Clinical trial NCT04739917 - References

Malaria, Vivax — Efficacy of a Synthetic Vaccine Derived From Plasmodium Vivax Circumsporozoite Protein (PvCS) in naïve and Semi-immune Volunteers

Citation(s)

•   Ademolue TW, Awandare GA
  Evaluating antidisease immunity to malaria and implications for vaccine design. Immunology. 2018 Apr;153(4):423-434. doi: 10.1111/imm.12877. Epub 2017 Dec 26. Review.
•   Aliprandini E, Tavares J, Panatieri RH, Thiberge S, Yamamoto MM, Silvie O, Ishino T, Yuda M, Dartevelle S, Traincard F, Boscardin SB, Amino R
  Cytotoxic anti-circumsporozoite antibodies target malaria sporozoites in the host skin. Nat Microbiol. 2018 Nov;3(11):1224-1233. doi: 10.1038/s41564-018-0254-z. Epub 2018 Oct 22.
•   Arévalo-Herrera M, Chitnis C, Herrera S
  Current status of Plasmodium vivax vaccine. Hum Vaccin. 2010 Jan;6(1):124-32. Epub 2010 Jan 26. Review.
•   Arévalo-Herrera M, Herrera S
  Plasmodium vivax malaria vaccine development. Mol Immunol. 2001 Dec;38(6):443-55. Review.
•   Arévalo-Herrera M, Roggero MA, Gonzalez JM, Vergara J, Corradin G, López JA, Herrera S
  Mapping and comparison of the B-cell epitopes recognized on the Plasmodium vivax circumsporozoite protein by immune Colombians and immunized Aotus monkeys. Ann Trop Med Parasitol. 1998 Jul;92(5):539-51.
•   Arévalo-Herrera M, Soto L, Perlaza BL, Céspedes N, Vera O, Lenis AM, Bonelo A, Corradin G, Herrera S
  Antibody-mediated and cellular immune responses induced in naive volunteers by vaccination with long synthetic peptides derived from the Plasmodium vivax circumsporozoite protein. Am J Trop Med Hyg. 2011 Feb;84(2 Suppl):35-42. doi: 10.4269/ajtmh.2011.09-0507.
•   Arévalo-Herrera M, Vera O, Castellanos A, Céspedes N, Soto L, Corradin G, Herrera S
  Preclinical vaccine study of Plasmodium vivax circumsporozoite protein derived-synthetic polypeptides formulated in montanide ISA 720 and montanide ISA 51 adjuvants. Am J
•   Arnot DE, Barnwell JW, Tam JP, Nussenzweig V, Nussenzweig RS, Enea V
  Circumsporozoite protein of Plasmodium vivax: gene cloning and characterization of the immunodominant epitope. Science. 1985 Nov 15;230(4727):815-8.
•   Arnot DE, Stewart MJ, Barnwell JW
  Antigenic diversity in Thai Plasmodium vivax circumsporozoite proteins. Mol Biochem Parasitol. 1990 Nov;43(1):147-9.
•   Barnwell JW, Galinski MR, DeSimone SG, Perler F, Ingravallo P
  Plasmodium vivax, P. cynomolgi, and P. knowlesi: identification of homologue proteins associated with the surface of merozoites. Exp Parasitol. 1999 Mar;91(3):238-49.
•   Barnwell JW, Galinski MR
  Plasmodium vivax: a glimpse into the unique and shared biology of the merozoite. Ann Trop Med Parasitol. 1995 Apr;89(2):113-20. Review.
•   Bermúdez M, Moreno-Pérez DA, Arévalo-Pinzón G, Curtidor H, Patarroyo MA
  Plasmodium vivax in vitro continuous culture: the spoke in the wheel. Malar J. 2018 Aug 20;17(1):301. doi: 10.1186/s12936-018-2456-5. Review.
•   Burkot TR, Wirtz RA, Paru R, Garner P, Alpers MP
  The population dynamics in mosquitoes and humans of two Plasmodium vivax polymorphs distinguished by different circumsporozoite protein repeat regions. Am J Trop Med Hyg. 1992 Dec;47(6):778-86.
