Sequential Phase 1 and Phase 2 randomized, controlled trials of the safety, immunogenicity and efficacy of combined pre-erythrocytic vaccine antigens RTS,S and TRAP formulated with AS02 Adjuvant System in healthy, malaria naïve adults.

@article{Kester2014SequentialP1,
  title={Sequential Phase 1 and Phase 2 randomized, controlled trials of the safety, immunogenicity and efficacy of combined pre-erythrocytic vaccine antigens RTS,S and TRAP formulated with AS02 Adjuvant System in healthy, malaria na{\"i}ve adults.},
  author={Kent E. Kester and D Gray Heppner and Philippe J. Moris and Opokua Ofori-Anyinam and Urszula Krzych and Nadia Tornieporth and Denise McKinney and Martine Delchambre and Christian F. Ockenhouse and G. S. Voss and Carolyn A. Holland and Jolie Palensky Beckey and William Ripley Ballou and Joe Cohen},
  journal={Vaccine},
  year={2014},
  volume={32 49},
  pages={6683-91}
}
In an attempt to improve the efficacy of the candidate malaria vaccine RTS,S/AS02, two studies were conducted in 1999 in healthy volunteers of RTS,S/AS02 in combination with recombinant Plasmodium falciparum thrombospondin-related anonymous protein (TRAP). In a Phase 1 safety and immunogenicity study, volunteers were randomized to receive TRAP/AS02 (N=10), RTS,S/AS02 (N=10), or RTS,S+TRAP/AS02 (N=20) at 0, 1 and 6-months. In a Phase 2 challenge study, subjects were randomized to receive either… CONTINUE READING