GBS EPI Study (1091006)

Epidemiology of obstetric and neonatal outcomes in South Africa

Rationele

Epidemiology of obstetric and neonatal outcomes in South Africa Research (Maternal and Child) Group B streptococcal (GBS) infection is a leading cause of sepsis and meningitis in neonates and young infants. Pfizer is developing a vaccine aimed at the prevention of group B streptococcal disease in young infants by active immunization of pregnant women. A Phase 1/2, randomized, placebocontrolled, observer-blinded trial to evaluate the safety, tolerability, and immunogenicity of this vaccine in healthy non-pregnant women and pregnant women aged 18 to 40 years and their infants will be conducted in South Africa, including at the Wits RHI Shandukani site. This GBS Epidemiological study is a pre-cursor to the vaccine study and aims to provide baseline data describing maternal, pregnancy and infant outcomes in the same sites where the vaccine study will be conducted.

This is essential in a maternal study since often the interpretation of adverse events (AEs) seen in clinical trials, even if placebo-controlled, is limited by insufficient sample size to measure the incidence rate of specific AEs in the comparison group. In these settings, external epidemiologic data are useful to evaluate whether or not the observed number of cases of the event in the treatment group is higher than the expected number of cases, and to understand how the incidence of the AE may vary according to various risk factors.

Epidemiology data are also useful for contextualizing potential safety events of interest that are identified post approval, either in ongoing clinical trials, in published studies, via spontaneous reports or active surveillance. Such data provide a broader context for adverse events, as clinical trial data are often not generalizable to the types of patients who use the vaccine and the circumstances in which it is prescribed and used in the real world, given trial exclusion criteria.

This study, conducted within the setting of tertiary and secondary hospitals and their referring antenatal clinics and midwife obstetric units (MOU) in which the Phase I/II GBS clinical trial will take place, will estimate the incidence of obstetric and perinatal birth outcomes in a population as similar as possible to the population included in the Phase I/II trial. The data generated from this study will enable contextualization of emergent safety signals.

Primary Objectives

The specific objectives are to:

  1. Estimate the incidence of obstetric outcomes among pregnant women who delivered at institutions from which patients enrolled in a GBS clinical trial will be recruited.
  2. Estimate the incidence of neonatal outcomes among neonates whose mothers delivered at institutions from which patients enrolled in a GBS clinical trial will be recruited.
  3. Estimate the incidence of obstetric outcomes among pregnant women who received antenatal care (ANC) and delivered at institutions from which patients enrolled in a GBS clinical trial will be recruited and have characteristics similar to women who enrolled in a GBS clinical trial.
  4. Estimate the incidence of neonatal outcomes among neonates whose mothers received ANC care and delivered at institutions from which patients enrolled in a GBS clinical trial will be recruited and whose mothers have characteristics similar to women who will be enrolled in a GBS clinical trial.

Study Population

This study will utilize birth registers and maternity case records (MCR) from the population (institutions) from which subjects enrolled in a Group B Streptococcus (GBS) vaccine clinical trial in South Africa. The three regions are Soweto, Inner City Johannesburg, and Metro East, Cape Town, South Africa. Wits RHI will conduct the inner city component of the trial.

Invetigators

  • Dr Lee Fairlie, Principal Investigator
  • Dr Clare Cutland

Donor

Pfizer

Latest Update: 15 February 2021

For more about GBS EPI Study (1091006) please email rhicomms@wrhi.ac.za