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Malaria Vaccine R&D in the Decade of Vaccines

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Malaria Vaccine R&D in the Decade of Vaccines Vaccine 31S (2013) B233–B243 Contents lists available at SciVerse ScienceDirect Vaccine jou rnal homepage: www.elsevier.com/locate/vaccine Review Malaria vaccine R&D in the Decade of Vaccines: Breakthroughs, challenges and opportunities a,∗ b c d a Ashley J. Birkett , Vasee S. Moorthy , Christian Loucq , Chetan E. Chitnis , David C. Kaslow a PATH Malaria Vaccine Initiative, Washington DC, USA b Initiative for Vaccine Research, Department of Immunization, Vaccines & Biologicals, World Health Organization, Geneva, Switzerland c International Vaccine Institute, Seoul, South Korea d International Centre for Genetic Engineering and Biotechnology, New Delhi, India a r t i c l e i n f o a b s t r a c t Article history: While recent progress has been made in reducing malaria mortality with other interventions, vaccines are Received 13 August 2012 still urgently needed to further reduce the incidence of clinical disease, including during pregnancy, and Received in revised form 6 February 2013 to provide “herd protection” by blocking parasite transmission. The most clinically advanced candidate, Accepted 25 February 2013 RTS,S, is presently undergoing Phase 3 evaluation in young African children across 13 clinical sites in eight African countries. In the 12-month period following vaccination, RTS,S conferred approximately 50% pro- tection from clinical Plasmodium falciparum disease in children aged 5–17 months, and approximately Keywords: 30% protection in children aged 6–12 weeks when administered in conjunction with Expanded Program P. falciparum for Immunization (EPI) vaccines. The development of more highly efficacious vaccines to prevent clinical P. vivax Malaria disease caused by both P. falciparum and Plasmodium vivax, as well as vaccines to support elimination Vaccine efforts by inducing immunity that blocks malaria parasite transmission, are priorities. Some key barri- Elimination ers to malaria vaccine development include: a paucity of well-characterized target immunogens and an Eradication absence of clear correlates of protection to enable vaccine development targeting all stages of the P. falcip- malERA arum and P. vivax lifecycles; a limited number of safe and effective delivery systems, including adjuvants, Malaria Vaccine Technology Roadmap that induce potent, long-lived protective immunity, be it by antibody, CD4+, and/or CD8+ T cell responses; and, for vaccines designed to provide “herd protection” by targeting sexual stage and/or mosquito anti- gens, the lack of a clear clinical and regulatory pathway to licensure using non-traditional endpoints. Recommendations to overcome these, and other key challenges, are suggested in this document. © 2013 Elsevier Ltd. All rights reserved. Contents 1. Introduction . B233 2. Overview of malaria vaccines in development . B234 3. Vaccines to prevent infection and/or clinical disease . B235 3.1. Pre-erythrocytic vaccines . B236 3.2. Asexual blood-stage vaccines . B238 4. Vaccines to prevent malaria parasite transmission . B239 5. Summary . B241 Acknowledgements . B242 Conflict of interest . B242 References . B242 1. Introduction Malaria is caused by five species of Plasmodium that infect ∗ humans (Plasmodium falciparum, Plasmodium vivax, Plasmodium Corresponding author at: PATH Malaria Vaccine Initiative, 455 Massachusetts ovale spp., Plasmodium malariae and Plasmodium knowlesi) and is Avenue NW, Suite 1000, Washington, DC 20001-2621, USA. Tel.: +1 202 540 4432; transmitted by the bite of infected female Anopheline mosquitoes. fax: +1 202 457 1466. E-mail address: [email protected] (A.J. Birkett). In 2010, approximately 3.3 billion people were at risk of malaria; 0264-410X/$ – see front matter © 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.vaccine.2013.02.040 B234 A.J. Birkett et al. / Vaccine 31S (2013) B233–B243 Table 1 there were an estimated 216 million cases and an estimated General considerations for malaria vaccine development: key challenges and 655,000 deaths [1]. The vast majority of clinical cases (81%) and opportunities. deaths (91%) occur in sub-Saharan Africa, with children under Key challenges Opportunities five years of age and primigravid pregnant women most affected [1]. Between 2000 and 2010, the estimated incidence of malaria • Clear alignment on • Revise Malaria Vaccine Technology declined by 17% and malaria-specific mortality rates by 26% [1]. community goals for malaria Roadmap to more effectively vaccine development communicate community goals, Despite these encouraging gains, associated with the scale-up of particularly with respect to P. vivax and preventive, diagnostic and treatment measures, new interventions, the need for vaccines to interrupt including