H7N9 Boost in Healthy Adults

Summary

The study will be an open-label phase 2 clinical trial of a single dose of an inactivated H7N9 influenza vaccine (non-adjuvanted). The subjects of the study will have previously participated in DMID trial 07-0023, evaluating inactivated Influenza A/H7N7 vaccine. In the previous study healthy adults 18 to 40 years old were randomized to receive two doses, 28 days apart, of placebo or 7.5, 15, 45, or 90 ug of the influenza vaccine by IM injection in a 1:1 ratio (N=25/vaccine group and 25 in placebo group). The primary objectives are to 1) assess the safety and reactogenicity of a single dose A/H7N9 vaccine in individuals who previously received two IM doses of an A/H7N7 vaccine or are A/H7 vaccine-naïve and 2) To assess the serum hemagglutination inhibition (HAI) antibody responses against A/H7N9 approximately 28 days following receipt of a single dose of A/H7N9 vaccine in individuals who previously received two IM doses of A/H7N7 vaccine or are A/H7 vaccine-naïve.

Timeline

Start

2016-01-12

Primary completion

2016-12-29

Completion

2016-12-29

Publications

• El Sahly HM, Atmar RL, Patel SM, Bellamy A, Liu L, Hong W, Zhu H, Guan Y, Keitel WA; DMID 13-0033 Vaccine Study Group. Safety and immunogenicity of an 8 year interval heterologous prime-boost influenza A/H7N7-H7N9 vaccination. Vaccine. 2019 May 1;37(19):2561-2568. doi: 10.1016/j.vaccine.2019.03.071. Epub 2019 Apr 4.

Drugs

Indications