First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090).

Background. We report the first-in-human safety and immunogenicity evaluation of a highly attenuated, replication-competent recombinant vesicular stomatitis virus (rVSV) human immunodeficiency virus (HIV)-1 vaccine. Methods. Sixty healthy, HIV-1-uninfected adults were enrolled in a randomized, double-blinded, placebo-controlled dose-escalation study. Groups of 12 participants received rVSV HIV-1 gag vaccine at 5 dose levels (4.6 × 10(3) to 3.4 × 10(7) particle forming units) (N = 10/group) or placebo (N = 2/group), delivered intramuscularly as bilateral injections at 0 and 2 months. Safety monitoring included VSV cultures from blood, urine, saliva, and swabs of oral lesions. Vesicular stomatitis virus-neutralizing antibodies, T-cell immunogenicity, and HIV-1 specific binding antibodies were assessed. Results. Local and systemic reactogenicity symptoms were mild to moderate and increased with dose. No severe reactogenicity or product-related serious adverse events were reported, and all rVSV cultures were negative. All vaccine recipients became seropositive for VSV after 2 vaccinations. gag-specific T-cell responses were detected in 63% of participants by interferon-γ enzyme-linked immunospot at the highest dose post boost. Conclusions. An attenuated replication-competent rVSV gag vaccine has an acceptable safety profile in healthy adults. This rVSV vector is a promising new vaccine platform for the development of vaccines to combat HIV-1 and other serious human diseases.

Healthy eating, exercise, and weight: impressions of sexual minority women.

Obesity is a risk factor for multiple disease outcomes, including cancer and cardiovascular disease. A healthy diet and physically active lifestyle can prevent obesity. Sexual orientation is an important demographic factor that has been suggested to affect engagement in health-related behaviors, and interventions developed for the general population of women are likely to be less effective in assisting sexual minority women to make healthy choices. We conducted seven focus groups with sexual minority women (i.e., lesbians and bisexual women) to explore issues, including barriers and motivations, regarding healthy eating, physical activity, and weight in this population. The participants reported a wide range of levels of engagement in health-related behaviors. While nearly all of the participants reported some awareness of the importance of good dietary choices, the majority reported some confusion about what constitutes a healthy diet. In contrast, the majority of participants seemed clearly aware that regular exercise was important for good health. These data can guide the design of effective intervention strategies to improve health behaviors in sexual minority women.