InfluenzaPhase 1NCT03581903
A Study in Healthy Adults to Assess Priming With Antigenically Mismatched Live Attenuated A/H7N3 Influenza Virus Vaccine Followed by Inactivated A/H7N9 Influenza Virus Vaccine
A Phase 1 study testing H7N3 pLAIV and H7N9 pIIV in people with Influenza, 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 assess priming with antigenically mismatched live attenuated A/H7N3 influenza virus vaccine followed by inactivated A/H7N9 influenza virus vaccine in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- H7N3 pLAIV and H7N9 pIIV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2017to 6 Feb 2019
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males and non-pregnant, non-breastfeeding females between 18 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 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 subjects will be considered being of child bearing potential except those who have undergone hysterectomy or tubal ligation 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.
- Female subjects of childbearing potential must have a negative urine and serum pregnancy test within 24 hours (urine) to 48 hours (serum) prior to study vaccination.
Who cannot join
- Pregnancy as determined by a positive human choriogonadotropin (beta-HCG) test.
- Currently breastfeeding or planning to breastfeed or become pregnant 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 principal investigator (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 vaccine trial or in any study of an avian influenza vaccine.
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- Seropositive to the H7N3 or 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, 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center Vaccine Research Unit (Outpatient)
Rochester, New York, 14642
About this study
Official title: A Phase I Study in Healthy Adults to Assess Priming With Antigenically Mismatched Live Attenuated A/H7N3 Influenza Virus Vaccine Followed by Inactivated A/H7N9 Influenza Virus Vaccine
The purpose of this study is to assess priming with antigenically mismatched live attenuated A/H7N3 influenza virus vaccine followed by inactivated A/H7N9 influenza virus vaccine in healthy adults.
Read the detailed description
This study will assess priming with antigenically mismatched live attenuated A/H7N3 influenza virus vaccine (H7N3 pLAIV) followed by inactivated A/H7N9 influenza virus vaccine (H7N9 pIIV) in healthy adults.
Participants will receive a dose of H7N3 pLAIV on Days 0 and 28, followed by a single dose of H7N9 pIIV on Day 84.
On Days -2 and 26, participants will be admitted to an inpatient clinic. They will receive the H7N3 pLAIV vaccine on Days 0 and 28. They will remain in the clinic for 9 days after receiving the vaccine and until they are no longer shedding vaccine virus. An additional study visit will occur on Day 56.
On Day 84, participants will receive the H7N9 pIIV vaccine. Additional study visits will occur on Days 87, 91, 98, 112, 140, and 180. Study visits may include physical examinations, nasal washes, and blood and urine collection. Participants will be contacted by phone on Day 264 for follow-up health monitoring.
- Conditions
- Influenza
- Being tested
- H7N3 pLAIV, H7N9 pIIV
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H7N3 pLAIVBiological
Also called Live attenuated A/H7N3 influenza virus vaccine
Approximately 10^7.0 fluorescent focus units (FFUs) administered intranasally by an Accuspray device
H7N9 pIIVBiological
Also called Inactivated A/H7N9 influenza virus vaccine
30 micrograms administered by intramuscular (IM) injection
| Study group | Role | What they receive |
|---|---|---|
| H7N3 pLAIV + H7N9 pIIV | Experimental | Participants will receive H7N3 pLAIV on Days 0 and 28, followed by H7N9 pIIV on Day 84. Receives: Biological: H7N3 pLAIV; Biological: H7N9 pIIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemagglutination-inhibition (HAI) antibody response to H7N9 virus following administration of pIIV
Defined as 4-fold or greater response to a titer of 1:40 or above with 95% confidence intervals for both antigens
Measured: Measured through Day 28
Secondary outcomes (7)
Frequency of reactogenicity events following each dose of vaccine
Reactogenicity events will be collected and assessed for each individual subject, taking the pattern of viral shedding into account.
Measured: Measured through Day 180
Severity of reactogenicity events following each dose of vaccine
Assessed according to the Reactogenicity Event Severity Grading System provided in the protocol
Measured: Measured through Day 180
Frequency of adverse events following each dose of vaccine
All adverse events will be recorded and relationship to study product will be assessed.
