Kathleen H. Krause

First-in-human evaluation of the safety and immunogenicity of a recombinant adenovirus serotype 26 HIV-1 Env vaccine (IPCAVD 001).

BACKGROUND We report the first-in-human safety and immunogenicity assessment of a prototype Ad26 vector-based human immunodeficiency virus (HIV) vaccine in humans. METHODS Sixty Ad26-seronegative, healthy, HIV-uninfected subjects were enrolled in a randomized, double-blinded, placebo-controlled, dose-escalation phase 1 study. Five groups of 12 subjects received 10(9)-10(11) vp of the Ad26-EnvA vaccine (N = 10/group) or placebo (N = 2/group) at weeks 0 and 24 or weeks 0, 4, and 24. Safety and immunogenicity were assessed. RESULTS Self-limited reactogenicity was observed after the initial immunization at the highest (10(11) vp) dose. No product-related SAEs were observed. All subjects who received the Ad26-EnvA vaccine developed Ad26 NAb titers, EnvA-specific enzyme-linked immunosorbent assays (ELISA) titers, and EnvA-specific enzyme-linked immunospot assays (ELISPOT) responses. These responses persisted at week 52. At week 28 in the 10(9), 10(10), 10(11) vp 3-dose and the 10(10) and 5 × 10(10) vp 2-dose groups, geometric mean EnvA ELISA titers were 6113, 12 470, 8545, 3470, and 9655 and mean EnvA ELISPOT responses were 397, 178, 736, 196, and 1311 SFC/10(6) peripheral blood mononuclear cells, respectively. CONCLUSION This Ad26 vectored vaccine was generally safe and immunogenic at all doses tested. Reactogenicity was minimal with doses of 5 × 10(10) vp or less. Ad26 is a promising new vaccine vector for HIV-1. CLINICAL TRIALS REGISTRATION NCT00618605.

Men’s Perpetration of Intimate Partner Violence in Vietnam Gendered Social Learning and the Challenges of Masculinity

Using the survey responses of 522 married men (eighteen to fifty-one years) in Vietnam, we explored how gendered social learning in boyhood and challenges to men’s expected status in marriage may increase the risk that men perpetrate intimate partner violence (IPV) against their wives. Over one-third (36.6 percent) of the participants reported having ever perpetrated psychological, physical, or sexual IPV against their current wife. Accounting for other characteristics of men in the sample, witnessing IPV as a boy, being physically maltreated as a boy, and being the same age or younger than one’s wife were associated with almost two to three times higher odds of perpetrating any IPV. Men with thirteen to eighteen completed grades of schooling had about half the adjusted odds of ever perpetrating any IPV than men with twelve or fewer completed grades (aOR = 0.56). The determinants of men’s perpetration of physical IPV and psychological IPV were, largely, similar. Programs to prevent men’s perpetration of IPV should address the parenting practices of boys that legitimize men’s aggression and gendered status expectations in marriage, which when challenged, may lead husbands to respond with violence. Engaging men to endorse nonviolent masculinities is an important consideration for future intervention.

Violence in childhood, attitudes about partner violence, and partner violence perpetration among men in Vietnam

PURPOSE We assess the association of mens exposure to violence in childhood-witnessing physical violence against ones mother and being hit or beaten by a parent or adult relative-with their attitudes about intimate partner violence (IPV) against women. We explore whether mens perpetration of IPV mediates this relationship and whether mens attitudes about IPV mediate any relationship of exposure to violence in childhood with perpetration of IPV. METHODS Five hundred twenty-two married men 18-51 years in Vietnam were interviewed. Multivariate regressions for ordinal and binary responses were estimated to assess these relationships. RESULTS Compared with men experiencing neither form of violence in childhood, men experiencing either or both had higher adjusted odds of reporting more reasons to hit a wife (aOR, 1.43; 95% CI, 1.03-2.00 and aOR, 1.66; 95% CI, 1.05-2.64, respectively). Mens lifetime perpetration of IPV accounted fully for these associations. Compared with men experiencing neither form of violence in childhood, men experiencing either or both had higher adjusted odds of ever perpetrating IPV (aOR, 3.28; 95% CI, 2.15-4.99 and aOR, 4.56; 95% CI, 2.90-7.17, respectively). Attitudes about IPV modestly attenuated these associations. CONCLUSIONS Addressing violence in childhood is needed to change mens risk of perpetrating IPV and greater subsequent justification of it.

