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.
  1. 11 sites in seven African countries.
  2. 16,000 children (10,000 children ages 5-17 months; 6,000 children ages 6-12 weeks).
  3. >1,600 children will be enrolled at the Kombewa CRC and followed for three years.
  4. Vaccination with RTS,S or another potentially beneficial vaccine in blinded fashion.
  5. Vaccine at 0, 1, 2, and 15 months.
  6. 2/3’s of the population receive RTS,S vaccine for three doses; ½ of this population will receive a booster at 15 months.
  7. Randomization of the “older” children started on 24 August 2009.
  8. Over 800 children vaccinated by 16 October 2009.
  9. 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.

Other Objectives.

• 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.