Duration of vaccine efficacy against malaria: 5TH year of follow-up in children vaccinated with RTS,S/AS02 in Mozambique

Vaccine

Volumn 32, Issue 19, 2014, Pages 2209-2216

  Campo, Joseph J ^a,b   Sacarlal, Jahit ^b,c   Aponte, John J ^a,b   Aide, Pedro ^a,d   Nhabomba, Augusto J ^b   Dobaño, Carlota ^a,b   Alonso, Pedro L ^a,b  

^a CENTRE FOR RESEARCH IN ENVIRONMENTAL EPIDEMIOLOGY CREAL   (Spain)

^b Manhiça Health Research Center   (Mozambique)

^c EDUARDO MONDLANE UNIVERSITY   (Mozambique)

^d INSTITUTO NACIONAL DE SAÚDE   (Mozambique)

Author keywords

Immunogenicity; Plasmodium falciparum; Prevalence; RTS,S; Vaccine

Indexed keywords

HAEMOPHILUS INFLUENZAE TYPE B VACCINE; HEPATITIS B VACCINE; MALARIA VACCINE; PNEUMOCOCCUS VACCINE; RTS S ASO2 VACCINE; UNCLASSIFIED DRUG;

AGE; ANEMIA; ANTIBODY TITER; ARTICLE; CHILD; CLINICAL ASSESSMENT; COHORT ANALYSIS; CORRELATION ANALYSIS; DRUG EFFICACY; FEVER; FOLLOW UP; HUMAN; IMMUNOGENICITY; MAJOR CLINICAL STUDY; MALARIA; MOZAMBIQUE; OUTCOME ASSESSMENT; PARASITE PREVALENCE; PARASITEMIA; PHASE 2 CLINICAL TRIAL; PLASMODIUM FALCIPARUM; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; VACCINATION;

IMMUNOGENICITY; PLASMODIUM FALCIPARUM; PREVALENCE; RTS,S; VACCINE;

ANTIBODIES, PROTOZOAN; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; CROSS-SECTIONAL STUDIES; FOLLOW-UP STUDIES; HUMANS; IMMUNOGLOBULIN G; INFANT; MALARIA VACCINES; MALARIA, FALCIPARUM; MOZAMBIQUE; PARASITEMIA; PLASMODIUM FALCIPARUM; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84897109395     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2014.02.042     Document Type: Article

References (33)

