Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants

Summary

The purpose of this study is to describe the safety, tolerability and immunogenicity of two doses of purified inactivated Zika virus vaccine (PIZV) given 28 days apart. Three different vaccine doses containing different protein concentrations (2, 5 or 10 microgram \[mcg\]) each, will be given as 2 dose schedule to flavivirus naive and primed healthy adults. Participants will be followed for 7 days post each dose for tolerability and up to 6 months post dose 2 for safety. Immunogenicity assessment will be performed at 28 days post each dose and 6 months post dose 2. In addition, the selected dose group and control group will be followed till 24 months post dose 2 for safety and persistence of immunity.

Timeline

Start

2017-11-13

Primary completion

2018-12-28

Completion

2020-11-24

Publications

• Acosta CJ, Diaz C, Nordio F, Han HH, Moss KJ, Bohning K, Kumar P, Liu M, Patel H, Pacciarini F, Mwangi V, Walter E, Powell TD, El Sahly HM, Baldwin WR, Santangelo J, Anderson EJ, Dubin G. Persistence of Immunogenicity of a Purified Inactivated Zika Virus Vaccine Candidate in Healthy Adults: 2 Years of Follow-up Compared With Natural Infection. J Infect Dis. 2023 May 29;227(11):1303-1312. doi: 10.1093/infdis/jiac482.
• Han HH, Diaz C, Acosta CJ, Liu M, Borkowski A. Safety and immunogenicity of a purified inactivated Zika virus vaccine candidate in healthy adults: an observer-blind, randomised, phase 1 trial. Lancet Infect Dis. 2021 Sep;21(9):1282-1292. doi: 10.1016/S1473-3099(20)30733-7. Epub 2021 May 18.

Drugs

Indications