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NISH (NITAG SUPPORT HUB) 3 - Malaria vaccines: March 2022 WHO Malaria Position Paper and its References

This Library Guide is a collection of useful documents & evidence on the efficacy, effectiveness and impact of the RTS,S/AS01 malaria vaccine to support NITAG members and other policy makers throughout Africa with making evidence-based recommendations.

WHO Malaria Position Paper March 2022

 

 

Mondiale de la Santé, O. and World Health Organization, 2022. Malaria vaccine: WHO position paper–March 2022–Rapport mensuel des cas de dracunculose, janvier 2022. Weekly Epidemiological Record= Relevé épidémiologique hebdomadaire97(09), pp.60-78.

https://apps.who.int/iris/bitstream/handle/10665/352332/WER9709-eng-fre.pdf?sequence=1&isAllowed=y

 

References

Adjuvant development for vaccines and for autoimmune and allergic diseases. Washington DC, United States of America. The Small Business Innovation Research and Small Business Technology Transfer (SBIR and STTR): 2020 (

https://www.sbir.gov/node/1710229

Agnandji, S.T., Asante, K.P., Lyimo, J., Vekemans, J., Soulanoudjingar, S.S., Owusu, R., Shomari, M., Leach, A., Fernandes, J., Dosoo, D. and Chikawe, M., 2010. Evaluation of the safety and immunogenicity of the RTS, S/AS01E malaria candidate vaccine when integrated in the expanded program of immunization. The Journal of infectious diseases202(7), pp.1076-1087. (NOT OA)

Asante, K.P., Abdulla, S., Agnandji, S., Lyimo, J., Vekemans, J., Soulanoudjingar, S., Owusu, R., Shomari, M., Leach, A., Jongert, E. and Salim, N., 2011. 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. The Lancet infectious diseases11(10), pp.741-749. (NOT OA)

Assessment report Mosquirix. Amsterdam: European Medicines Agency; 2015
(https://www.ema.europa.eu/en/documents/outside-eu-assessment-report/mosquirix-public-assessment-report_en.pdf)

Bangirana, P., Opoka, R.O., Boivin, M.J., Idro, R., Hodges, J.S., Romero, R.A., Shapiro, E. and John, C.C., 2014. Severe malarial anemia is associated with long-term neurocognitive impairment. Clinical Infectious Diseases59(3), pp.336-344. (NOT OA)

Bryan D, et al. International collaborative study to evaluate and establish the 1st WHO Reference Reagent for anti-malaria (Plasmodium falciparum) human serum. WHO/BS/2014.2235

(https://apps.who.int/iris/bitstream/handle/10665/137468/WHO_BS_2014.2235_eng.pdf)

Butler D. Promising malaria vaccine to be tested in first large field trial. Nature.
2019 (https://www.nature.com/articles/d41586-019-01232-4). (NOT OA)

Cairns, M., Ceesay, S.J., Sagara, I., Zongo, I., Kessely, H., Gamougam, K., Diallo, A., Ogboi, J.S., Moroso, D., Van Hulle, S. and Eloike, T., 2021. Effectiveness of seasonal malaria chemoprevention (SMC) treatments when SMC is implemented at scale: Case–control studies in 5 countries. PLoS medicine18(9), p.e1003727.

https://doi.org/10.1371/journal.pmed.1003727

Chandramohan D, et al. Seasonal malaria vaccination with or without seasonal malaria chemoprevention. N Engl J Med. 2021; 3 (NOT OA)

Datoo MS, et al.Efficacy of a low-dose candidate malaria vaccine, R21 in adjuvant Matrix-M, with seasonal administration to children in Burkina Faso: a randomised controlled trial. Lancet. 2021; 397(10287): 1809–1818.

https://reader.elsevier.com/reader/sd/pii/S0140673621009430?

Draper SJ, et al. Recent advances in recombinant protein-based malaria vaccines.
Vaccine. 2015; 33(52): 7433–43.

https://www.sciencedirect.com/science/article/pii/S0264410X15013833

Efficacy, safety and immunogenicity study of GSK biologicals’ candidate malaria vaccine (SB257049) evaluating schedules with or without fractional doses, early dose 4 and yearly doses, in children 5–17 months of age. National Institutes of Health

https://clinicaltrials.gov/ct2/show/NCT03276962

Esu, E.B., Oringanje, C. and Meremikwu, M.M., 2021. Intermittent preventive treatment for malaria in infants. Cochrane Database of Systematic Reviews, (7).

