Evaluating the Safety and Immunogenicity of a H7N9 Vaccine for the Prevention of Influenza H7N9 Disease in Adults 50 to 70 Years Old
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|ClinicalTrials.gov Identifier: NCT02274545|
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : April 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Influenza A Virus, H7N9 Subtype||Biological: H7N9 Anhui 2013/AA ca Biological: Inactivated subvirion H7N9 vaccine||Phase 1|
H7N9 viruses caused an outbreak of severe respiratory disease in China in 2013-2014, which was associated with severe respiratory illness, acute respiratory distress syndrome (ARDS), intensive care unit (ICU) admissions, and death. The outbreak affected older adults and highlighted the need for a vaccine that is effective in this population. Prior studies have demonstrated the safety and immunogenicity of a vaccination regimen in which administration of the experimental H7N9 vaccine (H7N9 Anhui 2013/AA ca) was followed by an H7N9 inactivated vaccine in younger adults. This study will evaluate the safety and immunogenicity of a similar vaccination regimen in healthy adults, 50 to 70 years old, who are H7N9 seronegative.
Participants will be admitted to the inpatient unit 2 days before they will receive their first vaccination with the H7N9 Anhui 2013/AA ca vaccine. All participants will receive one dose of the H7N9 vaccine, delivered as a nasal spray, on Day 0. While in the inpatient unit, study procedures will include physical examinations, medical history reviews, nasal swabs, and blood and urine collections. On Day 9, participants will be discharged from the inpatient unit provided they meet certain medical criteria. If not, they will remain in the isolation unit until the criteria are met.
On Day 26, participants will be readmitted to the inpatient unit, and on Day 28, they will receive one dose of the H7N9 vaccine delivered as a nasal spray. Participants will remain in the inpatient unit until Day 37 and will take part in all of the same study procedures that occurred during the first inpatient stay. On Day 56, all participants will attend a study visit for a blood collection and nasal swab. On Day 98, all participants will receive one dose of the inactivated subvirion H7N9 vaccine. They will attend study visits on Days 101, 105, 112, 126, 154, and 180, which will include the same study procedures that occurred during the inpatient visits.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 50 to 70 Year Olds in the Event of a Pandemic|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||May 2016|
Experimental: H7N9 live attenuated vaccine & inactivated subvirion H7N9 vac.
Participants will receive one dose of the H7N9 vaccine at Days 0 and 28. They will receive one dose of the inactivated subvirion H7N9 vaccine on Day 98.
Biological: H7N9 Anhui 2013/AA ca
10^7.0 fluorescent focus units (FFU); 0.5 mL of vaccine will be delivered as a nasal spray by an Accuspray device (0.25 mL per nostril)
Biological: Inactivated subvirion H7N9 vaccine
Other Name: H7N9 pIIV
- Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring (inpatient) phase of the study [ Time Frame: Measured through Day 37 ]
- Area under the curve (AUC) of nasal virus shedding after each dose of vaccine [ Time Frame: Measured through Day 180 ]Assessed by liquid titration of nasal secretions on Madin Darby canine kidney (MDCK) cells at 33°C
- Development of serum antibody assessed by either hemagglutination inhibition (HAI) or microneutralization (MN) assays following the H7N9 pLAIV or pIIV doses [ Time Frame: Measured through Day 180 ]
- Development of a significant increase in nasal secretion hemagglutinin (HA)-specific antibody assessed by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Measured through Day 180 ]
- Development of greater than 200 influenza-specific interferon-gamma-secreting cells per million lymphocytes as assessed by enzyme-linked immuno spot assay (ELISPOT) on Day 28 after immunization [ Time Frame: Measured through Day 28 ]
- Detection of influenza-specific IgG or IgA secreting B cells on Day 7 following pLAIV vaccination assessed by antibody secreting cells (ASC) assay [ Time Frame: Measured through Day 7 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274545
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||John Treanor, MD||University of Rochester|