Malaria Vaccine Development Branch

Product Development Timeline

Milestones

Discovery Milestones

1. Rationale for candidate antigen
2. Viable process for candidate antigen production
3. Resources to develop investigational vaccine based on candidate antigen

Preclinical Milestones

4. Preclinical animal studies establishing potency parameters (e.g., ELISA, GIA, TBA)
5. cGMP production of drug substance (MCB, PCB, manufacture and testing); release of drug substance
6. Optimized formulation (including conjugation), cGMP production of drug product (manufacture and testing); release of drug product
7. GLP toxicity study of the drug product in an appropriate animal model with no signs of general toxicity

Clinical Milestones

8. FDA effective Investigational New Drug Application
9. Malaria-Naïve Phase I Trial
1. Blood-stage vaccine, Phase I trial in malaria-naïve adults: safety and immunogenicity (ELISA)
2. Transmission-blocking vaccine, Phase I trial in malaria-naïve adults: safety and immunogenicity (TBA)
3. Pre-erythrocytic vaccine, Phase I/IIa trial in malaria-naïve adults: safety, immunogenicity, and protectiveness
10. Malaria-Exposed Phase I Trial
1. Blood-stage vaccine, Phase I trial in malaria-exposed adults: safety
2. Blood-stage vaccine, Phase I trial in malaria-exposed children or infants: safety and immunogenicity (ELISA)
11. Blood-stage vaccine, Phase II trial in malaria-exposed children or infants: safety, immunogenicity, and biologic impact
12. Transmission-blocking vaccine, malaria-exposed village, Phase I/II/III trial: safety and immunogenicity (TBA)

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