Measured: Measured through Day 180
Severity of adverse events following each dose of vaccine
Assessed according to the Adverse Event Severity Grading System provided in the study protocol
Measured: Measured through Day 180
Frequency of vaccine viral shedding after each dose
Determined by rtRT-PCR and culture at each day tested after inoculation
Measured: Measured through Day 180
Serum HAI and neutralizing antibody response following 1 or 2 doses of pLAIV
Response rates defined as 4-fold or greater response to a titer of 1:40 or above with 95% confidence intervals for both antigens
Measured: Measured through Day 56
Neutralizing and HAI responses after pIIV boost against antigenic variants of H7 virus, including H7N7, H7N3, and H7N9 North American and Eurasian lineage viruses
Response rates defined as 4-fold or greater response to a titer of 1:40 or above with 95% confidence intervals for both antigens
Measured: Measured through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start19 Sep 2017
- Primary completion14 Sep 2018
- Study completion6 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Angela Branche, M.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581903
- Sponsor's protocol ID
- 16-003
- Status last verified
- Mar 2019
- First submitted
- 26 Jun 2018
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study in Healthy Adults to Assess Priming With Antigenically Mismatched Live Attenuated A/H7N3 Influenza Virus Vaccine Followed by Inactivated A/H7N9 Influenza Virus Vaccine
- ClinicalTrials.gov ID
- NCT03581903
- Acronym / sponsor ID
- 16-003
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 10 Jul 2018 (actual)
- 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 assess priming with antigenically mismatched live attenuated A/H7N3 influenza virus vaccine followed by inactivated A/H7N9 influenza virus vaccine in healthy adults.
Detailed description
This study will assess priming with antigenically mismatched live attenuated A/H7N3 influenza virus vaccine (H7N3 pLAIV) followed by inactivated A/H7N9 influenza virus vaccine (H7N9 pIIV) in healthy adults.
Participants will receive a dose of H7N3 pLAIV on Days 0 and 28, followed by a single dose of H7N9 pIIV on Day 84.
On Days -2 and 26, participants will be admitted to an inpatient clinic. They will receive the H7N3 pLAIV vaccine on Days 0 and 28. They will remain in the clinic for 9 days after receiving the vaccine and until they are no longer shedding vaccine virus. An additional study visit will occur on Day 56.
On Day 84, participants will receive the H7N9 pIIV vaccine. Additional study visits will occur on Days 87, 91, 98, 112, 140, and 180. Study visits may include physical examinations, nasal washes, and blood and urine collection. Participants will be contacted by phone on Day 264 for follow-up health monitoring.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H7N3 pLAIV + H7N9 pIIV | Experimental | Biological: H7N3 pLAIV, Biological: H7N9 pIIVParticipants will receive H7N3 pLAIV on Days 0 and 28, followed by H7N9 pIIV on Day 84. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adult males and non-pregnant, non-breastfeeding females between 18 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 (31 listed)
- Pregnancy as determined by a positive human choriogonadotropin (beta-HCG) test.
- Currently breastfeeding or planning to breastfeed or become pregnant 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 principal investigator (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 |
|---|---|---|
| H7N3 pLAIVAlso: Live attenuated A/H7N3 influenza virus vaccineApproximately 10^7.0 fluorescent focus units (FFUs) administered intranasally by an Accuspray device | Biological | H7N3 pLAIV + H7N9 pIIV |
| H7N9 pIIVAlso: Inactivated A/H7N9 influenza virus vaccine30 micrograms administered by intramuscular (IM) injection | Biological | H7N3 pLAIV + H7N9 pIIV |
Primary outcome
Hemagglutination-inhibition (HAI) antibody response to H7N9 virus following administration of pIIV
Time frame: Measured through Day 28
Defined as 4-fold or greater response to a titer of 1:40 or above with 95% confidence intervals for both antigens
7 secondary outcomes
Frequency of reactogenicity events following each dose of vaccine
Time frame: Measured through Day 180
Severity of reactogenicity events following each dose of vaccine
Time frame: Measured through Day 180
Frequency of adverse events following each dose of vaccine
Time frame: Measured through Day 180
Severity of adverse events following each dose of vaccine
Time frame: Measured through Day 180
Frequency of vaccine viral shedding after each dose
Time frame: Measured through Day 180
Serum HAI and neutralizing antibody response following 1 or 2 doses of pLAIV
Time frame: Measured through Day 56
Neutralizing and HAI responses after pIIV boost against antigenic variants of H7 virus, including H7N7, H7N3, and H7N9 North American and Eurasian lineage viruses
Time frame: Measured through Day 28
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 25 Mar 2019.
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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, M.D. 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 H7N3 pLAIV and H7N9 pIIV in people with Influenza, 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 8 inclusion and 31 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 25 Mar 2019. 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?
Hemagglutination-inhibition (HAI) antibody response to H7N9 virus following administration of pIIV (time frame: Measured through Day 28). 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 25 Mar 2019.