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

نویسندگان

  • Caroline Ogwang
  • Muhammed Afolabi
  • Domtila Kimani
  • Ya Jankey Jagne
  • Susanne H. Sheehy
  • Carly M. Bliss
  • Christopher J. A. Duncan
  • Katharine A. Collins
  • Miguel A. Garcia Knight
  • Eva Kimani
  • Nicholas A. Anagnostou
  • Eleanor Berrie
  • Sarah Moyle
  • Sarah C. Gilbert
  • Alexandra J. Spencer
  • Peninah Soipei
  • Jenny Mueller
  • Joseph Okebe
  • Stefano Colloca
  • Riccardo Cortese
  • Nicola K. Viebig
  • Rachel Roberts
  • Katherine Gantlett
  • Alison M. Lawrie
  • Alfredo Nicosia
  • Egeruan B. Imoukhuede
  • Philip Bejon
  • Britta C. Urban
  • Katie L. Flanagan
  • Katie J. Ewer
  • Roma Chilengi
  • Adrian V. S. Hill
  • Kalifa Bojang
چکیده

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). METHODOLOGY 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. TRIAL REGISTRATION Pactr.org PACTR2010020001771828 Pactr.org PACTR201008000221638 ClinicalTrials.gov NCT01373879 NCT01373879 ClinicalTrials.gov NCT01379430 NCT01379430.

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عنوان ژورنال:

دوره 8  شماره 

صفحات  -

تاریخ انتشار 2013