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011525.pub3/full

Good, M.F., 2011. Our impasse in developing a malaria vaccine. Cellular and Molecular Life Sciences68, pp.1105-1113. (NOT OA)

Guerra Mendoza, Y., Garric, E., Leach, A., Lievens, M., Ofori-Anyinam, O., Pirçon, J.Y., Stegmann, J.U., Vandoolaeghe, P., Otieno, L., Otieno, W. and Owusu-Agyei, S., 2019. Safety profile of the RTS, S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa. Human vaccines & immunotherapeutics15(10), pp.2386-2398.

https://www.tandfonline.com/doi/full/10.1080/21645515.2019.1586040

Joint Technical Expert Group (JTEG). Summary of RTS,S/ AS01 Clinical Trial Data.
https://terrance.who.int/mediacentre/data/sage/SAGE_Docs_Ppt_Oct2015/7_session_malaria/Oct2015_session7_malaria%20vaccines.pdf

Lengeler, C., 2004. Insecticide‐treated bed nets and curtains for preventing malaria. Cochrane database of systematic reviews, (2).

Malaria eradication: benefits, future scenarios and feasibility. Geneva: World Health Organization; 2020 (https://www.who.int/publications/i/item/9789240003675

Meremikwu, M.M., Donegan, S., Sinclair, D., Esu, E. and Oringanje, C., 2012. Intermittent preventive treatment for malaria in children living in areas with seasonal transmission. Cochrane database of systematic reviews, (2).

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003756.pub4/full

Minassian AM, et al. Reduced blood-stage malaria growth and immune correlates in humans following RH5 vaccination. Med (NY). 2021; 2(6): 701–719.e19.

https://reader.elsevier.com/reader/sd/pii/S2666634021001161?

Moorthy, V.S. and Ballou, W.R., 2009. Immunological mechanisms underlying protection mediated by RTS, S: a review of the available data. Malaria journal8(1), pp.1-7.

https://malariajournal.biomedcentral.com/articles/10.1186/1475-2875-8-312

Mosquirix: Opinion on medicine for use outside EU. Amsterdam, The Netherlands.
European Medicine Agency

https://www.ema.europa.eu/en/opinion-medicine-useoutside-EU/human/mosquirix

Olliaro, P., 2008. Mortality associated with severe Plasmodium falciparum malaria increases with age. Clinical Infectious Diseases47(2), pp.158-160. (NOT OA)

Olomu C, et al. Collaborative study to evaluate the proposed World Health Organization Reference Reagent for Anti-Malaria (Plasmodium vivax) human plasma. WHO/BS/2020.2382 

https://cdn.who.int/media/docs/default-source/biologicals/ecbs/reference-materials/2020/bs-2020-2382-first-who--ref-reagent-for-anti-malaria

Otieno L, 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. (NOT OA)

Paton, R.S., Kamau, A., Akech, S., Agweyu, A., Ogero, M., Mwandawiro, C., Mturi, N., Mohammed, S., Mpimbaza, A., Kariuki, S. and Otieno, N.A., 2021. Malaria infection and severe disease risks in Africa. Science373(6557), pp.926-931. (NOT OA)

Penny, M.A., Verity, R., Bever, C.A., Sauboin, C., Galactionova, K., Flasche, S., White, M.T., Wenger, E.A., Van de Velde, N., Pemberton-Ross, P. and Griffin, J.T., 2016. Public health impact and cost-effectiveness of the RTS, S/AS01 malaria vaccine: a systematic comparison of predictions from four mathematical models. The Lancet387(10016), pp.367-375.

https://www.sciencedirect.com/science/article/pii/S0140673615007254

Pryce, J., Richardson, M. and Lengeler, C., 2018. Insecticide‐treated nets for preventing malaria. Cochrane Database of Systematic Reviews, (11).

