NCT02274545

Brief Summary

H7N9 viruses have caused an outbreak of severe respiratory disease in 2013-2014 in China that affected many older adults. This study will evaluate the safety of and immune response to a live attenuated H7N9 vaccine in adults 50 to 70 years old.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

October 22, 2014

Last Update Submit

April 18, 2017

Conditions

Influenza A Virus, H7N9 Subtype

Outcome Measures

Primary Outcomes (3)

  • Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring (inpatient) phase of the study

    Measured through Day 37

  • Area under the curve (AUC) of nasal virus shedding after each dose of vaccine

    Assessed by liquid titration of nasal secretions on Madin Darby canine kidney (MDCK) cells at 33°C

    Measured through Day 180

  • Development of serum antibody assessed by either hemagglutination inhibition (HAI) or microneutralization (MN) assays following the H7N9 pLAIV or pIIV doses

    Measured through Day 180

Secondary Outcomes (3)

  • Development of a significant increase in nasal secretion hemagglutinin (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 immuno spot assay (ELISPOT) on Day 28 after immunization

    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

    Measured through Day 7

Study Arms (1)

H7N9 live attenuated vaccine & inactivated subvirion H7N9 vac.

EXPERIMENTAL

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 caBiological: Inactivated subvirion H7N9 vaccine

Interventions

H7N9 Anhui 2013/AA caBIOLOGICAL

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)

Also known as: H7N9 (6-2) AA ca recombinant vaccine, A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca, H7N9 A/Anhui/13 ca pLAIV
H7N9 live attenuated vaccine & inactivated subvirion H7N9 vac.
Inactivated subvirion H7N9 vaccineBIOLOGICAL

30 mcg

Also known as: H7N9 pIIV
H7N9 live attenuated vaccine & inactivated subvirion H7N9 vac.

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult males and non-pregnant females between 50 years and 70 years of age inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, and for safety considerations and because of the need for isolation.
  • Agree to storage of blood specimens for future research
  • Available for the duration of the trial. Participants must be willing and able to remain within the Isolation Unit for the specified duration of confinement.
  • Willingness to participate in the study as evidenced by signing the informed consent document
  • Female participants of child-bearing potential must agree to use effective birth control methods for the duration of the study (for example, pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse; surgical sterilization). All female participants will be considered being of child-bearing potential except those who have undergone hysterectomy and those in whom menopause occurred at least 1 year prior to the study.
  • Agrees not to participate in another clinical trial with an investigational product for the entire duration of the study

You may not qualify if:

  • Pregnancy as determined by a positive human choriogonadotropin (beta-HCG) test
  • Any current illness requiring daily medication other than the following: vitamins, birth control, anti-hypertensive medication, antihistamines, anti-depressant medication, cholesterol lowering medication, treatment for gastroesophageal reflux disease (GERD), and thyroid medication unless approved by the principal investigator.
  • Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
  • Previous enrollment in an H7 or H9 influenza vaccine trial or in any study of an avian influenza vaccine
  • Seropositive to the H7N9 influenza A virus (serum HAI titer greater than 1:8)
  • Positive urine drug toxicology test indicating narcotic use/dependency
  • Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
  • Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
  • History of anaphylaxis to any components of the H7N9 vaccines
  • Allergy to oseltamivir as determined by participant report
  • Current diagnosis of asthma or reactive airway disease (within the past 2 years)
  • History of Guillain-Barré Syndrome
  • Positive ELISA and confirmatory Western blot tests for human immunodeficiency virus-1 (HIV-1)
  • Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for hepatitis C virus (HCV)
  • Positive hepatitis B virus surface antigen (HBsAg) by ELISA
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • 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.

    PMID: 26655841DERIVED

Study Officials

  • John Treanor, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 24, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2016

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations

US(1)