TetraVax-DV-TV003 is a live attenuated recombinant tetravalent investigational dengue vaccine.
The vaccine was developed by Dr. Stephen Whitehead’s laboratory in NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
November 17, 2016, Medigen Vaccine Biologics enters a license agreement with the US NIH to develop, make, sell and sublicense this dengue vaccine to 17 countries.
This license is for 17 countries including, Taiwan, Korea, Australia, India, Philippines, Indonesia, Vietnam, Thailand, Malaysia, Singapore, Pakistan, Saudi Arabia, United Arab Emirates, Kuwait, Bahrain, Oman, and Qatar. These regions cover 1/3 of the global population with the highest dengue incidence rate.
Additional institutions received license agreements including Butantan Institute in Brazil and Merck in North America and Europe.
TetraVax-DV-TV003 is indicated to protect against infection with a controlled human infection strain of either DENV-2 or DENV-3 in adults 18 to 50 years of age with no history of previous flavivirus infection.
TetraVax-DV-TV003 will be administered by subcutaneous injection in the deltoid region of the upper arm
Clinical Trial NCT03416036: Evaluation of the Efficacy of the Live Attenuated Tetravalent Dengue Vaccine Against DENV-2 and DENV-3 Challenge (Completed)
- This Phase 1 study will evaluate the ability of a single dose of a live attenuated recombinant tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect against infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169) or DENV-3 (rDEN3Δ30) in adults 18 to 50 years of age with no history of previous flavivirus infection.
- Participants will be randomly assigned to receive either TV003 or placebo at study entry (Day 0) and either rDEN2Δ30-7169 or rDEN3Δ30 on Day 28.
- Study visits will occur on Days 0, 4, 6, 8, 10, 12, 14, 16, 21, 28, 32, 34, 36, 38, 40, 42, 44, 49, 56, 84, 118, and 208. Visits may include a physical examination and blood collection.
Clinical Trial NCT03485144: A Phase II Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Immunogenicity and Safety of TetraVax-DV in Healthy Adults in Taiwan
- The goal of this Phase 2 study is to determine the immunogenicity and safety of TV003(TetraVax-DV), a live attenuated tetravalent dengue vaccine candidate, in healthy human subjects in Taiwan