NCT03816878

Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1 and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine Naïve Individuals

An Exploration of a Prime-Boost Approach for Universal Influenza Vaccination: Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1 and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine Naïve Individuals

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and safety of inactivated subunit H5N1 influenza vaccine in individuals who have previously received live attenuated H2N2, H6N1, or H9N2 influenza vaccine, as well as in individuals who have never previously received H5N1 or other pandemic live attenuated influenza vaccines.

Detailed description

This study will evaluate the immunogenicity and safety of inactivated subunit H5N1 influenza vaccine in individuals who have previously received live attenuated H2N2, H6N1, or H9N2 influenza vaccine, as well as in individuals who have never previously received H5N1 or other pandemic live attenuated influenza vaccines (pLAIVs). Participants will be enrolled in two cohorts. Cohort 1 will include participants who received two doses of live attenuated H2N2, H6N1, or H9N2 influenza vaccine during a prior Center for Immunization Research (CIR) study; Cohort 2 will include participants who have never previously received a pLAIV. Participants in both cohorts will receive one dose of H5N1 pISV vaccine by injection at Day 0. Participants will attend study visits on Days 0, 7, 14, 28, 56, 90, and 360. Study visits may include a physical examination, medical history, and blood and urine collection. All participants will be followed for approximately 360 days after receiving the H5N1 pISV vaccine.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	H5N1 pISV	Administered as an intramuscular (IM) injection

Timeline

• Start date: 2019-01-08
• Primary completion: 2019-04-18
• Completion: 2020-03-17
• First posted: 2019-01-25
• Last updated: 2025-09-22
• Results posted: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study