Clinical Research Center
Overview. The Muriithi-Wellde Clinical Research Center (CRC), established in 2003, is located in Kombewa approximately 40km from the Kisumu Field Station (USAMRU-K) Headquarters in Kondele in western Kenya. USAMRU-K has been operating in partnership for over 40 years with the Kenya Medical Research Institute (KEMRI), conducting research studies focused on malaria vaccines, anti-malarial drugs, supplements and diagnostics. The CRC is involved in both medical research and clinical care. The clinical care includes PEPFAR, clinical care provided in conjunction with all medical research, Demographic Surveillance Survey (DSS) Mapping and capacity building throughout the district. The CRC has a catchment population of ~150,000-200,000K, with a presence in over 20 Ministry of Health (MOH) Health Centers.
Vaccine Studies. From 1991 – 2005, the CRC has completed seven FDA compliant trials that include over 1,000 study volunteers.
- 2008 – Phase Ib Tb vaccine (20 adults).
- 2008-2009 – Pre MAL55 which included capacity building and testing as well as 311 children receiving care at the Kisumu West District Hospital.
- 2009 – Phase 1b malaria FMP10 (30 adults).
- 2009 – MAL55 Phase 3 RTS,S Clinical Trail.
- 11 sites in seven African countries.
- 16,000 children (10,000 children ages 5-17 months; 6,000 children ages 6-12 weeks).
- >1,600 children will be enrolled at the Kombewa CRC and followed for three years.
- Vaccination with RTS,S or another potentially beneficial vaccine in blinded fashion.
- Vaccine at 0, 1, 2, and 15 months.
- 2/3’s of the population receive RTS,S vaccine for three doses; ½ of this population will receive a booster at 15 months.
- Randomization of the “older” children started on 24 August 2009.
- Over 800 children vaccinated by 16 October 2009.
- Second highest enrollment of the 11 other African study sites.
- 2010 – MAL58 (RTS,S efficacy in HIV positive children).
Drug Studies. Between 1991-2008, Kombewa CRC conducted ten U.S. FDA-compliant malaria drug trials. Studies for the malaria medication currently advised in Kenya were done, in part, at the USAMRU-K Kisumu Field Station.
- Rapid Diagnostic Tests – three projects completed from 2006-2008. Automated malaria microscopy project underway. Also, aim to conduct future testing for new field unit allowing viral-load testing in HIV positive patients.
- Zinc supplementation for reduction in diarrhea morbidity study in 500 adults (18-55 years) from 2007-2008.
Capacity Building. Capacity building in Kisumu-West District Hospital through collaboration with the Kenya Ministry of Health to improve quality of care.
- Construction – new roof, septic system, electrical wiring, painting, benches (GSK), HIV clinic waiting area (PEPFAR), x-ray building and machine (MCTA).
- Drilled well. Added water pump to supply water.
- Ran power lines, emergency power cut-over switch and supply back-up power.
- Laboratory assistance to include blood bank, hematology, and chemistry analyzers.
- Provide 24 hours x 7 days a week clinical officers, nurses, and increased medical support; protocol driven care with outside referrals; blood and spinal fluid cultures; laboratory testing profiles; oxygen therapy; and a new building with a digital radiology unit (Pre-MAL).