The RTS,S/AS01 malaria vaccine in children 5 to 17 months of age at first vaccination

Expert Review of Vaccines

Volumn 15, Issue 12, 2016, Pages 1481-1493

  Vandoolaeghe, Pascale ^a   Schuerman, Lode ^a  

^a GSK   (Belgium)

Author keywords

Malaria; P. falciparum; RTS,S AS01; safety; vaccine efficacy

Indexed keywords

MALARIA VACCINE; RECOMBINANT VACCINE; RTS,S-AS01 VACCINE;

ADVERSE DRUG REACTION; AGE DISTRIBUTION; ARTICLE; CHILD; CHILD CARE; CHILD SAFETY; CHILDHOOD MORTALITY; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); DISEASE SEVERITY; DRUG SAFETY; DRUG TOLERABILITY; FOLLOW UP; HEALTH CARE PLANNING; HUMAN; IMMUNOGENICITY; INFANT; MALARIA; MULTICENTER STUDY (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PLASMODIUM FALCIPARUM; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); VACCINATION; IMMUNIZATION; IMMUNOLOGY;

HUMANS; IMMUNIZATION SCHEDULE; INFANT; MALARIA; MALARIA VACCINES; VACCINES, SYNTHETIC;

EID: 84996587631     PISSN: 14760584     EISSN: 17448395     Source Type: Journal    
DOI: 10.1080/14760584.2016.1236689     Document Type: Article

References (59)

