Sanaria welcomes Indonesian delegation to mark the restart of clinical trial activities
Rockville MD, 11-15 October 2021
Sanaria was honored and delighted to welcome Colonel Nur Abdul Goni and Major Yogi Ertanto from the Pharmacy, Biomedics and Vaccines section of the Indonesian Institution of Armed Forces Health Centre (TNA) along with Prof. Amin Soebandrio, Dr. Rintis Noviyanti, and Prof. Kevin Baird of the Eijkman Institute for Molecular Biology (EIMB) in Jakarta. The visit marked the restart of activities for an important clinical study of Sanaria® PfSPZ Vaccine and Sanaria® PfSPZ-CVac that aims to demonstrate the protective efficacies of these two malaria vaccines against naturally transmitted Plasmodium falciparum and Plasmodium vivax malaria in Papua, Indonesia. This study will determine for the first time the use of Sanaria’s PfSPZ products as vaccines for malaria-naïve travelers to high-risk areas.
The trial utilizes a unique partnership in which volunteers from an Indonesian Army battalion will be vaccinated at their home base in Sumatra, which is located in an area largely free of malaria transmission. Following vaccination, during which research subjects will be randomly allocated to active vaccine or to normal saline placebo in a double-blind fashion, the battalion will be deployed to Papua where the soldiers will be stationed for 6 to 9 months beginning in August, 2022. Deployment will be to the Keerom District of Papua, where both P. falciparum and P. vivax malaria are intensely transmitted. During this time, protection from the two vaccines will be stringently tested. Subsequently, on redeployment back to their home base in Sumatra, protection against relapsing P. vivax malaria will be determined over the ensuing 6 months.
The Indonesian collaborators bring critical expertise to a unique project. An embedded clinical team of researchers from the Eijkman-Oxford Clinical Research Unit (EOCRU) and the University of Indonesia School of Medicine will join with Army medical personnel to conduct the study during the battalion’s posting to Papua. Their primary responsibility will be to ensure the soldiers’ health and safety through a network of military paramedics trained in malaria diagnostics and sample collections for the trial. EOCRU and the EIMB will provide the expertise for detailed analysis of the samples and the data that they generate, with support from Sanaria. This will be the most stringent test of PfSPZ vaccines to date due to the fact that the malaria parasites of Papua, an Indonesian Province located on the island of New Guinea, are antigenically divergent from the African strain of P. falciparum comprising the two vaccines. Not only will the trial provide critical data for using PfSPZ vaccines for protection of travelers, it will be the first field-based test of cross-species protection (P. falciparum vaccine cross-protecting against P. vivax) for any malaria vaccine.
