Immunogenicity Trial of Recombinant Influenza Vaccine Among HCP in Israel

Summary

This randomized, open-label, active-controlled trial will assess humoral immune responses to a single dose of 2019-20 recombinant hemagglutinin quadrivalent influenza vaccines (RIV4) compared with standard egg-based unadjuvanted quadrivalent influenza vaccines (IIV4) among healthcare personnel (HCP) vaccinated during the previous 2018-19 season with IIV4. The trial will be conducted at two hospital sites in Israel during the 2019-20 influenza season among HCP who were enrolled in the Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI).

Timeline

Start

2019-10-31

Primary completion

2020-01-30

Completion

2022-08-30

Publications

• Background Hirsch A, Katz MA, Laufer Peretz A, Greenberg D, Wendlandt R, Shemer Avni Y, Newes-Adeyi G, Gofer I, Leventer-Roberts M, Davidovitch N, Rosenthal A, Gur-Arie R, Hertz T, Glatman-Freedman A, Monto AS, Azziz-Baumgartner E, Ferdinands JM, Martin ET, Malosh RE, Neyra Quijandria JM, Levine M, Campbell W, Balicer R, Thompson MG; SHIRI workgroup. Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI): study protocol. BMC Infect Dis. 2018 Nov 6;18(1):550. doi: 10.1186/s12879-018-3444-7.
• Fowlkes AL, Peretz A, Greenberg D, Hirsch A, Martin ET, Levine MZ, Edwards L, Radke S, Lauring AS, Ferdinands JM, Zhang C, Yoo YM, Dreiher J, Newes-Adeyi G, Azziz-Baumgartner E, Fry AM, Monto AS, Balicer R, Thompson MG, Katz MA. Randomised immunogenicity trial comparing 2019-2020 recombinant and egg-based influenza vaccines among frequently vaccinated healthcare personnel in Israel. Int J Infect Dis. 2024 Dec;149:107260. doi: 10.1016/j.ijid.2024.107260. Epub 2024 Oct 10.

Drugs

Indications