The International Vaccine Institute (IVI) said it has received a $15.7 million grant from the Bill & Melinda Gates Foundation to develop a typhoid conjugate vaccine for public sector markets.
Typhoid is a poverty-associated infectious disease. Like cholera, the disease strikes the poor and frequently occurs in low-income settings where there is a lack of access to clean water, and where sanitation and hygiene are poor. Although antibiotics can treat typhoid fever, the World Health Organization has noted that the typhoid germ is becoming increasingly resistant to antibiotics and poses a significant threat to populations in developing countries.
The grant will fund the phase 3 clinical trials of the Vi-DT typhoid conjugate vaccine (TCV) to take place in Nepal and the Philippines over the next two years.
IVI developed the vaccine and transferred technology to its Korean partner SK Bioscience, which produces the vaccine. SK Bioscience has completed process development and scale-up activities. The company has completed phase 1 studies and is conducting a phase 2 study in the Philippines as a longer-term follow-up.
“The new grant will allow SK bioscience and IVI to complete the clinical development of the Vi-DT typhoid conjugate vaccine,” said Sushant Sahastrabuddhe, director of IVI’s typhoid program. “Phase 3 trials, which will be supported by the grant, will bring the vaccine one step closer to receiving regulatory approval from the Ministry of Food and Drug Safety and ultimately WHO prequalification.”
The approval will allow the introduction of another affordable TCV into the global market, Sahastrabuddhe added.
IVI and SK Bioscience aim to ensure the global supply of the vaccine at a predefined cost for people in low- and lower-middle income countries where typhoid burden is endemic.
“We believe that both institutions will continue successful collaboration for the development and global supply of TCV to protect and save millions of young lives at risk in low- and lower-middle income countries,” SK Bioscience CEO Ahn Jae-yong said.
IVI Director General Jerome Kim also said, “With the launch of Phase 3 clinical trials, we have reached the final milestone in our quest to develop an innovative typhoid vaccine that should be safe and effective for children six months and older.”
The new vaccine will make a significant contribution to global efforts to reduce disease and death from typhoid infection among children in low- and middle-income countries, Kim added.