Influenza A Subtype H7N7 InfectionPhase 1NCT01534468
Evaluating the Safety and Immune Response of an H7N7 Vaccine in Healthy Adults
A Phase 1 study testing Monovalent Influenza Subvirion Vaccine, H7N7 in people with Influenza A Subtype H7N7 Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
H7N7 is one type of influenza virus that may pose a threat to humans if an outbreak occurs. This study will evaluate the safety and immune response to an H7N7 vaccine in people who have previously received a live attenuated influenza vaccine (LAIV) as part of a research study and people who have not previously… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A Subtype H7N7 Infection
- What is being tested?
- Monovalent Influenza Subvirion Vaccine, H7N7
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2014
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Previous participant in a study of pandemic LAIV or H7-naive participant, as described in the protocol
- Adult males and non-pregnant females between 18 and 50 years of age
- In good general health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
- Agree to storage of blood specimens for future research
- Available for the duration of the trial
- Willing to participate in the study as evidenced by signing the informed consent document
- Female participants must agree to use effective birth control methods for the duration of the study. More information on this criterion can be found in the protocol.
Who cannot join
- Pregnant, as determined by a positive beta-human chorionic gonadotropin (HCG) test
- Currently breastfeeding
- 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 transaminase (ALT) levels more than twice the upper limit of normal, or otherwise clinically significant as determined by the principal investigator (PI), will be exclusionary at baseline, prior to vaccination.
- 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 inactivated H7N7 influenza vaccine trial
- Seropositive to the H7N7 influenza A virus (serum HAI titer greater than 1:8) for H7-naive participants
Show all 24Show fewer
- Positive urine drug toxicity test indicating use of drugs of abuse
- Medical, occupational, or family problems as a result of alcohol or illicit drug use in the 12 months prior to study entry
- 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
- History of Guillain-Barre syndrome
- Positive ELISA and confirmatory Western blot tests for HIV-1
- Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay [RIBA]) 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 a surgical splenectomy
- Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
- Travel to the Southern Hemisphere within 14 days prior to study vaccination
- Travel on a cruise ship within 14 days prior to study vaccination
- Current involvement with the poultry industry, i.e., direct contact with poultry within the 14 days prior to study entry or after the study completion
- Receipt of another investigational vaccine or drug within 30 days prior to study vaccination
- Allergy to eggs or egg products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Priming by Pandemic Live Attenuated Influenza Vaccine (LAIV) on the Subsequent Response to Inactivated H7N7 Vaccine in Healthy Adults: A Non-Randomized, Open Label Study
H7N7 is one type of influenza virus that may pose a threat to humans if an outbreak occurs. This study will evaluate the safety and immune response to an H7N7 vaccine in people who have previously received a live attenuated influenza vaccine (LAIV) as part of a research study and people who have not previously received a LAIV.
Read the detailed description
Influenza A viruses are widely found in nature and can infect a wide variety of birds and mammals, including humans. Some types of influenza A viruses are more likely to spread from animals to humans, and researchers are interested in monitoring these viruses and developing potential vaccines for them. H7N7 is one type of influenza A virus. In recent years, there have been several H7N7 outbreaks among humans, and the development of an H7N7 vaccine is a high priority. This study will enroll two groups of participants: people who have previously received one of three types of a pandemic LAIV as part of a research study and people who have not previously received a LAIV vaccine. The purpose of this study is to evaluate the safety and immunogenicity of a single dose of an inactivated H7N7 vaccine in these two groups of participants.
At a baseline study visit, all participants will undergo a medical history review, physical examination, vital sign measurements, blood collection, and nasal secretion collection. Female participants will provide a urine sample for pregnancy testing. All participants will then receive one intramuscular (IM) injection of the H7N7 study vaccine in their upper arm. They will remain in the clinic for 30 minutes for observation and monitoring. Participants will monitor and record any adverse symptoms between study visits. Additional study visits will occur at Days 4, 7, 14, 28, 56, and 180. At select study visits, participants will undergo a medical history review, physical examination, and nasal secretion collection. Blood collection will occur at each visit; some blood samples may be stored for future research.
