Group B streptococcus vaccination in pregnant women with or without HIV in Africa: a non-randomised phase 2, open-label, multicentre trial

摘要: Summary Background Neonates born to women infected with HIV are at increased risk for invasive group B streptococcus (GBS) disease. We aimed compare safety and immunogenicity of trivalent glycoconjugate GBS vaccine in pregnant without Malawi South Africa. Methods In our non-randomised phase 2, open-label, multicentre study, we recruited attending two antenatal clinics, one Blantyre, Malawi, Soweto, Johannesburg, Participants were divided into three groups on the basis their infection status (no infection, high CD4 cell count [>350 cells per μL], low [>50 ≤350 μL]) received a 5 μg dose (serotypes Ia, Ib, III, CRM 197 [Novartis Vaccines, Siena, Italy]) intramuscularly 24–35 weeks' gestation. serotype-specific antibody concentrations measured before vaccination (day 1), day 15, 31, delivery, infants birth 42 life. The primary outcomes mothers amount placental transfer antibodies from infants. All analyses done full analysis set, including participants who, or whose mother, correctly who provided least valid assessable serum sample. This study is registered ClinicalTrials.gov, number NCT01412801. Findings 270 266 enrolled between Sept 26, 2011, Dec 4, 2012 (90 87 HIV, 89 88 counts, 91 respectively). Seven lost follow-up, six withdrew consent, died, relocated. Eight died stillborn follow-up. Across serotypes, fold change higher HIV-uninfected than HIV-infected groups. Transfer ratios similar across all (0·49–0·72; ratio infant geometric mean concentration blood collected within 72 h by maternal delivery); however, birth, maternally derived lower (0·52–1·62 μg/mL) those not (2·67–3·91 μg/mL). 151 (57%) 265 reported solicited adverse reaction: 39 (45%) 52 (59%) 60 (67%) 90 group. 49 (18%) 269 had event deemed possibly related (six [7%] group, 12 [13%] 21 [23%] group), as did (1%) neonates (zero, [1%], [1%]); none these events was regarded serious. Interpretation less immunogenic it infected, irrespective count, resulting levels transferred infants, which could reduce protection against A validated assay correlate needed understand potential protective value this vaccine. Funding Novartis Vaccines Diagnostics division (now part GlaxoSmithKline companies), Wellcome Trust UK, Medical Research Council: Respiratory Meningeal Pathogens Unit.