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Background Herpes simplex virus 2 (HSV2) causes genital herpes in >400 million persons worldwide. Methods We conducted a randomized, double-blinded, placebo-controlled trial of a replication-defective HSV2 vaccine, HSV529. Twenty adults were enrolled in each of 3 serogroups of individuals: those negative for both HSV1 and HSV2 (HSV1−/HSV2−), those positive or negative for HSV1 and positive for HSV2 (HSV1±/HSV2+), and those positive for HSV1 and negative for HSV2 (HSV1+/HSV2−). Sixty participants received vaccine or placebo at 0, 1, and 6 months. The primary end point was the frequency of solicited local and systemic reactions to vaccination. Results Eighty-nine percent of vaccinees experienced mild-to-moderate solicited injection site reactions, compared with 47% of placebo recipients (95% confidence interval [CI], 12.9%–67.6%; P = .006). Sixty-four percent of vaccinees experienced systemic reactions, compared with 53% of placebo recipients (95% CI, −17.9% to 40.2%; P = .44). Seventy-eight percent of HSV1−/HSV2− vaccine recipients had a ≥4-fold increase in neutralizing antibody titer after 3 doses of vaccine, whereas none of the participants in the other serogroups had such responses. HSV2-specific CD4+ T-cell responses were detected in 36%, 46%, and 27% of HSV1−/HSV2−, HSV1±/HSV2+, and HSV1+/HSV2− participants, respectively, 1 month after the third dose of vaccine, and CD8+ T-cell responses were detected in 14%, 8%, and 18% of participants, respectively. Conclusions HSV529 vaccine was safe and elicited neutralizing antibody and modest CD4+ T-cell responses in HSV-seronegative vaccinees. Clinical Trials Registration NCT01915212.

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Background: Objective assessment of the unilateral cleft lip nasal deformity and the longitudinal changes with treatment is critical for optimizing cleft care. Methods: Consecutive patients undergoing cleft lip repair and foundation-based rhinoplasty were included (n = 102). Three-dimensional images preoperatively, postoperatively, and at 5 years of age were assessed and compared to age-matched controls. Images were normalized to standard horizontal, craniocaudal, and anteroposterior axes. Results: Cleft subalare was similar in position relative to controls but was 1.6 mm retrodisplaced. Subnasale was deviated 4.6 mm lateral to midline and had the greatest displacement of any landmark. Noncleft subalare was displaced 2.3 mm laterally. Regression analysis with deviation of subnasale from the midline as a dependent variable revealed progressive lateral displacement of noncleft subalare, narrowing of noncleft nostril, and intercanthal widening. Surgery corrected nasal base displacements along all axes, resulting in landmark positions similar to controls. Symmetry of nasal base correction persisted at 5-year follow-up, with no recurrent cleft alar base retrusion, regardless of initial cleft type. Conclusions: Unilateral cleft lip nasal deformity may be “driven” by displacement of the anterior nasal spine and caudal septum. The cleft alar base is normal in position but retruded, whereas the noncleft alar base is displaced laterally. Changes with surgery involve anterior movement of the cleft alar base but also include medial movement of the noncleft alar base and columella. Symmetry of correction, including alar base retrusion, was stable over time and did not rely on alveolar bone grafting.