Publications
50 results found
Keefer MC, Gilmour J, Hayes P, et al., 2012, A phase I double blind, placebo-controlled, randomized study of a multigenic HIV-1 adenovirus subtype 35 vector vaccine in healthy uninfected adults, PLoS One, Vol: 7, ISSN: 1932-6203
Njai HF, Gombe B, Khamis T, et al., 2011, Setting Up a Standardized Peripheral Blood Mononuclear Cells Processing Laboratory to Support Multi-center HIV/AIDS Vaccine and Intervention Trials, LABMEDICINE, Vol: 42, Pages: 711-718, ISSN: 0007-5027
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- Citations: 4
Cox JH, Hayes P, Cormier E, et al., 2011, T-Cell Responses Induced by Immunization with Ad35-HIV-1 Vaccines Are Broad, Durable, Polyfunctional and Can Mediate Inhibition of HIV, Conference on AIDS Vaccine, Publisher: MARY ANN LIEBERT INC, Pages: A20-A20, ISSN: 0889-2229
Vasan S, Hurley A, Schlesinger SJ, et al., 2011, <i>In Vivo</i> Electroporation Enhances the Immunogenicity of an HIV-1 DNA Vaccine Candidate in Healthy Volunteers, PLOS ONE, Vol: 6, ISSN: 1932-6203
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- Citations: 148
Vasan S, Hurley A, Schlesinger SJ, et al., 2011, In vivo electroporation enhances the immunogenicity of an HIV-1 DNA vaccine candidate in healthy volunteers, PLoS One, Vol: 6, ISSN: 1932-6203
Jaoko W, Karita E, Kayitenkore K, et al., 2010, Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa., PloS one, Vol: 5
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. 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. 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. ClinicalTr ials.gov NCT00124007.
Keefer M, Hachaambwa L, Bunce C, et al., 2010, Preliminary results of safety and immunogenicity of Ad35-GRIN/ENV HIV Vaccine in HIV-uninfected subjects (IAVI B001), AIDS Vaccine 2010, Publisher: MARY ANN LIEBERT INC, Pages: A16-A17, ISSN: 0889-2229
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- Citations: 1
Mehendale S, Sahay S, Thakar M, et al., 2010, Safety & immunogenicity of tgAAC09, a recombinant adeno-associated virus type 2 HIV-1 subtype C vaccine in India, INDIAN JOURNAL OF MEDICAL RESEARCH, Vol: 132, Pages: 168-175, ISSN: 0971-5916
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- Citations: 14
Vardas E, Kaleebu P, Bekker LG, et al., 2010, A phase 2 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 vaccine based on adeno-associated virus, AIDS Res Hum Retroviruses, Vol: 26, Pages: 933-942, ISSN: 1931-8405
Jaoko W, Karita E, Kayitenkore K, et al., 2010, Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa, PLoS One, Vol: 5, ISSN: 1932-6203
Gill DK, Huang Y, Levine GL, et al., 2010, Equivalence of ELISpot assays demonstrated between major HIV network laboratories, PLoS One, Vol: 5, ISSN: 1932-6203
Howles S, Guimaraes-Walker A, Yang H, et al., 2010, Vaccination with a modified vaccinia virus Ankara (MVA)-vectored HIV-1 immunogen induces modest vector-specific T cell responses in human subjects, Vaccine, Vol: 28, Pages: 7306-7312, ISSN: 1873-2518
Vasan S, Hurley A, Schlesinger SJ, et al., 2009, OA05-01. In vivo electroporation enhances the immunogenicity of ADVAX, a DNA-based HIV-1 vaccine candidate, in healthy volunteers, Retrovirology, Vol: 6
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- Citations: 6
Huang Y, Sato A, Wood B, et al., 2009, P16-19. Statistical design and analysis of the CAVD-VIMC Elispot transfer study 001, Retrovirology, Vol: 6
Stevens G, Chetty P, Stout J, et al., 2009, P06-07. A GCLP accredited Clinical Trial Laboratory Network in Africa and India: A collaborative effort between IAVI and in country research organizations, Retrovirology, Vol: 6
Simek MD, Rida W, Priddy FH, et al., 2009, Human Immunodeficiency Virus Type 1 Elite Neutralizers: Individuals with Broad and Potent Neutralizing Activity Identified by Using a High-Throughput Neutralization Assay together with an Analytical Selection Algorithm, JOURNAL OF VIROLOGY, Vol: 83, Pages: 7337-7348, ISSN: 0022-538X
