Maternal and Child Health

Summary of activities

Maternal and child health has improved significantly in recent decades in sub-Saharan Africa, although maternal mortality and child mortality remain much higher than in other regions. Furthermore, neonatal mortality has fallen less markedly than that of children under 5 years of age more generally.

Clinical trials of new medical treatment and prevention interventions typically exclude pregnant women. To address this the maternal and child team has contributed to numerous global and local initiatives to develop frameworks for safe inclusion of this population in studies. Specific studies are needed to ensure that this group can also benefit from new innovations.

Similarly, treatment and prevention therapies need to be tailored to children and adolescents, and new formulations of existing drugs may be required to make them accessible to younger age groups. These are evaluated in detailed, very specific trials with small number of participants.

The Directorate conducts large-scale vaccine trials, epidemiological studies, and qualitative research into novel interventions particularly regarding infectious and vaccine preventable diseases. HIV and TB, together with vaccine preventable diseases are the main focus of our studies, given their major impact on the health of women and children in sub-Saharan Africa. This includes studies of new treatment options in both groups and use of pre-exposure prophylaxis (PrEP) in pregnant women. We are also contributing to studies including adults affected by TB including landmark TB prevention trials, such as the phase III trial of the M72/AS01E vaccines which Lee Fairlie is the National Co-PI on, and TB prevention studies in children and adolescents including treatment and vaccines. Our work also encompasses interventions targeting other regionally infections that affect maternal, neonatal and child health, such as respiratory syncytial virus (RSV) and group B streptococcus (GBS).

The programme is a member of the International Maternal Paediatric Adolescent Clinical Trials Network (IMPAACT), which focuses on multi-country trials of new interventions related to HIV and TB treatment, prevention and control.

Successful outcomes

• P1020 and P1093: These were paediatric and adolescent dosing studies for Atazanavir and dolutegravir respectively, evaluating dosing, safety and efficacy for children and adolescents living with HIV and led to the registration of these medications for paediatric populations, abroad and in South Africa. These studies broadened the availability of antiretroviral choices for children resulting in dolug=tegravir rollout to all populations, including children.
• MATISSE: Demonstrating efficacy and safety of Pfizer’s Abrysvo vaccine for prevention of RSV infections in neonates by vaccination during pregnancy. This international trial, including mothers recruited in South Africa, demonstrated an efficacy at 90 days of 82% for severe RSV infection. In 2023, Abrysvo was approved by both the US FDA and European EMA.
  Funding: Pfizer.
  Kampmann B, Madhi SA, Munjal I et al. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants. N Engl J Med. 2023;388(16):1451-1464. doi: 10.1056/NEJMoa2216480.
• BaSiS: This study was conducted to evaluate options for boosting of COVID-19 vaccines using full or half-dose Johnson & Johnson Ad26.CoV2.S or full or half dose Pfizer/BioNtech BNT162b2 booster after an Ad26.CoV2.S prime, within the SISONKE phase III implementation study. This study reported that  full dose BNT162b2 provided the largest boost to immune responses. The study has also continued to produce high quality immunogenicity date, specifically regarding the durability of COVID-19 vaccines and hybrid immunity.

Riou C, Bhiman JN, Ganga Y et al. Safety and immunogenicity of booster vaccination and fractional dosing with Ad26.COV2.S or BNT162b2 in Ad26.COV2.S-vaccinated participants. medRxiv [Preprint]. 2023 Nov 20:2023.11.20.23298785. doi: 10.1101/2023.11.20.23298785.