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Mosquito bite immunization with radiation-attenuated Plasmodium falciparum sporozoites: safety, tolerability, protective efficacy and humoral immunogenicity.

Bradley W HickeyJoanne M LumsdenSharina ReyesMartha SedegahMichael R HollingdaleDaniel A FreilichThomas C LukeYupin CharoenvitLucy M GohMara P BerzinsLolita BebrisJohn B SacciPatricia De La VegaRuobing WangHarini GaneshanEsteban N AbotDaniel J CarucciDenise L DoolanGary T BriceAnita KumarJoao AguiarThomas B NutmanSusan F LeitmanStephen L HoffmanJudith E EpsteinThomas L Richie
Published in: Malaria journal (2016)
The protective efficacy of this clinical trial (50 %) was notably less than previously reported (>90 %). This may be related to differences in host genetics or the inherent variability in mosquito biting behavior and numbers of sporozoites injected. Differences in trial procedures, such as the use of leukapheresis prior to CHMI and of a longer interval between the final immunization and CHMI in these subjects compared to earlier trials, may also have reduced protective efficacy. This trial has been retrospectively registered at ISRCTN ID 17372582, May 31, 2016.
Keyphrases
  • clinical trial
  • phase iii
  • study protocol
  • phase ii
  • plasmodium falciparum
  • open label
  • immune response
  • aedes aegypti
  • randomized controlled trial
  • double blind