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A phase IIA randomized clinical trial of a multiclade HIV-1 DNA prime followed by a multiclade rAd5 HIV-1 vaccine boost in healthy adults (HVTN204)

Churchyard, Gavin J ; Morgan, Cecilia ; Adams, Elizabeth ; Hural, John ; Graham, Barney S ; Moodie, Zoe ; Grove, Doug ; Gray, Glenda ; Bekker, Linda-Gail ; McElrath, M Juliana ; Tomaras, Georgia D ; Goepfert, Paul ; Kalams, Spyros ; Baden, Lindsey R ; Lally, Michelle ; Dolin, Raphael ; Blattner, William ; Kalichman, Artur ; Figueroa, J Peter ; Pape, Jean ; Schechter, Mauro ; Defawe, Olivier ; De Rosa, Stephen C ; Montefiori, David C ; Nabel, Gary J ; Corey, Lawrence ; Keefer, Michael C Gray, Clive M.

PloS one, 2011-08, Vol.6 (8), p.e21225 [Peer Reviewed Journal]

United States: Public Library of Science

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Title:
A phase IIA randomized clinical trial of a multiclade HIV-1 DNA prime followed by a multiclade rAd5 HIV-1 vaccine boost in healthy adults (HVTN204)
Author: Churchyard, Gavin J ; Morgan, Cecilia ; Adams, Elizabeth ; Hural, John ; Graham, Barney S ; Moodie, Zoe ; Grove, Doug ; Gray, Glenda ; Bekker, Linda-Gail ; McElrath, M Juliana ; Tomaras, Georgia D ; Goepfert, Paul ; Kalams, Spyros ; Baden, Lindsey R ; Lally, Michelle ; Dolin, Raphael ; Blattner, William ; Kalichman, Artur ; Figueroa, J Peter ; Pape, Jean ; Schechter, Mauro ; Defawe, Olivier ; De Rosa, Stephen C ; Montefiori, David C ; Nabel, Gary J ; Corey, Lawrence ; Keefer, Michael C
Gray, Clive M.
Subjects: Acquired immune deficiency syndrome ; Adenoviridae - genetics ; Adenoviruses ; Adolescent ; Adult ; Adults ; AIDS ; AIDS vaccines ; AIDS Vaccines - administration & dosage ; AIDS Vaccines - immunology ; Anemia - chemically induced ; Antibodies ; Antibodies, Viral - blood ; Antibodies, Viral - immunology ; Antigenic determinants ; Binding ; Biological response modifiers ; Biology ; Cancer ; CD4 antigen ; CD8 antigen ; Clinical trials ; Cohort Studies ; Cytokines ; Deoxyribonucleic acid ; Disease prevention ; DNA ; env Gene Products, Human Immunodeficiency Virus - genetics ; env Gene Products, Human Immunodeficiency Virus - immunology ; Enzyme-Linked Immunosorbent Assay ; Epidemiology ; Epitopes ; Female ; gag Gene Products, Human Immunodeficiency Virus - genetics ; gag Gene Products, Human Immunodeficiency Virus - immunology ; Health care ; HIV ; HIV (Viruses) ; HIV-1 - genetics ; HIV-1 - immunology ; Hospitals ; Human immunodeficiency virus ; Human Immunodeficiency Virus Proteins - genetics ; Human Immunodeficiency Virus Proteins - immunology ; Humans ; Immune response (cell-mediated) ; Immune response (humoral) ; Immunization - adverse effects ; Immunization - methods ; Immunization, Secondary - adverse effects ; Immunization, Secondary - methods ; Immunogenicity ; Immunoglobulin G - blood ; Immunoglobulin G - immunology ; Immunoglobulins ; Immunotherapy ; Infections ; Infectious diseases ; Inserts ; Interferon ; Interferon-gamma - blood ; Interferon-gamma - immunology ; Lymphocytes T ; Male ; Medical research ; Medicine ; Middle Aged ; nef Gene Products, Human Immunodeficiency Virus - genetics ; nef Gene Products, Human Immunodeficiency Virus - immunology ; Oligomers ; pol Gene Products, Human Immunodeficiency Virus - genetics ; pol Gene Products, Human Immunodeficiency Virus - immunology ; Product development ; T cells ; T-Lymphocytes - immunology ; T-Lymphocytes - metabolism ; Vaccines ; Vaccines, DNA - administration & dosage ; Vaccines, DNA - immunology ; Young Adult ; γ-Interferon
Is Part Of: PloS one, 2011-08, Vol.6 (8), p.e21225
Notes: Conceived and designed the experiments: GJC MCK CM EA JH BSG ZM DG OD SCD GDT DCM MJM GJN LC. Performed the experiments: GJC MCK GG L-GB PG SK LB ML RD WB AK JPF JP MS. Analyzed the data: GJC MCK ZM DG. Wrote the paper: GJC MCK CM EA JH BSG ZM DG OD SCD GDT DCM MJM GJN LC.
Description: The safety and immunogenicity of a vaccine regimen consisting of a 6-plasmid HIV-1 DNA prime (envA, envB, envC, gagB, polB, nefB) boosted by a recombinant adenovirus serotype-5 (rAd5) HIV-1 with matching inserts was evaluated in HIV-seronegative participants from South Africa, United States, Latin America and the Caribbean. 480 participants were evenly randomized to receive either: DNA (4 mg i.m. by Biojector) at 0, 1 and 2 months, followed by rAd5 (10(10) PU i.m. by needle/syringe) at 6 months; or placebo. Participants were monitored for reactogenicity and adverse events throughout the 12-month study. Peak and duration of HIV-specific humoral and cellular immune responses were evaluated after the prime and boost. The vaccine was well tolerated and safe. T-cell responses, detected by interferon-γ (IFN-γ) ELISpot to global potential T-cell epitopes (PTEs) were observed in 70.8% (136/192) of vaccine recipients overall, most frequently to Gag (54.7%) and to Env (54.2%). In U.S. vaccine recipients T-cell responses were less frequent in Ad5 sero-positive versus sero-negative vaccine recipients (62.5% versus 85.7% respectively, p = 0.035). The frequency of HIV-specific CD4+ and CD8+ T-cell responses detected by intracellular cytokine staining were similar (41.8% and 47.2% respectively) and most secreted ≥2 cytokines. The vaccine induced a high frequency (83.7%-94.6%) of binding antibody responses to consensus Group M, and Clades A, B and C gp140 Env oligomers. Antibody responses to Gag were elicited in 46% of vaccine recipients. The vaccine regimen was well-tolerated and induced polyfunctional CD4+ and CD8+ T-cells and multi-clade anti-Env binding antibodies. ClinicalTrials.gov NCT00125970.
Publisher: United States: Public Library of Science
Language: English

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A phase IIA randomized clinical trial of a multiclade HIV-1 DNA prime followed by a multiclade rAd5 HIV-1 vaccine boost in healthy adults (HVTN204)

United States: Public Library of Science

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