Influenza A Virus InfectionPhase 1NCT01175122
Evaluation of the Safety and Immunogenicity of a Live Attenuated Virus Vaccine for the Prevention of H2N3 Influenza
A Phase 1 study testing H2N3 MO 2003/AA ca Vaccine in people with Influenza A Virus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
In recent years, influenza viruses that have traditionally infected animals have infected humans as well. The H2N3 influenza virus, which first appeared in pigs in the Midwest United States in 2006, may pose a potential health concern to humans. Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A Virus Infection
- What is being tested?
- H2N3 MO 2003/AA ca Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Apr 2011
- 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 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In general good 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 or 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. Clinically significant alanine aminotransferase (ALT) levels, 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 procedures
- Previous enrollment in an H2 influenza vaccine trial or in any study of an avian influenza vaccine
- Seropositive to the H2N3 influenza A virus (serum HAI titer greater than 1:8)
- Positive urine drug toxicology test indicating narcotic use/dependency
Show all 25Show fewer
- Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the 12 months prior to study entry
- Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a person participating in the trial or would render the person unable to comply with the study procedures
- History of anaphylaxis
- Allergy to oseltamivir as determined by participant report
- Current diagnosis of asthma or reactive airway disease (within the 2 years prior to study entry)
- 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 a surgical splenectomy
- 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 study. More information on this criterion can be found in the protocol.
- 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 or egg products
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 H2N3 (6-2) AA ca Recombinant (A/Swine/Missouri/4296424/2006 (H2N3) x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H2N3 Infection in the Event of a Pandemic
In recent years, influenza viruses that have traditionally infected animals have infected humans as well. The H2N3 influenza virus, which first appeared in pigs in the Midwest United States in 2006, may pose a potential health concern to humans. This study will evaluate the safety of and immune response to a vaccine designed to protect people from the H2N3 influenza virus.
Read the detailed description
Animal influenza viruses, such as the H1N1 and H5N1 viruses, typically infect animals like birds or pigs, but these viruses can also infect humans. The recent outbreak of the H1N1 influenza virus demonstrates that it is possible for these viruses to cause a pandemic outbreak in humans. Researchers are specifically interested in evaluating vaccines for H2 viruses, as these viruses caused a pandemic outbreak in humans in the late 1950s to 1960s. In addition, over half of the world's current population has no previous exposure to related viruses, which means a pandemic outbreak could pose a serious health risk as many people would have no immunity against the virus. In 2006, an outbreak of H2N3 infection occurred in pigs in the Midwest United States. While no humans contracted the virus during that outbreak, it remains a concern for researchers in the event that the virus ever spreads to humans. The purpose of this study is to evaluate the safety and immunogenicity of two doses of an experimental H2N3 vaccine, H2N3 MO 2006/AA ca in healthy adults. This is a live attenuated vaccine, which means that participants will be exposed to small amounts of the H2N3 vaccine virus and will need to remain isolated for at least 12 days when receiving the vaccine to prevent spreading the virus to others.
This study will enroll healthy adults. Participants will receive two doses of the vaccine, 4 weeks apart, and will stay in an isolation facility during both 12-day vaccination periods. Participants will be admitted to the isolation facility 2 days before they receive their first vaccination. They will receive one nasal spray administration of the vaccine and will be monitored for side effects. On various days while in the isolation facility, they will undergo a physical exam, blood and urine collection, and a nasal wash procedure. Participants will remain in the isolation facility for at least 9 days after receiving the vaccine and possibly longer, until the nasal wash tests negative for the vaccine virus for 2 consecutive days. Participants will be readmitted to the isolation facility 26 days after the first vaccination. They will receive a second vaccination and all study procedures will be repeated. Participants will attend study visits 56, 82, and 208 days after the first vaccination for follow-up health and safety monitoring, blood collection, and a nasal wash procedure.
