Insights into long-lasting protection induced by RTS,S/AS02A malaria vaccine: Further results from a phase IIb trial in Mozambican children

PLoS ONE

Volumn 4, Issue 4, 2009, Pages

  Guinovart, Caterina ^a,b   Aponte, John J ^a,b   Sacarlal, Jahit ^b,c   Aide, Pedro ^b,d   Leach, Amanda ^e   Bassat, Quique ^a,b   Macete, Eusébio ^b,f   Dobaño, Carlota ^a,b   Lievens, Marc ^e   Loucq, Christian ^g   Ballou, W Ripley ^e   Cohen, Joe ^e   Alonso, Pedro L ^a,b  

^a UNIVERSITY OF BARCELONA   (Spain)

^b Ministérioda Saúde   (Mozambique)

^c EDUARDO MONDLANE UNIVERSITY   (Mozambique)

^d INSTITUTO NACIONAL DE SAÚDE   (Mozambique)

^e GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^f Ministério de Saúde ^*  (Mozambique)

^g PATH Malaria Vaccine Initiative   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMODIAQUINE; ARTEMETHER PLUS BENFLUMETOL; CHLOROQUINE; FANSIDAR; HAEMOPHILUS INFLUENZAE TYPE B VACCINE; HEPATITIS B VACCINE; MALARIA VACCINE; PNEUMOCOCCUS VACCINE; PYRIMETHAMINE; QUININE; SULFADOXINE; RTS,S AS02A VACCINE; RTS,S-AS02A VACCINE;

ARTICLE; CHILD; CHILD HEALTH; CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SURVEILLANCE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; HUMAN; MAJOR CLINICAL STUDY; MALARIA; MOZAMBIQUE; PHASE 2 CLINICAL TRIAL; PRESCHOOL CHILD; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; ADULT; ANIMAL; INFANT; KAPLAN MEIER METHOD; PARASITEMIA; PHASE 3 CLINICAL TRIAL; TREATMENT OUTCOME;

ADULT; ANIMALS; CHILD, PRESCHOOL; DOUBLE-BLIND METHOD; HUMANS; INFANT; KAPLAN-MEIERS ESTIMATE; MALARIA; MALARIA VACCINES; MOZAMBIQUE; PARASITEMIA; TREATMENT OUTCOME;

EID: 65349096887     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0005165     Document Type: Article

References (25)

