Nancy* walks into Siaya District Hospital carrying her twin babies. While she knows that only one of them is unwell, she could not leave the other unattended at home. Since her children are part of the Kenya Medical Research Institute/US Centers for Disease Control and Prevention RTS,S malaria vaccine trial, she is received by the clinical team led by study pediatrician Dr. Martina Oneko. Samples are taken from the sick baby and in record time, Nancy is informed that her baby has a rare form of meningitis caused by salmonella bacteria. On hearing that one of the twins has salmonella, the other child is tested, and soon, it is discovered that both children have meningitis. They are both put on treatment.
Dr. Oneko’s eyes light up as she recounts this story. She is talking about a revolution in health care that is taking place in the Siaya District Hospital (SDH) pediatric ward with the ongoing RTS,S malaria vaccine trial.
“We would not have found the salmonella before the trial began because SDH lacked microbiology equipment,” says Dr. Oneko.
SDH, which serves as the district referral hospital, is the largest hospital in Siaya district and one of the largest district hospitals in Nyanza province in southwestern Kenya. The mortality rate for children younger than five years is high in Karemo division, where SDH is located, with about 184 deaths per 1,000 live births, according to the Kenya Medical Research Institute/US Centers for Disease Control and Prevention (KEMRI/CDC) health and demographic surveillance system (HDSS). The area also has a high burden of infectious diseases, and malnutrition is common. According to the HDSS, the highest cause of mortality among infants in Karemo division is malaria. Of the 3,138 children admitted to SDH in 2008, 223 died, and 66 of these deaths were due to malaria. Siaya district is also one of the poorest in Kenya.
In late 2008, plans were afoot to launch a large-scale trial on a groundbreaking malaria vaccine candidate called RTS,S. With its track record of world-class medical research, KEMRI/CDC was well-positioned to host the trial, which is being conducted at 11 sites in seven African countries and is meant to include up to 16,000 participants. The trial officially began in Siaya on July 7, 2009. Given the burden of malaria in the Siaya area, few places could be in greater need of a new weapon in the fight against the disease. As of mid-December, about 1,500 participants, of a target 1,800 infants and children, were enrolled in the study. Already, medical and research staff are seeing positive, if unpredicted, changes in the health of their clients, especially in children younger than five.
These changes started with the significant investment in equipment, staff, training, and renovations that were carried out during a preparatory study for the large-scale malaria trial. During this study, known as pre-MAL 055, GlaxoSmithKline Biologicals, the developer and manufacturer of the RTS,S malaria vaccine candidate, and the PATH Malaria Vaccine Initiative, which funds trial site activities, conducted an evaluation and developed a plan to ensure that the site was ready for this major vaccine trial. During this period, equipment was provided to the hospital, including oxygen concentrators, vital signs monitoring devices, and a modern digital x-ray machine. In addition, the acute room in the pediatric ward was given a facelift, with new and better beds and a laboratory with state-of-the art equipment.
The RTS,S malaria vaccine trial at Siaya employs about 68 clinical staff at four health facilities, including a pediatrician, medical officers, clinical officers, nurses, laboratory technologists, and pharmacists. There is a staff member on call every night in the pediatric ward. The doctors and pediatrician are often consulted for unusual illnesses in the ward for non-study participants, while the hospital also benefits from the other clinical staff assisting in activities such as resuscitations and inserting of intravenous lines.
From the beginning of the trial, the participants were offered free health care, and KEMRI/CDC provided high-level care quickly. Since the trial’s launch, ten of the 1,200 children enrolled have died, a rate that is far lower than the district’s mortality rate of 184 per 1,000 children. None of the deaths have been attributed to the vaccine candidate.
Children are also tested for HIV if the test is thought to be necessary, so that they can be put on HIV care and treatment. Of the 1,200 children in the study, 20 HIV positive children are now being provided with the appropriate care. . In one incident, a mother, Jane*, brought her child to join the trial. Jane knew that she herself was HIV positive but had not participated in a prevention of mother-to-child transmission program. While she also knew that her baby may have HIV, she did not divulge this information. Her baby lost weight precipitously and at 18 months, he weighed only 6 kg (a healthy child this age generally weighs about 10–11 kg). Jane was frantic and revealed her status because she thought she was going to lose her baby. The child was tested, found to be HIV positive, and placed on care and treatment. Now, just a few months later, he weighs almost 10 kg and his mother is all smiles.
Dr. Oneko is proud to be part of the team that is improving the lives of the children who come to the hospital. “I am excited that now there are facilities to check disease quickly,” she says. “This is an exciting opportunity for a district hospital, where such diagnoses and care are not usually the case.”
*Names changed to protect identities.
Linet Atieno Otieno is a communications officer at the KEMRI/CDC research center headquartered in Kisian, Kenya. The center’s trial site at Siaya hosts several RTS,S studies.