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD000363.pub3/epdf/full

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

https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001685

Rts, S.C.T.P., 2015. 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. The Lancet386(9988), pp.31-45. (NOT OA)

Safety and immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 vaccines, transmission blocking vaccines against Plasmodium falciparum, at full and fractional dosing in adults in Mali. National Institutes of Health Clinical Center https://clinicaltrials.gov/ct2/show/NCT02942277

Samba, E., 2001. The malaria burden and Africa. Am J Trop Med Hyg64(1), p.ii. (NOT OA)

Sarma, N., Patouillard, E., Cibulskis, R.E. and Arcand, J.L., 2019. The economic burden of malaria: revisiting the evidence. The American journal of tropical medicine and hygiene101(6), p.1405.(NOT OA)

Schiess, N., Villabona-Rueda, A., Cottier, K.E., Huether, K., Chipeta, J. and Stins, M.F., 2020. Pathophysiology and neurologic sequelae of cerebral malaria. Malaria journal19(1), pp.1-12.

https://malariajournal.biomedcentral.com/articles/10.1186/s12936-020-03336-z

Smith P on behalf of the Joint Technical Expert Group (JTEG). Summary of RTS,S/ AS01 clinical trial data. Geneva: World Health Organization                                                                         https://cdn.who.int/media/docs/default-source/immunization/mvip/full-evidence-report-on-the-rtss-as01-malaria-vaccine-for-sage-mpag

Tinto H, et al. Long-term incidence of severe malaria following RTS,S/AS01 vaccination in children and infants in Africa: an open-label 3-year extension study of a phase 3 randomised controlled trial. Lancet Infect Dis. 2019; 19(8): 821 (NOT OA)

Vandoolaeghe P, et al. The RTS,S/AS01 malaria vaccine in children 5 to 17 months of age at first vaccination. Expert Rev Vaccines. 2016 NOT OA)

Vekemans, J., Guerra, Y., Lievens, M., Benns, S., Lapierre, D., Leach, A. and Verstraeten, T., 2011. Pooled analysis of safety data from pediatric Phase II RTS, S/AS malaria candidate vaccine trials. Human vaccines7(12), pp.1309-1316.

https://www.tandfonline.com/doi/abs/10.4161/hv.7.12.18046

WHO. 2023. Malaria vaccines: WHO Position Paper – January 2016. Geneva: World Health Organization; 2016.                                                      https://ahpsr.who.int/publications/i/item/who-position-paper-onmalaria-vaccines,

WHO. World Health Organization, 2015. Guidelines for the treatment of malaria. World Health Organization.

https://books.google.co.za/books?hl=en&lr=&id=IVo0DgAAQBAJ&oi=fnd&pg=PP1&dq=Guidelines+for+the+treatment+of+malaria+(third+edition).+Geneva:+World+Health+Organization&ots=9Uq71oS9hQ&sig=I47HmDNEtegvUn9eN-

WHO. World Health Organization, 2012. WHO Policy Recommendation: Seasonal Malaria Chemoprevention (SMC) for Plasmodium falciparum malaria control in highly seasonal transmission areas of the Sahel sub-region in Africa (No. WHO/HTM/GMP/2012.02). World Health Organization.

https://apps.who.int/iris/bitstream/handle/10665/337978/WHO-HTM-GMP-2012.02-eng.pdf

WHO. World Health Organization, 2012. Intermittent preventive treatment of malaria in pregnancy using sulfadoxine-pyrimethamine (IPTp-SP): updated WHO policy recommendation (No. WHO/HTM/GMP. 2012.05). World Health Organization.

https://cdn1.sph.harvard.edu/wp-content/uploads/sites/2413/2014/08/iptp_sp_updated_policy_recommendation_en_102012.pdf

WHO. Guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum, Annex 3, TRS No 980. Geneva, Switzerland. World Health Organization: 3 July 2014

https://www.who.int/publications/m/item/recombinant-malaria-vaccine-annex-3-trs-980.

WHO preferred product characteristics (PPC) for malaria vaccines. Geneva: World Health Organization; 2012

https://apps.who.int/iris/handle/10665/149822

WHO. Full evidence report on the RTS,S/AS01 malaria vaccine. Geneva: World Health Organization

https://www.who.int/initiatives/malaria-vaccine-implementationprogramme

WHO. World Health Organization, 2014. WHO policy brief for the implementation of intermittent preventive treatment of malaria in pregnancy using sulfadoxine-pyrimethamine (IPTp-SP) (No. WHO/HTM/GMP/2014.4). World Health Organization.

https://apps.who.int/iris/bitstream/handle/10665/338350/WHO-HTM-GMP-2014.4-eng.pdf

World malaria report 2021. Geneva: World Health Organization; 2021                                                    

https:// www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2021, accessed March 2023

Wilson, A.L. and IPTc Taskforce, 2011. A systematic review and meta-analysis of the efficacy and safety of intermittent preventive treatment of malaria in children (IPTc). PloS one6(2), p.e16976.

https://doi.org/10.1371/journal.pone.0016976