InfluenzaPhase 1NCT00110279
Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study A)
A Phase 1 study testing H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) in people with Influenza and Virus Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and other parts of the world. The purpose of this study is to test the safety of and immune response to a new AI vaccine in healthy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Virus Diseases
- What is being tested?
- H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Sep 2005
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Born after 1968
- Good general health
- Available for the duration of the trial
Who cannot join
- Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
- Liver, renal, or hematologic disease
- Alcohol or drug abuse within 12 months of study entry
- History of severe allergic reaction or anaphylaxis
- Current asthma or reactive airway disease
Show all 26Show fewer
- History of Guillain-Barre syndrome
- HIV-1 infected
- Hepatitis C virus infected
- Positive for hepatitis B surface antigen (HBsAg)
- Known immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical corticosteroids are not excluded.
- Live vaccine within 4 weeks of study entry
- Killed vaccine within 2 weeks of study entry
- Absence of spleen
- Blood products within 6 months of study entry
- Current smoker
- Have traveled to the Southern Hemisphere or Asia within 30 days prior to study entry
- Have traveled on a cruise ship within 30 days prior to study entry
- Work in the poultry industry
- Investigational agents within 60 days prior to study entry, or currently participating in another investigational vaccine or drug trial
- Allergy to eggs or egg products
- Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
- Family member with immunodeficiency
- Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: Phase I Inpatient Study of the Safety and Immunogenicity of H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H9N2 Infection in the Event of a Pandemic (Study A)
Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and other parts of the world. The purpose of this study is to test the safety of and immune response to a new AI vaccine in healthy adults.
Study hypothesis: Influenza A viruses are widely distributed in nature and infect a wide variety of birds and mammals. The direct transmission of avian influenza viruses from birds to humans has recently become a major health concern in Asia and other parts of the world, raising concern of a possible influenza pandemic in humans. This vaccine will evaluate the safety, infectivity and immunogenicity of Live Influenza A vaccine H9N2 (6-2) AA ca reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca), a cold-adapted, live attenuated virus vaccine administered intranasally for the protection of humans against pandemic influenza viruses of the H9N2 subtype.
Read the detailed description
AI viruses in their natural reservoir in waterfowl are the source from which novel HA and NA subtypes are introduced into the human population, and have the potential to initiate an influenza pandemic. This study will evaluate the safety and immunogenicity of a live, attenuated, cold-adapted reassortant AI virus vaccine, H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca).
Patient participation in this study will be for at least 60 days, with patients followed for at least 42 days after vaccination. In this study, participants will be enrolled sequentially, from highest to lowest dose of vaccine, into one of three groups. At study entry at Day 0, participants will be admitted to the hospital in order to familiarize them with trial procedures. Blood and nasal wash samples will be collected prior to vaccination. On Day 2, participants will have a physical exam and will receive one dose of vaccine; the vaccine will be administered as nose drops. Participants will undergo directed physical examinations daily while they are in the hospital. Nasal washes will also be collected daily from the day of admission through the day prior to discharge to test for the presence of vaccine virus. Participants may be discharged from the hospital after 3 consecutive negative viral cultures, but not before Day 14. Additional blood collection will occur daily from Day 0 to Day 7 and again on Day 21. Participants will return for follow-up visits 28 to 32 days and 42 to 46 days after receiving the vaccine. Blood and nasal wash collection will occur at these 2 study visits, and participants will also have directed physical exams.
Depending on the immune response to the first dose of vaccine, some participants may be asked to return to the hospital 1 to 2 months after their first vaccination to receive an additional dose of vaccine.
- Conditions
- Influenza, Virus Diseases
- Being tested
- H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)
- Keywords
- Bird Flu
- Medical subject headings
- Influenza, Human, Virus Diseases, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)Biological
Live attenuated H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | One vaccination with H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine at a dose of 10^7 TCID50 delivered by nose drops. Receives: Biological: H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) |
| 2 | Experimental | One vaccination with H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine at a dose of 10^7 TCID50 delivered by nose drops. This Arm will enroll 4 weeks after Arm 1. Enrolled volunteers must have participated in Arm 1. Receives: Biological: H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vaccine-related reactogenicity events and other adverse effects for each dose of the H9N2 G9/AA ca reassortant vaccine
Measured: Throughout study
Immunogenicity and infectivity for each dose of the H9N2 G9/AA ca reassortant vaccine
Measured: Throughout study
Secondary outcomes (7)
To compare antibody responses
Measured: At Days 28 and 42
To determine the number of vaccinees infected with the H9N2 G9/AA ca reassortant vaccine candidate.
