• Vaccine Name: PfAMA1-FVO/ Alhydrogel
• Target Pathogen: Plasmodium spp.
• Target Disease: Malaria
• Type: Subunit vaccine
• Status: Clinical trial
• Host Species for Licensed Use: None
• Antigen: Recombinant protein Pichia pastoris-expressed AMA-1, surface protein expressed during the asexual blood stage of Plasmodium falciparum. PfAMA1-FVO is a lyophilized preparation of the ectodomain of the FVO clone of P. falciparum AMA1 (Thera et al., 2016)
• AMA1 from P. falciparum 3D7 gene engineering:
  • Type: Recombinant protein preparation
  • Description: A lyophilized preparation of the ectodomain of the FVO clone of P. falciparum AMA1 (Thera et al., 2016)
  • Detailed Gene Information: Click Here.
• Preparation: The vaccine was prepared in single dose vials containing 62.5 µg AMA1 protein, 23.3 µg EDTA, 25 mg saccharose, 187 µg NaH2PO4·2H₂O, 226 µg Na2HPO4. Vials were reconstituted by adding 625 µL 0.2 % Alhydrogel® suspension. he reconstituted vaccine was then incubated for 60 min at room temperature to facilitate adsorption to the Alhydrogel® and a dose of 0.5 mL containing 50 µg AMA1 and approximately 0.5 mg aluminium was used for injection. (Thera et al., 2016)
• Immunization Route: Intramuscular injection (i.m.)
• Description: The PfAMA1-FVO vaccine uses the FVO clone of the AMA1 surface protein as the vaccine antigen and Alhydrogel as the adjuvant.

Human Response

• Host Strain: Adults in Bandiagara aged 18–55 years old
• Vaccination Protocol: The study vaccines were given on study days 0, 28 and 56. (Thera et al., 2016)
• Immune Response: The PfAMA1 vaccine induced a significant increase in AMA1-specific IgG following vaccination (p < 0.05); after vaccination, titres increased gradually in the PfAMA1 recipients until day 84 when a maximum level was observed with a geometric mean of 17,584 arbitrary units 95 % CI (9889 to 31,267). Antibody titres peaked 1 month after the third dose reaching a 3.5 fold rise. (Thera et al., 2016)
• Side Effects: The 40 participants experienced a total of 257 adverse events, 136 were solicited AEs and 121 were unsolicited AEs. Additional vaccine doses did not globally increase the number of AEs. injection site pain was reported at least by 60 % of the participants after any dose compared to 40 % in the control group. Overall, the results showed a good biological safety profile. (Thera et al., 2016)
• Description: PfAMA1-FVO malaria vaccine candidate clinical development was stopped after the present trial was completed, partly because of the potential limits imposed by strain specificity of protection to polymorphic AMA1 confirmed in human (Thera et al., 2016)