Universitas Indonesia (UI) through the Faculty of Medicine (FK) with the University of Oxford has announced the completion of Phase 2 Clinical Trials of a new malaria vaccine manufactured by Sanaria Inc. This trial is the first malaria vaccine trial done in Indonesia and Asia-Pacific after 30 years.
In its implementation, this clinical trial, officially announced on May 27, 2024, is in collaboration with the Army Health Center (PUSKESAD) and the Eijkman Molecular Biology Research Center from the National Research and Innovation Agency (BRIN) by involving 345 Indonesian soldiers from Battalion 132 in Bangkinang, Riau, who participated in the study voluntarily. The soldiers are divided into two groups, namely the group who received vaccination and the group who received a placebo shot.
After that, the soldiers left for duty from Bangkinang, a malaria-free area, to Keerom Regency, Papua, a malaria-endemic area. The purpose is to see how the vaccination works for people who have never been infected with malaria when they are in a high-risk area for malaria.
“This study is unique because it involved a population that had never been exposed to malaria, which will then travel to a malaria endemic area. By vaccinating the soldiers, who have never been affected before traveling to high-risk areas, we can assess the effectiveness of this vaccine in a real condition,” said Prof. Dr. dr. Erni Juwita Nelwan, Ph.D., Sp.PD., K-PTI., FACP., FINASIM., Professor of FKUI and the principal researcher in this research.
Furthermore, the soldiers were vaccinated from May to September 2022 before then leaving for duty to Keerom Regency. The research team observed and handled more than 700 malaria cases during the assignment in Papua. The team also continued their observation of the soldiers for six months after their return to Bangkinang and treated 300 malaria cases during this period.
Both vaccines being tested are made from live malaria parasites, specifically the West African strain, weakened in different ways. Parasites in the Sanaria’s PfSPZ vaccine are weakened using radiation. Parasites in the Sanaria’s PfSPZ-CVac vaccine are weakened using chloroquine drug given orally to the study participants.
The result of the testing showed that the Sanaria’s PfSPZ vaccine is safe and can be tolerated well, the same as a placebo in the form of a physiological saline solution. The Sanaria’s PfSPZ-CVac vaccine is also proven to be safe with mild side effects. Both vaccines give protection to malaria caused by the Plasmodium falciparum parasites found in Papua, even though the vaccines were made from various types of malaria.
The Dean of FKUI, Prof. Dr. dr. Ari Fahrial Syam, Sp.PD-KGEH., MMB, stated, “ The phase 2 clinical trials of malaria vaccines are important research in vaccine development. Hopefully, clinical trials can continue so that the existence of this vaccine is truly useful in efforts to eradicate malaria in Indonesia and the world. FKUI continues to support various clinical trials. The Oxford University Clinical Research Unit (OUCRU) continues the collaboration that has been going on for the past 13 years,” said Prof. Ari.
Continuing from this, the Director of OUCRU Indonesia, Prof. J. Kevin Baird, conveyed how malaria is a big issue in Indonesia and the world. “Our job in OUCRU Indonesia prioritizes working with local partners to find effective solutions for infectious diseases that can be applied worldwide. The success of this trial demonstrates the strength of that partnership and is an important step towards malaria elimination,” said Prof. Baird.
Sanaria Medical Director, Thomas L. Richie, said that this cross-species effectiveness is very important for global malaria elimination, as there are many species of malaria in the world. Based on these findings, they are developing a next-generation vaccine called PfSPZ-LARC2 in the hope of showing even better results.
More detailed study results will be published at the end of the year after going through peer-review. This research, funded by the Congressionally Directed Medical Research Program (AS) and chaired by Prof. Erni J. Nelwan from FK UI, is an important step in the effort against malaria.
