Malaria vaccine development
Status of vaccine development
The complexity of the malaria parasite makes development of a malaria vaccine a very difficult task. Given this, there is currently no commercially available malaria vaccine, despite many decades of intense research and development effort. Over 20 subunit vaccine constructs are currently being evaluated in clinical trials or are in advanced preclinical development.
The malaria vaccine candidate RTS,S/AS01
RTS,S/AS01 is the most advanced vaccine candidate against the most deadly form of human malaria, Plasmodium falciparum. A Phase III trial began in May 2009 and has completed enrolment in 2011 with 15 460 children in the following seven countries in sub-Saharan Africa: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and the United Republic of Tanzania.
There are two age groups in the trial: 1) children aged 5-17 months at first dose receiving only the RTS,S/AS01 vaccine; and 2) children aged 6-12 weeks at first dose who receive the same malaria vaccine co-administered with pentavalent vaccines in the routine immunization schedule. Both groups receive 3 doses of RTS,S/AS01 vaccine at 1 month intervals.
According to the current trial schedule, the Phase III trial data required in order for WHO to formulate evidence-based policy recommendations are expected to become available to WHO in 2014-2015. Based on currently available data the vaccine will be evaluated as an addition to, not a replacement for, existing preventive, diagnostic and treatment measures. The need for long-lasting insecticidal nets, rapid diagnostic tests and artemisinin-based combination therapies will continue, if RTS,S/AS01 becomes available and is used.
Tracking the global malaria vaccine portfolio
The WHO Initiative for Vaccine Research (IVR) tracks all clinical and advanced preclinical malaria vaccine projects activity in spreadsheets, updates of which are posted on the IVR web pages. These spreadsheets are known as the WHO Rainbow Tables, and are compiled with help from funders, sponsors and investigators around the world. A review of malaria vaccine clinical projects based on the Rainbow Table was published in the Malaria Journal in January 2012.
Guiding the policy process
The Joint Technical Expert Group on Malaria Vaccines reviews data emerging from the ongoing Phase III trial of RTS,S/AS01 and jointly advises the WHO Global Malaria Programme and IVR on the results.
Providing a forum for malaria vaccine stakeholders
WHO IVR acts as the Secretariat to the Malaria Vaccine Funders Group, which was established to facilitate exchange of information and opinions among internationally active funding bodies for malaria vaccine development. The group enables a better coordination of ongoing and planned vaccine research activities, and identifies areas of research that can be supported in a complementary manner.
In addition, IVR’s Malaria Vaccine Advisory Committee (MALVAC) is a scientific group of experts that meets regularly to address a specific theme; a recent meeting of the group in February 2012 discussed the accelerated development of second-generation malaria vaccines. Details of previous MALVAC meetings are available on the IVR web pages listed below.
Further information on malaria vaccine research
- Overview of malaria vaccine R&D
- Joint Technical Expert Group on Malaria Vaccines Entering Pivotal Phase 3 Trials & Beyond
- A review of malaria vaccine clinical projects based on the WHO rainbow table, 2012, Malaria Journal