Safety and immunogenicity of a modified pox vector-based HIV/AIDS vaccine candidate expressing Env, Gag, Pol and Nef proteins of HIV-1 subtype B (MVA-B) in healthy HIV-1-uninfected volunteers: A phase I clinical trial (RISVAC02).

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.

Negative influence of age on CD4+ cell recovery after highly active antiretroviral therapy in naive HIV-1-infected patients with severe immunodeficiency.

OBJECTIVE: To study the effect of age on several outcomes among 187 antiretroviral-naive infected patients who started highly active antiretroviral therapy (HAART) with 500/microl at 6, 12 and 18 months after the initiation of HAART were 2.2 (95% CI: 1.5; 3.2), 1.8 (95% CI: 1.2; 2.6), and 1.8 (95% CI: 1.2; 2.9) times less likely, respectively. We also found that patients >or=45 years old had worse complete CD4(+) recovery (CD4(+)>500 cells/microl) than patients <45 years old. CONCLUSION: The CD4(+) recovery after HAART is a prolonged and continuous process which extends for several years. Age at baseline is inversely correlated with the magnitude and speed of CD4(+) recovery among HIV-1 infected patients.