Influenza A Virus, H7N9 SubtypePhase 1NCT02957656
Safety and Immunogenicity of Priming With Live Attenuated A/H7N9 Influenza Virus Vaccine Followed By Inactivated A/H7N9 Influenza Virus Vaccine With AS03 Adjuvant
A Phase 1 study testing H7N9 pLAIV, H7N9 pIIV and AS03 adjuvant 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
The purpose of this study is to evaluate the safety and immunogenicity of one dose of H7N9 pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9 pandemic inactivated influenza vaccine (H7N9 pIIV). Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A Virus, H7N9 Subtype
- What is being tested?
- H7N9 pLAIV, H7N9 pIIV and AS03 adjuvant
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Jun 2018
- 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 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males and non-pregnant, non-breastfeeding females between 20 years and 49 years of age, inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, 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. Subjects must be willing and able to remain within the Isolation Unit for the specified duration of confinement.
- Provide written informed consent prior to initiation of any study procedures, including future use of specimens.
- Female subjects of childbearing 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 subjects will be considered being of childbearing potential except those who have undergone hysterectomy or tubal ligation and those in whom menopause occurred at least 1 year prior to the study.
Show all 12Show fewer
- Agrees not to participate in another clinical trial with an investigational product for the entire duration of the study.
- Oral temperature is less than 100.4°F.
- Pulse is 50 to 115 bpm, inclusive.
- Systolic blood pressure is 85 to 150 mm Hg, inclusive.
- Diastolic blood pressure is 55 to 95 mm Hg, inclusive.
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.
Who cannot join
- Pregnancy as determined by a positive human choriogonadotropin (beta-HCG) test.
- Currently breastfeeding or planning to breastfeed at some point during the duration of the study.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, electrocardiogram (EKG) 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, and thyroid medication unless approved by the PI.
- Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject 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.
Show all 33Show fewer
- 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 subject participating in the trial or would render the subject unable to comply with the protocol.
- Have a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines.
- Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine.
- Allergy to oseltamivir as determined by subject report.
- Current diagnosis of asthma or reactive airway disease (within the past 2 years).
- History of Guillain-Barré Syndrome.
- Positive enzyme-linked immunosorbent assay (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.
- Planned receipt of any vaccine from the first study vaccination through the follow-up visit at approximately 180 days after the final study vaccination.
- History of asplenia.
- Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 36 months prior to vaccination.
- Have known active neoplastic disease or a history of any hematologic malignancy.
- 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.
- Any potential Immune Mediated Disease (pIMD) listed in the protocol, or other diseases that may have an autoimmune origin.
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: A Phase I Study In Healthy Adults To Assess The Safety And Immunogenicity Of Priming With Live Attenuated A/H7N9 Influenza Virus Vaccine Followed By Inactivated A/H7N9 Influenza Virus Vaccine With AS03 Adjuvant
The purpose of this study is to evaluate the safety and immunogenicity of one dose of H7N9 pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9 pandemic inactivated influenza vaccine (H7N9 pIIV).
Read the detailed description
This study will evaluate the safety and immunogenicity of one dose of H7N9 pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9 pandemic inactivated influenza vaccine (H7N9 pIIV).
This study will enroll healthy adults who will choose which study group to join. Participants in Group 1 will receive one dose of H7N9 pLAIV in an inpatient setting at study entry (Day 0). They will remain in an isolation unit through at least Day 9. They will also receive one dose of AS03-adjuvanted H7N9 pIIV on Day 84.
Participants in Group 2 will receive one dose of AS03-adjuvanted H7N9 pIIV at study entry (Day 0) and a second dose of AS03-adjuvanted H7N9 pIIV at Day 84. Participants in Group 3 will receive one dose of AS03-adjuvanted H7N9 pIIV at study entry (Day 0).
All participants will attend multiple study visits through Day 264. Study visits may include blood collection, physical examinations, and nasal wash and nasal wick procedures.
These three groups will be compared to two historical control groups who received one dose of H7N9 pLAIV at study entry (Day 0), one dose of H7N9 pLAIV at Day 28, and one dose of unadjuvanted H7N9 pIIV at Day 84.