Measured: Throughout study
If 10^7 , 10^5 , and 10^3 TCID50 doses of vaccine are administered, to compare the infectivity rates, safety, and immunogenicity between dose groups, and to estimate the HID50 for this vaccine
Measured: Throughout study
To determine the phenotypic stability of vaccine virus shed
Measured: Throughout study
To determine whether immunogenicity is enhanced by a second dose of vaccine, and whether the first dose of vaccine restricts replication of the second dose
Measured: At study completion
To evaluate T-cell mediated and innate immune responses against the H9N2 G9/AA ca reassortant vaccine candidate
Measured: Throughout study
To develop a serum bank so that the capacity of the H9N2 G9/AA ca reassortant vaccine candidate to elicit HI and neutralizing antibodies to future H9N2 influenza viruses can be tested
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2005 (estimated)
- Study startJun 2005
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Investigators
- Ruth A. Karron, MD, Principal investigator, Center of Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110279
- Sponsor's protocol ID
- CIR 211 (Study A)
- Other IDs
- H.22.05.03.11.B2
- Status last verified
- Jan 2008
- First submitted
- 5 May 2005
- Last updated
- 21 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen H, Matsuoka Y, Swayne D, Chen Q, Cox NJ, Murphy BR, Subbarao K. Generation and characterization of a cold-adapted influenza A H9N2 reassortant as a live pandemic influenza virus vaccine candidate. Vaccine. 2003 Oct 1;21(27-30):4430-6. doi: 10.1016/s0264-410x(03)00430-4.
PubMed 14505926Choi YK, Ozaki H, Webby RJ, Webster RG, Peiris JS, Poon L, Butt C, Leung YH, Guan Y. Continuing evolution of H9N2 influenza viruses in Southeastern China. J Virol. 2004 Aug;78(16):8609-14. doi: 10.1128/JVI.78.16.8609-8614.2004.
PubMed 15280470Stephenson I, Nicholson KG, Wood JM, Zambon MC, Katz JM. Confronting the avian influenza threat: vaccine development for a potential pandemic. Lancet Infect Dis. 2004 Aug;4(8):499-509. doi: 10.1016/S1473-3099(04)01105-3.
PubMed 15288823Swayne DE. Vaccines for List A poultry diseases: emphasis on avian influenza. Dev Biol (Basel). 2003;114:201-12.
PubMed 14677690Karron RA, Callahan K, Luke C, Thumar B, McAuliffe J, Schappell E, Joseph T, Coelingh K, Jin H, Kemble G, Murphy BR, Subbarao K. A live attenuated H9N2 influenza vaccine is well tolerated and immunogenic in healthy adults. J Infect Dis. 2009 Mar 1;199(5):711-6. doi: 10.1086/596558.
PubMed 19210163
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Inpatient Study of the Safety and Immunogenicity of H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H9N2 Infection in the Event of a Pandemic (Study A)
- ClinicalTrials.gov ID
- NCT00110279
- Acronym / sponsor ID
- CIR 211 (Study A)
- Conditions
- Influenza, Virus Diseases
- Keywords
- Bird Flu
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Study start
- Jun 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 6 May 2005 (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.
Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and other parts of the world. The purpose of this study is to test the safety of and immune response to a new AI vaccine in healthy adults.
Study hypothesis: Influenza A viruses are widely distributed in nature and infect a wide variety of birds and mammals. The direct transmission of avian influenza viruses from birds to humans has recently become a major health concern in Asia and other parts of the world, raising concern of a possible influenza pandemic in humans. This vaccine will evaluate the safety, infectivity and immunogenicity of Live Influenza A vaccine H9N2 (6-2) AA ca reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca), a cold-adapted, live attenuated virus vaccine administered intranasally for the protection of humans against pandemic influenza viruses of the H9N2 subtype.
Detailed description
AI viruses in their natural reservoir in waterfowl are the source from which novel HA and NA subtypes are introduced into the human population, and have the potential to initiate an influenza pandemic. This study will evaluate the safety and immunogenicity of a live, attenuated, cold-adapted reassortant AI virus vaccine, H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca).
