Influenza A Virus, H7N9 SubtypePhase 1NCT02274545
Evaluating the Safety and Immunogenicity of a H7N9 Vaccine for the Prevention of Influenza H7N9 Disease in Adults 50 to 70 Years Old
A Phase 1 study testing H7N9 Anhui 2013/AA ca and Inactivated subvirion H7N9 vaccine in people with Influenza A Virus, H7N9 Subtype, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A Virus, H7N9 Subtype
- What is being tested?
- H7N9 Anhui 2013/AA ca and Inactivated subvirion H7N9 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Are in good health, as determined by medical history and targeted physical examination to ensure any existing medical diagnoses or conditions (except those exclusionary) are stable. More information on this criterion can be found in the protocol.
- 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
Who cannot join
- Pregnancy as determined by a positive human choriogonadotropin (beta-HCG) test
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing. Alanine aminotransferase (ALT) levels greater than 2 times the upper normal limit will be exclusionary at baseline, prior to vaccination.
- 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)
Show all 26Show fewer
- 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
- Known immunodeficiency syndrome
- Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination
- Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination
- History of asplenia
- Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
- Current smoker unwilling to stop smoking for the duration of the inpatient stay. A current smoker includes anyone stating they currently smoke or use any amount of a tobacco product, including electronic cigarettes. After admission to the unit, nicotine patches will be provided to current smokers who request them for the inpatient portion of the study.
- Travel to the Southern Hemisphere within 14 days prior to study vaccination
- Travel on a cruise ship within 14 days prior to study vaccination
- Receipt of another investigational vaccine or drug within 30 days prior to study vaccination
- Allergy to eggs, egg products, or formaldehyde
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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
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.
Read the detailed description
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.
- Conditions
- Influenza A Virus, H7N9 Subtype
- Being tested
- H7N9 Anhui 2013/AA ca, Inactivated subvirion H7N9 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H7N9 Anhui 2013/AA caBiological
Also called 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
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)
Inactivated subvirion H7N9 vaccineBiological
Also called H7N9 pIIV
30 mcg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: H7N9 Anhui 2013/AA ca; Biological: Inactivated subvirion H7N9 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring (inpatient) phase of the study
Measured: 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: 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: 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: 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: 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: Measured through Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza A Virus, H7N9 SubtypeStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- John Treanor, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274545
- Sponsor's protocol ID
- URMC 14-004
- Status last verified
- Apr 2017
- First submitted
- 22 Oct 2014
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26655841
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02274545
- Acronym / sponsor ID
- URMC 14-004
- Conditions
- Influenza A Virus, H7N9 Subtype
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2014
- Primary completion
- May 2016 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H7N9 live attenuated vaccine & inactivated subvirion H7N9 vac. | Experimental | Biological: H7N9 Anhui 2013/AA ca, Biological: Inactivated subvirion H7N9 vaccineParticipants 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Are in good health, as determined by medical history and targeted physical examination to ensure any existing medical diagnoses or conditions (except those exclusionary) are stable. More information on this criterion can be found in the protocol.
- 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
Key exclusion criteria (26 listed)
- Pregnancy as determined by a positive human choriogonadotropin (beta-HCG) test
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing. Alanine aminotransferase (ALT) levels greater than 2 times the upper normal limit will be exclusionary at baseline, prior to vaccination.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H7N9 Anhui 2013/AA caAlso: H7N9 (6-2) AA ca recombinant vaccine, A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca, H7N9 A/Anhui/13 ca pLAIV10^7.0 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 | H7N9 live attenuated vaccine & inactivated subvirion H7N9 vac. |
| Inactivated subvirion H7N9 vaccineAlso: H7N9 pIIV30 mcg | Biological | H7N9 live attenuated vaccine & inactivated subvirion H7N9 vac. |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Derived from this study: PubMed 26655841Sobhanie 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.
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Avian Influenza A Virus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Treanor, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing H7N9 Anhui 2013/AA ca and Inactivated subvirion H7N9 vaccine in people with Influenza A Virus, H7N9 Subtype, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring (inpatient) phase of the study (time frame: Measured through Day 37). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02274545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.