The safety and immunogenicity of four adjuvanted formulations of an investigational tetravalent dengue purified inactivated vaccine (DPIV) were evaluated in a predominantly dengue-primed population in Puerto Rico. In this placebo-controlled, randomized, observer-blind, phase I trial, 100 healthy adults were randomized 1:1:1:1:1 to receive DPIV at Day (D)0 and D28 (1 μg per dengue virus [DENV] type 1–4 adjuvanted with either alum, AS01_E or AS03_B, or 4 μg per DENV type adjuvanted with alum) or saline placebo. Functional antibody responses were assessed using a microneutralization assay at D56, Month (M)7, and M13. All DPIV formulations were well tolerated and no safety signals were identified through M13. The M13 according-to-protocol (ATP) immunogenicity cohort included 83 participants. The ATP analysis of immunogenicity was performed only on the 78 subjects seropositive for ≥ 1 DENV type at baseline: 69 tetravalent, three trivalent, two bivalent, and four monovalent. In all DPIV groups, geometric mean antibody titers (GMTs) increased from D0 to D56 and waned modestly through M13, while remaining well above prevaccination levels. The 4 μg + alum and the AS01_E- and AS03_B-adjuvanted formulations were highly immunogenic, with M13-neutralizing antibody GMTs against all four DENV types above 1,000. M13/D0 GMT ratios were highest in the 1 μg + AS03_B group (ranging 3.2–3.7 depending on the DENV type). These results encourage continued clinical development of DPIV (ClinicalTrials.gov: NCT01702857).

Background: Inappropriate gestational weight gain (GWG) has been associated with adverse perinatal events. High rates of GWG have been reported among Hispanic women. Observational studies indicate that dietary and physical activity interventions during the prenatal period may improve maternal and infant health, but very few randomized trials have been conducted among high-risk overweight/obese Hispanic women. Accordingly, we conducted a lifestyle intervention among high-risk pregnant women and evaluated its impact on achieving appropriate GWG and on improving birthweight. Methods: Eligible overweight/obese women presenting at the University Hospital in Puerto Rico with a singleton pregnancy before 16 gestational weeks were recruited and randomized to lifestyle intervention (n=15) or control group (n=16). The lifestyle intervention focused on improving physical activity and diet quality and optimizing caloric intake. We evaluated the impact of the lifestyle intervention on achieving appropriate GWG and on infant birthweight. Poisson and linear regression analyses were performed. Results: The primary intent to treat analysis showed no significant effect on achievement of appropriate GWG/week through 36 weeks in the intervention group (4/15 women) when compared with the control group (3/16 women) (adjusted incidence rate ratio =1.14; 95% CI: 0.20, 6.67). Although not statistically significant, women in the intervention group (6/15) were 1.7 times more likely to achieve appropriate weekly GWG until delivery when compared with controls (4/16 women) (adjusted incidence rate ratio = 1.67; 95% CI: 0.40, 6.94). We observed lower adjusted birthweight-for-length z-scores in the intervention compared with the control group among male newborns with z-score difference −1.74 (−3.04, −0.43), but not among females −0.83 (−3.85, 2.19). These analyses were adjusted for age and baseline body mass index. Conclusion: Although larger studies are required to determine whether women with obesity may benefit from prenatal lifestyle interventions targeting GWG, our results are suggestive of the intervention improving adherence to established Institute of Medicine guidelines.

Low-income and minority children are at increased risk for obesity. Text messaging offers advantages for delivering education, but few studies have assessed the acceptability of text messaging in interventions aimed at preventing excessive weight gain in infants. This study investigated the acceptability of a text message-based intervention for prevention of excessive weight gain in infants from Hawai‘i and Puerto Rico WIC clinics. The four-month text message based intervention designed to improve infant feeding practices and reduce excessive weight gain was a randomized controlled trial that included mothers with infants ages 0–2 months at baseline. Participants in the intervention arm received 18 text messages (1/week) promoting breastfeeding and appropriate complementary feeding. Acceptability of the intervention was assessed from participant retention, satisfaction, and evidence of behavior change in a sequential multimethod approach, quantitatively from questions sent via text and qualitatively during the in-person exit interview. The final analysis included 80 mother-infant pairs from the intervention arm. When asked about messages liked and disliked the most, the majority of responses via text indicated that they liked all messages. From the qualitative analyses, most participants reported that all messages were useful and that the messages led them to make changes in the way they fed their infants. Participant retention was good at 78.4%. The intervention was acceptable to participants based upon participant retention, measures of satisfaction, and reports of behavior change. Results may inform development of mobile health programs for minority childhood obesity prevention. ClinicalTrials.gov Identifier; NCT02903186; September 16, 2016.