Phase 1 Evaluation of the Safety and Immunogenicity of Live Influenza A Vaccine H7N9 (6-2) AA ca Recombinant (A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H7N9 Disease in the Event of a Pandemic
Sponsor study identifier
interventional
48
1 country
1
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
Not reported
Date not reportedH7N9 avian influenza (AI) viruses have caused a recent outbreak of severe respiratory disease in humans in China. The purpose of this study is to evaluate the safety and immunogenicity of a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults. A single dose of inactivated subvirion H7N9 influenza vaccine will be administered 3 months later.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 21, 2013
Actual (reported)November 26, 2013
Actual (reported)January 2016
Actual (reported)Frequency of vaccine-related reactogenicity events that occur during the acute monitoring (inpatient) phase of the study
Measured through Day 9 (Group 1) or Day 37 (Group 2)
Area under the curve (AUC) of nasal virus shedding after each dose of vaccine, as assessed by liquid titration of nasal secretions on Madin Darby canine kidney (MDCK) cells at 33°C
Measured through Day 180
Vaccine virus shedding on one or more days on Days 2 through 9 as assessed by culture or real-time reverse transcriptase polymerase chain reaction (rRT-PCR)
Measured through Day 9
Evidence of a 4-fold or greater increase in either hemagglutination inhibition (HAI) or microneutralization (MN) antibody comparing pre-vaccination to either Day 29 or Day 56 post-dose two samples
Measured through Day 56
Development of serum antibody assessed by either HAI or MN assays
Measured through Day 180
Development of a significant increase in nasal secretion HA-specific antibody assessed by enzyme-linked immunosorbent assay (ELISA)
Measured through Day 180
Development of greater than 200 influenza-specific interferon-gamma-secreting cells per million lymphocytes as assessed by enzyme-linked immunosorbent spot (ELISPOT) on Day 28 after immunization
Measured through Day 28
Detection of influenza-specific immunoglobulin G (IgG) or IgA secreting B cells on Day 7 following vaccination assessed by antibody secreting cells (ASC) assay
Measured through Day 7
Participants will receive one dose of live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine at study entry. They will then receive one dose of inactivated subvirion H7N9 influenza vaccine on Day 98.
Participants will receive two doses of live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine: one dose at study entry and one dose on Day 28. They will then receive one dose of inactivated subvirion H7N9 influenza vaccine on Day 98.
Participants will receive approximately 10\^7.0 focus forming units (FFU) of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine. The vaccine will be delivered by an Accuspray nasal spray device (0.25 mL per nostril for a total of 0.5 mL of vaccine).
University of Rochester Medical Center
Rochester, New York, 14642, United States
Sobhanie M, Matsuoka Y, Jegaskanda S, Fitzgerald T, Mallory R, Chen Z, Luke C, Treanor J, Subbarao K. Evaluation of the Safety and Immunogenicity of a Candidate Pandemic Live Attenuated Influenza Vaccine (pLAIV) Against Influenza A(H7N9). J Infect Dis. 2016 Mar 15;213(6):922-9. doi: 10.1093/infdis/jiv526. Epub 2015 Dec 9.
John Treanor, M.D.
University of Rochester
First Submitted
November 21, 2013
First Posted
November 26, 2013
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Participants will receive 30 mcg of the inactivated subvirion H7N9 vaccine by intramuscular injection.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Last Updated
July 27, 2016
Record last verified: 2016-07
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Source: ClinicalTrials.gov.
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