- Conditions
- Influenza A Virus Infection
- Being tested
- H2N3 MO 2003/AA ca Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H2N3 MO 2003/AA ca VaccineBiological
0.2 mL of H2N3 MO 2003/AA ca vaccine delivered by an Accuspray nasal spray device on Day 0 and Day 28
| Study group | Role | What they receive |
|---|---|---|
| H2N3 MO 2003/AA ca Vaccine | Experimental | Participants will receive a nasal spray administration of the H2N3 MO 2003/AA ca vaccine on Day 0 and Day 28. Receives: Biological: H2N3 MO 2003/AA ca Vaccine |
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 (inpatient) phase of the study
Measured: Measured through Day 37 or until participants are discharged from the isolation unit
Area under the curve (AUC) of nasal virus shedding after each dose of vaccine as assessed by liquid titration of nasal secretions on Madin Darby canine kidney (MDCK) cells at 33°C
Measured: Measured after each vaccination
Development of serum antibody assessed by either hemagglutination inhibition (HAI) or microneutralization (MN) assays
Measured: Measured after each vaccination
Secondary outcomes (3)
Development of a significant increase in nasal secretion hemagglutinin (HA)-specific antibody assessed by enzyme-linked immunosorbent assay (ELISA)
Measured: Measured until participants are discharged from the isolation unit
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 28 days after vaccination
Detection of influenza-specific IgG or IgA secreting B cells on Day 7 following vaccination assessed by antibody secreting cells (ASC) assay
Measured: Measured 7 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionApr 2011
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 Virus 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
- 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
- John Treanor, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175122
- Sponsor's protocol ID
- URMC 10-004
- Status last verified
- Feb 2013
- First submitted
- 3 Aug 2010
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ma W, Vincent AL, Gramer MR, Brockwell CB, Lager KM, Janke BH, Gauger PC, Patnayak DP, Webby RJ, Richt JA. Identification of H2N3 influenza A viruses from swine in the United States. Proc Natl Acad Sci U S A. 2007 Dec 26;104(52):20949-54. doi: 10.1073/pnas.0710286104. Epub 2007 Dec 18.
PubMed 18093945Chen GL, Lamirande EW, Yang CF, Jin H, Kemble G, Subbarao K. Evaluation of replication and cross-reactive antibody responses of H2 subtype influenza viruses in mice and ferrets. J Virol. 2010 Aug;84(15):7695-702. doi: 10.1128/JVI.00511-10. Epub 2010 May 26.
PubMed 20504935
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. 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 H2N3 (6-2) AA ca Recombinant (A/Swine/Missouri/4296424/2006 (H2N3) x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H2N3 Infection in the Event of a Pandemic
- ClinicalTrials.gov ID
- NCT01175122
- Acronym / sponsor ID
- URMC 10-004
- Conditions
- Influenza A Virus Infection
- 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
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Aug 2010 (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.
In recent years, influenza viruses that have traditionally infected animals have infected humans as well. The H2N3 influenza virus, which first appeared in pigs in the Midwest United States in 2006, may pose a potential health concern to humans. This study will evaluate the safety of and immune response to a vaccine designed to protect people from the H2N3 influenza virus.
Detailed description
Animal influenza viruses, such as the H1N1 and H5N1 viruses, typically infect animals like birds or pigs, but these viruses can also infect humans. The recent outbreak of the H1N1 influenza virus demonstrates that it is possible for these viruses to cause a pandemic outbreak in humans. Researchers are specifically interested in evaluating vaccines for H2 viruses, as these viruses caused a pandemic outbreak in humans in the late 1950s to 1960s. In addition, over half of the world's current population has no previous exposure to related viruses, which means a pandemic outbreak could pose a serious health risk as many people would have no immunity against the virus. In 2006, an outbreak of H2N3 infection occurred in pigs in the Midwest United States. While no humans contracted the virus during that outbreak, it remains a concern for researchers in the event that the virus ever spreads to humans. The purpose of this study is to evaluate the safety and immunogenicity of two doses of an experimental H2N3 vaccine, H2N3 MO 2006/AA ca in healthy adults. This is a live attenuated vaccine, which means that participants will be exposed to small amounts of the H2N3 vaccine virus and will need to remain isolated for at least 12 days when receiving the vaccine to prevent spreading the virus to others.
