At the Malaria Forum hosted by the Bill and Melinda Gates Foundation in October, the latest findings on what is currently the most viable malaria vaccine candidate in medical history, known as RTS,S, were announced.
Amidst the videotaping, camera flashes, Tweeting and blogging, Dr. Patricia Wamboi Njuguna awaited her turn at center stage at the Seattle forum. The only African woman in a team of 22 principal investigators on the Phase III trial of RTS,S, Njuguna couldn't give in to jet-lag after 24 hours of travel through five time zones. She couldn't afford to be nervous or hesitant. After all, she was representing not only the African scientists involved in this historic research, but all African scientists, of which women are a tiny minority.
And Njuguna also knew that after the pomp and ceremony of the Gates Foundation event, back home in Kenya, yet another a series of media interviews awaited her.
"It was such a hectic time. I spoke a lot more than I am used to," Njuguna recalls, laughing. "The best part of it all was the response of the community in Kilifi whose children were enrolled in the study. People were very excited by those findings."
And they should be. The October 18th announcement on the RTS,S vaccine candidate, produced by GlaxoSmithKline, found that it reduced the risk of clinical malaria by 56 percent, and severe malaria by 47 percent, in studies involving 6,000 children in 11 trial sites in Africa. The analysis was performed on data from children aged five to 17 months, during the 12 months after they received the vaccine.
Though researchers and global health officials quickly acknowledged that the data is just a milepost towards the ultimate goal of a licensed, effective vaccine, excitement about the data was palpable. The results were heralded in news outlets around the world, and many observers linked the research to the potential for many African nations to reach one of the United Nations Millennium Development Goals of reducing child mortality.
Njuguna, who headed the trial at the Kilifi, Kenya, site, spoke to AllAfrica.com about what sparked her interest in science and her role in the historic RTS,S project.
"My father was a plant breeder and director of the Kenya Agricultural Research Institute in Thika. We lived within the center and often got to see him at work on papaya and Valencia oranges," Njuguna said. "I always thought I would end up in agricultural research. But he advised me to try medicine instead."
So after high school at Bishop Gatimu Ngandu girls in Karatina, Njuguna joined the University of Nairobi for undergraduate medical training in 1992. During her fifth year, Njuguna spent six weeks at the KEMRI-Wellcome Trust Research Programme in Kilifi.
"I did a small project supervised by Professor Charles Newton, which was my very first exposure to clinical research," she said. "I found the process of research interesting, the exercise of attempting to answer scientific questions in this way, challenging."
In 1999, Njuguna completed her medical training and began an internship at the Coast Provincial General Hospital before returning to a medical posting at Kilifi District Hospital. Eventually, she applied for a medical research officer position at KEMRI-Wellcome Trust-Kilifi in 2001, the same year she married a fellow research scientist at the unit, Sam Kinyanjui, the current director of training and capacity building for KWT-Kilifi. The next three years were spent doing both clinical studies and working on larger research projects. One of those projects involved assessing children for neurological impairments and performing brain CT scans on a select few.
"As I was working with children all the time, I realized that I needed to have a good grasp of pediatrics. So I abandoned my dream of being a radiologist, which would have suited work/life balance as a woman, and went back to the University of Nairobi to pursue a Masters degree in pediatrics," Njuguna said.
"While I undertook my post-graduate training between 2003 and 2006, my husband was in the UK on a training fellowship conducting laboratory-based research in malaria immunology," she said. "We were both determined to acquire a certain level of training and expertise before starting a family. We wanted to be able to raise our children together."
When her training was finished, Njuguna was employed as a safety physician for the Phase II RTS,S malaria vaccine study. "I was in charge of surveillance for safety of study participants during this trial," she said. "Every ailment, whether it was perceived to be vaccine-related or not, was recorded so that an analysis would be conducted to determine the safety profile of the vaccine."
That Phase II trial, conducted between 2007 to 2008, was the landmark study were the RTS,S vaccine was shown to have a 53-percent protective effect against malaria. That meant the vaccine could qualify to proceed into the all-important Phase III trial stage, which would involve more children-and much higher stakes.
In 2009, Njuguna was asked to head the Phase III RTS,S malaria vaccine trial in Kilifi. "It was a daunting task, as double the number of children were recruited into the Phase III trial, compared to the trial we had just completed," Njuguna said. "We also had to set up different systems to run the trial. We have recruited 904 study participants, and to do this, 60 people are employed to work on the project. Training the varying teams was very labor intensive, especially since I also had my firstborn child around this time. However, once the teams were up and running, my work has been mainly managerial duties."
The research also yielded a massive investment in infrastructure. When the Phase II study was conducted in Junju and Pingilikani, the dispensary facilities were refurbished. With the Phase III trial, three new sites were selected: Ganze, Dida and Madamani. Government health facilities in these areas were extended and water tanks put in place, thanks to funding from the Malaria Clinical Trials Alliance. This funding also allowed for installation of a digital X-ray facility at the Kilifi District Hospital.
Although all these inputs are primarily for the study participants, the whole community and hospital benefits from their presence.
"Another benefit to the community is that we offer basic life support training to all the clinical staff in the health facilities were we work, a skill that will remain in the community long after we are gone," Njuguna said. "While the study is going on, we work very closely with staff at these facilities. We provide assistance with difficult cases, share drugs during stock-outs and assist in transport of services to the facility. We have ended up having a very good relationship with our study community, the staff at the health facilities and the district health management team."
In Kilifi, recruitment of children aged five to 17 months old was complete by August 2009 when the vaccinations began. Three doses were administered, and then data collected on the cases of clinical malaria among vaccinated children compared to those who were not. After a year, the data was analyzed and these were the results announced at the Malaria Forum.
By 2015, the global malaria research and public health community seems certain that the studies will yield a vaccine that will provide 50 percent protection against severe malaria. It will also be possible to tell whether the vaccine provides long-term protection as each child in the phase III trial will have been followed up for a period of at least 30 months.
The global public health community is also eagerly awaiting the results of the trials that recruited children six-12 weeks old for the three-dose RTS,S malaria vaccine. This data is the most precious, as it will yield information about whether the malaria vaccine can be used with maximum benefit in the EPI system.
But because the current vaccine candidate only gives about 50 percent protection at best, the scientific community is not resting. Malaria vaccine trials in Africa will continue until a vaccine with at least 80 percent efficacy is developed. GSK together with a company called Crucell are already working on creating a second-generation RTS,S vaccine that improves on the current vaccine. Even now, trials for other malaria vaccine candidates are underway on the continent.
In Kilifi, another colleague, Dr. Caroline Ogwang, has just completed data collection for a Phase I trial of a malaria vaccine candidate developed by a group at Oxford University. Through the African Malaria Network Trust (Amanet), another malaria vaccine candidate, GMZ-2 is undergoing Phase II field trials.
In the meantime, Njuguna may be over her jetlag, but her enthusiasm about the RTS,S is still going strong.
She said, "The road ahead is both challenging and exciting. So far collaborations within Africa are working very well and we have a lot to look forward to."