Award type :
Product Development Award
Product Development Award
Product type :
Vaccines
Vaccines
Award year :
2019
2019
Project start date :
06 / 26 / 2019
06 / 26 / 2019
Project end date :
10 / 31 / 2021
10 / 31 / 2021
Project duration (months) :
28
28
Development stage :
Phase 1
Phase 1
Target disease :
Cholera
Cholera
Region served :
Low- and Middle-Income Countries
Low- and Middle-Income Countries
Recipient organization / Country of funding recipient organization :
EuBiologics / Republic of Korea
EuBiologics / Republic of Korea
Collaborator(s) / Country :
International Vaccine Institute (IVI) / Republic of Korea, Massachusetts General Hospital (MGH) / USA
International Vaccine Institute (IVI) / Republic of Korea, Massachusetts General Hospital (MGH) / USA
Funding amount(KRW) :
888,053,000
888,053,000
This project builds on technology transfer of a cholera conjugate vaccine (CCV) product from Massachusetts General Hospital (MGH) to EuBiologics, which was funded through a previous award. The target of this project is the production of GMP clinical trial material in several formulations to support phase I evaluation. The phase I first-in-human (FIH) study will generate exploratory data on product safety and the effect of antigen doses formulated with or without Alum adjuvant on humoral immune responses in a non-endemic population, which will provide valuable guidance on dose selection. Development of an injectable conjugated cholera vaccine is the key to improving protection in young children.