This study will enroll healthy adults. Participants will receive two doses of the vaccine, 4 weeks apart, and will stay in an isolation facility during both 12-day vaccination periods. Participants will be admitted to the isolation facility 2 days before they receive their first vaccination. They will receive one nasal spray administration of the vaccine and will be monitored for side effects. On various days while in the isolation facility, they will undergo a physical exam, blood and urine collection, and a nasal wash procedure. Participants will remain in the isolation facility for at least 9 days after receiving the vaccine and possibly longer, until the nasal wash tests negative for the vaccine virus for 2 consecutive days. Participants will be readmitted to the isolation facility 26 days after the first vaccination. They will receive a second vaccination and all study procedures will be repeated. Participants will attend study visits 56, 82, and 208 days after the first vaccination for follow-up health and safety monitoring, blood collection, and a nasal wash procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H2N3 MO 2003/AA ca Vaccine | Experimental | Biological: H2N3 MO 2003/AA ca VaccineParticipants will receive a nasal spray administration of the H2N3 MO 2003/AA ca vaccine on Day 0 and Day 28. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- In general good 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.
Key exclusion criteria (25 listed)
- Pregnant or 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. Clinically significant alanine aminotransferase (ALT) levels, 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 procedures
- Previous enrollment in an H2 influenza vaccine trial or in any study of an avian influenza vaccine
- Seropositive to the H2N3 influenza A virus (serum HAI titer greater than 1:8)
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 |
|---|---|---|
| H2N3 MO 2003/AA ca Vaccine0.2 mL of H2N3 MO 2003/AA ca vaccine delivered by an Accuspray nasal spray device on Day 0 and Day 28 | Biological | H2N3 MO 2003/AA ca Vaccine |
Primary outcome
Frequency of vaccine-related reactogenicity events that occur during the acute monitoring (inpatient) phase of the study
Time frame: Measured through Day 37 or until participants are discharged from the isolation unit
Area under the curve (AUC) of nasal virus shedding after each dose of vaccine as assessed by liquid titration of nasal secretions on Madin Darby canine kidney (MDCK) cells at 33°C
Time frame: Measured after each vaccination
Development of serum antibody assessed by either hemagglutination inhibition (HAI) or microneutralization (MN) assays
Time frame: Measured after each vaccination
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 until participants are discharged from the isolation unit
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 28 days after vaccination
Detection of influenza-specific IgG or IgA secreting B cells on Day 7 following vaccination assessed by antibody secreting cells (ASC) assay
Time frame: Measured 7 days after vaccination
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 11 Feb 2013.
- Background: PubMed 18093945Ma W, Vincent AL, Gramer MR, Brockwell CB, Lager KM, Janke BH, Gauger PC, Patnayak DP, Webby RJ, Richt JA. Identification of H2N3 influenza A viruses from swine in the United States. Proc Natl Acad Sci U S A. 2007 Dec 26;104(52):20949-54. doi: 10.1073/pnas.0710286104. Epub 2007 Dec 18.
- Background: PubMed 20504935Chen GL, Lamirande EW, Yang CF, Jin H, Kemble G, Subbarao K. Evaluation of replication and cross-reactive antibody responses of H2 subtype influenza viruses in mice and ferrets. J Virol. 2010 Aug;84(15):7695-702. doi: 10.1128/JVI.00511-10. Epub 2010 May 26.
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Healthy Participants
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 H2N3 MO 2003/AA ca Vaccine in people with Influenza A Virus 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 5 inclusion and 25 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 11 Feb 2013. 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 (inpatient) phase of the study (time frame: Measured through Day 37 or until participants are discharged from the isolation unit). 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 NCT01175122, 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 11 Feb 2013.