A phase 3 study of safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine, in children with HIV.

OBJECTIVES: To evaluate the safety and immunogenicity of V114 [15-valent pneumococcal conjugate vaccine (PCV) containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9 V, 14, 18C, 19A, 19F, 22F, 23F, 33F], followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, in children with HIV. DESIGN: This phase 3 study (NCT03921424) randomized participants 6-17 years of age with HIV (CD4 + T-cell count ≥200 cells/µl, plasma HIV RNA <50 000 copies/ml) to receive V114 or 13-valent PCV (PCV13) in a double-blind manner on Day 1, followed by PPSV23 at Week 8. METHODS: Adverse events (AEs), pneumococcal serotype-specific immunoglobulin G (IgG), and opsonophagocytic activity (OPA) were evaluated 30 days after each vaccination. RESULTS: The proportion of participants experiencing at least one AE post-PCV was 78.8% in the V114 group ( n  = 203) and 69.6% in the PCV13 group ( n  = 204); respective proportions post-PPSV23 were 75.4% ( n  = 203) and 77.2% ( n  = 202). There were no vaccine-related serious AEs. IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) were generally comparable between V114 and PCV13 for shared serotypes at Day 30, and were higher for V114 compared with PCV13 for the additional V114 serotypes 22F and 33F. Approximately 30 days after PPSV23, IgG GMCs and OPA GMTs were generally comparable between the V114 and PCV13 groups for all 15 serotypes in V114. CONCLUSIONS: In children with HIV, a sequential administration of V114 followed 8 weeks later with PPSV23 is well tolerated and induces immune responses for all 15 pneumococcal serotypes included in V114.

Treatment outcomes of drug-resistant tuberculosis in people living with HIV in Odesa province, Ukraine, 2014-2016.

INTRODUCTION: Odesa province has the highest TB/HIV prevalence in Ukraine, exceeding the total prevalence in the country by 3 times. The objective of this study was to investigate the unfavorable treatment outcomes and associated factors in patient with drug-resistant (DR) TB in people living with HIV (PLH) in Odesa. METHODOLOGY: A cohort study with secondary data analysis was conducted among 373 PLH with confirmed pulmonary DR TB for 2014-2016. RESULTS: About 2/3rd of the cohort were males from urban areas. Mean age and CD4 counts were 39 and 203, respectively. The overall treatment success was 44.2% with the most unfavorable treatment outcomes being observed in extensively and pre-extensively drug resistant (XDR and PreXDR) TB. The mean time between the results of GeneXpert (manufactured by Cepehid) and DR TB treatment based on GeneXpert was 1.3 days. However, the mean time between DR TB treatment based on GeneXpert and results of drug susceptibility test (DST) was 37.0 days referring to a late reporting of DST and to a late adjustment of previously prescribed treatment. The factors associated with the treatment unfavorable outcome included XDR and Pre-XDR TB, lack of antiretroviral treatment (ART), contrimoxazole preventive therapy (CPT) and CD4 test. CONCLUSIONS: The rate of successful DR TB treatment in PLH in Odesa remains low. The delayed reporting of DST contributes to lack of timely adjusted treatments. XDR and Pre-XDR TB, lack of ART and CPT are associated with unfavorable treatment outcomes. Additional studies would help to understand the temporal relationship between CD4 test and treatment outcomes.