The purpose of this study is to assess priming with antigenically mismatched live attenuated A/H7N3 influenza virus vaccine followed by inactivated A/H7N9 influenza virus vaccine in healthy adults.
This study will assess priming with antigenically mismatched live attenuated A/H7N3 influenza virus vaccine (H7N3 pLAIV) followed by inactivated A/H7N9 influenza virus vaccine (H7N9 pIIV) in healthy adults. Participants will receive a dose of H7N3 pLAIV on Days 0 and 28, followed by a single dose of H7N9 pIIV on Day 84. On Days -2 and 26, participants will be admitted to an inpatient clinic. They will receive the H7N3 pLAIV vaccine on Days 0 and 28. They will remain in the clinic for 9 days after receiving the vaccine and until they are no longer shedding vaccine virus. An additional study visit will occur on Day 56. On Day 84, participants will receive the H7N9 pIIV vaccine. Additional study visits will occur on Days 87, 91, 98, 112, 140, and 180. Study visits may include physical examinations, nasal washes, and blood and urine collection. Participants will be contacted by phone on Day 264 for follow-up health monitoring.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
20
Approximately 10\^7.0 fluorescent focus units (FFUs) administered intranasally by an Accuspray device
30 micrograms administered by intramuscular (IM) injection
University of Rochester Medical Center Vaccine Research Unit (Outpatient)
Rochester, New York, United States
Hemagglutination-inhibition (HAI) antibody response to H7N9 virus following administration of pIIV
Defined as 4-fold or greater response to a titer of 1:40 or above with 95% confidence intervals for both antigens
Time frame: Measured through Day 28
Frequency of reactogenicity events following each dose of vaccine
Reactogenicity events will be collected and assessed for each individual subject, taking the pattern of viral shedding into account.
Time frame: Measured through Day 180
Severity of reactogenicity events following each dose of vaccine
Assessed according to the Reactogenicity Event Severity Grading System provided in the protocol
Time frame: Measured through Day 180
Frequency of adverse events following each dose of vaccine
All adverse events will be recorded and relationship to study product will be assessed.
Time frame: Measured through Day 180
Severity of adverse events following each dose of vaccine
Assessed according to the Adverse Event Severity Grading System provided in the study protocol
Time frame: Measured through Day 180
Frequency of vaccine viral shedding after each dose
Determined by rtRT-PCR and culture at each day tested after inoculation
Time frame: Measured through Day 180
Serum HAI and neutralizing antibody response following 1 or 2 doses of pLAIV
Response rates defined as 4-fold or greater response to a titer of 1:40 or above with 95% confidence intervals for both antigens
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Time frame: Measured through Day 56
Neutralizing and HAI responses after pIIV boost against antigenic variants of H7 virus, including H7N7, H7N3, and H7N9 North American and Eurasian lineage viruses
Response rates defined as 4-fold or greater response to a titer of 1:40 or above with 95% confidence intervals for both antigens
Time frame: Measured through Day 28