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A phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 subtype C adeno-associated virus vaccine.

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A phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 subtype C adeno-associated virus vaccine. / Mehendale, Sanjay; van Lunzen, Jan; Clumeck, Nathan; Rockstroh, Jurgen; Vets, Eva; Johnson, Philip R; Anklesaria, Pervin; Barin, Burc; Boaz, Mark; Kochhar, Sonali; Lehrman, Jennifer; Schmidt, Claudia; Peeters, Mathieu; Schwarze-Zander, Carolynne; Kabamba, Kabeya; Glaunsinger, Tobias; Sahay, Seema; Thakar, Madhuri; Paranjape, Ramesh; Gilmour, Jill; Excler, Jean-Louis; Fast, Patricia; Heald, Alison E.

in: AIDS RES HUM RETROV, Jahrgang 24, Nr. 6, 6, 2008, S. 873-880.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Mehendale, S, van Lunzen, J, Clumeck, N, Rockstroh, J, Vets, E, Johnson, PR, Anklesaria, P, Barin, B, Boaz, M, Kochhar, S, Lehrman, J, Schmidt, C, Peeters, M, Schwarze-Zander, C, Kabamba, K, Glaunsinger, T, Sahay, S, Thakar, M, Paranjape, R, Gilmour, J, Excler, J-L, Fast, P & Heald, AE 2008, 'A phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 subtype C adeno-associated virus vaccine.', AIDS RES HUM RETROV, Jg. 24, Nr. 6, 6, S. 873-880. <http://www.ncbi.nlm.nih.gov/pubmed/18544020?dopt=Citation>

APA

Mehendale, S., van Lunzen, J., Clumeck, N., Rockstroh, J., Vets, E., Johnson, P. R., Anklesaria, P., Barin, B., Boaz, M., Kochhar, S., Lehrman, J., Schmidt, C., Peeters, M., Schwarze-Zander, C., Kabamba, K., Glaunsinger, T., Sahay, S., Thakar, M., Paranjape, R., ... Heald, A. E. (2008). A phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 subtype C adeno-associated virus vaccine. AIDS RES HUM RETROV, 24(6), 873-880. [6]. http://www.ncbi.nlm.nih.gov/pubmed/18544020?dopt=Citation

Vancouver

Mehendale S, van Lunzen J, Clumeck N, Rockstroh J, Vets E, Johnson PR et al. A phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 subtype C adeno-associated virus vaccine. AIDS RES HUM RETROV. 2008;24(6):873-880. 6.

Bibtex

@article{27a64b5e623246f1a0073661bffaa0c3,
title = "A phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 subtype C adeno-associated virus vaccine.",
abstract = "A novel prophylactic AIDS vaccine candidate, consisting of single-stranded DNA for HIV-1 subtype C gag, protease, and part of reverse transcriptase genes, enclosed within a recombinant adeno-associated virus serotype-2 protein capsid (tgAAC09) induced T cell responses and antibodies in nonhuman primates. In this randomized, dose escalation phase I trial, HIV-uninfected healthy volunteers (50 in Europe, 30 in India) received a single intramuscular injection of tgAAC09 at 3 x 10(9) DNase resistant particles (DRP) (n = 16), 3 x 10(10) DRP (n = 23), 3 x 10(11) DRP (n = 25), or placebo (n = 16). Twenty-one participants in Europe received a second (boost) dose of 3 x 10(11) DRP tgAAC09 or placebo at least 24 weeks after the first injection. The vaccine was safe and well-tolerated after initial and boost vaccination. Local and systemic reactogenicity was experienced by 13-25% of participants and was not dose related. No vaccine-related serious adverse events were reported. Modest HIV-specific T cell responses were detected in 7/64 vaccinees (40-385 SFC/10(6) PBMC), with 16% (4/25) responders in the highest dose group. All responses were to Gag epitopes. tgAAC09 appears to be safe, well-tolerated, and modestly immunogenic. Further evaluation of higher doses of tgAAC09 and boost injections is ongoing in Africa.",
author = "Sanjay Mehendale and {van Lunzen}, Jan and Nathan Clumeck and Jurgen Rockstroh and Eva Vets and Johnson, {Philip R} and Pervin Anklesaria and Burc Barin and Mark Boaz and Sonali Kochhar and Jennifer Lehrman and Claudia Schmidt and Mathieu Peeters and Carolynne Schwarze-Zander and Kabeya Kabamba and Tobias Glaunsinger and Seema Sahay and Madhuri Thakar and Ramesh Paranjape and Jill Gilmour and Jean-Louis Excler and Patricia Fast and Heald, {Alison E}",
year = "2008",
language = "Deutsch",
volume = "24",
pages = "873--880",
journal = "AIDS RES HUM RETROV",
issn = "0889-2229",
publisher = "Mary Ann Liebert Inc.",
number = "6",

}

RIS

TY - JOUR

T1 - A phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 subtype C adeno-associated virus vaccine.

