26 May 2017
Under the theme, New Interventions to Improve Maternal and Child Health, MRC Unit The Gambia will be organising an open day to provide feedback to the Bundung community on the Pneumococcal Conjugate Vaccine (PCV10) and the PregnAnZI-2 trials. The event will take place at the Bundung Maternal and Child Health Hospital (BMCHH) on Saturday 27 May 2017 at 9:30 am.
The PregnAnZI-2 is a phase III double-blind trial that will assess the effect of one oral dose of azithromycin (an antibiotic) given during labour on neonatal mortality as well as maternal and neonatal severe infections (namely sepsis). This trial is a follow-up from PregnAnZI-1, which was successfully implemented at BMCHH. PregnAnZI-1 showed that azithromycin given to women during labour decreased carriage of bacterial, a necessary step for disease, among newborns. The former trial also showed a decrease in infections in both mothers and newborns. The aim of this series of PregnAnZI trials is to address a global health priority, maternal and neonatal health. This new trial has been designed to evaluate if the intervention will reduce neonatal mortality. To do that, the trial aims to recruit 12,500 women during
The aim of this series of PregnAnZI trials is to address a global health priority, maternal and neonatal health. This new trial has been designed to evaluate if the intervention will reduce neonatal mortality. To do that, the trial aims to recruit 12,500 women during labour, half of them in The Gambia and the other half in Burkina Faso. The recruitment of study participants is expected to start in August 2017 and will last three years.
The PCV10 trail with routine childhood vaccinations of an affordable pneumococcal conjugate vaccine candidate is a phase 3 vaccine randomized trial that will assess a new vaccine (PNEUMOSIL) against pneumococcus, the most common cause of life threatening pneumonia (chest infection) as well as other serious infections in infants and children. The current vaccines against pneumococcus are effective and have led to important reductions in deaths and disease from pneumonia – including in The Gambia. However, the vaccines are extremely expensive despite support from external donors. The Serum Institute of India, which is the largest vaccine manufacturer in the world, has produced a new vaccine which will be much cheaper than the current vaccines while we expect it to be as effective at protecting infants and children from pneumonia and other diseases.
This trial follows the smaller trial of the same vaccine conducted at BMCHH in 2015 and 2016. The results of the previous trial suggested the vaccine was as safe as the current vaccine in the schedule in The Gambia and that the amount of immune protection it generated was likely to be the similar. The new trial will generate the data required by the WHO in order to license the vaccine for use across the world. The ultimate aim is to produce a high quality vaccine which provided as much protection as the current vaccines while also being significantly cheaper leaving more money available for other vaccines and other health expenditure.
The aim of both studies is to improve neonatal and children’s health to save lives, not only in The Gambia but also across the developing world. To grace the occasion, the Government of The Gambia through the Ministry of Health and Social Welfare, MRCG staff, BMCHH staff and the Bundung local community have been invited to attend.