Safety and immunogenicity of a three-component blood-stage malaria vaccine in adults living in an endemic area of Papua New Guinea

Vaccine

Volumn 18, Issue 23, 2000, Pages 2504-2511

  Genton, Blaise ^a   Al Yaman, Fadwa ^a   Anders, Robin ^b   Saul, Allan ^c   Brown, Graham ^b   Pye, David ^d   Irving, David O ^e   Briggs, William R S ^f   Mai, Absalom ^a   Ginny, Meza ^a   Adiguma, Thomas ^a   Rare, Lawrence ^a   Giddy, Andrew ^g   Reber Liske, Rosemaria ^h   Stuerchler, Dieter ^h   Alpers, Michael P ^a  

^a PAPUA NEW GUINEA INSTITUTE OF MEDICAL RESEARCH   (Papua New Guinea)

^b WALTER AND ELIZA HALL INSTITUTE OF MEDICAL RESEARCH   (Australia)

^c QIMR BERGHOFER MEDICAL RESEARCH INSTITUTE   (Australia)

^d CSL LIMITED   (Australia)

^e Biotechnology Australia   (Australia)

^f Saramane Pty Ltd   (Australia)

^g Roche Products Australia   (Australia)

^h F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Malaria vaccine; MSP1; MSP2; Papua New Guinea; Phase I; Plasmodium falciparum; RESA

Indexed keywords

ANTIGEN; MALARIA VACCINE; PLACEBO;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; HUMAN; HUMAN EXPERIMENT; HUMORAL IMMUNITY; IMMUNOGENICITY; INJECTION PAIN; MALARIA; MALE; NORMAL HUMAN; PAPUA NEW GUINEA; PHASE 1 CLINICAL TRIAL; PLASMODIUM FALCIPARUM; PRIORITY JOURNAL; SKIN NODULE; VACCINATION;

EID: 0034701833     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0264-410X(00)00036-0     Document Type: Article

References (30)