1. WHO, World Malaria Report 2011 [cited 2013 Mar 20]. Available from: http://www.who.int/malaria/world_malaria_report_2011/en/.
2. Roll Back Malaria Partnership, Global Malaria Action Plan [cited 2013 Mar 20]. Available from: http://www.rbm.who.int/gmap/index.html.
3. The malERA Consultative Group on Vaccines A research agenda for malaria eradication: vaccines. PLoS Med 2011, 8:e1000398.
4. Sacarlal J., Aide P., Aponte J.J., Renom M., Leach A., Mandomando I., et al. Long-term safety and efficacy of the RTS, S/AS02A malaria vaccine in Mozambican children. J Infect Dis 2009, 200:329-336.
5. Olotu A., Fegan G., Wambua J., Nyangweso G., Awuondo K.O., Leach A., et al. Four-year efficacy of RTS, S/AS01E and its interaction with malaria exposure. N Engl J Med 2013, 368:1111-1120.
6. Vidor E. Evaluation of the persistence of vaccine-induced protection with human vaccines. J Comp Pathol 2010, 142(Suppl):S96-101.
7. Agnandji S.T., Lell B., Soulanoudjingar S.S., Fernandes J.F., Abossolo B.P., Conzelmann C., et al. First results of phase 3 trial of RTS, S/AS01 malaria vaccine in African children. N Engl J Med 2011, 365:1863-1875.
8. Agnandji S.T., Lell B., Fernandes J.F., Abossolo B.P., Methogo B.G.N.O., Kabwende A.L., et al. A phase 3 trial of RTS, S/AS01 malaria vaccine in African infants. N Engl J Med 2012, 367. 121109010018002.
9. Stoute J.A., Slaoui M., Heppner D.G., Momin P., Kester K.E., Desmons P., et al. A preliminary evaluation of a recombinant circumsporozoite protein vaccine against Plasmodium falciparum malaria. RTS, S malaria vaccine evaluation group. N Engl J Med 1997, 336:86-91.
10. Garçon N., Chomez P., van Mechelen M. GlaxoSmithKline adjuvant systems in vaccines: concepts, achievements and perspectives. Expert Rev Vaccines 2007, 6:723-739.
11. Stoute J.A., Kester K.E., Krzych U., Wellde B.T., Hall T., White K., et al. Long-term efficacy and immune responses following immunization with the RTS, S malaria vaccine. J Infect Dis 1998, 178:1139-1144.
12. Kester K.E., McKinney D.A., Tornieporth N., Ockenhouse C.F., Heppner D.G., Hall T., et al. Efficacy of recombinant circumsporozoite protein vaccine regimens against experimental Plasmodium falciparum malaria. J Infect Dis 2001, 183:640-647.
13. Kester K.E., Cummings J.F., Ofori-Anyinam O., Ockenhouse C.F., Krzych U., Moris P., et al. Randomized, double-blind, phase 2a trial of falciparum malaria vaccines RTS, S/AS01B and RTS, S/AS02A in malaria-naive adults: safety, efficacy, and immunologic associates of protection. J Infect Dis 2009, 200:337-346.
14. Bojang K.A., Milligan P.J.M., Pinder M., Vigneron L., Alloueche A., Kester K.E., et al. Efficacy of RTS, S/AS02 malaria vaccine against Plasmodium falciparum infection in semi-immune adult men in The Gambia: a randomised trial. Lancet 2001, 358:1927-1934.
15. Alonso P.L., Sacarlal J., Aponte J.J., Leach A., Macete E., Milman J., et al. Efficacy of the RTS, S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial. Lancet 2004, 364:1411-1420.
16. Bejon P., Lusingu J., Olotu A., Leach A., Lievens M., Vekemans J., et al. Efficacy of RTS, S/AS01E vaccine against malaria in children 5-17 months of age. N Engl J Med 2008, 359:2521-2532.
17. Abdulla S., Oberholzer R., Juma O., Kubhoja S., Machera F., Membi C., et al. Safety and immunogenicity of RTS, S/AS02D malaria vaccine in infants. N Engl J Med 2008, 359:2533-2544.
18. Aponte J.J., Aide P., Renom M., Mandomando I., Bassat Q., Sacarlal J., et al. 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 2007, 370:1543-1551.
19. Aide P., Dobaño C., Sacarlal J., Aponte J.J., Mandomando I., Guinovart C., et al. Four year immunogenicity of the RTS, S/AS02A malaria vaccine in Mozambican children during a phase IIb trial. Vaccine 2011, 29:6059-6067.
20. Aide P., Aponte J.J., Renom M., Nhampossa T., Sacarlal J., Mandomando I., et al. Safety, immunogenicity and duration of protection of the RTS, S/AS02(D) malaria vaccine: one year follow-up of a randomized controlled phase I/IIb trial. PLoS One 2010, 5:e13838.
21. Olotu A., Lusingu J., Leach A., Lievens M., Vekemans J., Msham S., et al. Efficacy of RTS, S/AS01E malaria vaccine and exploratory analysis on anti-circumsporozoite antibody titres and protection in children aged 5-17 months in Kenya and Tanzania: a randomised controlled trial. Lancet Infect Dis 2011, 11:102-109.
22. Guinovart C., Aponte J.J., Sacarlal J., Aide P., Leach A., Bassat Q., et al. Insights into long-lasting protection induced by RTS, S/AS02A malaria vaccine: further results from a phase IIb trial in Mozambican children. PLoS One 2009, 4:e5165.
23. Alonso P.L., Sacarlal J., Aponte J.J., Leach A., Macete E., Aide P., et al. 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 2005, 366:2012-2018.
24. Saúte F., Aponte J., Almeda J., Ascaso C., Abellana R., Vaz N., et al. Malaria in southern Mozambique: malariometric indicators and malaria case definition in Manhiúa district. Trans R Soc Trop Med Hyg 2003, 97:661-666.
25. Clement F., Dewar V., Van Braeckel E., Desombere I., Dewerchin M., Swysen C., et al. Validation of an enzyme-linked immunosorbent assay for the quantification of human IgG directed against the repeat region of the circumsporozoite protein of the parasite Plasmodium falciparum. Malar J 2012, 11:384.
26. Abdulla S., Salim N., Machera F., Kamata R., Juma O., Shomari M., et al. Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS, S/AS02(D) malaria vaccine in infants living in a malaria-endemic region. Malar J 2013, 12:11.
27. Schellenberg D., Menendez C., Aponte J.J., Kahigwa E., Tanner M., Mshinda H., et al. Intermittent preventive antimalarial treatment for Tanzanian infants: follow-up to age 2 years of a randomised, placebo-controlled trial. Lancet 2005, 365:1481-1483.
28. Agnandji S.T., Fendel R., Mestré M., Janssens M., Vekemans J., Held J., et al. Induction of Plasmodium falciparum-specific CD4+ T cells and memory B cells in Gabonese children vaccinated with RTS, S/AS01(E) and RTS, S/AS02(D). PLoS One 2011, 6:e18559.
29. Campo J.J., Dobaño C., Sacarlal J., Guinovart C., Mayor A., Angov E., et al. Impact of the RTS,S malaria vaccine candidate on naturally acquired antibody responses to multiple asexual blood stage antigens. PLoS One 2011, 6:e25779.
30. Bejon P., White M.T., Olotu A., Bojang K., Lusingu J.P., Salim N., et al. Efficacy of RTS, S malaria vaccines: individual-participant pooled analysis of phase 2 data. Lancet Infect Dis 2013, 13:319-327.
31. White M.T., Bejon P., Olotu A., Griffin J.T., Riley E.M., Kester K.E., et al. The relationship between RTS, S vaccine-induced antibodies, CD4+ T cell responses and protection against Plasmodium falciparum infection. PLoS One 2013, 8:e61395.
32. D.Schoenfeld Partial residuals for the proportional hazards regression model. Biometrika 1982, 69:239-241.
33. Therneau T.M., Grambsch P.M. Modeling survival data: extending the Cox Model 2000, Springer-Verlag, New York.