• Vaccine Name: AMA1-C1Alhydrogel
• Target Pathogen: Plasmodium spp.
• Target Disease: Malaria
• Type: Subunit vaccine
• Status: Clinical trial
• Host Species for Licensed Use: Human
• Antigen: AMA1-C1(Malkin et al., 2005): Apical membrane antigen 1. An 83-kDa antigen that may be involved in the process of erythrocyte invasion (Hodder et al., 2001).
• AMA1 from P. falciparum 3D7 gene engineering:
  • Type: Recombinant protein preparation
  • Description: An equal mixture of recombinant proteins based on sequences from the FVO and 3D7 P. falciparum, expressed in Pichia pastoris and adsorbed on Alhydrogel. (Malkin et al., 2005)
  • Detailed Gene Information: Click Here.
• Immunization Route: Intramuscular injection (i.m.)

Human Response

• Host age: 21 to 48 years (Malkin et al., 2005)
• Vaccination Protocol: Open-label, dose-escalating phase 1 clinical trial
  Ten volunteers in each of three dose groups (5 μg, 20 μg, and 80 μg of AMA1-C1) were vaccinated by a 0.5-ml intramuscular injection on study days 0, 28, and 180 (Malkin et al., 2005).
• Immune Response: Anti-AMA1 IgG antibodies: Two weeks after the second vaccination, 20%, 55%, and 89% individuals in 5-μg, 20-μg, and 80-μg groups respectively had detectable antibody responses to AMA1-3D7, and 20%, 55%, and 78% had detectable antibody responses to AMA1-FVO. There was significant dose-response relationship for both responses in the all groups on day 42. Antibody levels declined and became undetectable in 53% responders for the AMA1-3D7 and 43% responders for AMA1-FVO on ay180. 92% individuals boosted their antibody levels two weeks after the third vaccination, . Antibody responses from the 5-μg, 20-μg, and 80-μg groups were 153, 1,041, and 978 U on average for AMA-3D7 and 113, 649, and 712 U on average for AMA-FVO. A relationship was found between antigen dose and antibody response to AMA1-FVO two weeks after the third vaccination. Antibody level declined on day 364. (Malkin et al., 2005)
  Significant AMA specific inhibition of both P. falciparum 3D7 and FVO growth was achieved in the in vitro growth inhibition assay. (Malkin et al., 2005)
• Side Effects: Mild or moderate headaches, nausea, malaise and localized myalgia. (Malkin et al., 2005)