Background During the large 2013-16 Ebola virus outbreak caused by the Zaire Ebola virus, about 20% of cases were reported in children. This study is the first, to our knowledge, to evaluate an Ebola vaccine in children younger than 6 years. We aimed to evaluate the safety, reactogenicity, and immunogenicity of a monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z) in a paediatric population.Methods This phase 2, randomised, observer-blind, controlled trial was done in a vaccine centre in Mali and a university hospital centre in Senegal. Healthy children were randomly assigned through a web-based system (1:1; stratified by age group, gender, and centre) to receive ChAd3-EBO-Z (day 0) and meningococcal serogroups A,C,W-135,Y tetanus toxoid conjugate vaccine (MenACWY-TT; month 6), or MenACWY-TT (day 0) and ChAd3-EBO-Z (month 6). The study was observer-blind from study start until interim day 30 analysis and became single-blind as of interim analysis. Primary outcomes assessed were serious adverse events (up to study end, month 12), solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia (day 0-6). As secondary endpoints, we evaluated anti-glycoprotein Zaire Ebola virus antibody titres (ELISA) pre-vaccination and 30 days postvaccination. This study is registered with ClinicalTrials.gov, NCT02548078. FindingsFrom Nov 11, 2015, to May 9, 2016, of 776 children screened for eligibility, 600 were randomly assigned (200 [33%] in each age strata: 1-5, 6-12, 13-17 years), 300 (50%) to the ChAd3-EBO-Z/MenACWY-TT group and 300 (50%) to the MenACWY-TT/ChAd3-EBO-Z group; all were included in the total vaccinated cohort. Post-day 0 vaccination, the most common solicited injection site symptom was pain (127 [42%] of 300 in the ChAd3-EBO-Z/ MenACWY-TT group vs 60 [20%] of 300 in the MenACWY-TT/ChAd3-EBO-Z group); the most common solicited general adverse event was fever (95 [32%] of 300 in the ChAd3-EBO-Z/MenACWY-TT group vs 28 [9%] of 300 in the MenACWY-TT/ChAd3-EBO-Z group). Unsolicited adverse events post-day 0 vaccination were reported by 41 (14%) of 300 participants in the ChAd3-EBO-Z/MenACWY-TT group and 24 (8%) of 300 MenACWY-TT/ChAd3-EBO-Z recipients. Serious adverse events were reported for two (1%) of 300 children in each group; none were considered vaccination related. No clinical symptoms of thrombocytopenia were reported. At day 30, anti-glycoprotein Ebola virus antibody geometric mean concentrations (GMC) in the ChAd3-EBO-Z/MenACWY-TT group were 1564 (95% CI 1340-1826) for those aged 13-17 years, 1395 (1175-1655) for 6-12 years, and 2406 (1942-2979) for 1-5 years. Antiglycoprotein Ebola virus IgG antibody responses persisted up to 12 months post-vaccination, with a GMC of 716 (95% CI 619-828) for those aged 13-17 years, 752 (645-876) for 6-12 years, and 1424 (1119-1814) for 1-5 years. Interpretation ChAd3-EBO...

Background: The 2014 Zaire Ebola virus disease epidemic accelerated vaccine development for the virus. We aimed to assess the safety, reactogenicity, and immunogenicity of one dose of monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z) in adults. Methods This phase 2, randomised, observer-blind, controlled trial was done in study centres in Cameroon, Mali, Nigeria, and Senegal. Healthy adults (≥18 years) were randomly assigned with a web-based system (1:1; minimisation procedure accounting for age, gender, centre) to receive ChAd3-EBO-Z (day 0), or saline placebo (day 0) and ChAd3-EBO-Z (month 6). The study was observer-blind until planned interim day 30 analysis, single-blind until month 6, and open-label after month 6 vaccination. Primary outcomes assessed in the total vaccinated cohort, which comprised all participants with at least one study dose administration documented, were serious adverse events (up to study end, month 12); and for a subcohort were solicited local or general adverse events (7 days postvaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia (day 0-6). Secondary endpoints (subcohort; per-protocol cohort) evaluated anti-glycoprotein Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination. This study is registered with ClinicalTrials.gov, NCT02485301.

Disclosure of same-sex sexual practices by men who have sex with men (MSM) and transgender women (TGW) may facilitate appropriate healthcare engagement, including risk assessment for HIV and other sexually transmitted infections (STIs), and negotiation of condom use with partners. However, disclosure may also generate stigma. In these cross-sectional analyses, MSM and TGW were categorized based on self-report of disclosure to family members and healthcare providers (HCP) at enrollment into the TRUST/RV368 study of comprehensive HIV and STI care programs in Abuja and Lagos, Nigeria. Multivariable Poisson regression models with robust error variance were used to estimate relative risk of disclosure with 95% confidence intervals. Pearson's chi-squared test was used to compare condom use and stigma indicators by disclosure status. Of 2557 participants who answered baseline questions about disclosure, 384 (15.0%) had ever disclosed to a family member and 733 (28.7%) to HCP, including 192 (7.5%) who disclosed to both. Higher education, prevalent HIV infections, and residence in Lagos were each associated with increased likelihood of disclosure to family and HCP. Older participants were more likely to disclose to HCP but not family. Participants who made a disclosure to family or HCP were more likely to report condom use during anal sex as well as perceived and experienced stigma that included healthcare avoidance, blackmail, assault, and sexual violence as compared to participants who had not disclosed. Improved disclosure practices within safe spaces may enhance engagement of MSM and TGW in healthcare and HIV prevention services.

