A human phase I/IIa malaria challenge trial of a polyprotein malaria vaccine

Vaccine

Volumn 29, Issue 43, 2011, Pages 7514-7522

  Porter, David W ^a   Thompson, Fiona M ^a   Berthoud, Tamara K ^b   Hutchings, Claire L ^b   Andrews, Laura ^b   Biswas, Sumi ^b   Poulton, Ian ^a   Prieur, Eric ^b,f   Correa, Simon ^c   Rowland, Rosalind ^a   Lang, Trudie ^a   Williams, Jackie ^d   Gilbert, Sarah C ^b   Sinden, Robert E ^e   Todryk, Stephen ^b,g   Hill, Adrian V S ^a,b  

^a CHURCHILL HOSPITAL   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c MEDICAL RESEARCH COUNCIL LABORATORIES   (Gambia)

^d WALTER REED ARMY INSTITUTE OF RESEARCH   (United States)

^e IMPERIAL COLLEGE LONDON   (United Kingdom)

^f INSTITUT PASTEUR   (France)

^g NORTHUMBRIA UNIVERSITY   (United Kingdom)

Author keywords

Heterologous prime boost; Malaria; Vaccine

Indexed keywords

ARTEMETHER PLUS BENFLUMETOL; EXPORTED PROTEIN 1; GAMMA INTERFERON; LIVER STAGE ANTIGEN 1; LIVER STAGE ANTIGEN 3; MALARIA VACCINE; PARASITE ANTIGEN; PFS16 PROTEIN; SPOROZOITE THREONINE AND ASPARAGINE RICH PROTEIN; THROMBOSPONDIN RELATED ADHESION PROTEIN; UNCLASSIFIED DRUG; VIRUS VECTOR;

ADULT; ARTICLE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG SAFETY; DRUG SCREENING; ENZYME LINKED IMMUNOSPOT ASSAY; FATIGUE; FEMALE; FOWLPOX VIRUS; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INJECTION SITE SWELLING; LOCAL SKIN REACTION; LOW DRUG DOSE; MALARIA FALCIPARUM; MALE; MYALGIA; NORMAL HUMAN; PAIN; PARASITEMIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PLASMODIUM FALCIPARUM; PRIORITY JOURNAL; PROVOCATION TEST; SINGLE BLIND PROCEDURE; SINGLE DRUG DOSE; SKIN REDNESS; SPOROZOITE; UNSPECIFIED SIDE EFFECT; VACCINATION; VACCINE FAILURE; VACCINIA VIRUS;

ADOLESCENT; ADULT; ANTIBODIES, PROTOZOAN; ANTIGENS, PROTOZOAN; HUMANS; IMMUNIZATION, SECONDARY; INTERFERON-GAMMA; MALARIA VACCINES; MALARIA, FALCIPARUM; MIDDLE AGED; PLASMODIUM FALCIPARUM; POLYPROTEINS; PROTOZOAN PROTEINS; TREATMENT OUTCOME; VACCINATION; VACCINES, SUBUNIT; YOUNG ADULT;

EID: 80053443026     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.03.083     Document Type: Article

References (30)

