The world’s first vaccine for malaria will be tested in a pilot study beginning this month in three countries with a high burden of the disease among children, according to researchers leading the project from the University of North Carolina at Chapel Hill and UNC Project-Malawi. A previous study found the vaccine RTS,S/AS01 provides partial protection against malaria in young children. In Malawi, malaria is the main cause of illness and death among children age five and younger.

“Malaria can kill a child in less than 24 hours,” said Tisungane Mvalo, a pediatrician at UNC Project-Malawi in Lilongwe and one of the study’s investigators. “And even if the child survives, malaria can impact every organ, causing brain injury or even kidney issues. Prevention is better than treatment.”

The vaccine was originally studied in a Phase III trial conducted over five years from 2009 until 2014. It enrolled approximately 15,000 children in seven sub-Saharan countries. UNC Project-Malawi was one of the 11 sites involved in the trial. Over four years of follow up, the vaccine prevented 39 percent of clinical cases of malaria in children ages 17 months to five years old who received four doses of the vaccine. These results were published in The Lancet. After these results, the World Health Organization recognized the public health potential of the RTS,S vaccine, while also acknowledging the need for further evaluation before considering wide-scale deployment.

“Despite gains over the last decade, we have seen a stagnation in malaria control efforts in recent years,” said Jonathan Juliano, one of the study’s investigators and an associate professor of medicine in the UNC Division of Infectious Diseases. “In certain areas of Africa, we have actually seen rates of malaria infection get worse. New interventions are needed to continue advancing toward elimination. Careful evaluation of candidate malaria vaccines is an essential part in the development of these new tools.”

Based on the protective effect seen in the Phase III trial of RTS,S, the Malaria Vaccine Implementation Program (MVIP) was formed to evaluate the feasibility and safety of administering the vaccine. Three countries—Malawi, Ghana and Kenya—were selected as evaluation partners. UNC clinician-researchers Mvalo, Juliano and Irving Hoffman, international director of UNC Project-Malawi, are partnering with the Malawian College of Medicine to monitor the implementation of the vaccine and its impact on preventing mortality from malaria in Malawi. The goal is to vaccinate approximately 120,000 children a year beginning April 2019. MVIP is expected to continue evaluation through 2022, and the data and feasibility assessment from the program will be used to inform future decisions on the wide-scale deployment of the vaccine.

“Evaluating the safety and preventative effect of the vaccine at the facility- and community-level is a real challenge,” said Hoffman. “However, Dr. Mvalo’s leadership in Malawi, with support from Dr. Juliano and myself, form a strong and collaborative team that is designed for success.”

This research was funded by Gavi, The Vaccine Alliance; The Global Fund to Fight AIDS, Tuberculosis and Malaria; and Unitaid.