1. World Health Organization. Investing in health research and development. Report of the ad hoc committee on health research relating to future intervention option. TDR/gen/96.1, 1996.
2. Tanner M., Teuscher T., Alonso P.L. SPf66 - The first malaria vaccine. Parasitology Today. 11:1995;10-13.
3. Facer C.A., Tanner M. Clinical trials of malaria vaccines: progress and prospects. Adv. Parasitol. 39:1997;2-68.
4. D'Alessandro U., Leach A., Drakely C.J., et al. Efficacy trial of malaria vaccine SPf66 in Gambian infants. Lancet. 346:1995;462-467.
5. Nosten F., Luxemberger C., Kyle D.E., et al. Randomized double-blind placebo-controlled trial of SPf66 malaria vaccine in children in northwestern Thailand. Lancet. 348:1996;701-708.
6. Urdaneta M., Prata A., Struchiner C.J., Tosta C.E., Tauil P., Boulos M. Evaluation of SPf66 malaria vaccine efficacy in Brazil. Am. J. Trop. Med. Hyg. 58:1998;378-385.
7. Acosta C.J., Galindo C.M., Schellenberg D., et al. Evaluation of the SPf66 vaccine for malaria control when delivered through the EPI scheme in Tanzania. Tropical Medicine and International Health. 4:1999;368-376.
8. Alpers M.P., Al-Yaman F., Beck H.-P., et al. The Malaria Vaccine Epidemiology and Evaluation Project of Papua New Guinea: rationale and baseline studies. Papua New Guinea Med. J. 35:1992;285-297.
9. Al-Yaman F., Genton B., Anders R., et al. Assessment of the role of humoral response to Plasmodium falciparum MSP2 compared to RESA and SPf66 in protecting Papua New Guinean children from clinical malaria. Parasite Immunology. 17:1995;493-501.
10. Al-Yaman F., Genton B., Kramer K., et al. Assessment of the role of naturally acquired antibody levels to Plasmodium falciparum merozoite surface protein-1 in protecting Papua New Guinean children from malaria morbidity. Am. J. Trop. Med. Hyg. 54:1996;443-448.
11. Al-Yaman F., Genton B., Taraika J., Anders R., Alpers M.P. Association between cellular response (IL-4) to RESA/Pf155 and protection from clinical malaria among Papua New Guinean children living in a malaria endemic area. Parasite Immunol. 19:1997;249-254.
12. Al-Yaman F., Genton B., Anders R., et al. Relationship between humoral response to Plasmodium falciparum merozoite surface antigen 2 and malaria morbidity in a highly endemic area of Papua New Guinea. Am. J. Trop. Med. Hyg. 51:1994;593-602.
13. Al-Yaman F., Genton B., Falk, et al. Humoral response to Plasmodium falciparum ring-infected erythrocyte surface antigen in a highly endemic area of Papua New Guinea. Am. J. Trop. Med. Hyg. 52:1995;66-71.
14. Lawrence G.W., Saul A., Giddy A.J., Kemp R., Pye D. Phase I trial in humans of an oil-based adjuvant SEPPIC Montanide ISA 720. Vaccine. 15:1997;176-178.
15. Saul A, Lawrence G, Smillie A et al. Human phase I vaccine trials of 3 recombinant asexual stage malaria antigens, Vaccine 1999; (in press).
16. Holder A.A. The precursor to major merozoite surface antigens: structure and role in immunity. Prog. Allergy. 41:1988;72-97.
17. Smythe J.A., Coppel R.L., Day K.P., et al. Structural diversity in the Plasmodium falciparum merozoite surface antigen 2. PNAS. 88:1991;1751-1755.
18. Stuerchler D., Berger R., Rudin C., et al. Safety, immunogenicity, and pilot efficacy of Plasmodium falciparum sporozoite and asexual blood-stage combination vaccine in Swiss adults. Am. J. Trop. Med. Hyg. 53:1995;423-431.
19. Culvenor J.G., Day K.P., Anders R.F. Plasmodium falciparum ring-infected erythrocyte surface antigen is released from merozoite dense granules after erythrocyte invasion. Infect. Immun. 59:1991;1183-1187.
20. Genton B., Smith T., Baea K., et al. Malaria: how useful are clinical criteria for improving the diagnosis among presumptive cases in a highly endemic area? Trans. R. Soc. Trop. Med. Hyg. 88:1994;537-541.
21. Genton B., Al-Yaman F., Beck H.-P., et al. The epidemiology of malaria in the Wosera area, East Sepik Province of Papua New Guinea, in preparation for vaccine trials. I. Malariometric indices and immunity. Ann. Trop. Med. Parasitol. 89:1995;359-376.
22. Marshall V.M., Anthony R.L., Bangs M.J., Purnomo, Anders R.F., Coppel R.L. Allelic variants of the Plasmodium falciparum merozoite surface antigen 2 (MSA-2) in a geographically restricted area of Irian Jaya. Mol. Biochem. Parasitol. 63:1994;13-21.
23. Kirkwood B.R. Transformations. Medical Statistics. 1988;142-144 Blackwell Scientific Publications, London.
24. Leach A., Drakeley C.J., D'Alessandro U., et al. A pilot safety and immunogenicity of the malaria vaccine SPf66 in Gambian infants. Parasite Immunol. 17:1995;441-444.
25. Bojang K.A., Obaro S.K., Leach A., et al. Follow-up of Gambian children recruited to a pilot safety and immunogenicity study of the malaria vaccine SPf66. Parasite Immunol. 19:1997;579-581.
26. Genton B., Al-Yaman F., Beck H.-P., et al. The epidemiology of malaria in the Wosera area, East Sepik Province of Papua New Guinea, in preparation for vaccine trials. II. Mortality and morbidity. Ann. Trop. Med. Parasitol. 89:1995;377-390.
27. Smith T., Genton B., Baea K., et al. Relationships between Plasmodium falciparum infection and morbidity in a highly endemic area. Parasitology. 109:1994;539-549.
28. Cohen S., McGregor I.A., Carrington S. Gamma-globulin and acquired immunity to human malaria. Nature. 192:1961;733-737.
29. Sabchareon A., Burnouf T., Outtara D., et al. Parasitologic and clinical human response to immunoglobulin administration in falciparum malaria. Am. J. Trop. Med. Hyg. 45:1991;297-308.
30. Bouharoun-Tayoun H., Attanath P., Sabchareon A., et al. Antibodies that protect humans against Plasmodium falciparum blood-stages do not on their own inhibit parasite growth and invasion in vitro, but act in cooperation with monocytes. J. Exp. Med. 172:1990;1633-1641.