title: Safety and immunogenicity of heterologous prime-boost immunisation with Plasmodium falciparum malaria candidate vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in healthy Gambian and Kenyan adults.
abstract: BACKGROUND
  Heterologous prime boost immunization with chimpanzee adenovirus 63 (ChAd63) and Modified vaccinia Virus Ankara (MVA) vectored vaccines is a strategy recently shown to be capable of inducing strong cell mediated responses against several antigens from the malaria parasite. ChAd63-MVA expressing the Plasmodium falciparum pre-erythrocytic antigen ME-TRAP (multiple epitope string with thrombospondin-related adhesion protein) is a leading malaria vaccine candidate, capable of inducing sterile protection in malaria naïve adults following controlled human malaria infection (CHMI).
  
  
  METHODS
  We conducted two Phase Ib dose escalation clinical trials assessing the safety and immunogenicity of ChAd63-MVA ME-TRAP in 46 healthy malaria exposed adults in two African countries with similar malaria transmission patterns.
  
  
  RESULTS
  ChAd63-MVA ME-TRAP was shown to be safe and immunogenic, inducing high-level T cell responses (median >1300 SFU/million PBMC).
  
  
  CONCLUSIONS
  ChAd63-MVA ME-TRAP is a safe and highly immunogenic vaccine regimen in adults with prior exposure to malaria. Further clinical trials to assess safety and immunogenicity in children and infants and protective efficacy in the field are now warranted.
  
  
  BACKGROUND
  Pactr.org PACTR2010020001771828 Pactr.org PACTR201008000221638 ClinicalTrials.gov NCT01373879 NCT01373879 ClinicalTrials.gov NCT01379430 NCT01379430.
authors.affiliation: Kenya Medical Research Institute, Centre for Geographical Medical Research Coast, Kilifi, Kenya.
authors.forename: Caroline
authors.initials: C
authors.lastname: Ogwang
authors.forename: Muhammed
authors.initials: M
authors.lastname: Afolabi
authors.forename: Domtila
authors.initials: D
authors.lastname: Kimani
authors.forename: Ya Jankey
authors.initials: YJ
authors.lastname: Jagne
authors.forename: Susanne H
authors.initials: SH
authors.lastname: Sheehy
authors.forename: Carly M
authors.initials: CM
authors.lastname: Bliss
authors.forename: Christopher J A
authors.initials: CJ
authors.lastname: Duncan
authors.forename: Katharine A
authors.initials: KA
authors.lastname: Collins
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Garcia Knight
authors.forename: Eva
authors.initials: E
authors.lastname: Kimani
authors.forename: Nicholas A
authors.initials: NA
authors.lastname: Anagnostou
authors.forename: Eleanor
authors.initials: E
authors.lastname: Berrie
authors.forename: Sarah
authors.initials: S
authors.lastname: Moyle
authors.forename: Sarah C
authors.initials: SC
authors.lastname: Gilbert
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Spencer
authors.forename: Peninah
authors.initials: P
authors.lastname: Soipei
authors.forename: Jenny
authors.initials: J
authors.lastname: Mueller
authors.forename: Joseph
authors.initials: J
authors.lastname: Okebe
authors.forename: Stefano
authors.initials: S
authors.lastname: Colloca
authors.forename: Riccardo
authors.initials: R
authors.lastname: Cortese
authors.forename: Nicola K
authors.initials: NK
authors.lastname: Viebig
authors.forename: Rachel
authors.initials: R
authors.lastname: Roberts
authors.forename: Katherine
authors.initials: K
authors.lastname: Gantlett
authors.forename: Alison M
authors.initials: AM
authors.lastname: Lawrie
authors.forename: Alfredo
authors.initials: A
authors.lastname: Nicosia
authors.forename: Egeruan B
authors.initials: EB
authors.lastname: Imoukhuede
authors.forename: Philip
authors.initials: P
authors.lastname: Bejon
authors.forename: Britta C
authors.initials: BC
authors.lastname: Urban
authors.forename: Katie L
authors.initials: KL
authors.lastname: Flanagan
authors.forename: Katie J
authors.initials: KJ
authors.lastname: Ewer
authors.forename: Roma
authors.initials: R
authors.lastname: Chilengi
authors.forename: Adrian V S
authors.initials: AV
authors.lastname: Hill
authors.forename: Kalifa
authors.initials: K
authors.lastname: Bojang
mesh_terms: D000261:Adenoviruses, Simian / Q000235:genetics; D000328:Adult; D000953:Antigens, Protozoan / Q000235:genetics; D005714:Gambia; D005822:Genetic Vectors; D006801:Humans; D007117:Immunization, Secondary; D007371:Interferon-gamma / Q000097:blood; D007630:Kenya; D017780:Malaria Vaccines / Q000008:administration & dosage* / Q000235:genetics / Q000276:immunology; D016778:Malaria, Falciparum / Q000276:immunology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D010963:Plasmodium falciparum / Q000235:genetics / Q000276:immunology*; D013601:T-Lymphocytes / Q000276:immunology; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000235:genetics / Q000276:immunology; D014616:Vaccinia virus / Q000235:genetics; D055815:Young Adult
chemical_list: D000953:Antigens, Protozoan; D017780:Malaria Vaccines; D014614:Vaccines, Synthetic; D007371:Interferon-gamma