Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa.

<h4>Background</h4>We conducted a double-blind, randomized, placebo-controlled Phase I study of a recombinant replication-defective adenovirus type 5 (rAd5) vector expressing HIV-1 Gag and Pol from subtype B and Env from subtypes A, B and C, given alone or as boost following a DNA plasmi...

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Autores principales:	Walter Jaoko, Etienne Karita, Kayitesi Kayitenkore, Gloria Omosa-Manyonyi, Susan Allen, Soe Than, Elizabeth M Adams, Barney S Graham, Richard A Koup, Robert T Bailer, Carol Smith, Len Dally, Bashir Farah, Omu Anzala, Claude M Muvunyi, Jean Bizimana, Tony Tarragona-Fiol, Philip J Bergin, Peter Hayes, Martin Ho, Kelley Loughran, Wendy Komaroff, Gwynneth Stevens, Helen Thomson, Mark J Boaz, Josephine H Cox, Claudia Schmidt, Jill Gilmour, Gary J Nabel, Patricia Fast, Job Bwayo
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2010
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/e14cd23e1bda4c33ac138fcbe3751b52
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spelling	oai:doaj.org-article:e14cd23e1bda4c33ac138fcbe3751b522021-11-18T06:34:59ZSafety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa.1932-620310.1371/journal.pone.0012873https://doaj.org/article/e14cd23e1bda4c33ac138fcbe3751b522010-09-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/20877623/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>We conducted a double-blind, randomized, placebo-controlled Phase I study of a recombinant replication-defective adenovirus type 5 (rAd5) vector expressing HIV-1 Gag and Pol from subtype B and Env from subtypes A, B and C, given alone or as boost following a DNA plasmid vaccine expressing the same HIV-1 proteins plus Nef, in 114 healthy HIV-uninfected African adults.<h4>Methodology/principal findings</h4>Volunteers were randomized to 4 groups receiving the rAd5 vaccine intramuscularly at dosage levels of 1×10(10) or 1×10(11) particle units (PU) either alone or as boost following 3 injections of the DNA vaccine given at 4 mg/dose intramuscularly by needle-free injection using Biojector® 2000. Safety and immunogenicity were evaluated for 12 months. Both vaccines were well-tolerated. Overall, 62% and 86% of vaccine recipients in the rAd5 alone and DNA prime - rAd5 boost groups, respectively, responded to the HIV-1 proteins by an interferon-gamma (IFN-γ) ELISPOT. The frequency of immune responses was independent of rAd5 dosage levels. The highest frequency of responses after rAd5 alone was detected at 6 weeks; after DNA prime - rAd5 boost, at 6 months (end of study). At baseline, neutralizing antibodies against Ad5 were present in 81% of volunteers; the distribution was similar across the 4 groups. Pre-existing immunity to Ad5 did not appear to have a significant impact on reactogenicity or immune response rates to HIV antigens by IFN-γ ELISPOT. Binding antibodies against Env were detected in up to 100% recipients of DNA prime - rAd5 boost. One volunteer acquired HIV infection after the study ended, two years after receipt of rAd5 alone.<h4>Conclusions/significance</h4>The HIV-1 rAd5 vaccine, either alone or as a boost following HIV-1 DNA vaccine, was well-tolerated and immunogenic in African adults. DNA priming increased the frequency and magnitude of cellular and humoral immune responses, but there was no effect of rAd5 dosage on immunogenicity endpoints.<h4>Trial registration</h4>ClinicalTrials.gov NCT00124007.Walter JaokoEtienne KaritaKayitesi KayitenkoreGloria Omosa-ManyonyiSusan AllenSoe ThanElizabeth M AdamsBarney S GrahamRichard A KoupRobert T BailerCarol SmithLen DallyBashir FarahOmu AnzalaClaude M MuvunyiJean BizimanaTony Tarragona-FiolPhilip J BerginPeter HayesMartin HoKelley LoughranWendy KomaroffGwynneth StevensHelen ThomsonMark J BoazJosephine H CoxClaudia SchmidtJill GilmourGary J NabelPatricia FastJob BwayoPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 5, Iss 9, p e12873 (2010)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Walter Jaoko Etienne Karita Kayitesi Kayitenkore Gloria Omosa-Manyonyi Susan Allen Soe Than Elizabeth M Adams Barney S Graham Richard A Koup Robert T Bailer Carol Smith Len Dally Bashir Farah Omu Anzala Claude M Muvunyi Jean Bizimana Tony Tarragona-Fiol Philip J Bergin Peter Hayes Martin Ho Kelley Loughran Wendy Komaroff Gwynneth Stevens Helen Thomson Mark J Boaz Josephine H Cox Claudia Schmidt Jill Gilmour Gary J Nabel Patricia Fast Job Bwayo Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa.
