Background
The Thai phase III HIV vaccine trial's modest efficacy (VE 31.2% 95% CI 1.1, 51.2) represents the first demonstration that a vaccine can protect against HIV acquisition. Baseline variables of age, gender, marital status, and risk did not modify vaccine efficacy (VE). Here we explore behavioral risk and efficacy at 6 monthly intervals following vaccination.
Methods
Behavioral risk was assessed with a self-administered questionnaire every 6 months during trial participation. Both the acquisition endpoint and the early viral load endpoint are examined for interactions with risk status over time and temporal effects following vaccination.
Finding
Risk for HIV acquisition is low in each risk group, but the majority of participants reported higher-risk behavior at least once during the study (N= 9187, 58%). In post-hoc analyses, comparing those participants categorized as high or rising risk at least once during study follow-up versus those who maintained low or medium risk behavior as a time-varying covariate, the interaction of risk status and acquisition efficacy is significant (P = 0.010) with greater benefit in the lower risk individuals. VE appears to peak early with an estimate of cumulative VE = 60% through 12 months after initial vaccination (95% CI 22 –80%), and declines quickly. Vaccination did not appear to affect viral load in either early or late infections.
Interpretation
Future HIV vaccine trials must recognize potential interactions between challenge intensity and risk heterogeneity in the population and treatment effects. The regimen tested in the Thai phase III trial may benefit from extended immunization schedules.
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 microg 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.
OBJECTIVE
To explore and understand key cultural contexts of tobacco use among South Asian communities in the United States.
DESIGN
Focus groups, with homogenous compositions of gender, generational status, and length of time in the United States, were conducted in two distinct South Asian ethnic enclaves. Focus group findings were triangulated with observational data regarding availability of culturally-specific tobacco from commercial ethnic outlets and cultural events.
SUBJECTS
Respondents included 88 men and women of South Asian descent, aged 18 to 65 years, immigrant and native born, representing diversity of religion, socioeconomic status, and region of origin, with use of at least one culturally-specific tobacco product in previous 24 months.
RESULTS
A large number of culturally-specific products are commonly used by community members. Knowledge of product-specific health risks was lacking or inaccurate. Many culturally-specific tobacco products were considered to have beneficial properties. South Asian tobacco items were used to preserve cultural traditions and express ethnic identity in a new dominant culture. The social and cultural value ascribed to use helped distinguish community members from mainstream society and from other minority populations.
CONCLUSIONS
Many cultural factors govern tobacco use among diverse global populations. Especially for migrants with a common regional origin, the role of ethnic identity may strongly influence culturally-specific tobacco patterns. Qualitative inquiry helps elucidate such culturally-framed behaviors in culturally-diverse populations. These cultural contexts should be integrated into research and practice. Understanding multidimensional factors influencing non-traditional tobacco use is key to ensuring that comprehensive tobacco control strategies address tobacco-related disparities.
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