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Malaria Vaccine Development Branch |
Product Development Timeline
Leading Vaccine Products |
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Updated 04/13/2009 |
2009 |
2010 |
2011 |
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Q1 |
Q2 |
Q3 |
Q4 |
Q1 |
Q2 |
Q3 |
Q4 |
Q1 |
Q2 |
Q3 |
Q4 |
Blood-stage vaccines |
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AMA1-C1/Alhydrogel+CPG 7909 |
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9a |
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BSAM-2/Alhydrogel+CPG 7909 |
7 |
8, 9a |
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10a |
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BSAM-2/Alhydrogel+CPG 10104
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6 |
7 |
8 |
9a |
10a |
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10b |
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Transmission-blocking vaccines |
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Pfs25-Pfs25/Alhydrogel* |
4, 5, |
6 |
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8 |
9b |
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PpPvs25-Pvs25/Alhydrogel* |
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4, 5 |
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8 |
9b |
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Pfs48/45 or Pfs230 |
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4 |
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5 |
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Pre-erythrocytic vaccine |
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CSP-rEPA/Alhydrogel* |
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4 |
5 |
6 |
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7 |
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8 |
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*Conjugate vaccine |
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Milestones
Discovery Milestones
- Rationale for candidate antigen
- Viable process for candidate antigen production
- Resources to develop investigational vaccine based on candidate antigen
Preclinical Milestones
- Preclinical animal studies establishing potency parameters (e.g., ELISA, GIA, TBA)
- cGMP production of drug substance (MCB, PCB, manufacture and testing); release of drug substance
- Optimized formulation (including conjugation), cGMP production of drug product (manufacture and testing); release of drug product
- GLP toxicity study of the drug product in an appropriate animal model with no signs of general toxicity
Clinical Milestones
- FDA effective Investigational New Drug Application
- Malaria-Naïve Phase I Trial
- Blood-stage vaccine, Phase I trial in malaria-naïve adults: safety and immunogenicity (ELISA)
- Transmission-blocking vaccine, Phase I trial in malaria-naïve adults: safety and immunogenicity (TBA)
- Pre-erythrocytic vaccine, Phase I/IIa trial in malaria-naïve adults: safety, immunogenicity, and protectiveness
- Malaria-Exposed Phase I Trial
- Blood-stage vaccine, Phase I trial in malaria-exposed adults: safety
- Blood-stage vaccine, Phase I trial in malaria-exposed children or infants: safety and immunogenicity (ELISA)
- Blood-stage vaccine, Phase II trial in malaria-exposed children or infants: safety, immunogenicity, and biologic impact
- Transmission-blocking vaccine, malaria-exposed village, Phase I/II/III trial: safety and immunogenicity (TBA)
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