Novel Malaria Vaccine Passes Human Safety Test

Scientists have come one step closer to introducing a preventive vaccine against pregnancy-associated malaria (PAM) to the market.

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Malaria in pregnancy poses a big health risk to the mother and her fetus, and increases the risk of abortion, stillbirth, premature delivery and low birth weight – a major cause of child mortality. It’s estimated that PAM results in 20 000 maternal and 200 000 infant deaths every year. The strategies for its prevention and management as recommended by the World Health Organization (WHO) include intermittent preventive treatment and use of insecticide-treated mosquito bed nets. To complement these methods, a team of researchers have developed a malaria vaccine candidate called PAMVAC. Partially supported by the EU-funded PLACMALVAC project, the team published its findings in the journal ‘Clinical Infectious Diseases’

The results of the study, which was an exploratory phase one clinical trial, show that the vaccine is safe to use and sets in motion the right antibody response in the blood. “PAMVAC formulated with Alhydrogel or GLA-based adjuvants was safe, well-tolerated and induced functionally active antibodies. PAMVAC will next be assessed in women before first pregnancies in an endemic area.” An adjuvant is an ingredient added to a drug to increase or aid its effect and GLA refers to glucopyranosyl lipid adjuvant. Such substances play a key role in shaping the immune response to vaccination.

Further trials

Quoted in a news release by the University of Copenhagen, the study’s main author and Associate Professor Morten Agertoug Nielsen says: “It is a great milestone for us to be able to show that our vaccine is completely safe and induces the exact antibody response in the blood we want. Because it is the immune response that has been shown to be connected with protection from pregnancy malaria. The next step is to document that it prevents pregnancy malaria in African women who would otherwise have contracted the disease.” 

Prof. Nielsen adds: “The next step in the process is a phase two clinical trial, which will show whether the vaccine is still safe, but also whether it can prevent disease. Concurrently, we have developed a method for transforming the vaccine into a virus-like particle. This increases the antibody response. But the crux of the matter is whether it is sufficient for attacking all the different forms of the protein hook found in the malaria parasite.”

The most severe form of malaria is caused by the parasite Plasmodium falciparum, which is transmitted to humans by infected female mosquitoes. The research findings are crucial because despite the reduction in malaria cases worldwide from 239 million in 2010 to 219 million in 2017, progress in controlling malaria outbreaks has slowed down recently, according to a report by WHO. The PLACMALVAC (Clinical development of a VAR2CSA-based placental malaria vaccine) project that ended in 2017 included the production and clinical testing of the vaccine.

For more information, please see: 
CORDIS project web page