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NIAID > Labs & Scientific Resources > Labs at NIAID > Info about NIAID Labs > Malaria Immunology and Vaccinology > Product Development Timeline

Product Development Timeline


Updated 05/21/2010 2010 2011
  Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Blood-stage Vaccines                
AMA1-C1/Alhydrogel+CPG 7909 9a 9d 9d          
BSAM-2/Alhydrogel+CPG 7909 9a 10a 10a          
                 
Pregnanacy Malaria Vaccines 2,3 2,3 2,3          
                 
Transmission-blocking Vaccines                
Pfs25-EPA/Alhydrogel 2,4 4,5 4,5 7 8 9b    
Pfs230   2,4 2,4          
Pfs25-Pfs25/Alhydrogel 8 9b 9b          
                 
Pre-erythrocytic vaccine                
CSP-EPA/Alhydrogel 2,4   8          
                 
Liver Stage Vaccines   2,3,4 2,3,4          

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

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

Clinical Milestones

  1. FDA effective Investigational New Drug Application
  2. 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
    4. Phase 2 efficacy study in malaria-naïve adults, including parasite challenge studies
  3. 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)
    3. Blood-stage vaccine, Phase II trial in malaria-exposed children or infants: safety, immunogenicity, and biologic impact
    4. Transmission-blocking vaccine, malaria-exposed village, Phase I/II/III trial: safety and immunogenicity (TBA)

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Last Updated May 26, 2010