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- Citations: 449
Sarzotti-Kelsoe M, Cox J, Cleland N, et al., 2009, Evaluation and Recommendations on Good Clinical Laboratory Practice Guidelines for Phase I–III Clinical Trials, PLoS Medicine, Vol: 6, Pages: 1-5
Sarzotti-Kelsoe M, Cox J, Cleland N, et al., 2009, Evaluation and recommendations on good clinical laboratory practice (GCLP) guidelines for phase I-III HIV vaccine clinical trials, RETROVIROLOGY, Vol: 6, ISSN: 1742-4690
Ramanathan VD, Kumar M, Mahalingam J, et al., 2009, A Phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 subtype C-modified vaccinia Ankara virus vaccine candidate in Indian volunteers, AIDS Res Hum Retroviruses, Vol: 25, Pages: 1107-1116, ISSN: 1931-8405
Huang Y, Sato A, Wood B, et al., 2009, Statistical design and analysis of the CAVD-VIMC Elispot transfer study 001, Publisher: BIOMED CENTRAL LTD, ISSN: 1742-4690
Stevens G, Chetty P, Stout J, et al., 2009, A GCLP accredited Clinical Trial Laboratory Network in Africa and India: a collaborative effort between IAVI and in country research organizations, Publisher: BIOMED CENTRAL LTD, ISSN: 1742-4690
Boaz MJ, Hayes P, Tarragona T, et al., 2009, Concordant proficiency in measurement of T-cell immunity in human immunodeficiency virus vaccine clinical trials by peripheral blood mononuclear cell and enzyme-linked immunospot assays in laboratories from three continents, Clin Vaccine Immunol, Vol: 16, Pages: 147-155, ISSN: 1556-679X
Gilmour J, Gill D, Huang Y, et al., 2008, Excellent Concordance between IFN-gamma ELISpot Assay Results in Two Comprehensive T Cell Vaccine Immune Monitoring Consortium (CTC-VIMC) Laboratories, AIDS Vaccine 2008 Conference, Publisher: MARY ANN LIEBERT INC, Pages: 137-137, ISSN: 0889-2229
Jaoko W, Nakwagala FN, Anzala O, et al., 2008, Safety and immunogenicity of recombinant low-dosage HIV-1 A vaccine candidates vectored by plasmid pTHr DNA or modified vaccinia virus Ankara (MVA) in humans in East Africa, Pages: 2788-2795, ISSN: 0264-410X
The safety and immunogenicity of plasmid pTHr DNA, modified vaccinia virus Ankara (MVA) human immunodeficiency virus type 1 (HIV-1) vaccine candidates were evaluated in four Phase I clinical trials in Kenya and Uganda. Both vaccines, expressing HIV-1 subtype A gag p24/p17 and a string of CD8 T-cell epitopes (HIVA), were generally safe and well-tolerated. At the dosage levels and intervals tested, the percentage of vaccine recipients with HIV-1-specific cell-mediated immune responses, assessed by a validated ex vivo interferon gamma (IFN-gamma) ELISPOT assay and Cytokine Flow Cytometry (CFC), did not significantly differ from placebo recipients. These trials demonstrated the feasibility of conducting high-quality Phase 1 trials in Africa.
Barry SP, Walter J, Eftyhia V, et al., 2007, Studies of a prophylactic HIV-1 vaccine candidate based on Modified vaccinia virus Ankara (MVA) with and without DNA priming: Effects of dosage and route on safety and immunogenicity, Vaccine, Vol: 25, Pages: 2120-2127
Gilmour J, Stevens G, Gill D, et al., 2007, Laboratory development and assay standardization for the evaluation of HIV vaccines in Africa and India, Cytom part B-Clin CY, Vol: 72B, Pages: 120-120
Gilmour J, Stevens G, Gill D, et al., 2007, Laboratory development and assay standardization for the evaluation of HIV vaccines in Africa and India, 6th Euroconference on Clinical Cell Analysis, Publisher: WILEY-LISS, Pages: 120-120, ISSN: 1552-4949
Bashir F, Ogola S, Idangasi J, et al., 2007, Ensuring Good Clinical Laboratory Practice (GCLP) compliance during the conduct of HIV-1 Vaccine clinical trials at Kenya AIDS Vaccine Initiative (KAVI)., AIDS Vacinne 2007 Conference
Peters BS, Jaoko W, Vardas E, et al., 2007, Studies of a prophylactic HIV-1 vaccine candidate based on modified vaccinia virus Ankara (MVA) with and without DNA priming: effects of dosage and route on safety and immunogenicity, Vaccine, Vol: 25, Pages: 2120-2127, ISSN: 0264-410X
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