description	<h4>Background</h4>We conducted a double-blind, randomized, placebo-controlled Phase I study of a recombinant replication-defective adenovirus type 5 (rAd5) vector expressing HIV-1 Gag and Pol from subtype B and Env from subtypes A, B and C, given alone or as boost following a DNA plasmid vaccine expressing the same HIV-1 proteins plus Nef, in 114 healthy HIV-uninfected African adults.<h4>Methodology/principal findings</h4>Volunteers were randomized to 4 groups receiving the rAd5 vaccine intramuscularly at dosage levels of 1×10(10) or 1×10(11) particle units (PU) either alone or as boost following 3 injections of the DNA vaccine given at 4 mg/dose intramuscularly by needle-free injection using Biojector® 2000. Safety and immunogenicity were evaluated for 12 months. Both vaccines were well-tolerated. Overall, 62% and 86% of vaccine recipients in the rAd5 alone and DNA prime - rAd5 boost groups, respectively, responded to the HIV-1 proteins by an interferon-gamma (IFN-γ) ELISPOT. The frequency of immune responses was independent of rAd5 dosage levels. The highest frequency of responses after rAd5 alone was detected at 6 weeks; after DNA prime - rAd5 boost, at 6 months (end of study). At baseline, neutralizing antibodies against Ad5 were present in 81% of volunteers; the distribution was similar across the 4 groups. Pre-existing immunity to Ad5 did not appear to have a significant impact on reactogenicity or immune response rates to HIV antigens by IFN-γ ELISPOT. Binding antibodies against Env were detected in up to 100% recipients of DNA prime - rAd5 boost. One volunteer acquired HIV infection after the study ended, two years after receipt of rAd5 alone.<h4>Conclusions/significance</h4>The HIV-1 rAd5 vaccine, either alone or as a boost following HIV-1 DNA vaccine, was well-tolerated and immunogenic in African adults. DNA priming increased the frequency and magnitude of cellular and humoral immune responses, but there was no effect of rAd5 dosage on immunogenicity endpoints.<h4>Trial registration</h4>ClinicalTrials.gov NCT00124007.
format	article
author	Walter Jaoko Etienne Karita Kayitesi Kayitenkore Gloria Omosa-Manyonyi Susan Allen Soe Than Elizabeth M Adams Barney S Graham Richard A Koup Robert T Bailer Carol Smith Len Dally Bashir Farah Omu Anzala Claude M Muvunyi Jean Bizimana Tony Tarragona-Fiol Philip J Bergin Peter Hayes Martin Ho Kelley Loughran Wendy Komaroff Gwynneth Stevens Helen Thomson Mark J Boaz Josephine H Cox Claudia Schmidt Jill Gilmour Gary J Nabel Patricia Fast Job Bwayo
author_facet	Walter Jaoko Etienne Karita Kayitesi Kayitenkore Gloria Omosa-Manyonyi Susan Allen Soe Than Elizabeth M Adams Barney S Graham Richard A Koup Robert T Bailer Carol Smith Len Dally Bashir Farah Omu Anzala Claude M Muvunyi Jean Bizimana Tony Tarragona-Fiol Philip J Bergin Peter Hayes Martin Ho Kelley Loughran Wendy Komaroff Gwynneth Stevens Helen Thomson Mark J Boaz Josephine H Cox Claudia Schmidt Jill Gilmour Gary J Nabel Patricia Fast Job Bwayo
author_sort	Walter Jaoko
title	Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa.
title_short	Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa.
title_full	Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa.
title_fullStr	Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa.
title_full_unstemmed	Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa.
title_sort	safety and immunogenicity study of multiclade hiv-1 adenoviral vector vaccine alone or as boost following a multiclade hiv-1 dna vaccine in africa.
publisher	Public Library of Science (PLoS)
publishDate	2010
url	https://doaj.org/article/e14cd23e1bda4c33ac138fcbe3751b52
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Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa.

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