- Conditions
- Influenza A Subtype H7N7 Infection
- Being tested
- Monovalent Influenza Subvirion Vaccine, H7N7
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monovalent Influenza Subvirion Vaccine, H7N7Biological
At study entry, all participants will receive one IM injection of approximately 45 micrograms of inactivated Monovalent Influenza Subvirion Vaccine, H7N7.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Previous H7N7 ca LAIV recipients | Experimental | Participants in Group 1 will have previously received an H7N7 ca LAIV. In this study, they will receive one intramuscular (IM) injection of the H7N7 vaccine at study entry. Receives: Biological: Monovalent Influenza Subvirion Vaccine, H7N7 |
| Group 2: Previous H7N3 ca LAIV recipients | Experimental | Participants in Group 2 will have previously received an H7N3 ca LAIV. In this study, they will receive one IM injection of the H7N7 vaccine at study entry. Receives: Biological: Monovalent Influenza Subvirion Vaccine, H7N7 |
| Group 3: Previous H2N3 ca LAIV recipients | Experimental | Participants in Group 3 will have previously received an H2N3 ca LAIV. In this study, they will receive one IM injection of the H7N7 vaccine at study entry. Receives: Biological: Monovalent Influenza Subvirion Vaccine, H7N7 |
| Group 4: Vaccine-naive participants | Experimental | Participants in Group 4 will have not previously received a LAIV. In this study, they will receive one IM injection of the H7N7 vaccine at study entry. Receives: Biological: Monovalent Influenza Subvirion Vaccine, H7N7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vaccine-related reactogenicity events that occur during the acute monitoring phase of the study
Measured: Measured through Day 7
Development of serum antibody assessed by either hemagglutination inhibition (HAI) or micronucleus (MN) assays
Measured: Measured through Day 180
Secondary outcomes (3)
Development of a significant increase in nasal secretion hemagglutinin (HA)-specific antibody, as assessed by enzyme-linked immunosorbent assay (ELISA)
Measured: Measured through Day 180
Development of greater than 200 influenza-specific interferon-gamma (IFN-γ)-secreting cells per million lymphocytes, as assessed by enzyme-linked immunosorbent spot (ELISPOT)
Measured: Measured on Day 28
Detection of influenza-specific immunoglobulin G (IgG)- or immunoglobulin A (IgA)-secreting B cells, as assessed by antibody secreting cells (ASC) assay
Measured: Measured on Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Influenza A Subtype H7N7 InfectionStudies 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
- 45 participants (actual)
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
- NCT01534468
- Sponsor's protocol ID
- URMC 11-001
- Status last verified
- Dec 2015
- First submitted
- 13 Feb 2012
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Halliley JL, Khurana S, Krammer F, Fitzgerald T, Coyle EM, Chung KY, Baker SF, Yang H, Martinez-Sobrido L, Treanor JJ, Subbarao K, Golding H, Topham DJ, Sangster MY. High-Affinity H7 Head and Stalk Domain-Specific Antibody Responses to an Inactivated Influenza H7N7 Vaccine After Priming With Live Attenuated Influenza Vaccine. J Infect Dis. 2015 Oct 15;212(8):1270-8. doi: 10.1093/infdis/jiv210. Epub 2015 Apr 2.
PubMed 25838266Babu TM, Levine M, Fitzgerald T, Luke C, Sangster MY, Jin H, Topham D, Katz J, Treanor J, Subbarao K. Live attenuated H7N7 influenza vaccine primes for a vigorous antibody response to inactivated H7N7 influenza vaccine. Vaccine. 2014 Nov 28;32(50):6798-804. doi: 10.1016/j.vaccine.2014.09.070. Epub 2014 Oct 16.
PubMed 25446831
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Priming by Pandemic Live Attenuated Influenza Vaccine (LAIV) on the Subsequent Response to Inactivated H7N7 Vaccine in Healthy Adults: A Non-Randomized, Open Label Study
- ClinicalTrials.gov ID
- NCT01534468
- Acronym / sponsor ID
- URMC 11-001
- Conditions
- Influenza A Subtype H7N7 Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 16 Feb 2012 (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.
H7N7 is one type of influenza virus that may pose a threat to humans if an outbreak occurs. This study will evaluate the safety and immune response to an H7N7 vaccine in people who have previously received a live attenuated influenza vaccine (LAIV) as part of a research study and people who have not previously received a LAIV.
Detailed description
Influenza A viruses are widely found in nature and can infect a wide variety of birds and mammals, including humans. Some types of influenza A viruses are more likely to spread from animals to humans, and researchers are interested in monitoring these viruses and developing potential vaccines for them. H7N7 is one type of influenza A virus. In recent years, there have been several H7N7 outbreaks among humans, and the development of an H7N7 vaccine is a high priority. This study will enroll two groups of participants: people who have previously received one of three types of a pandemic LAIV as part of a research study and people who have not previously received a LAIV vaccine. The purpose of this study is to evaluate the safety and immunogenicity of a single dose of an inactivated H7N7 vaccine in these two groups of participants.
