Skip to main content
SpringerLink
Log in

RTS,S/AS01 malaria vaccine (Mosquirix™): a guide to its use

  • Adis Drug Q&A
  • Published:
Drugs & Therapy Perspectives Aims and scope Submit manuscript

Abstract

RTS,S/AS01 (Mosquirix™), the first malaria vaccine against Plasmodium falciparum, is indicated for the active immunization of infants and children aged 6 weeks to 17 months, with three intramuscular doses administered at months 0, 1 and 2 and a booster dose administered at month 20. In a phase 3 trial, RTS,S/AS01 had efficacy in both infants aged 6–12 weeks and children aged 5–17 months, with an acceptable tolerability profile. However, the duration of protection afforded by RTS,S/AS01 remains unclear. In modelling studies, RTS,S/AS01 had a significant public health impact was cost effective. The WHO has recommended pilot implementation of RTS,S/AS01 in children aged 5–17 months before a wider scale-up is considered.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. 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):207–11.

    Article  CAS  PubMed  Google Scholar 

  2. World Health Organization. World Malaria Report 2015. Geneva: WHO Press; 2015.

    Book  Google Scholar 

  3. World Health Organization and the United Nations Children’s Fund. Achieving the malaria MDG target: reversing the incidence of malaria 2000–2015. Geneva: WHO Press; 2015.

  4. Hoffman SL, Vekemans J, Richie TL, et al. The march toward malaria vaccines. Vaccine. 2015;33(Suppl 4):D13–23.

    Article  CAS  PubMed  Google Scholar 

  5. Mosquirix powder and suspension for suspension for injection: EU summary of product characteristics. London: European Medicines Agency; 2015.

  6. Article 58 procedure. London: European Medicines Agency; 2015.

  7. Tsuboi T, Takashima E. Antibody titre as a surrogate of protection of the first malaria subunit vaccine, RTS,S/AS01. Lancet Infect Dis. 2015;15(12):1371–2.

    Article  CAS  PubMed  Google Scholar 

  8. 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):1450–8.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. 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):2521–32.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  10. Lell B, Agnandji S, von Glasenapp I, et al. A randomized trial assessing the safety and immunogenicity of AS01 and AS02 adjuvanted RTS,S malaria vaccine candidates in children in Gabon. PLoS One. 2009;4(10):e7611.

    Article  PubMed  PubMed Central  Google Scholar 

  11. 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):741–9.

    Article  CAS  PubMed  Google Scholar 

  12. Agnandji ST, Lell B, Fernandes JF, et al. A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants. N Engl J Med. 2012;367(24):2284–95.

    Article  CAS  PubMed  Google Scholar 

  13. Agnandji ST, Lell B, Soulanoudjingar SS, et al. First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children. N Engl J Med. 2011;365(20):1863–75.

    Article  PubMed  Google Scholar 

  14. 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.

  15. 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.

  16. Mosquirix: EU assessment report. London: European Medicines Agency; 2015.

  17. 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):2025–37.

    Article  PubMed  Google Scholar 

  18. White MT, Bejon P, Olotu A, et al. A combined analysis of immunogenicity, antibody kinetics and vaccine efficacy from phase 2 trials of the RTS,S malaria vaccine. BMC Med. 2014;12:117.

    Article  PubMed  PubMed Central  Google Scholar 

  19. 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):367–75.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Galactionova K, Bertram M, Lauer J, et al. Costing RTS,S introduction in Burkina Faso, Ghana, Kenya, Senegal, Tanzania, and Uganda: a generalizable approach drawing on publicly available data. Vaccine. 2015;33(48):6710–8.

    Article  PubMed  Google Scholar 

  21. World Health Organization. Malaria vaccine: WHO position paper—January 2016. Wkly Epidemiol Rec. 2016;91(4):33–52.

    Google Scholar 

Download references

Acknowledgments

The review was reviewed by: V. S. Atluri, Florida International University, Miami, FL, USA; G. Singh, Indian Institute of Technology Delhi, New Dehli, India. During the peer review process, the manufacturer of RTS,S/AS01 was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Gillian M. Keating

Authors
  1. Gillian M. Keating
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Gillian M. Keating.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Conflicts of interest

G. Keating is a salaried employee of Adis/Springer, is responsible for the article content and declares no conflicts of interest.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Keating, G.M. RTS,S/AS01 malaria vaccine (Mosquirix™): a guide to its use. Drugs Ther Perspect 32, 143–148 (2016). https://doi.org/10.1007/s40267-016-0290-9

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40267-016-0290-9

Keywords

Search

Navigation