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

ABSTRACT

The RTS,S/AS01 malaria vaccine received a positive scientific opinion from the European Medicines Agency in July 2015. The World Health Organization recommended pilot implementation of the vaccine in children at least 5 months of age according to an initial 3-dose schedule given at least 1 month apart, and a 4th dose 15–18 months post-dose 3. Clinical trials and mathematical modeling demonstrated that the partial protection provided by RTS,S/AS01 against malaria has the potential to provide substantial public health benefit when used in parallel with other malaria interventions, especially in highly endemic regions. The highest impact was seen with 4 vaccine doses in children aged 5 months or older. The vaccine will be evaluated in real-life settings to further assess its impact on mortality, vaccine safety in the context of routine immunization, and programmatic feasibility of delivering a 4-dose vaccination schedule requiring new immunization contacts. If successful, this will pave the way for larger-scale implementation.

KEYWORDS:

• Malaria
• P. falciparum
• RTS,S/AS01
• vaccine efficacy
• safety

Box 1. Primary case definitions for clinical and severe malaria in the phase III trial

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Acknowledgments

The authors thank Myriam Wilbaux (XPE Pharma & Science, Belgium c/o GSK Vaccines) for publication management and Joke Vandewalle and Petronela M. Petrar (XPE Pharma & Science, Belgium) for drafting the manuscript.

Declaration of interest

P Vandoolaeghe and L Schuerman are employees of the GSK group of companies. P Vandoolaeghe and L Schuerman own stock options/restricted shares in the GSK group of companies. Writing assistance and publication management were utilised in the preparation of this manuscript; it was funded by GlaxoSmithKline Biologicals SA and carried out by Myriam Wilbaux, Joke Vandewalle and Petronela M. Petrar from XPE Pharma & Science, Belgium. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Trademark statement

Mosquirix is a registered trademark of the GSK group of companies.

Supplementary material

Supplemental data for this article can be accessed here.

Authors’ contributions

All authors were involved in the literature search and interpretation of the data reviewed. All authors provided critical contributions during the development of the manuscript. All authors approve and take responsibility for the content of this manuscript.

Additional information

Funding

GlaxoSmithKline Biologicals SA paid for all costs associated with the development and the publishing of the present manuscript.