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.