Subject(s)
AIDS Vaccines , HIV Infections/prevention & control , Human Experimentation , Patient Selection , Adult , Clinical Trials, Phase I as Topic , Female , HIV Infections/epidemiology , Human Experimentation/statistics & numerical data , Humans , Informed Consent , Male , Motivation , Randomized Controlled Trials as Topic , Risk Factors , Spain/epidemiology , Young AdultABSTRACT
BACKGROUND: To investigate the safety and immunogenicity of a modified vaccinia virus Ankara vector expressing HIV-1 antigens from clade B (MVA-B), a phase-I, doubled-blind placebo-controlled trial was performed. METHODS: 30 HIV-uninfected volunteers at low risk of HIV-1 infection were randomly allocated to receive 3 intramuscular injections (1×10(8)pfu/dose) of MVA-B (n=24) or placebo (n=6) at weeks 0, 4 and 16. All volunteers were followed 48 weeks. Primary end-points were adverse events and immunogenicity. RESULTS: A total of 169 adverse events were reported, 164 of grade 1-2, and 5 of grade 3 (none related to vaccination). Overall 75% of the volunteers showed positive ELISPOT responses at any time point. The magnitude (median) of the total responses induced was 288SFC/10(6)PBMC at week 18. Antibody responses against Env were observed in 95% and 72% of vaccinees at week 18 and 48, respectively. HIV-1 neutralizing antibodies were detected in 33% of volunteers. CONCLUSIONS: MVA-B was safe, well tolerated and elicited strong and durable T-cell and antibody responses in 75% and 95% of volunteers, respectively. These data support further exploration of MVA-B as an HIV-1 vaccine candidate. Clinical Trials.gov identifier: NCT00679497.
Subject(s)
AIDS Vaccines/adverse effects , AIDS Vaccines/immunology , Drug Carriers , Genetic Vectors , HIV-1/immunology , Vaccinia virus/genetics , Viral Proteins/immunology , AIDS Vaccines/administration & dosage , AIDS Vaccines/genetics , Adolescent , Adult , Cytokines/metabolism , Double-Blind Method , Enzyme-Linked Immunospot Assay , Female , HIV Antibodies/blood , HIV-1/genetics , Human Experimentation , Humans , Injections, Intramuscular , Leukocytes, Mononuclear/immunology , Male , Middle Aged , Placebos/administration & dosage , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/genetics , Vaccines, Synthetic/immunology , Viral Proteins/genetics , Young AdultABSTRACT
OBJECTIVE: To study the effect of age on several outcomes among 187 antiretroviral-naive infected patients who started highly active antiretroviral therapy (HAART) with