The Eijkman Molecular Biology Research Center (PRBM) in collaboration with the Faculty of Medicine, University of Indonesia (FKUI), the Indonesian National Armed Forces (TNI), Eijkman-Oxford Clinical Research Unit (EOCRU) and the Malaria Vaccine Manufacturing Center “Sanaria” in America are ready to conduct malaria clinical trials at least 400 Army personnel will be sent to Papua in mid-2022. Papua is one of the malaria endemic areas.
The PRBM team of Eijkman, EOCRU and Sanaria last week held a meeting in Maryland, America, to discuss preparations for the world’s first clinical trial.
Interviewed on the sidelines of the meeting, Director Eijkman Prof. Dr. dr. Amin Soebandrio said “this meeting is a follow up for the preparation of testing the malaria vaccine candidate developed by Sanaria. This is the first clinical trial in the world on troops to be sent to malaria endemic areas, namely Papua. We will monitor them from the time they leave and work for 6-9 months, until they return to their original areas where there is little or no malaria, we will monitor everything. It requires tremendous preparation.”
The study planning has been carried out since 2018, and received ethical approval from the FKUI Ethics Committee in 2019. Approval for the use of vaccines for phase two clinical trials on Army personnel has also been granted by the Food and Drug Supervisory Agency (BPOM). However, the widespread outbreak of the corona virus pandemic had delayed this study. The PRBM team, Eijkman, EOCRU and Sanaria, continued their research in June 2021.
Early last October the World Health Organization (WHO) recommended the first vaccine to ward off malaria called RTS, S, or Mosquirix. The vaccine, which has been in development for 30 years and completed large-scale clinical trials, is considered significant for reducing malaria and strengthening the immune system against Plasmodium falciparum, the deadliest and most common malaria parasite in Africa. However, according to a number of experts, this vaccine is not appropriate for areas with certain geographic uniqueness and which have different types of parasites that cause malaria.
Sanaria Confident Vaccine Efficacy 95-100%
Stephen L. Hoffman, Chief Executive and Scientific Officer of Sanaria explained this to FLY. “We discussed with TNI representatives who had big problems when their troops departed from areas such as Sumatra, Java or Bali where malaria rates were low, to Papua where malaria was high. These dispatched personnel are not immune,” he said.
“They can get sick and can’t do what they should do in that place. Indonesia is also different from Africa where the parasite that causes 95% of malaria there is Plasmodium falciparum. The parasite in Indonesia is Plasmodium vivax, the second most important type of parasite that causes malaria. in the world. We think our vaccine, which has up to 95-100 percent efficacy, can prevent this,” continued Hoffman.
The two vaccines that will be clinically tested in the Indonesian Army are PfSPZ Vaccine and PfSPZ-CVac. The PfSPZ vaccine has advantages as an anti-infection of the malaria parasite, so it is claimed to be superior to the RTS, S vaccine, which is limited to use in children to prevent severe malaria. The PfSPZ vaccine has 100% protection against the malaria-causing parasite known as Plasmodium falciparum so that it can prevent infection, transmission and disease. The PfSPZ vaccine can also be used in all age groups over the age of 2 years and initial studies have shown no systemic reactions to vaccination.
Indonesia Needs Malaria Vaccine For Asymptomatic People
Kevin Baird PhD, Head of the Research Team who is also Director of the Eijkman-Oxford Clinical Research Unit (EOCRU) explained the advantages of the PfSPZ and PfSPZ-CVac vaccines.
“The current RTS,S vaccine protects people who are symptomatic, but does not protect against transmission. Then how about people who are infected but don’t get sick, don’t show symptoms? Now in Indonesia this is a very big problem because if people don’t get sick, they don’t seek help, don’t check their health, while they can still spread the infection. If we want to eradicate malaria, finding asymptomatic carriers of this virus is a big problem. So the RTS, S vaccine might even make it difficult (for Indonesia.red) to eradicate malaria. We don’t know for sure and therefore clinical trials have to be conducted.”
Clinical trials will be conducted on at least 400 Indonesian Army personnel who will leave for Keerom, Papua, in June 2022, and are expected to return to their home areas or homebase in Pekanbaru, Riau, in March 2023. Vaccination will be carried out in Riau before departure.
The research team will observe these vaccinated personnel during their assignment in Papua and upon their return to Pekanbaru. Observations were also made to see the ability of the PfSPZ vaccine to produce cross-protection against other parasitic species, such as Plasmodium vivax. These two types of parasites are the main cause of malaria in Papua.
“Why are clinical trials conducted on the military? This is because we need a population that is at high risk of contracting malaria, and soldiers (deployed in Papua.red) are very high risk and they will be given a vaccine with a high level of efficacy. With this small number of study subjects, clinical trials will not be very expensive. I mean, we could do it on ordinary people, but the chances of them contracting malaria are so small that we would need a subject population 10 times larger at a cost that is also 10 times greater,” said Baird, who has been studying malaria for a long time. Indonesia.
Furthermore, Hoffman said he was “very honored to be able to work with the Indonesian military” which will be the subject of the study. “We have been collaborating for a long time with the Eijkman Institute in Indonesia and the EOCRU, but this is the first time we are working together and meeting representatives of the Indonesian military directly.”
Minister of Health Fully Supports Clinical Trials
Minister of Health Budi Gunadi Sadikin to FLY said he fully supports this clinical trial. “We fully support this clinical trial in Papua. Indeed, clinical trials for diseases like this are usually at least one year old, only to find out the results. But learning from yesterday’s COVID-19, vaccines like Moderna or Pfizer or Sinovac can already be used after preliminary report six month clinical trial. So maybe it can be the same with malaria clinical trials. What is certain is that we support, fully support, because it will greatly reduce malaria in our country.”
Eastern Region of Indonesia Vulnerable to Malaria
Malaria is a disease caused by parasites and is difficult to completely eradicate. Based on the World Health Organization report in the “World Malaria Report 2020,” Indonesia has the second highest number of malaria cases in Southeast Asia after India. Although there was a decline in cases in 2010-2014, the trend of the disease, which is mainly transmitted through mosquito bites, tends to stagnate and shows concentration in the eastern part of Indonesia.
Based on data from the Ministry of Health, around 86% of malaria cases in 2019 occurred in Papua province, which was 216,380 cases. Followed by the provinces of East Nusa Tenggara and West Papua. However, high endemic areas are also found in central Indonesia, namely in North Penajaman Paser Regency, in East Kalimantan.
Efforts to obtain an effective vaccine have been made for a long time, but some have not really shown efficacy.
Clinical Test Collaboration Towards Technology Transfer
The first collaboration in research and clinical trials of malaria vaccines in Indonesia and the world between the Eijkman Center for Molecular Biology Research (PRBM), the Indonesian National Armed Forces (TNI), Eijkman-Oxford Clinical Research Unit (EOCRU) and the Malaria Vaccine Manufacturing Center “Sanaria” in America is expected will last in the long term. Not only to get results that can later be used widely, but also to transfer technology to malaria researchers in Indonesia.[(em/ah]