Safety and immunogenicity of an HIV subtype B and E prime-boost vaccine combination in HIV-negative Thai adults

ALVAC-HIV (vCP1521) and AIDSVAX B/E were evaluated in a phase 1/2 trial of human immunodeficiency virus (HIV)- negative Thai adults. Of 133 volunteers enrolled, 122 completed the trial. There were no serious vaccine-related adverse events, nor were there intercurrent HIV infections. Lymphoproliferat...

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Bibliographic Details
Published in:The Journal of infectious diseases 2004-08, Vol.190 (4), p.702-706
Main Authors: Nitayaphan, Sorachai, Pitisuttithum, Punnee, Karnasuta, Chitraporn, Eamsila, Chirapa, de Souza, Mark, Morgan, Patricia, Polonis, Victoria, Benenson, Michael, VanCott, Tom, Ratto-Kim, Silvia, Kim, Jerome, Thapinta, Darawan, Garner, Robin, Bussaratid, Valai, Singharaj, Pricha, el Habib, Raphaelle, Gurunathan, Sanjay, Heyward, William, Birx, Deborah, McNeil, John, Brown, Arthur E.
Format: Article
Language:English
Subjects:
Adult
AIDS Vaccines - administration & dosage
AIDS Vaccines - adverse effects
AIDS Vaccines - immunology
Antibodies
Applied microbiology
Biological and medical sciences
CD8-Positive T-Lymphocytes - immunology
Cytotoxicity, Immunologic
Experimentation
Female
Fundamental and applied biological sciences. Psychology
HIV
HIV 1
HIV Antibodies - biosynthesis
HIV Antibodies - blood
HIV Envelope Protein gp120 - immunology
HIV Envelope Protein gp120 - pharmacology
HIV Infections - blood
HIV Infections - immunology
HIV Infections - prevention & control
HIV Seronegativity - immunology
Human immunodeficiency virus
Human immunodeficiency virus 1
Human immunodeficiency virus 2
Humans
Immune response
Immunization Schedule
Immunization, Secondary
Infectious diseases
Leukocytes, Mononuclear - immunology
Lymphocyte Activation
Major Articles and Brief Reports
Male
Medical research
Medical sciences
Microbiology
Middle Aged
Miscellaneous
Neutralization Tests
Placebos
T lymphocytes
Thailand
Time Factors
Vaccination
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Virology
Volunteerism
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Summary:ALVAC-HIV (vCP1521) and AIDSVAX B/E were evaluated in a phase 1/2 trial of human immunodeficiency virus (HIV)- negative Thai adults. Of 133 volunteers enrolled, 122 completed the trial. There were no serious vaccine-related adverse events, nor were there intercurrent HIV infections. Lymphoproliferative responses to glycoprotein 120 E were induced in 63% of the volunteers, and HIV-specific CD8 cytotoxic T lymphocyte responses were induced in 24%. Antibody responses increased in frequency and magnitude in association with the dose level of AIDSVAX B/E. Binding and neutralizing antibodies to the MN strain were induced in 100% and 98%, respectively, of the volunteers receiving 600 µg of AIDSVAX B/E, and such antibodies to E strains were induced in 96% and 71%, respectively, of these volunteers. This vaccine combination was well tolerated and was immunogenic, meeting milestones for advancement to phase 3 evaluation.
ISSN:0022-1899
1537-6613
DOI:10.1086/422258