BACKGROUND Congenital infection with cytomegalovirus (CMV) is an important cause of hearing, cognitive, and motor impairments in newborns. METHODS In this phase 2, placebo-controlled, randomized, double-blind trial, we evaluated a vaccine consisting of recombinant CMV envelope glycoprotein B with MF59 adjuvant, as compared with placebo. Three doses of the CMV vaccine or placebo were given at 0, 1, and 6 months to CMV-seronegative women within 1 year after they had given birth. We tested for CMV infection in the women in quarterly tests during a 42-month period, using an assay for IgG antibodies against CMV proteins other than glycoprotein B. Infection was confirmed by virus culture or immunoblotting. The primary end point was the time until the detection of CMV infection. RESULTS We randomly assigned 234 subjects to receive the CMV vaccine and 230 subjects to receive placebo. A scheduled interim analysis led to a stopping recommendation because of vaccine efficacy. After a minimum of 1 year of follow-up, there were 49 confirmed infections, 18 in the vaccine group and 31 in the placebo group. Kaplan-Meier analysis showed that the vaccine group was more likely to remain uninfected during a 42-month period than the placebo group (P = 0.02). Vaccine efficacy was 50% (95% confidence interval, 7 to 73) on the basis of infection rates per 100 person-years. One congenital infection among infants of the subjects occurred in the vaccine group, and three infections occurred in the placebo group. There were more local reactions (pain, erythema, induration, and warmth) and systemic reactions (chills, arthralgias, and myalgias) in the vaccine group than in the placebo group. CONCLUSIONS CMV glycoprotein B vaccine has the potential to decrease incident cases of maternal and congenital CMV infection. (ClinicalTrials.gov number, NCT00125502.)

CONTEXT Social norms and stigma may play an important role in reproductive health behavior and decision-making for young women in the U.S. South, who disproportionately experience unintended pregnancies. Research has yet to describe the presence and manifestations of social norms and stigmas around unintended pregnancy, parenting, adoption and abortion from the perspective of this population. METHODS Six focus groups and 12 cognitive interviews (n=46) were conducted with young (19-24), low-income women in Birmingham, Alabama from December 2013-July 2014, recruited from two public health department centers and a community college. Semi-structured interview guides were used to facilitate discussion around social perceptions of unintended pregnancy and subsequent pregnancy decisions. The sessions were audio-recorded, transcribed, and analyzed using a theme-based approach. RESULTS Respondents described community expectations for pregnancy to occur in the context of monogamous relationships, where both partners were mature, educated and financially stable. In contrast, participants reported that unintended pregnancy outside of those circumstances is common, and that the community expects young women to bear and raise their child when faced with an unintended pregnancy. Social views about women who choose to do so are more positive than those about women who choose abortion or adoption, which the participants generally perceived as unacceptable alternatives to parenting and discussed in terms of negative labels, social judgment, and non-disclosure. CONCLUSIONS Findings inform the development of interventions to reduce stigma and create the social environment in which young women are empowered to make the best reproductive decisions for themselves.

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This study indicates that early onset of vaginal douching is associated with false beliefs and sexual debut at younger age.

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