Phase 1 safety and immunogenicity trial of malaria vaccine RTS,S/AS02A in adults in a hyperendemic region of western Kenya

José A. Stoute, D. Gray Heppner, Carl J. Mason, Joram Siangla, Malachi O. Opollo, Kent E. Kester, Laurence Vigneron, Gerald Voss, Michael J. Walter, Nadia Tornieporth, Joe D. Cohen, W. Ripley Ballou

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

We conducted a phase 1 trial of candidate malaria vaccine RTS,S/AS02A in western Kenya to determine its safety and immunogenicity in healthy adults in an area hyperendemic for malaria. Twenty adults were enrolled and received RTS,S/AS02A (50 μg of RTS,S in 0.5 mL of AS02A) by intramuscular injection on a 0-, 28-, and 178-day schedule. All 60 scheduled immunizations were given, and 18 of 20 volunteers completed the last study visit on day 210. The vaccine was safe and well-tolerated. There were no vaccine-related severe adverse events. The most common solicited adverse events associated with immunization were injection site pain and headache. The geometric mean concentration of antibodies to circumsporozoite protein was 1.9 μg/mL at baseline and it increased 2-4 weeks after each dose to 16, 17.8, and 36.6 μg/mL, respectively. These safety and immunogenicity data from adults in hyperendemic Kenya are comparable to data reported earlier from two trials in west African adults in hypo-endemic and meso-endemic areas of The Gambia. We conclude that in this small study, RTS,S/AS02A is safe and similarly immunogenic in malaria-exposed African adults of different ethnicity in different transmission settings.

Original languageEnglish (US)
Pages (from-to)166-170
Number of pages5
JournalAmerican Journal of Tropical Medicine and Hygiene
Volume75
Issue number1
StatePublished - Jul 1 2006

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Malaria Vaccines
Kenya
Safety
Malaria
Immunization
Vaccines
Gambia
Intramuscular Injections
Headache
Volunteers
Appointments and Schedules
Pain
Injections
Antibodies
Proteins

All Science Journal Classification (ASJC) codes

  • Parasitology
  • Virology
  • Infectious Diseases

Cite this

Stoute, José A. ; Heppner, D. Gray ; Mason, Carl J. ; Siangla, Joram ; Opollo, Malachi O. ; Kester, Kent E. ; Vigneron, Laurence ; Voss, Gerald ; Walter, Michael J. ; Tornieporth, Nadia ; Cohen, Joe D. ; Ballou, W. Ripley. / Phase 1 safety and immunogenicity trial of malaria vaccine RTS,S/AS02A in adults in a hyperendemic region of western Kenya. In: American Journal of Tropical Medicine and Hygiene. 2006 ; Vol. 75, No. 1. pp. 166-170.
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Stoute, JA, Heppner, DG, Mason, CJ, Siangla, J, Opollo, MO, Kester, KE, Vigneron, L, Voss, G, Walter, MJ, Tornieporth, N, Cohen, JD & Ballou, WR 2006, 'Phase 1 safety and immunogenicity trial of malaria vaccine RTS,S/AS02A in adults in a hyperendemic region of western Kenya', American Journal of Tropical Medicine and Hygiene, vol. 75, no. 1, pp. 166-170.

Phase 1 safety and immunogenicity trial of malaria vaccine RTS,S/AS02A in adults in a hyperendemic region of western Kenya. / Stoute, José A.; Heppner, D. Gray; Mason, Carl J.; Siangla, Joram; Opollo, Malachi O.; Kester, Kent E.; Vigneron, Laurence; Voss, Gerald; Walter, Michael J.; Tornieporth, Nadia; Cohen, Joe D.; Ballou, W. Ripley.

In: American Journal of Tropical Medicine and Hygiene, Vol. 75, No. 1, 01.07.2006, p. 166-170.

Research output: Contribution to journalArticle

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AU - Stoute, José A.

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N2 - We conducted a phase 1 trial of candidate malaria vaccine RTS,S/AS02A in western Kenya to determine its safety and immunogenicity in healthy adults in an area hyperendemic for malaria. Twenty adults were enrolled and received RTS,S/AS02A (50 μg of RTS,S in 0.5 mL of AS02A) by intramuscular injection on a 0-, 28-, and 178-day schedule. All 60 scheduled immunizations were given, and 18 of 20 volunteers completed the last study visit on day 210. The vaccine was safe and well-tolerated. There were no vaccine-related severe adverse events. The most common solicited adverse events associated with immunization were injection site pain and headache. The geometric mean concentration of antibodies to circumsporozoite protein was 1.9 μg/mL at baseline and it increased 2-4 weeks after each dose to 16, 17.8, and 36.6 μg/mL, respectively. These safety and immunogenicity data from adults in hyperendemic Kenya are comparable to data reported earlier from two trials in west African adults in hypo-endemic and meso-endemic areas of The Gambia. We conclude that in this small study, RTS,S/AS02A is safe and similarly immunogenic in malaria-exposed African adults of different ethnicity in different transmission settings.

AB - We conducted a phase 1 trial of candidate malaria vaccine RTS,S/AS02A in western Kenya to determine its safety and immunogenicity in healthy adults in an area hyperendemic for malaria. Twenty adults were enrolled and received RTS,S/AS02A (50 μg of RTS,S in 0.5 mL of AS02A) by intramuscular injection on a 0-, 28-, and 178-day schedule. All 60 scheduled immunizations were given, and 18 of 20 volunteers completed the last study visit on day 210. The vaccine was safe and well-tolerated. There were no vaccine-related severe adverse events. The most common solicited adverse events associated with immunization were injection site pain and headache. The geometric mean concentration of antibodies to circumsporozoite protein was 1.9 μg/mL at baseline and it increased 2-4 weeks after each dose to 16, 17.8, and 36.6 μg/mL, respectively. These safety and immunogenicity data from adults in hyperendemic Kenya are comparable to data reported earlier from two trials in west African adults in hypo-endemic and meso-endemic areas of The Gambia. We conclude that in this small study, RTS,S/AS02A is safe and similarly immunogenic in malaria-exposed African adults of different ethnicity in different transmission settings.

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