References
- WHO. World Malaria Report. 2015. Accessed on June 14, 2016.
- 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 May 17;383(9930):1739-47. PubMed | Google Scholar
- Bhatt S, Weiss DJ, Cameron E et al. The effect of
malaria control on Plasmodium falciparum in Africa between 2000 and 2015.
Nature. 2015 Oct 8;526(7572):207-11. PubMed | Google
Scholar
- Pluess B, Tanser FC, Lengeler C, Sharp BL. Indoor residual spraying for preventing malaria. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD006657. PubMed | Google Scholar
- 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 May 2;12:149. PubMed | Google Scholar
- European Medicine Agencies, CHMP. Assessment report Mosquirix, 2015. Accessed on April 7, 2016.
- WHO. Malaria vaccine: WHO position paper-January 2016. Wkly Epidemiol Rec. 2016 Jan 4;91(4):33-51. PubMed | Google Scholar
- Cohen J, Nussenzweig V, Nussenzweig R et al. From the circumsporozoite protein to the RTS, S/AS candidate vaccine. Hum Vaccin. 2010 Jan;6(1):90-6. PubMed | Google Scholar
- Regules JA, Cummings JF, Ockenhouse CF. The RTS,S vaccine candidate for malaria. Expert Rev Vaccines. 2011 May;10(5):589-99. PubMed | Google Scholar
- Mosquirix Product Information, 2015. Accessed on April 7, 2016.
- Birkett AJ. Status of vaccine research and development
of vaccines for malaria. Vaccine. 2016 Jun 3;34(26):2915-20. PubMed | Google
Scholar
- WHO. 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. Accessed on 27 April 2016.
- Agnandji ST, Fernandes JF, Bache EB, Ramharter
M. Clinical development of RTS,S/AS malaria vaccine:
a systematic review of clinical Phase I-III trials.
Future Microbiol. 2015;10(10):1553-78.| Google
Scholar
- 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. Google
Scholar
- 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 Oct 2;4(10):e7302. Google
Scholar
- 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 Feb;11(2):102-9. Google
Scholar
- 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 Oct 1;202(7):1076-87. Google
Scholar
- 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 Dec 11;359(24):2521-32. PubMed | Google Scholar
- 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. Google
Scholar
- 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 Jul 1;204(1):9-18. PubMed | Google Scholar
- 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. Google
Scholar
- 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 Nov 29;5(11):e14090. PubMed | Google Scholar
- 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 Oct;11(10):741-9. Google
Scholar
- 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 Aug 4;10:224. Google
Scholar
- 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 Jul 4;386(9988):31-45. PubMed | Google Scholar
- 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 Aug 4;10:222. PubMed | Google Scholar
- 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 Jul 29;11(7):e1001685. Google
Scholar
- 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 Nov 19;373(21):2025-37. PubMed | Google
Scholar
- 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 Nov 17;365(20):1863-75. PubMed | Google Scholar
- 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 Aug 4;10:223. PubMed | Google Scholar
- 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 Aug 4;10:221. PubMed | Google Scholar
- RTS,S Clinical Trials Partnership. A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants. N Engl J Med. 2012 Dec 13;367(24):2284-95. PubMed | Google Scholar
- 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 Oct;16(10):1134-1144. PubMed | Google Scholar
- 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 Nov 12;32(48):6556-62. PubMed | Google Scholar
- Vandoolaeghe P, Schuerman L. The RTS, S/AS01 malaria
vaccine in children 5 to 17 months of age at first
vaccination. Expert Rev Vaccines. 2016 Dec;15(12):1481-93. PubMed | Google
Scholar
- Joint Technical Expert Group & World Health Organization. Background paper on the RTS,S/AS01 malaria vaccine, 2015. Accessed on April 7, 2016.
- 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 Mar 21;368(12):1111-20. PubMed | Google Scholar
- 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 Jun 30;374(26):2519-29. PubMed | Google Scholar
- 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 Apr;13(4):319-27. PubMed | Google Scholar
- 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 Mar 23;293(12):1461-70. PubMed | Google Scholar
- 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 Jul;100(7):615-22. PubMed | Google Scholar
- 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. PubMed | Google Scholar
- 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 Nov 13;376(9753):1647-57. PubMed | Google Scholar
- 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. 63rd Annual Meeting of the American Society of Tropical Medicine and
Hygiene; New Orleans, USA; Nov 2–6, 2014. 631 (abstr). Google
Scholar
- Alloueche A, Milligan P, Conway DJ et al. Protective efficacy of the RTS, S/AS02 Plasmodium falciparum malaria vaccine is not strain specific. The American journal of tropical medicine and hygiene. 2003;68(1):97-101. Google Scholar
- 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. Google Scholar
- 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 Nov
17;4(11):e7849. Google
Scholar
- 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
Jan 23;387(10016):367-75. Google
Scholar
- 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 Nov
4;14:437. Google
Scholar
- 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 Apr 11;6(4):e18559. PubMed | Google Scholar
- 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 Feb 13;14:72. Google
Scholar
- 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
May 15;188(10):5054-62. Google
Scholar
- 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 Aug 1;200(3):337-46. Google
Scholar
- 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 Dec;15(12):1450-8. Google
Scholar
- 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 Dec;7(12):1309-16. Google
Scholar
- Guerra Mendoza Y, Garric E, Schuerman L et al.
Discussion of meningitis, cerebral malaria and all-cause mortality followind
immunization of children with the RTS,S/AS01 malaria vaccine in the phase
III efficacy trial. MVW, Leiden, Netherlands. 2-5 May 2016.
- Klein SL, Shann F, Moss WJ et al. RTS,S Malaria
Vaccine and Increased Mortality in Girls. MBio. 2016
Apr 26;7(2):e00514-16. Google
Scholar