vaccines to prevent clinical disease and transmission, are malaria transmission • • urgently needed [2]. This paper provides a synopsis of the state Ensuring vaccines under Develop TPPs with input from key development have profile to stakeholders, including national of current malaria vaccine development efforts, with particular meet global need authorities in endemic countries emphasis on the impact of the possible availability of a first gen- • Pharmacovigilance studies for • Strengthening of the routine eration malaria vaccine in the near future, and highlights some of vaccines developed exclusively pharmacovigilance surveillance the key product development challenges and opportunities that for use in developing world systems in developing countries and will need to be considered to ensure maximal progress during the the establishment of a network of pharmacovigilance sentinel sites, current decade. including via the Global Vaccine Safety Since 2006, the primary strategic guidance document inform- Initiative [23] ing malaria vaccine development has been the Malaria Vaccine • • Absence of dual market Wherever possible, prioritize Technology Roadmap, which was developed through an extensive opportunity for malaria cost-efficient delivery and adjuvant vaccines to help offset the platforms for which significant safety consultative process [3]. In recognition of the disproportionate and development burdens databases are available from developed massive disease burden in young African children, the vision, as world products well as landmark and strategic goals, focused primarily on this target population and geography, with an exclusive focus on P. falciparum morbidity and mortality and little discussion of the P. vivax, and other strategic changes and thus re-launch an up-to- transmission perspective. To accelerate progress toward achieving date strategic goal. the vision and goals, a series of 11 priority areas were described that were broadly categorized under research, vaccine development, key capacities, and policy/commercialization [3]. 2. Overview of malaria vaccines in development At the Malaria Forum convened by the Bill & Melinda Gates Foundation in October 2007 and with the support of the World A comprehensive database summarizing the malaria vaccines Health Organization (WHO), the Roll back Malaria (RBM) Partner- under development (‘Malaria Vaccine Rainbow Tables’) is main- ship, and many other key stakeholders, there was a re-affirmation tained by WHO [9,10]. Two strategic goals from malaria vaccine that the ultimate long-term goal of the global community must be use are currently being sought: the first targets induction of immu- malaria eradication [4]. In 2008, the Malaria Eradication Research nity to prevent clinical disease, be it uncomplicated or severe, Agenda (malERA) initiative was convened to define the knowl- and the second targets induction of immunity to interrupt trans- edge base, strategies, and tools required to eradicate malaria from mission and thereby support elimination and eradication efforts the human population [5]. The outcome of this consultation was [11]. In both cases, vaccines are needed that target all Plasmodia a research and development agenda for regional elimination and species that cause human disease, but most notably P. falcip- eventual global eradication of malaria, communicated in the form arum and P. vivax. Vaccines to prevent clinical disease target of a series of manuscripts, outlining the transformational tools and pre-erythrocytic (PE) and/or asexual blood stage (BS) antigens, and strategies, including vaccines, needed to support malaria eradica- are primarily intended for those enduring the greatest burden of tion [2,6]. disease; whereas, vaccines targeting transmission primarily target A series of general challenges in the quest to develop vac- PE and/or sexual, sporogonic or mosquito stage (SSM) antigens, and cines that are effectively aligned with community goals to reduce are targeted to populations at risk of endemic transmission. While it and eventually eliminate the suffering from malaria are outlined may be possible to develop vaccines that are highly effective at both in Table 1. In February 2012, consensus was reached at a WHO preventing clinical disease (i.e., cases averted, toward saving lives Scientific Forum held in Geneva to update the Malaria Vaccine and preventing disease) and interrupting the cycle of transmission Technology Roadmap. It is expected that the update will broaden (i.e., transmission interrupted, to support control and elimination), the Roadmap Vision and Strategic Goal(s) to include: a larger geo- they are associated with distinct clinical endpoints, overlapping but graphic scope, older age groups, species beyond P. falciparum, and different target populations, discrete TPPs, regulatory approval pro-
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