h4>Intervention</h4>Ten subjects continued their ongoing antiretroviral treatment (ART, Group A) and 10 were immunized with a HIV-DNA vaccine in addition to their previous therapy (ART and vaccine, Group B). The genetic vaccine represented HIV-1 subtypes A, B and C, encoded Env, Rev, Gag and RT and had no additional adjuvant. Immunizations took place at weeks 0, 4 and 12, with a boosting dose at week 36. Monitoring was performed until week 60 and extended to week 96.<h4>Results</h4>Safety data showed good tolerance of the vaccine. Adherence to ART remained high and persistent during the study and did not differ significantly between controls and vaccinees. Neither group experienced either virological failure or a decline of CD4+ counts from baseline. Higher HIV-specific cellular immune responses were noted transiently to Gag but not to other components of the vaccine. Lymphoproliferative responses to a virion antigen HIV-1 MN were higher in the vaccinees than in the controls (p = 0.047), whereas differences in reactivity to clade-specific Gag p24, RT or Env did not reach significance. Compared to baseline, the percentage of HIV-specific CD8+ lymphocytes releasing perforin in the Group B was higher after the vaccination schedule had been completed (p = 0.031). No increased CD8+ perforin levels were observed in control Group A.<h4>Conclusions</h4>The present study demonstrates the feasibility, safety and moderate immunogenicity of genetic vaccination in vertically HIV-infected children, paving the way for amplified immunotherapeutic approaches in the pediatric population.<h4>Trial registration</h4>clinicaltrialsregister.eu _2007-002359-18IT.
format	article
author	Paolo Palma Maria Luisa Romiti Carla Montesano Veronica Santilli Nadia Mora Angela Aquilani Stefania Dispinseri Hyppolite K Tchidjou Marco Montano Lars E Eriksson Stefania Baldassari Stefania Bernardi Gabriella Scarlatti Britta Wahren Paolo Rossi
author_facet	Paolo Palma Maria Luisa Romiti Carla Montesano Veronica Santilli Nadia Mora Angela Aquilani Stefania Dispinseri Hyppolite K Tchidjou Marco Montano Lars E Eriksson Stefania Baldassari Stefania Bernardi Gabriella Scarlatti Britta Wahren Paolo Rossi
author_sort	Paolo Palma
title	Therapeutic DNA vaccination of vertically HIV-infected children: report of the first pediatric randomised trial (PEDVAC).
title_short	Therapeutic DNA vaccination of vertically HIV-infected children: report of the first pediatric randomised trial (PEDVAC).
title_full	Therapeutic DNA vaccination of vertically HIV-infected children: report of the first pediatric randomised trial (PEDVAC).
title_fullStr	Therapeutic DNA vaccination of vertically HIV-infected children: report of the first pediatric randomised trial (PEDVAC).
title_full_unstemmed	Therapeutic DNA vaccination of vertically HIV-infected children: report of the first pediatric randomised trial (PEDVAC).
title_sort	therapeutic dna vaccination of vertically hiv-infected children: report of the first pediatric randomised trial (pedvac).
publisher	Public Library of Science (PLoS)
publishDate	2013
url	https://doaj.org/article/2fae08b895b048feaa4b1ba130fb66aa
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Therapeutic DNA vaccination of vertically HIV-infected children: report of the first pediatric randomised trial (PEDVAC).

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