- Conditions
- Influenza A Virus, H7N9 Subtype
- Being tested
- H7N9 pLAIV, H7N9 pIIV, AS03 adjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H7N9 pLAIVBiological
Also called Live Influenza A Vaccine H7N9 (6-2) AA ca Recombinant (A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca)
10^7.0 fluorescent focus units (FFU); delivered by an Accuspray device
H7N9 pIIVBiological
Administered by intramuscular injection in the deltoid.
AS03 adjuvantBiological
Mixed with H7N9 pIIV vaccine; administered by intramuscular injection in the deltoid
| Study group | Role | What they receive |
|---|---|---|
| Group 1: H7N9 pLAIV + AS03-adjuvanted H7N9 pIIV | Experimental | Participants will receive one dose of approximately 10^7.0 FFU of H7N9 pLAIV at study entry (Day 0). They will receive one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at Day 84. Receives: Biological: H7N9 pLAIV; Biological: H7N9 pIIV; Biological: AS03 adjuvant |
| Group 2: AS03-adjuvanted H7N9 pIIV + AS03-adjuvanted H7N9 pIIV | Experimental | Participants will receive one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at study entry (Day 0) and one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at Day 84. Receives: Biological: H7N9 pIIV; Biological: AS03 adjuvant |
| Group 3: AS03-adjuvanted H7N9 pIIV | Experimental | Participants will receive one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at study entry (Day 0). Receives: Biological: H7N9 pIIV; Biological: AS03 adjuvant |
| University of Rochester URMC 13-001 Participants | Experimental | Participants received one dose of 10^7 FFU of H7N9 pLAIV at study entry (Day 0), one dose of 10^7 FFU of H7N9 pLAIV at Day 28, and one dose of 30 µg of unadjuvanted H7N9 pIIV at Day 84. Receives: Biological: H7N9 pLAIV; Biological: H7N9 pIIV |
| Johns Hopkins School of Public Health CIR293 Participants | Experimental | Participants received one dose of 10^7 FFU of H7N9 pLAIV at study entry (Day 0), one dose of 10^7 FFU of H7N9 pLAIV at Day 28, and one dose of 30 µg of unadjuvanted H7N9 pIIV at Day 84. Receives: Biological: H7N9 pLAIV; Biological: H7N9 pIIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of local and systemic reactogenicity events
Measured: Measured through Day 264
Development of adverse events at any time point during the study
Measured: Measured through Day 264
Geometric mean titer (GMT) of H7N9-specific serum hemagglutination inhibition (HAI) and/or microneutralization (MN) antibody responses
Measured: Measured through Day 264
Rates of H7N9-specific serum HAI and/or MN antibody responses
Measured: Measured through Day 264
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Angela Branche, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957656
- Sponsor's protocol ID
- 16-002
- Status last verified
- Oct 2018
- First submitted
- 2 Nov 2016
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study In Healthy Adults To Assess The Safety And Immunogenicity Of Priming With Live Attenuated A/H7N9 Influenza Virus Vaccine Followed By Inactivated A/H7N9 Influenza Virus Vaccine With AS03 Adjuvant
- ClinicalTrials.gov ID
- NCT02957656
- Acronym / sponsor ID
- 16-002
- Conditions
- Influenza A Virus, H7N9 Subtype
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- First posted
- 8 Nov 2016 (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.
The purpose of this study is to evaluate the safety and immunogenicity of one dose of H7N9 pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9 pandemic inactivated influenza vaccine (H7N9 pIIV).
Detailed description
This study will evaluate the safety and immunogenicity of one dose of H7N9 pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9 pandemic inactivated influenza vaccine (H7N9 pIIV).
This study will enroll healthy adults who will choose which study group to join. Participants in Group 1 will receive one dose of H7N9 pLAIV in an inpatient setting at study entry (Day 0). They will remain in an isolation unit through at least Day 9. They will also receive one dose of AS03-adjuvanted H7N9 pIIV on Day 84.
Participants in Group 2 will receive one dose of AS03-adjuvanted H7N9 pIIV at study entry (Day 0) and a second dose of AS03-adjuvanted H7N9 pIIV at Day 84. Participants in Group 3 will receive one dose of AS03-adjuvanted H7N9 pIIV at study entry (Day 0).
All participants will attend multiple study visits through Day 264. Study visits may include blood collection, physical examinations, and nasal wash and nasal wick procedures.