1. Snow R.W., Guerra C.A., Noor A.M., Myint H.Y., Hay S.I. The global distribution of clinical episodes of Plasmodium falciparum malaria. Nature 2005, 434(March (7030)):214-217.
2. WHO. World Malaria Report; August 2008.
3. Hoffman S.L., Goh L.M., Luke T.C., Schneider I., Le T.P., Doolan D.L., et al. Protection of humans against malaria by immunization with radiation-attenuated Plasmodium falciparum sporozoites. J Infect Dis 2002, 185(April (8)):1155-1164.
4. Prieur E., Gilbert S.C., Schneider J., Moore A.C., Sheu E.G., Goonetilleke N., et al. A Plasmodium falciparum candidate vaccine based on a six-antigen polyprotein encoded by recombinant poxviruses. Proc Natl Acad Sci U S A 2004, 101(January (1)):290-295.
5. Kumar K.A., Sano G., Boscardin S., Nussenzweig R.S., Nussenzweig M.C., Zavala F., et al. The circumsporozoite protein is an immunodominant protective antigen in irradiated sporozoites. Nature 2006, 444(December (7121)):937-940.
6. Moorthy V.S., Pinder M., Reece W.H., Watkins K., Atabani S., Hannan C., et al. Safety and immunogenicity of DNA and modified vaccinia virus Ankara malaria vaccination in African adults. J Infect Dis 2003, 188(8):1239-1244.
7. Webster D.P., Dunachie S., Vuola J.M., Berthoud T., Keating S., Laidlaw S.M., et al. Enhanced T cell-mediated protection against malaria in human challenges by using the recombinant poxviruses FP9 and modified vaccinia virus Ankara. Proc Natl Acad Sci U S A 2005, 102(March (13)):4836-4841.
8. Imoukhuede E.B., Berthoud T., Milligan P., Bojang K., Ismaili J., Keating S., et al. Safety and immunogenicity of the malaria candidate vaccines FP9 CS and MVA CS in adult Gambian men. Vaccine 2006, 24(October (42-43)):6526-6533.
9. McShane H., Pathan A.A., Sander C.R., Keating S.M., Gilbert S.C., Huygen K., et al. Recombinant modified vaccinia virus Ankara expressing antigen 85A boosts BCG-primed and naturally acquired antimycobacterial immunity in humans. Nat Med 2004, 10(November (11)):1240-1244.
10. Schneider J., Gilbert S.C., Blanchard T.J., Hanke T., Robson K.J., Hannan C.M., et al. Enhanced immunogenicity for CD8+ T cell induction and complete protective efficacy of malaria DNA vaccination by boosting with modified vaccinia virus Ankara. Nat Med 1998, 4(April (4)):397-402.
11. Ferreira A., Schofield L., Enea V., Schellekens H., van der Meide P., Collins W.E., et al. Inhibition of development of exoerythrocytic forms of malaria parasites by gamma-interferon. Science 1986, 232(May (4752)):881-884.
12. Daubersies P., Thomas A.W., Millet P., Brahimi K., Langermans J.A., Ollomo B., et al. Protection against Plasmodium falciparum malaria in chimpanzees by immunization with the conserved pre-erythrocytic liver-stage antigen 3. Nat Med 2000, 6(November (11)):1258-1263.
13. Fidock D.A., Bottius E., Brahimi K., Moelans I.I., Aikawa M., Konings R.N., et al. Cloning and characterization of a novel Plasmodium falciparum sporozoite surface antigen, STARP. Mol Biochem Parasitol 1994, 64(April (2)):219-232.
14. Hope I.A., Hall R., Simmons D.L., Hyde J.E., Scaife J.G. Evidence for immunological cross-reaction between sporozoites and blood stages of a human malaria parasite. Nature 1984, 308(March (5955)):191-194.
15. Moelans I.I., Cohen J., Marchand M., Molitor C., de Wilde P., van Pelt J.F., et al. Induction of Plasmodium falciparum sporozoite-neutralizing antibodies upon vaccination with recombinant Pfs16 vaccinia virus and/or recombinant Pfs16 protein produced in yeast. Mol Biochem Parasitol 1995, 72(June (1-2)):179-192.
16. Robson K.J., Hall J.R., Davies L.C., Crisanti A., Hill A.V., Wellems T.E. Polymorphism of the TRAP gene of Plasmodium falciparum. Proc R Soc Lond B Biol Sci 1990, 242(December (1305)):205-216.