AU - Mehendale, Sanjay

AU - van Lunzen, Jan

AU - Clumeck, Nathan

AU - Rockstroh, Jurgen

AU - Vets, Eva

AU - Johnson, Philip R

AU - Anklesaria, Pervin

AU - Barin, Burc

AU - Boaz, Mark

AU - Kochhar, Sonali

AU - Lehrman, Jennifer

AU - Schmidt, Claudia

AU - Peeters, Mathieu

AU - Schwarze-Zander, Carolynne

AU - Kabamba, Kabeya

AU - Glaunsinger, Tobias

AU - Sahay, Seema

AU - Thakar, Madhuri

AU - Paranjape, Ramesh

AU - Gilmour, Jill

AU - Excler, Jean-Louis

AU - Fast, Patricia

AU - Heald, Alison E

PY - 2008

Y1 - 2008

N2 - A novel prophylactic AIDS vaccine candidate, consisting of single-stranded DNA for HIV-1 subtype C gag, protease, and part of reverse transcriptase genes, enclosed within a recombinant adeno-associated virus serotype-2 protein capsid (tgAAC09) induced T cell responses and antibodies in nonhuman primates. In this randomized, dose escalation phase I trial, HIV-uninfected healthy volunteers (50 in Europe, 30 in India) received a single intramuscular injection of tgAAC09 at 3 x 10(9) DNase resistant particles (DRP) (n = 16), 3 x 10(10) DRP (n = 23), 3 x 10(11) DRP (n = 25), or placebo (n = 16). Twenty-one participants in Europe received a second (boost) dose of 3 x 10(11) DRP tgAAC09 or placebo at least 24 weeks after the first injection. The vaccine was safe and well-tolerated after initial and boost vaccination. Local and systemic reactogenicity was experienced by 13-25% of participants and was not dose related. No vaccine-related serious adverse events were reported. Modest HIV-specific T cell responses were detected in 7/64 vaccinees (40-385 SFC/10(6) PBMC), with 16% (4/25) responders in the highest dose group. All responses were to Gag epitopes. tgAAC09 appears to be safe, well-tolerated, and modestly immunogenic. Further evaluation of higher doses of tgAAC09 and boost injections is ongoing in Africa.

AB - A novel prophylactic AIDS vaccine candidate, consisting of single-stranded DNA for HIV-1 subtype C gag, protease, and part of reverse transcriptase genes, enclosed within a recombinant adeno-associated virus serotype-2 protein capsid (tgAAC09) induced T cell responses and antibodies in nonhuman primates. In this randomized, dose escalation phase I trial, HIV-uninfected healthy volunteers (50 in Europe, 30 in India) received a single intramuscular injection of tgAAC09 at 3 x 10(9) DNase resistant particles (DRP) (n = 16), 3 x 10(10) DRP (n = 23), 3 x 10(11) DRP (n = 25), or placebo (n = 16). Twenty-one participants in Europe received a second (boost) dose of 3 x 10(11) DRP tgAAC09 or placebo at least 24 weeks after the first injection. The vaccine was safe and well-tolerated after initial and boost vaccination. Local and systemic reactogenicity was experienced by 13-25% of participants and was not dose related. No vaccine-related serious adverse events were reported. Modest HIV-specific T cell responses were detected in 7/64 vaccinees (40-385 SFC/10(6) PBMC), with 16% (4/25) responders in the highest dose group. All responses were to Gag epitopes. tgAAC09 appears to be safe, well-tolerated, and modestly immunogenic. Further evaluation of higher doses of tgAAC09 and boost injections is ongoing in Africa.

M3 - SCORING: Zeitschriftenaufsatz

VL - 24

SP - 873

EP - 880

JO - AIDS RES HUM RETROV

JF - AIDS RES HUM RETROV

SN - 0889-2229

IS - 6

M1 - 6

ER -