Clinical trial to develop mpox vaccine set to begin in Kenya

NAIROBI, Nov. 13 (Xinhua) — Kenya Medical Research Institute (KEMRI), the country’s premier research institution, said Wednesday that it has signed a partnership deal with Tonix Pharmaceuticals, a U.S. biopharmaceutical company, to design and conduct a clinical trial on a vaccine designed to prevent mpox.
KEMRI said in a statement issued in Nairobi, the capital of Kenya, that the Phase I clinical trial of TNX-801, an investigational vaccine designed to prevent mpox will take place in Kenya, focusing on assessing the vaccine’s safety, tolerability, and immunogenicity.
“The planned clinical trial of TNX-801 reflects our ongoing commitment to advancing scientific research that not only benefits Kenya but also contributes to global efforts to prevent and manage emerging infectious diseases,” said KEMRI Director-General Elijah Songok.
According to KEMRI, TNX-801 is a live-attenuated horsepox virus vaccine that is being developed to provide immune protection against mpox.
“It is designed to be safer and better tolerated than older smallpox vaccines derived from vaccinia viruses,” it said.
TNX-801’s stability at ambient temperatures and its ease of administration without special equipment also make it an attractive candidate for large-scale vaccination programs, particularly in resource-limited settings.
Under the deal, Tonix will sponsor the trial, while KEMRI will oversee the execution of the study.
Tonix Pharmaceuticals Chief Executive Officer Seth Lederman said given the continued spread of mpox and the recent global health concerns, there is an urgent need for a durable, single-dose vaccine like TNX-801.
Data from the Africa Centers for Disease Control and Prevention, the African Union’s specialized healthcare agency, show that the number of confirmed mpox cases in Africa has surged by over 545 percent in 2024 compared to the total of last year. It said the Central Africa region is the most affected by the outbreak, accounting for 85.8 percent of all reported cases and 99.4 percent of deaths.
This announcement comes as the World Health Organization declared the recent rise in mpox cases across Africa a Public Health Emergency of International Concern in August. ■