Mouse Anti-Streptococcus B Monoclonal antibody, clone 8I8

Background: We evaluated the safety and immunogenicity of liquid and lyophilized formulations of an investigational trivalent group B streptococcus (GBS) vaccine in non-pregnant women and assessed the formulations' equivalence in terms of serotype-specific immune response. Methods: This phase II, randomized, comparative, observer-blind trial enrolled healthy non-pregnant women 18-40 years of age. Women received a single dose of fully liquid (n = 529) or lyophilized (n = 521) trivalent GBS vaccine on day 1. Safety assessments were performed up to day 181 (study termination). Serotype Ia/Ib/III-specific immunoglobulin G (IgG) antibodies were measured in sera from women on day 1 (pre-vaccination) and day 31. Equivalence between the two formulations was demonstrated if the two-sided 95% confidence interval (CI) for the ratio (liquid/lyophilized) of the geometric mean concentrations (GMCs) on day 31 was contained in a (0.5, 2.0) interval for each serotype. Results: Solicited and unsolicited adverse events were reported at similar rates for both formulations. Serious adverse events were reported for six (1.1%) liquid GBS and nine (1.7%) lyophilized GBS vaccinated women, none of which were considered related to vaccination or fatal. On day 31, serotype-specific IgG concentrations were 8-16-fold higher than on day 1 in both groups. Equivalence of the liquid to the lyophilized formulation 30 days post-vaccination was demonstrated as the 95% CIs of the GMC ratios were within the pre-specified interval for the three serotypes: GMC ratios were 1.02 (95% CI: 0.79, 1.32) for serotype Ia, 0.93 (0.71, 1.21) for serotype Ib and 0.99 (0.76, 1.30) for serotype III. Conclusions: Both formulations of the investigational trivalent GBS vaccine had favorable safety profiles and induced similar GBS serotype-specific antibody concentrations. This study demonstrated that the fully liquid formulation was equivalent to the lyophilized formulation in healthy non-pregnant women in terms of immunogenicity for all three serotypes. (C) 2020 GlaxoSmithKline Biologicals S.A. Published by Elsevier Ltd.

Purpose The aim of our study was to assess the outcomes of a prolonged induction carried out with a second sequential cycle of pharmacological stimulation after unsatisfactory response to a first attempt, and to highlight variables correlated with higher response rates. Methods A retrospective study was carried out on 157 women who underwent a two-step labor induction by vaginal prostaglandins followed by a second cycle of prostaglandins or intravenous oxytocin. Outcomes assessed were mode of delivery and maternal and neonatal morbidity. Main variables of pregnancy and delivery were collected to identify factors predicting the mode of delivery. Results Among 157 patients, 63 (40.1%) achieved a vaginal delivery, whereas 94 (59.9%) underwent Cesarean section, 9 women (5.7%) had postpartum hemorrhage; in 2 cases (1.3%), an Apgar score < 7 at 5 min from birth was reported. Higher risk of Cesarean section was observed with advanced maternal age (OR 1.13 for additional year, CI 1.04-1.22) and nulliparity (OR 8.84, CI 2.69-29.06), whereas the response rates were better in carriers of group B streptococcus colonization (OR 0.38, CI 0.17-0.84) and in women with favorable cervical status after the first stimulation (OR 0.81 for additional point of Bishop score, CI 0.70-0.94). Conclusion Labor induction with two cycles of pharmacological stimulation is a procedure with fairly good success rates and a low risk of maternal and neonatal complications. Factors predicting its success encompass younger age, parity, a positive recto-vaginal swab for group B streptococcus and a favorable cervix following the first cycle of stimulation.