11 June 2015
Dr Olubukola Idoko is a clinical trial coordinator and paediatrician at MRC Unit The Gambia. Here she tells us about a recent trial of a multi-dose pneumococcal disease vaccine, and why even the crazy hours are worthwhile.
Throughout my medical training I always felt I wanted to do something with a focus on preventative medicine, impacting many people at once rather than individual patients every day. I realised this played an important role in solving health challenges in Sub-Saharan Africa.
After finishing my medical training at the Jos University Teaching Hospital in Nigeria, I did some research and found that The Gambia had done well with their immunisation programmes for a small West African country. This led me to MRC Unit The Gambia in 2010 and I’ve been here ever since.
I coordinate clinical trials involving new vaccines for children. My role is wide-ranging and spans the whole clinical trial lifecycle. In the initial phase where we’re preparing to start a trial I recruit staff and ensure that ethical and regulatory approvals, protocols and procedures are in place. We prepare information for participants including consent forms, audio books in local languages and information sheets.
During the study I coordinate day-to-day activities in the field. I ensure clinics are set up properly, that we’re storing vaccines appropriately in freezer rooms, deliver training for staff and coordinate the recruitment and follow-up of participants. I communicate with sponsors, ethics and regulatory committees and ensure that monitoring activities go smoothly. As the trial wraps up I ensure we archive the essential documents and write up study reports and outputs.
We’ve recently completed a trial of a multi-dose vial pneumococcal conjugate vaccine, sponsored by biopharmaceutical company Pfizer. Pneumococcal disease ― including pneumonia and meningitis ― is predominantly caused by the Streptococcus pneumoniae bacteria. It mainly affects children under five and causes significant illness and death.
Pfizer developed the vaccine following an agreement with Gavi, the Vaccine Alliance. Called PCV13, it covers 13 of the more than 90 pneumococcal bacteria serotypes.
PCV13 is already used in the Gambian Expanded Programme for Immunisation (EPI) but the multi-dose vial has an additional preservative that isn’t in the single-dose vial syringe. There are also four doses of the vaccine in each vial as opposed to one in a pre-filled syringe/vial.
Although we do not expect these two vaccines to perform differently, the safety and effectiveness of the multi-dose vial needs to be established before it can be licensed.
The study has gone well and it’s been a great team effort. Our results are exciting and show that the new preparation is as safe and as immunogenic as the single-dose syringe. We recently presented this data at the European Society for Paediatric Infectious Diseases (ESPID) Annual Meeting.
We hope the multi-dose vial vaccine will drive down supply chain costs for storage, and ultimately reduce overall cost because it’s an expensive vaccine for EPI programmes. The supply of PCV13 to low-income countries is currently primarily funded by Gavi but over time support will be withdrawn. We need to find a way to ensure that vaccine use is sustainable across the region.
It usually takes 15-20 years to get from vaccine manufacturing to introduction. In this case, because it’s a vaccine which is already in use, we hope the licensing will be relatively quick. We also that The Gambia will be one of the first countries to get the new preparation of the vaccine since the country was involved with the clinical trials.
One of the things I enjoy most about working at the unit is the team spirit. You really have staff invested in their work. Everybody rallies together to achieve their goals and I think that makes it fun, enjoyable and worthwhile.
Another good thing is that for 10-15 per cent of my time I can still do clinical paediatrics. I provide on-call support and clinical care to patients at the MRC ward here at the unit and give lectures and bedside teaching to medical students from the University of The Gambia on their paediatric rotations.
I also enjoy the fact I’m able to see impact from the work that’s being done. It was a real joy to see the meningococcal A conjugate vaccine (MenAfriVac) introduced into the region within 10 years of its development.
The region has suffered epidemics of meningitis and in the short time since MenAfriVac was introduced there’s been notable impact. Epidemics caused by the serogroup in the vaccine are on the decline and the vaccine is currently provided at a cost cheaper than other available meningococcal vaccines.
Introduction in The Gambia was accelerated because the country participated in some initial trials held at the unit. Being able to see the impact, knowing that you’re part of something meaningful, makes it worthwhile.
I’m now trying to do some of my own research, pursuing ideas I have thought of in the process of working on multiple vaccine trials. This job has really become a passion of mine and I probably wouldn’t be here if I wasn’t that passionate about it – the hours can get crazy!
This article was first published by: www.insight.mrc.ac.uk website on 10 June 2015