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Malaria Vaccine Development
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Malaria Vaccine Development Branch

Product Development Timeline

Leading Vaccine Products

                       

Updated 04/13/2009

2009 2010 2011
  Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Blood-stage vaccines

                       
AMA1-C1/Alhydrogel+CPG 7909   9a                    
                         
BSAM-2/Alhydrogel+CPG 7909 7 8, 9a   10a                
BSAM-2/Alhydrogel+CPG 10104   6 7 8 9a 10a     10b      
                         

Transmission-blocking vaccines

                       
Pfs25-Pfs25/Alhydrogel* 4, 5, 6   8 9b              
PpPvs25-Pvs25/Alhydrogel*   4, 5     8 9b            
Pfs48/45 or Pfs230     4       5          
                         

Pre-erythrocytic vaccine

                       
CSP-rEPA/Alhydrogel*   4 5 6   7   8        
                         
                         
*Conjugate vaccine                        

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
  4. Preclinical Milestones

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

  10. FDA effective Investigational New Drug Application
  11. 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
  12. 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)
  13. Blood-stage vaccine, Phase II trial in malaria-exposed children or infants: safety, immunogenicity, and biologic impact
  14. Transmission-blocking vaccine, malaria-exposed village, Phase I/II/III trial: safety and immunogenicity (TBA)

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