1. WHO. World Malaria Report. 2015. [cited 2016 Jun14]. Available from:http://www.who.int/malaria/publications/world-malaria-report-2015/report/en/.
2. Noor AM, Kinyoki DK, Mundia CW, et al. The changing risk of Plasmodium falciparum malaria infection in Africa:2000-10:a spatial and temporal analysis of transmission intensity. Lancet. 2014;383(9930):1739–1747.
3. Bhatt S, Weiss DJ, Cameron E, et al. The effect of malaria control on Plasmodium falciparum in Africa between 2000 and 2015. Nature. 2015;526(7572):207–211.
4. Pluess B, Tanser FC, Lengeler C, et al. Indoor residual spraying for preventing malaria. Cochrane Database Syst Rev. 2010;4:CD006657.
5. Protopopoff N, Matowo J, Malima R, et al. High level of resistance in the mosquito Anopheles gambiae to pyrethroid insecticides and reduced susceptibility to bendiocarb in north-western Tanzania. Malar J. 2013;12:149.
6. European Medicine Agencies. CHMP. Assessment report Mosquirix, 2015. [cited 2016 Apr7]. Available from:http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/10/WC500194577.pdf.• The report contains an overview of the vaccine, a scientific discussion, a benefit–risk assessment and EMA recommendations for the use of RTS,S/AS01 for active immunization against malaria.
7. Malaria vaccine:WHO position paper-January 2016. Wkly Epidemiol Rec. 2016; 91(4):33–51.•• Summarizes important information on malaria and the RTS,S/AS01 and includes the WHO position on the use of the vaccine.
8. Cohen J, Nussenzweig V, Nussenzweig R, et al. From the circumsporozoite protein to the RTS, S/AS candidate vaccine. Hum Vaccin. 2010;6(1):90–96.
9. Regules JA, Cummings JF, Ockenhouse CF., The RTS,S vaccine candidate for malaria. Expert Rev Vaccines. 2011;10(5):589–599.
10. Mosquirix Product Information. 2015. [cited 2016 Apr7]. Available from:http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/document_listing/document_listing_000395.jsp&mid=.• Summary of product characteristics.
11. Birkett AJ. Status of vaccine research and development of vaccines for malaria. Vaccine. 2016;34(26):2915–2920.
12. WHO Expert Committee on Biological Standardization 63rd report, Annex 3:Guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum. 2014. [cited 2016 Apr27]. Available from:http://www.who.int/biologicals/vaccines/Malaria_Guidelines_TRS_980_Annex_3.pdf.
13. Agnandji ST, Fernandes JF, Bache EB, et al. Clinical development of RTS,S/AS malaria vaccine:a systematic review of clinical Phase I-III trials. Future Microbiol. 2015;10(10):1553–1578.
14. Leach A, Vekemans J, Lievens M, et al. Design of a phase III multicenter trial to evaluate the efficacy of the RTS,S/AS01 malaria vaccine in children across diverse transmission settings in Africa. Malar J. 2011;10:224.
15. RTS,S Clinical Trials Partnership. Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa:final results of a phase 3, individually randomised, controlled trial. Lancet. 2015;386(9988):31–45.•• Final results of the Phase III trial.
16. Ansong D, Asante KP, Vekemans J, et al. T cell responses to the RTS,S/AS01(E) and RTS,S/AS02(D) malaria candidate vaccines administered according to different schedules to Ghanaian children. PLoS One. 2011;6(4):e18891.
17. Owusu-Agyei S, Ansong D, Asante K, et al. Randomized controlled trial of RTS,S/AS02D and RTS,S/AS01E malaria candidate vaccines given according to different schedules in Ghanaian children. PLoS One. 2009;4(10):e7302.
18. Olotu A, Lusingu J, Leach A, 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(2):102–109.
19. Agnandji ST, Asante KP, Lyimo J, et al. Evaluation of the safety and immunogenicity of the RTS,S/AS01E malaria candidate vaccine when integrated in the expanded program of immunization. J Infect Dis. 2010;202(7):1076–1087.
20. Bejon P, Lusingu J, Olotu A, et al. Efficacy of RTS,S/AS01E vaccine against malaria in children 5 to 17 months of age. N Engl J Med. 2008;359(24):2521–2532.
21. Ndungu FM, Mwacharo J, Kimani D, et al. A statistical interaction between circumsporozoite protein-specific T cell and antibody responses and risk of clinical malaria episodes following vaccination with RTS,S/AS01E. PLoS One. 2012;7(12):e52870.
22. Bejon P, Cook J, Bergmann-Leitner E, et al. Effect of the pre-erythrocytic candidate malaria vaccine RTS,S/AS01E on blood stage immunity in young children. J Infect Dis. 2011;204(1):9–18.
23. Olotu A, Moris P, Mwacharo J, et al. Circumsporozoite-specific T cell responses in children vaccinated with RTS,S/AS01E and protection against P falciparum clinical malaria. PLoS One. 2011;6(10):e25786.
24. Lusingu J, Olotu A, Leach A, et al. Safety of the malaria vaccine candidate, RTS,S/AS01E in 5 to 17 month old Kenyan and Tanzanian children. PLoS One. 2010;5(11):e14090.
25. Asante KP, Abdulla S, Agnandji S, et al. Safety and efficacy of the RTS,S/AS01E candidate malaria vaccine given with expanded-programme-on-immunisation vaccines:19 month follow-up of a randomised, open-label, phase 2 trial. Lancet Infect Dis. 2011;11(10):741–749.
26. Lievens M, Aponte JJ, Williamson J, et al. Statistical methodology for the evaluation of vaccine efficacy in a phase III multi-centre trial of the RTS, S/AS01 malaria vaccine in African children. Malar J. 2011;10:222.
27. RTS,S Clinical Trials Partnership. Efficacy and safety of the RTS,S/AS01 malaria vaccine during 18 months after vaccination:a phase 3 randomized, controlled trial in children and young infants at 11 African sites. PLoS Med. 2014;11(7):e1001685.• Presents data from up 18 months of follow-up from the Phase III trial.
28. Neafsey DE, Juraska M, Bedford T, et al. Genetic diversity and protective efficacy of the RTS, S/AS01 malaria vaccine. N Engl J Med. 2015;373(21):2025–2037.
29. RTS,S Clinical Trials Partnership. First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children. N Engl J Med. 2011;365(20):1863–1875.• Presents data on efficacy and safety in children 5–17 months old from up to 12 months of follow-up from the Phase III trial.
