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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
32
Administered as an intramuscular (IM) injection
Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States
Fold Rise in Titer of Anti-group 1 Stalk-antibodies in Recipients of the Pandemic Live Attenuated Influenza Vaccines (pLAIVs) (H2N2, H6N1 and H9N2) Compared to the Control pLAIV-naïve Cohort
As measured by enzyme-linked immunosorbent assay (ELISA) and microneutralization assay (MN) using the chimeric cH6/N1 probe
Time frame: Measured through Day 28
Number of Participants With Vaccine-related Adverse Events in the pLAIV Compared to the Control Cohort
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Time frame: Measured through Day 28 for non serious adverse events
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