17. Guerin-Marchand C., Druilhe P., Galey B., Londono A., Patarapotikul J., Beaudoin R.L., et al. A liver-stage-specific antigen of Plasmodium falciparum characterized by gene cloning. Nature 1987, 329(September (6135)):164-167.
18. Chulay J.D., Schneider I., Cosgriff T.M., Hoffman S.L., Ballou W.R., Quakyi I.A., et al. Malaria transmitted to humans by mosquitoes infected from cultured Plasmodium falciparum. Am J Trop Med Hyg 1986, 35(January (1)):66-68.
19. Andrews L., Andersen R.F., Webster D., Dunachie S., Walther R.M., Bejon P., et al. Quantitative real-time polymerase chain reaction for malaria diagnosis and its use in malaria vaccine clinical trials. Am J Trop Med Hyg 2005, 73(July (1)):191-198.
20. Hermsen C.C., de Vlas S.J., van Gemert G.J., Telgt D.S., Verhage D.F., Sauerwein R.W. Testing vaccines in human experimental malaria: statistical analysis of parasitemia measured by a quantitative real-time polymerase chain reaction. Am J Trop Med Hyg 2004, 71(August (2)):196-201.
21. Vuola J.M., Keating S., Webster D.P., Berthoud T., Dunachie S., Gilbert S.C., et al. Differential immunogenicity of various heterologous prime-boost vaccine regimens using DNA and viral vectors in healthy volunteers. J Immunol 2005, 174(January (1)):449-455.
22. Moorthy V.S., Imoukhuede E.B., Keating S., Pinder M., Webster D., Skinner M.A., et al. Phase 1 evaluation of 3 highly immunogenic prime-boost regimens, including a 12-month reboosting vaccination, for malaria vaccination in Gambian men. J Infect Dis 2004, 189(June (12)):2213-2219.
23. Bejon P., Andrews L., Andersen R.F., Dunachie S., Webster D., Walther M., et al. Calculation of liver-to-blood inocula, parasite growth rates, and preerythrocytic vaccine efficacy, from serial quantitative polymerase chain reaction studies of volunteers challenged with malaria sporozoites. J Infect Dis 2005, 191(February (4)):619-626.
24. Barnes D.A., Wollish W., Nelson R.G., Leech J.H., Petersen C. Plasmodium falciparum: D260, an intraerythrocytic parasite protein, is a member of the glutamic acid dipeptide-repeat family of proteins. Exp Parasitol 1995, 81(August (1)):79-89.
25. Moelans I.I., Meis J.F., Kocken C., Konings R.N., Schoenmakers J.G. A novel protein antigen of the malaria parasite Plasmodium falciparum, located on the surface of gametes and sporozoites. Mol Biochem Parasitol 1991, 45(April (2)):193-204.
26. Stickl H., Hochstein-Mintzel V., Mayr A., Huber H.C., Schafer H., Holzner A. MVA vaccination against smallpox: clinical tests with an attenuated live vaccinia virus strain (MVA) (author's transl). Dtsch Med Wochenschr 1974, 99(November (47)):2386-2392.
27. Li S., Locke E., Bruder J., Clarke D., Doolan D.L., Havenga M.J., et al. Viral vectors for malaria vaccine development. Vaccine 2007, 25(March (14)):2567-2574.
28. Gasteiger G., Kastenmuller W., Ljapoci R., Sutter G., Drexler I. Cross-priming of cytotoxic T cells dictates antigen requisites for modified vaccinia virus Ankara vector vaccines. J Virol 2007, 81(November (21)):11925-11936.
29. Sanderson F., Andrews L., Douglas A.D., Hunt-Cooke A., Bejon P., Hill A.V. Blood-stage challenge for malaria vaccine efficacy trials: a pilot study with discussion of safety and potential value. Am J Trop Med Hyg 2008, 78(June (6)):878-883.
30. Ockenhouse C.F., Sun P.F., Lanar D.E., Wellde B.T., Hall B.T., Kester K., et al. Phase I/IIa safety, immunogenicity, and efficacy trial of NYVAC-Pf7, a pox-vectored, multiantigen, multistage vaccine candidate for Plasmodium falciparum malaria. J Infect Dis 1998, 177(June (6)):1664-1673.