•   Cattani JA, Tulloch JL, Vrbova H, Jolley D, Gibson FD, Moir JS, Heywood PF, Alpers MP, Stevenson A, Clancy R
  The epidemiology of malaria in a population surrounding Madang, Papua New Guinea. Am J Trop Med Hyg. 1986 Jan;35(1):3-15.
•   CDC (2020) 'CDC - Malaria - Malaria Worldwide - Impact of Malaria'
  Available in: https://www.cdc.gov/malaria/malaria_worldwide/impact.html
•   Cerami C, Frevert U, Sinnis P, Takacs B, Clavijo P, Santos MJ, Nussenzweig V
  The basolateral domain of the hepatocyte plasma membrane bears receptors for the circumsporozoite protein of Plasmodium falciparum sporozoites. Cell. 1992 Sep 18;70(6):1021-33.
•   Charoenvit Y, Collins WE, Jones TR, Millet P, Yuan L, Campbell GH, Beaudoin RL, Broderson JR, Hoffman SL
  Inability of malaria vaccine to induce antibodies to a protective epitope within its sequence. Science. 1991 Feb 8;251(4994):668-71.
•   Chitnis CE
  Molecular insights into receptors used by malaria parasites for erythrocyte invasion. Curr Opin Hematol. 2001 Mar;8(2):85-91. Review.
•   Clyde DF, McCarthy VC, Miller RM, Hornick RB
  Specificity of protection of man immunized against sporozoite-induced falciparum malaria. Am J Med Sci. 1973 Dec;266(6):398-403.
•   Clyde DF
  Immunization of man against falciparum and vivax malaria by use of attenuated sporozoites. Am J Trop Med Hyg. 1975 May;24(3):397-401.
•   Cochrane AH, Aikawa M, Jeng M, Nussenzweig RS
  Antibody-induced ultrastructural changes of malarial sporozoites. J Immunol. 1976 Mar;116(3):859-67.
•   Cochrane AH, Nardin EH, de Arruda M, Maracic M, Clavijo P, Collins WE, Nussenzweig RS
  Widespread reactivity of human sera with a variant repeat of the circumsporozoite protein of Plasmodium vivax. Am J Trop Med Hyg. 1990 Nov;43(5):446-51.
•   Collins WE, Jeffery GM
  A retrospective examination of sporozoite- and trophozoite-induced infections with Plasmodium falciparum in patients previously infected with heterologous species of Plasmodium: effect on development of parasitologic and clinical immunity. Am J Trop Med Hyg. 1999 Jul;61(1 Suppl):36-43.
•   Collins WE, Sullivan JS, Morris CL, Galland GG, Richardson BB
  Observations on the biological nature of Plasmodium vivax sporozoites. J Parasitol. 1996 Apr;82(2):216-9.
•   Comer RD, Young MD, Porter JA Jr, Gauld JR, Merritt W
  Chloroquine resistance in Plasmodium falciparum malaria on the Pacific coast of Colombia. Am J Trop Med Hyg. 1968 Nov;17(6):795-9.
•   RTS,S Clinical Trials Partnership
  Efficacy and safety of the RTS,S/AS01 malaria vaccine during 18 months after vaccination: a phase 3 randomized, controlled trial in children and young infants at 11 African sites. PLoS Med. 2014 Jul 29;11(7):e1001685. doi: 10.1371/journal.pmed.1001685. eCollection 2014 Jul.

Safety and Protective Efficacy of a Synthetic Vaccine Derived From the CS Protein of Plasmodium Vivax: a Double-blind, Placebo-controlled, Randomized Clinical Trial in naïve and Pre-immune Colombian Volunteers

Details for clinical trial NCT04739917