These three groups will be compared to two historical control groups who received one dose of H7N9 pLAIV at study entry (Day 0), one dose of H7N9 pLAIV at Day 28, and one dose of unadjuvanted H7N9 pIIV at Day 84.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: H7N9 pLAIV + AS03-adjuvanted H7N9 pIIV | Experimental | Biological: H7N9 pLAIV, Biological: H7N9 pIIV, Biological: AS03 adjuvantParticipants will receive one dose of approximately 10^7.0 FFU of H7N9 pLAIV at study entry (Day 0). They will receive one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at Day 84. |
| Group 2: AS03-adjuvanted H7N9 pIIV + AS03-adjuvanted H7N9 pIIV | Experimental | Biological: H7N9 pIIV, Biological: AS03 adjuvantParticipants will receive one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at study entry (Day 0) and one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at Day 84. |
| Group 3: AS03-adjuvanted H7N9 pIIV | Experimental | Biological: H7N9 pIIV, Biological: AS03 adjuvantParticipants will receive one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at study entry (Day 0). |
| University of Rochester URMC 13-001 Participants | Experimental | Biological: H7N9 pLAIV, Biological: H7N9 pIIVParticipants received one dose of 10^7 FFU of H7N9 pLAIV at study entry (Day 0), one dose of 10^7 FFU of H7N9 pLAIV at Day 28, and one dose of 30 µg of unadjuvanted H7N9 pIIV at Day 84. |
| Johns Hopkins School of Public Health CIR293 Participants | Experimental | Biological: H7N9 pLAIV, Biological: H7N9 pIIVParticipants received one dose of 10^7 FFU of H7N9 pLAIV at study entry (Day 0), one dose of 10^7 FFU of H7N9 pLAIV at Day 28, and one dose of 30 µg of unadjuvanted H7N9 pIIV at Day 84. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Adult males and non-pregnant, non-breastfeeding females between 20 years and 49 years of age, inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, 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. Subjects must be willing and able to remain within the Isolation Unit for the specified duration of confinement.
- Provide written informed consent prior to initiation of any study procedures, including future use of specimens.
Key exclusion criteria (33 listed)
- Pregnancy as determined by a positive human choriogonadotropin (beta-HCG) test.
- Currently breastfeeding or planning to breastfeed at some point during the duration of the study.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, electrocardiogram (EKG) 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, and thyroid medication unless approved by the PI.
- Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol.
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 pLAIVAlso: Live Influenza A Vaccine H7N9 (6-2) AA ca Recombinant (A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca)10^7.0 fluorescent focus units (FFU); delivered by an Accuspray device | Biological | Group 1: H7N9 pLAIV + AS03-adjuvanted H7N9 pIIV, Johns Hopkins School of Public Health CIR293 Participants, University of Rochester URMC 13-001 Participants |
| H7N9 pIIVAdministered by intramuscular injection in the deltoid. | Biological | Group 1: H7N9 pLAIV + AS03-adjuvanted H7N9 pIIV, Group 2: AS03-adjuvanted H7N9 pIIV + AS03-adjuvanted H7N9 pIIV, Group 3: AS03-adjuvanted H7N9 pIIV, Johns Hopkins School of Public Health CIR293 Participants, University of Rochester URMC 13-001 Participants |
| AS03 adjuvantMixed with H7N9 pIIV vaccine; administered by intramuscular injection in the deltoid | Biological | Group 1: H7N9 pLAIV + AS03-adjuvanted H7N9 pIIV, Group 2: AS03-adjuvanted H7N9 pIIV + AS03-adjuvanted H7N9 pIIV, Group 3: AS03-adjuvanted H7N9 pIIV |
Primary outcome
Rates of local and systemic reactogenicity events
Time frame: Measured through Day 264
Development of adverse events at any time point during the study
Time frame: Measured through Day 264
Geometric mean titer (GMT) of H7N9-specific serum hemagglutination inhibition (HAI) and/or microneutralization (MN) antibody responses
Time frame: Measured through Day 264
Rates of H7N9-specific serum HAI and/or MN antibody responses
Time frame: Measured through Day 264
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 2 Oct 2018.
Related trials for Influenza A Virus, H7N9 Subtype
RecruitingPhase 1/2
Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adults and Older Adults
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.
Angela Branche 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 pLAIV, H7N9 pIIV and AS03 adjuvant 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 12 inclusion and 33 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 2 Oct 2018. 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?
Rates of local and systemic reactogenicity events (time frame: Measured through Day 264). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2018.