Why do women justify violence against wives more often than do men in Vietnam

Intimate partner violence (IPV) harms the health of women and their children. In Vietnam, 31% of women report lifetime exposure to physical IPV, and surprisingly, women justify physical IPV against wives more often than do men. We compare men’s and women’s rates of finding good reason for wife hitting and assess whether differences in childhood experiences and resources and constraints in adulthood account for observed differences. Probability samples of married men (n = 522) and women (n = 533) were surveyed in Vietnam. Ordered logit models assessed the proportional odds for women versus men of finding more “good reasons” to hit a wife (never, 1-3 situations, 4-6 situations). In all situations, women found good reason to hit a wife more often than did men. The unadjusted odds for women versus men of reporting more good reasons to hit a wife were 6.55 (95% confidence interval [CI] = [4.82, 8.91]). This gap disappeared in adjusted models that included significant interactions of gender with age, number of children ever born, and experience of physical IPV as an adult. Having children was associated with justifying wife hitting among women but not men. Exposure to IPV in adulthood was associated with justifying wife hitting among men, but was negatively associated with justification of IPV among women. Further study of the gendered effects of resources and constraints in adulthood on attitudes about IPV against women will clarify women’s more frequent reporting than men’s that IPV against women is justified.

Economic Coercion and Partner Violence Against Wives in Vietnam A Unified Framework

Economic coercion refers to behaviors that control an intimate partner’s ability to acquire, use, and maintain economic resources. Little is known about economic coercion in Vietnam. Using survey responses from 533 married women ages 18 to 50 years, we estimated multinomial logistic regression models to compare the determinants of exposure to economic coercion only, co-occurring economic coercion, and any psychological, physical, or sexual intimate partner violence (IPV), and any IPV only, relative to no exposure. Women who, in their childhood, witnessed physical IPV against their mother had higher odds of exposure to co-occurring economic coercion and any IPV as an adult (adjusted Odds Ratio = 3.54, 95% confidence interval [CI] = [1.84, 6.83]) and any IPV only (adjust Odds Ratio = 1.75, 95% CI = [1.00, 3.06]), but not economic coercion only. Women who experienced violence as a child had higher odds of exposure to any IPV only (adjusted Odds Ratio = 1.63, 95% CI = [1.04, 2.56]) but not economic coercion only. Women with more schooling had higher odds of exposure to economic coercion only (adjusted Odds Ratio = 1.17, 95% CI = [1.03, 1.33]) but not other forms of violence. Overall, the estimates from the three models differed significantly. Thus, the determinants of economic coercion and common forms of IPV may differ. More research should focus on men’s perpetration of economic coercion.

Gendered Social Learning, Nonfamily Institutions, and Attitudes About Recourse After Partner Violence

Objective: To provide the first study in Vietnam of how gendered social learning about violence and exposure to nonfamily institutions influence women’s attitudes about a wife’s recourse after physical intimate partner violence (IPV). Method: A probability sample of 532 married women, ages 18 to 50 years, was surveyed in July through August, 2012 in M&U1EF9; Hào district. We fit a multivariate linear regression model to estimate correlates of favoring recourse in 6 situations using a validated attitudinal scale. We split attitudes toward recourse into 3 subscales (disfavor silence, favor informal recourse, favor formal recourse) and fit 1 multivariate ordinal logistic regression model for each behavior to estimate correlates of favoring recourse. Results: On average, women favored recourse in 2.8 situations. Women who were older and had witnessed physical IPV in childhood had less favorable attitudes about recourse. Women who were hit as children, had completed more schooling, worked outside agriculture, and had sought recourse after IPV had more favorable attitudes about recourse. Conclusions: Normative change among women may require efforts to curb family violence, counsel those exposed to violence in childhood, and enhance women’s opportunities for higher schooling and nonagricultural wage work. The state and organizations working on IPV might overcome pockets of unfavorable public opinion by enforcing accountability for IPV rather than seeking to alter ideas about recourse among women.

Schools must include faculty and staff in sexual violence prevention efforts

ABSTRACT Creating a normative campus environment intolerant to sexual violence is important for prevention. While prevention initiatives focusing on students are vital, faculty and staff have a central role in supporting and sustaining a comprehensive strategy for preventing campus sexual violence. Nationwide, colleges and universities recently implemented campus climate surveys. At Emory, we decided to survey faculty and staff as well as students, motivated by our use of an ecological framing of campus sexual violence. Faculty and staff are long-term members of the community, and can provide stability and continuity that reinforces prevention efforts prioritized for students. We recommend that schools use a trauma-informed approach to guide the involvement of faculty and staff in prevention. We encourage colleges and universities to consider the experiences and needs of their faculty and staff, as professionals who serve as leaders on campus and as those who guide students through their academic experiences.

First-in-human phase 1 trial of the safety and immunogenicity of a recombinant adenovirus serotype 5 HVR48 (rAd5HVR48) HIV-1 vaccine

Methods Recombinant Ad5 with seven HVRs derived from Ad48 and expressing the VRC EnvA test antigen (rAd5HVR48. ENVA) was made. 48 healthy volunteers who were seronegative to Ad5, Ad48, HIV-1, and HIV-2 were enrolled in a randomized, double-blind, placebo-controlled, doseescalation phase 1 study. The first three groups of 12 subjects received doses of 10, 10, or 10 vp of rAd5HVR48.ENVA vector (n=10/group) or placebo (n=2/ group) at weeks 0, 4, and 24 and the fourth group received a single injection of 10 vp or placebo. We performed pre-specified blinded immunogenicity analyses at day 56 and day 196 after the first immunization.