1. Bojang KA, Milligan PJ, Pinder M, Vigneron L, Alloueche A, et al. (2001) Efficacy of RTS,S/AS02 malaria vaccine against Plasmodium falciparum infection in semi-immune adult men in The Gambia: a randomised trial. Lancet 358: 1927-1934.
2. Kester KE, McKinney DA, Tornieporth N, Ockenhouse CF, Heppner DG, et al. (2001) Efficacy of recombinant circumsporozoite protein vaccine regimens against experimental Plasmodium falciparum malaria. J Infect Dis 183: 640-647.
3. Stoute JA, Slaoui M, Heppner DG, Momin P, Kester KE, et al. (1997) A preliminary evaluation of a recombinant circumsporozoite protein vaccine against Plasmodium falciparum malaria. RTS,S Malaria Vaccine Evaluation Group. N Engl J Med 336: 86-91.
4. Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, et al. (2004) Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial. Lancet 364: 1411-1420.
5. Aponte JJ, Aide P, Renom M, Mandomando I, Bassat Q, et al. (2007) Safety of the RTS,S/AS02D candidate malaria vaccine in infants living in a highly endemic area of Mozambique: a double blind randomised controlled phase I/IIb trial. Lancet 370: 1543-1551.
6. Bejon P, Lusingu J, Olotu A, Leach A, Lievens M, et al. (2008) Efficacy of RTS,S/AS01E vaccine against malaria in children 5 to 17 months of age. N Engl J Med 359: 2521-2532.
7. Abdulla S, Oberholzer R, Juma O, Kubhoja S, Machera F, et al. (2008) Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. N Engl J Med 359: 2533-2544.
8. Guinovart C, Alonso PL (2007) Methods for determining vaccine efficacy and effectiveness and the main barriers to developing a fully deployable malaria vaccine. Am J Trop Med Hyg 77: 276-281.
9. Moorthy V, Reed Z, Smith PG (2007) Measurement of malaria vaccine efficacy in phase III trials: report of a WHO consultation. Vaccine 25: 5115-5123.
10. Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, et al. (2005) Duration of protection with RTS,S/AS02A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children: single-blind extended follow-up of a randomised controlled trial. Lancet 366: 2012-2018.
11. Saute F, Aponte J, Almeda J, Ascaso C, Abellana R, et al. (2003) Malaria in southern Mozambique: malariometric indicators and malaria case definition in Manhica district. Trans R Soc Trop Med Hyg 97: 661-666.
12. Alonso PL, Aponte JJ (2002) Field Trials. In: Doolan DL, ed. Methods in Molecular Medicine, Vol 72: Malaria methods and Protocols. Totowa, NJ: Humana Press, Inc. pp 607-616.
13. Sutherland C, Drakeley C, Schellenberg D (2007) How is childhood development of immunity to Plasmodium falciparum enhanced by certain antimalarial interventions? Malaria Journal 6: 161.
14. Pombo DJ, Lawrence G, Hirunpetcharat C, Rzepczyk C, Bryden M, et al. (2002) Immunity to malaria after administration of ultra-low doses of red cells infected with Plasmodium falciparum. Lancet 360: 610-617.
15. John CC, Tande AJ, Moormann AM, Sumba PO, Lanar DE, et al. (2008) Antibodies to Pre-erythrocytic Plasmodium falciparum Antigens and Risk of Clinical Malaria in Kenyan Children. J Infect Dis 197: 519-526.
16. Favila-Castillo L, Monroy-Ostria A, Garcia-Tapia D (1999) Plasmodium chabaudi chabaudi: effect of low parasitaemias on immunity in CB6F1 mice. Exp Parasitol 92: 73-80.
17. Owusu-Agyei S, Koram KA, Baird JK, Utz GC, Binka FN, et al. (2001) Incidence of symptomatic and asymptomatic Plasmodium falciparum infection following curative therapy in adult residents of northern Ghana. Am J Trop Med Hyg 65: 197-203.
18. Schellenberg D, Menendez C, Aponte JJ, Kahigwa E, Tanner M, et al. (2005) Intermittent preventive antimalarial treatment for Tanzanian infants: follow-up to age 2 years of a randomised, placebo-controlled trial. Lancet 365: 1481-1483.
19. Hoffman SL, Goh LM, Luke TC, Schneider I, Le TP, et al. (2002) Protection of humans against malaria by immunization with radiation-attenuated Plasmodium falciparum sporozoites. J Infect Dis 185: 1155-1164.
20. Alonso PL, Saúte F, Aponte JJ, Gómez-Olivé FX, Nhacolo A, et al. (2002) Manhiça DSS, Mozambique. In: INDEPTH, editor. Population and Health in Developing Countries. Ottawa: International Development Research Centre (IDRC). pp 189-195.
21. Alonso P, Smith T, Schellenberg J, Masanja H, Mwankusye S, et al. (1994) Randomised trial of efficacy of SPf66 vaccine against Plasmodium falciparum malaria in children in southern Tanzania. The Lancet 344: 1175-1181.
22. Wirtz RA, Ballou WR, Schneider I, Chedid L, Gross MJ, et al. (1987) Plasmodium falciparum: immunogenicity of circumsporozoite protein constructs produced in Escherichia coli. Exp Parasitol 63: 166-172.
23. Therneau TM, Grambsch PM (2000) Modeling survival data: extending the Cox model. New York: Springer.
24. Hess KR (1995) Graphical methods for assessing violations of the proportional hazards assumption in Cox regression. Stat Med 14: 1707-1723.
25. Smith T, Schellenberg JA, Hayes R (1994) Attributable fraction estimates and case definitions for malaria in endemic areas. Stat Med 13: 2345-2358.