Safety and Immunogenicity of the Dengue Virus Vaccine TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh

Summary

The purpose of this study is to evaluate the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in healthy adults, adolescents, and children in Dhaka, Bangladesh.

Timeline

Start

2016-03

Primary completion

2017-08-10

Completion

2020-02-05

Publications

• Background Podder G, Breiman RF, Azim T, Thu HM, Velathanthiri N, Mai le Q, Lowry K, Aaskov JG. Origin of dengue type 3 viruses associated with the dengue outbreak in Dhaka, Bangladesh, in 2000 and 2001. Am J Trop Med Hyg. 2006 Feb;74(2):263-5.
• Background Kirkpatrick BD, Durbin AP, Pierce KK, Carmolli MP, Tibery CM, Grier PL, Hynes N, Diehl SA, Elwood D, Jarvis AP, Sabundayo BP, Lyon CE, Larsson CJ, Jo M, Lovchik JM, Luke CJ, Walsh MC, Fraser EA, Subbarao K, Whitehead SS. Robust and Balanced Immune Responses to All 4 Dengue Virus Serotypes Following Administration of a Single Dose of a Live Attenuated Tetravalent Dengue Vaccine to Healthy, Flavivirus-Naive Adults. J Infect Dis. 2015 Sep 1;212(5):702-10. doi: 10.1093/infdis/jiv082. Epub 2015 Mar 22.
• Walsh MR, Alam MS, Pierce KK, Carmolli M, Alam M, Dickson DM, Bak DM, Afreen S, Nazib F, Golam K, Qadri F, Diehl SA, Durbin AP, Whitehead SS, Haque R, Kirkpatrick BD. Safety and durable immunogenicity of the TV005 tetravalent dengue vaccine, across serotypes and age groups, in dengue-endemic Bangladesh: a randomised, controlled trial. Lancet Infect Dis. 2024 Feb;24(2):150-160. doi: 10.1016/S1473-3099(23)00520-0. Epub 2023 Sep 27.

Drugs

Indications