title: Safety and immunogenicity of the Plasmodium falciparum merozoite surface protein-3 long synthetic peptide (MSP3-LSP) malaria vaccine in healthy, semi-immune adult males in Burkina Faso, West Africa.
abstract: The merozoite surface protein-3 long synthetic peptide (MSP3-LSP) comprises the amino acid sequence 186-276 of the Plasmodium falciparum protein MSP3. It is currently in development as an erythrocytic stage (blood stage) malaria vaccine candidate. We report here the first data on the safety, reactogenicity and immunogenicity of three doses of MSP3-LSP, adjuvanted with aluminium hydroxide, in healthy male adults living in a malaria endemic area.
  
  
  METHODS
  A phase 1b single-blind controlled trial was performed in the village of Balonghin in Burkina Faso. Thirty male volunteers aged 18-40 years were randomised to receive either three doses of 30 microg MSP3-LSP or 0.5 ml of tetanus toxoid vaccine. The second and third vaccine doses were given 28 and 112 days after the first dose. We followed participants for 1 year.
  
  
  RESULTS
  There were no serious adverse events in either vaccine group. In both groups participants reported local reactions at the site of injection when compared to an earlier trial in European volunteers. Only one systemic adverse event (tachycardia) was identified which occurred immediately after the first vaccination in one individual receiving MSP3-LSP. No clinically significant biological abnormalities following vaccination were observed. Humoral immune responses (IgG, IgG subclasses, IgM) to MSP3-LSP peptide were similar in the two groups following vaccination. Some cell-mediated immune responses appeared to differ between the two vaccine groups. After the second dose of MSP3-LSP, there appeared to be a marked increase in the lymphocyte proliferation index and IFN-gamma in response to stimulation with MSP3-LSP.
  
  
  CONCLUSIONS
  These data suggest that three doses of 30 microg MSP3-LSP when administered subcutaneously on days 0, 28 and 112 are well-tolerated by adult males previously exposed to natural P. falciparum infection. They also suggest that MSP3-LSP is able to stimulate an enhanced cell-mediated immune response in individuals with some degree of preexisting immunity.
authors.affiliation: Centre National de Recherche et de Formation sur le Paludisme (CNRFP), 01 BP 2208 Ouagadougou 01, Burkina Faso. s.sirima.cnlp@fasonet.bf
authors.forename: Sodiomon B
authors.initials: SB
authors.lastname: Sirima
authors.forename: Issa
authors.initials: I
authors.lastname: Nébié
authors.forename: Alphonse
authors.initials: A
authors.lastname: Ouédraogo
authors.forename: Alfred B
authors.initials: AB
authors.lastname: Tiono
authors.forename: Amadou T
authors.initials: AT
authors.lastname: Konaté
authors.forename: Adama
authors.initials: A
authors.lastname: Gansané
authors.forename: Assetou I
authors.initials: AI
authors.lastname: Dermé
authors.forename: Amidou
authors.initials: A
authors.lastname: Diarra
authors.forename: Amidou
authors.initials: A
authors.lastname: Ouédraogo
authors.forename: Issiaka
authors.initials: I
authors.lastname: Soulama
authors.forename: Nadine
authors.initials: N
authors.lastname: Cuzzin-Ouattara
authors.forename: Simon
authors.initials: S
authors.lastname: Cousens
authors.forename: Odile
authors.initials: O
authors.lastname: Leroy
mesh_terms: D000328:Adult; D000595:Amino Acid Sequence; D000953:Antigens, Protozoan / Q000009:adverse effects* / Q000276:immunology; D006801:Humans; D007371:Interferon-gamma / Q000096:biosynthesis; D008213:Lymphocyte Activation; D017780:Malaria Vaccines / Q000009:adverse effects* / Q000276:immunology; D008297:Male; D008969:Molecular Sequence Data; D010446:Peptide Fragments / Q000009:adverse effects* / Q000276:immunology; D012449:Safety; D016037:Single-Blind Method; D014614:Vaccines, Synthetic / Q000009:adverse effects* / Q000276:immunology
chemical_list: D000953:Antigens, Protozoan; C506685:MSP3 protein, Plasmodium falciparum (181-276); D017780:Malaria Vaccines; D010446:Peptide Fragments; D014614:Vaccines, Synthetic; D007371:Interferon-gamma