30. Swysen C, Vekemans J, Bruls M, et al. Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine. Malar J. 2011;10:223.
31. Vekemans J, Marsh K, Greenwood B, et al. Assessment of severe malaria in a multicenter, phase III, RTS, S/AS01 malaria candidate vaccine trial:case definition, standardization of data collection and patient care. Malar J. 2011;10:221.
32. RTS,S Clinical Trials Partnership. A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants. N Engl J Med. 2012;367(24):2284–2295.
33. Otieno L, Oneko M, Otieno W, et al. Safety and immunogenicity of RTS,S/AS01 malaria vaccine in infants and children with WHO stage 1 or 2 HIV disease:a randomised, double-blind, controlled trial. Lancet Infect Dis. 2016;S1473–S3099(16):30161–X. doi:10.1016/S1473-3099(16)-X.
34. Umeh R, Oguche S, Oguonu T, et al. Immunogenicity and safety of the candidate RTS,S/AS01 vaccine in young Nigerian children:a randomized, double-blind, lot-to-lot consistency trial. Vaccine. 2014;32(48):6556–6562.
35. Joint Technical Expert Group & World Health Organization. Background paper on the RTS,S/AS01 malaria vaccine. 2015. [cited 2016 Apr7]. Available from:http://www.who.int/immunization/sage/meetings/2015/october/1_Final_malaria_vaccine_background_paper_v2015_09_30.pdf?ua=1.
36. Olotu A, Fegan G, Wambua J, et al. Four-year efficacy of RTS,S/AS01E and its interaction with malaria exposure. N Engl J Med. 2013;368(12):1111–1120.
37. Olotu A, Fegan G, Wambua J, et al. Seven-year efficacy of RTS,S/AS01 malaria vaccine among young African children. N Engl J Med. 2016;374(26):2519–2529.
38. Bejon P, White MT, Olotu A, et al. Efficacy of RTS,S malaria vaccines:individual-participant pooled analysis of phase 2 data. Lancet Infect Dis. 2013;13(4):319–327.
39. Reyburn H, Mbatia R, Drakeley C, et al. Association of transmission intensity and age with clinical manifestations and case fatality of severe Plasmodium falciparum malaria. JAMA. 2005;293(12):1461–1470.
40. Taylor T, Olola C, Valim C, et al. Standardized data collection for multi-center clinical studies of severe malaria in African children:establishing the SMAC network. Trans R Soc Trop Med Hyg. 2006;100(7):615–622.
41. Jallow M, Casals-Pascual C, Ackerman H, et al. Clinical features of severe malaria associated with death:a 13-year observational study in the Gambia. PLoS One. 2012;7(9):e45645.
42. Dondorp AM, Fanello CI, Hendriksen IC, et al. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT):an open-label, randomised trial. Lancet. 2010;376(9753):1647–1657.
43. Hamel MJ, Oneko M, Williamson J, et al. A marked reduction in mortality among participants in a clinical trial that removed barriers to care and implemented national case management guidelines. In:63rd Annual Meeting of the American Society of Tropical Medicine and Hygiene; 2014 Nov 2–6; New Orleans (LA). 631 (abstr).
44. Alloueche A, Milligan P, Conway DJ, et al. Protective efficacy of the RTS, S/AS02 Plasmodium falciparum malaria vaccine is not strain specific. Am J Trop Med Hyg. 2003;68(1):97–101.
45. Enosse S, Dobaño C, Quelhas D, et al. RTS, S/AS02A malaria vaccine does not induce parasite CSP T cell epitope selection and reduces multiplicity of infection. PLOS Clin Trial. 2006;1(1):e5.
46. Waitumbi JN, Anyona SB, Hunja CW, et al. Impact of RTS,S/AS02(A) and RTS,S/AS01(B) on genotypes of P. falciparum in adults participating in a malaria vaccine clinical trial. PLoS One. 2009;4(11):e7849.
47. Penny MA, Verity R, Bever CA, et al. Public health impact and cost-effectiveness of the RTS,S/AS01 malaria vaccine:a systematic comparison of predictions from four mathematical models. Lancet. 2016;387(10016):367–375.
48. Penny MA, Pemberton-Ross P, Smith TA. The time-course of protection of the RTS,S vaccine against malaria infections and clinical disease. Malar J. 2015;14(1):437.
49. Agnandji ST, Fendel R, Mestre M, 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(4):e18559.
50. Ajua A, Lell B, Agnandji ST, et al. The effect of immunization schedule with the malaria vaccine candidate RTS,S/AS01E on protective efficacy and anti-circumsporozoite protein antibody avidity in African infants. Malar J. 2015;14:72.
51. Horowitz A, Hafalla JC, King E, et al. Antigen-specific IL-2 secretion correlates with NK cell responses after immunization of Tanzanian children with the RTS,S/AS01 malaria vaccine. J Immunol. 2012;188(10):5054–5062.
52. Kester KE, Cummings JF, Ofori-Anyinam O, 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(3):337–346.
53. White MT, Verity R, Griffin JT, et al. Immunogenicity of the RTS,S/AS01 malaria vaccine and implications for duration of vaccine efficacy:secondary analysis of data from a phase 3 randomised controlled trial. Lancet Infect Dis. 2015;15(12):1450–1458.
54. Vekemans J, Guerra Y, Lievens M, et al. Pooled analysis of safety data from pediatric Phase II RTS,S/AS malaria candidate vaccine trials. Hum Vaccin. 2011;7(12):1309–1316.
55. Guerra Mendoza Y, Garric E, Schuerman L, et al. Discussion of meningitis, cerebral malaria and all-cause mortality followind immunization of childrren with the RTS,S/AS01 malaria vaccine in the phase III efficacy trial. In:MVW. 2016 May 2–5; Leiden (Netherlands).
56. Klein SL, Shann F, Moss WJ, et al. RTS,S malaria vaccine and increased mortality in girls. MBio. 2016;7:2.
57. White NJ. Artemisinin resistance–the clock is ticking. Lancet. 2010;376(9758):2051–2052.
58. WHO. Malaria Vaccine Rainbow Tables. 2016. [cited 2016 Apr7]. Available from:http://www.who.int/vaccine_research/links/Rainbow/en/index.html.
59. Regules JA, Cicatelli SB, Bennett JW, et al. Fractional third and fourth dose of RTS,S/AS01 malaria candidate vaccine:a phase 2a controlled human malaria parasite infection and immunogenicity study. J Infect Dis. 2016;214(5):762–771.