Clinical Trials Unit
The Clinical Trials Unit is responsible for human testing of MVDB’s malaria vaccines after preclinical testing has demonstrated both evidence of immunogenicity and lack of toxicity in animal systems. MVDB's charge is to produce malaria vaccines and develop them through to proof-of-concept trials in the target population. Thus, the unit is involved primarily in Phase I and Phase II testing. Unit staff includes two clinicians, a clinical trials coordinator, and a clinical trials assistant. Currently, the unit works with collaborators at the trial sites and does not conduct its own clinical trials.
MVDB has evaluated both transmission-blocking vaccines and blood-stage vaccines in Phase I trials. However, at this time, development of a transmission-blocking vaccine awaits further preclinical development. The goal of the blood-stage antigen program is to reduce severe disease and death in infants and young children in endemic areas. The general, four-step plan is as follows:
- Determine safety and immunogenicity in malaria-naïve adults
- Determine safety in semi-immune adults in malaria-endemic areas
- Evaluate safety and immunogenicity in children and infants in malaria-endemic areas
- Perform Phase II studies to demonstrate proof-of-concept in the target population
After Phase I testing of MVDB vaccines in healthy, malaria-naïve volunteers has demonstrated both safety and immunogenicity, the next step in the clinical development pathway is to re-test these vaccines in healthy adults living in a malaria-endemic area. This is necessary because of potential genetic differences between these individuals and those from a typical U.S. population, and because of differences due to repeated prior exposure to malaria and other chronic infectious diseases that may affect both the safety profile and immune response to vaccination.
After safety has been demonstrated in adults in an endemic area, Phase I age de-escalation into infants in the endemic area is planned. Phase I trials in infants are required to demonstrate safety and immunogenicity prior to Phase IIb testing.
Mali, West Africa
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