At a baseline study visit, all participants will undergo a medical history review, physical examination, vital sign measurements, blood collection, and nasal secretion collection. Female participants will provide a urine sample for pregnancy testing. All participants will then receive one intramuscular (IM) injection of the H7N7 study vaccine in their upper arm. They will remain in the clinic for 30 minutes for observation and monitoring. Participants will monitor and record any adverse symptoms between study visits. Additional study visits will occur at Days 4, 7, 14, 28, 56, and 180. At select study visits, participants will undergo a medical history review, physical examination, and nasal secretion collection. Blood collection will occur at each visit; some blood samples may be stored for future research.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Previous H7N7 ca LAIV recipients | Experimental | Biological: Monovalent Influenza Subvirion Vaccine, H7N7Participants in Group 1 will have previously received an H7N7 ca LAIV. In this study, they will receive one intramuscular (IM) injection of the H7N7 vaccine at study entry. |
| Group 2: Previous H7N3 ca LAIV recipients | Experimental | Biological: Monovalent Influenza Subvirion Vaccine, H7N7Participants in Group 2 will have previously received an H7N3 ca LAIV. In this study, they will receive one IM injection of the H7N7 vaccine at study entry. |
| Group 3: Previous H2N3 ca LAIV recipients | Experimental | Biological: Monovalent Influenza Subvirion Vaccine, H7N7Participants in Group 3 will have previously received an H2N3 ca LAIV. In this study, they will receive one IM injection of the H7N7 vaccine at study entry. |
| Group 4: Vaccine-naive participants | Experimental | Biological: Monovalent Influenza Subvirion Vaccine, H7N7Participants in Group 4 will have not previously received a LAIV. In this study, they will receive one IM injection of the H7N7 vaccine at study entry. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Previous participant in a study of pandemic LAIV or H7-naive participant, as described in the protocol
- Adult males and non-pregnant females between 18 and 50 years of age
- In good general health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
- Agree to storage of blood specimens for future research
- Available for the duration of the trial
Key exclusion criteria (24 listed)
- Pregnant, as determined by a positive beta-human chorionic gonadotropin (HCG) test
- Currently breastfeeding
- 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 transaminase (ALT) levels more than twice the upper limit of normal, or otherwise clinically significant as determined by the principal investigator (PI), will be exclusionary at baseline, prior to vaccination.
- 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 inactivated H7N7 influenza vaccine trial
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 |
|---|---|---|
| Monovalent Influenza Subvirion Vaccine, H7N7At study entry, all participants will receive one IM injection of approximately 45 micrograms of inactivated Monovalent Influenza Subvirion Vaccine, H7N7. | Biological | Group 1: Previous H7N7 ca LAIV recipients, Group 2: Previous H7N3 ca LAIV recipients, Group 3: Previous H2N3 ca LAIV recipients, Group 4: Vaccine-naive participants |
Primary outcome
Frequency of vaccine-related reactogenicity events that occur during the acute monitoring phase of the study
Time frame: Measured through Day 7
Development of serum antibody assessed by either hemagglutination inhibition (HAI) or micronucleus (MN) assays
Time frame: Measured through Day 180
3 secondary outcomes
Development of a significant increase in nasal secretion hemagglutinin (HA)-specific antibody, as assessed by enzyme-linked immunosorbent assay (ELISA)
Time frame: Measured through Day 180
Development of greater than 200 influenza-specific interferon-gamma (IFN-γ)-secreting cells per million lymphocytes, as assessed by enzyme-linked immunosorbent spot (ELISPOT)
Time frame: Measured on Day 28
Detection of influenza-specific immunoglobulin G (IgG)- or immunoglobulin A (IgA)-secreting B cells, as assessed by antibody secreting cells (ASC) assay
Time frame: Measured on 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 15 Dec 2015.
- Derived from this study: PubMed 25838266Halliley JL, Khurana S, Krammer F, Fitzgerald T, Coyle EM, Chung KY, Baker SF, Yang H, Martinez-Sobrido L, Treanor JJ, Subbarao K, Golding H, Topham DJ, Sangster MY. High-Affinity H7 Head and Stalk Domain-Specific Antibody Responses to an Inactivated Influenza H7N7 Vaccine After Priming With Live Attenuated Influenza Vaccine. J Infect Dis. 2015 Oct 15;212(8):1270-8. doi: 10.1093/infdis/jiv210. Epub 2015 Apr 2.
- Derived from this study: PubMed 25446831Babu TM, Levine M, Fitzgerald T, Luke C, Sangster MY, Jin H, Topham D, Katz J, Treanor J, Subbarao K. Live attenuated H7N7 influenza vaccine primes for a vigorous antibody response to inactivated H7N7 influenza vaccine. Vaccine. 2014 Nov 28;32(50):6798-804. doi: 10.1016/j.vaccine.2014.09.070. Epub 2014 Oct 16.
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 Monovalent Influenza Subvirion Vaccine, H7N7 in people with Influenza A Subtype H7N7 Infection, 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 24 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 15 Dec 2015. 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 that occur during the acute monitoring phase of the study (time frame: Measured through Day 7). The study lists 2 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 NCT01534468, which also lists 2 linked publications.
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 15 Dec 2015.