Oral Abstracts • OFID 2017:4 (Suppl 1) • S69 only. Median ages at diagnosis for AIS, AIS+CIN, and CIN3 were 37, 32, and 31 years, respectively. HPV typing results were available for 89 AIS, 99 AIS+CIN, and 2,923 CIN3 cases; HPV was detected in nearly all specimens (99% AIS, 100% AIS+CIN, 98% CIN3), and 21% of positive specimens had >1 HPV type identified. HPV16 (AIS: 51%, AIS+CIN: 64%, CIN3: 59%; p ≤ 0.001) and HPV18 (AIS: 39%, AIS+CIN: 31%, CIN3: 5%; P ≤ 0.001) were most common. Additional 9vHPV types (AIS: 3%, AIS+CIN: 12%, CIN3: 26%; P ≤ 0.001), and HR non-vaccine types (AIS: 6%, AIS+CIN2+: 2%, CIN3+: 9%; P ≤ 0.001) were detected less frequently.Conclusion. HPV types differed by histology, with AIS having a greater proportion of HPV 18 and a lower proportion of additional 9vHPV and HR non-vaccine types. This report on the largest sample of genotyped AIS cases to date provides data for vaccine impact monitoring, and suggests a high opportunity for vaccine prevention of AIS.Disclosures. M. R. Griffin, MedImmune: Grant Investigator, Grant recipient Methods. Per GISP protocol, cultures are collected from the first 25 men presenting with NG urethritis each month at GISP clinic sites in California, and antimicrobial susceptibility testing (AST) is performed via agar dilution at GISP regional laboratories. Reduced susceptibility (RS) to CRO was defined as minimum inhibitory concentration (MIC) ≥0.125 µg/ml and AZI MIC ≥2 µg/ml. Demographics and MIC trends over time were examined. Trends in Neisseria GonorrheaeResults. Between 2005 and 2016, there were 9,692 NG isolates submitted in California GISP clinics. There were 24 (0.25%) isolates with RS to CRO and 92 (0.96%) isolates with RS to AZI. There was a higher proportion of isolates from men who have sex with men with RS to AZI (but not CRO) compared with men who have sex with women (chi-squared P-values: AZI = 0.0015; CRO = 0.70). In 2016, the percent of isolates demonstrating RS to AZI increased to 3.69% (n = 32), compared with 0. Conclusion. Gonococcal surveillance data demonstrate an increase in the proportion of isolates with decreased susceptibility to azithromycin in 2016 in California compared with prior years. Although there has never been a documented treatment failure to the recommended therapy of CRO and AZI in California, clinicians should remain vigilant for treatment failures given these concerning increases.

BackgroundAmong men who have sex with men (MSM), lymphogranuloma venereum (LGV) has been associated with proctocolitis that can lead to chronic complications and requires a longer course of antibiotic therapy than is recommended for infections due to other serovars of Chlamydia trachomatis (CT). We describe the prevalence and clinical features of LGV among Nigerian MSM diagnosed with anorectal CT.MethodsMSM were recruited into the ongoing RV368 cohort in Lagos, Nigeria, using respondent-driven sampling. Participants were screened for HIV and bacterial sexually transmitted infections (STIs) every three months for up to 18 months. HIV was diagnosed using a parallel algorithm of rapid tests on fingerstick blood samples. PCR testing for Neisseria gonorrheae and CTwas performed on voided urine, oropharyngeal swab, and rectal swab specimens. For this analysis, prevalent and incident cases of rectal CT infection underwent additional testing to identify LGV serovars utilizing novel real-time PCR assays specific for the L serovars of CT Chlamydia trachomatis.ResultsFrom 28 April 2014–19 July 2016, 420 men underwent screening for rectal STIs, including 66 (15.7%) who had prevalent rectal infection with CT. An additional 68 participants developed incident infections during 208 person-years of follow-up. Of 134 eligible rectal swab specimens, 128 underwent further testing for LGV serovars. Seven (5.5%) of the tested samples were identified as LGV serovars of CT. None of the seven participants with LGV reported any symptoms such as fever or rectal pain. Two of the participants with LGV were simultaneously co-infected with rectal gonorrhea. HIV co-infection was common among participants with both LGV and non-LGV serovars of CT (71% and 77%, respectively, P = 0.74).ConclusionLGV was uncommon but present among Nigerian MSM in this study. LGV needs to be considered even in asymptomatic cases, particularly if anorectal CT infection fails to respond to the usual course of therapy. Consistent screening for L serovars of CT, or empiric treatment for LGV in cases with a high suspicion for this diagnosis, could potentially improve patient outcomes and decrease transmission.Disclosures All authors: No reported disclosures.