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Vaccine Detail

FMP1/AS02A
Vaccine Information
  • Vaccine Name: FMP1/AS02A
  • Target Pathogen: Plasmodium spp.
  • Target Disease: Malaria
  • Vaccine Ontology ID: VO_0000777
  • Type: Subunit vaccine
  • Antigen: Apical membrane antigen 1 (AMA-1) is an asexual blood stage antigen. AMA-1 is considered to be an important candidate malaria vaccine antigen (Morais et al., 2006; Polhemus et al., 2007).
  • AMA1 from P. falciparum 3D7 gene engineering:
    • Type: Recombinant protein preparation
    • Description:
    • Detailed Gene Information: Click Here.
  • Adjuvant: AS02 vaccine adjuvant
    • Adjuvant name: AS02 vaccine adjuvant
    • VO adjuvant ID: VO_0001264
    • Description: The Plasmodium falciparum vaccine candidate FMP2.1/AS02A , a recombinant E coli-expressed protein based upon the apical membrane antigen-1 (AMA-1 ) of the 3D7 clone formulated with the AS02A adjuvant(Polhemus et al., 2007)
  • Preparation: FMP2.1 antigen represents amino acids #83-531 of the P. falciparum (clone 3D7) AMA-1 protein. Just prior to immunization, the lyophilized FMP2.1 protein was mixed with AS02A such that approximately 8, 20 or 40 μg of FMP2.1 was delivered in a final volume of 0.5 mL of AS02A (Polhemus et al., 2007).
Host Response

Human Response

  • Vaccination Protocol: An open-label, staggered-start, dose-escalating Phase I trial was conducted in 23 malaria-naïve volunteers who received 8, 20 or 40 μg of FMP2.1 in a fixed volume of 0.5 mL of AS02A on a 0, 1, and 2 month schedule. Nineteen of 23 volunteers received all three scheduled immunizations (Polhemus et al., 2007).
  • Immune Response: All volunteers seroconverted after second immunization as determined by ELISA. Immune sera recognized sporozoites and merozoites by immunofluorescence assay (IFA), and exhibited both growth inhibition and processing inhibition activity against homologous (3D7) asexual stage parasites. Post-immunization, peripheral blood mononuculear cells exhibited FMP2.1-specific lymphoproliferation and IFN-γ and IL-5 ELISPOT assay responses (Polhemus et al., 2007).
  • Side Effects: The most frequent solicited local and systemic adverse events associated with immunization were injection site pain (68%) and headache (29%). There were no significant laboratory abnormalities or vaccine-related serious adverse events.
References
Morais et al., 2006: Morais CG, Soares IS, Carvalho LH, Fontes CJ, Krettli AU, Braga EM. Antibodies to Plasmodium vivax apical membrane antigen 1: persistence and correlation with malaria transmission intensity. The American journal of tropical medicine and hygiene. 2006 Oct; 75(4); 582-7. [PubMed: 17038677].
Polhemus et al., 2007: Polhemus ME, Magill AJ, Cummings JF, Kester KE, Ockenhouse CF, Lanar DE, Dutta S, Barbosa A, Soisson L, Diggs CL, Robinson SA, Haynes JD, Stewart VA, Ware LA, Brando C, Krzych U, Bowden RA, Cohen JD, Dubois MC, Ofori-Anyinam O, De-Kock E, Ballou WR, Heppner DG Jr. Phase I dose escalation safety and immunogenicity trial of Plasmodium falciparum apical membrane protein (AMA-1) FMP2.1, adjuvanted with AS02A, in malaria-naive adults at the Walter Reed Army Institute of Research. Vaccine. 2007 May 22; 25(21); 4203-12. [PubMed: 17442466].