Patient participation in this study will be for at least 60 days, with patients followed for at least 42 days after vaccination. In this study, participants will be enrolled sequentially, from highest to lowest dose of vaccine, into one of three groups. At study entry at Day 0, participants will be admitted to the hospital in order to familiarize them with trial procedures. Blood and nasal wash samples will be collected prior to vaccination. On Day 2, participants will have a physical exam and will receive one dose of vaccine; the vaccine will be administered as nose drops. Participants will undergo directed physical examinations daily while they are in the hospital. Nasal washes will also be collected daily from the day of admission through the day prior to discharge to test for the presence of vaccine virus. Participants may be discharged from the hospital after 3 consecutive negative viral cultures, but not before Day 14. Additional blood collection will occur daily from Day 0 to Day 7 and again on Day 21. Participants will return for follow-up visits 28 to 32 days and 42 to 46 days after receiving the vaccine. Blood and nasal wash collection will occur at these 2 study visits, and participants will also have directed physical exams.
Depending on the immune response to the first dose of vaccine, some participants may be asked to return to the hospital 1 to 2 months after their first vaccination to receive an additional dose of vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)One vaccination with H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine at a dose of 10^7 TCID50 delivered by nose drops. |
| 2 | Experimental | Biological: H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)One vaccination with H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine at a dose of 10^7 TCID50 delivered by nose drops. This Arm will enroll 4 weeks after Arm 1. Enrolled volunteers must have participated in Arm 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Born after 1968
- Good general health
- Available for the duration of the trial
Key exclusion criteria (26 listed)
- Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
- Liver, renal, or hematologic disease
- Alcohol or drug abuse within 12 months of study entry
- History of severe allergic reaction or anaphylaxis
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 |
|---|---|---|
| H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)Live attenuated H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine | Biological | 1, 2 |
Primary outcome
Frequency of vaccine-related reactogenicity events and other adverse effects for each dose of the H9N2 G9/AA ca reassortant vaccine
Time frame: Throughout study
Immunogenicity and infectivity for each dose of the H9N2 G9/AA ca reassortant vaccine
Time frame: Throughout study
7 secondary outcomes
To compare antibody responses
Time frame: At Days 28 and 42
To determine the number of vaccinees infected with the H9N2 G9/AA ca reassortant vaccine candidate.
Time frame: Throughout study
If 10^7 , 10^5 , and 10^3 TCID50 doses of vaccine are administered, to compare the infectivity rates, safety, and immunogenicity between dose groups, and to estimate the HID50 for this vaccine
Time frame: Throughout study
To determine the phenotypic stability of vaccine virus shed
Time frame: Throughout study
To determine whether immunogenicity is enhanced by a second dose of vaccine, and whether the first dose of vaccine restricts replication of the second dose
Time frame: At study completion
To evaluate T-cell mediated and innate immune responses against the H9N2 G9/AA ca reassortant vaccine candidate
Time frame: Throughout study
To develop a serum bank so that the capacity of the H9N2 G9/AA ca reassortant vaccine candidate to elicit HI and neutralizing antibodies to future H9N2 influenza viruses can be tested
Time frame: Throughout study
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 21 Jan 2008.
- Background: PubMed 14505926Chen H, Matsuoka Y, Swayne D, Chen Q, Cox NJ, Murphy BR, Subbarao K. Generation and characterization of a cold-adapted influenza A H9N2 reassortant as a live pandemic influenza virus vaccine candidate. Vaccine. 2003 Oct 1;21(27-30):4430-6. doi: 10.1016/s0264-410x(03)00430-4.
- Background: PubMed 15280470Choi YK, Ozaki H, Webby RJ, Webster RG, Peiris JS, Poon L, Butt C, Leung YH, Guan Y. Continuing evolution of H9N2 influenza viruses in Southeastern China. J Virol. 2004 Aug;78(16):8609-14. doi: 10.1128/JVI.78.16.8609-8614.2004.
- Background: PubMed 15288823Stephenson I, Nicholson KG, Wood JM, Zambon MC, Katz JM. Confronting the avian influenza threat: vaccine development for a potential pandemic. Lancet Infect Dis. 2004 Aug;4(8):499-509. doi: 10.1016/S1473-3099(04)01105-3.
- Background: PubMed 14677690Swayne DE. Vaccines for List A poultry diseases: emphasis on avian influenza. Dev Biol (Basel). 2003;114:201-12.
- Derived from this study: PubMed 19210163Karron RA, Callahan K, Luke C, Thumar B, McAuliffe J, Schappell E, Joseph T, Coelingh K, Jin H, Kemble G, Murphy BR, Subbarao K. A live attenuated H9N2 influenza vaccine is well tolerated and immunogenic in healthy adults. J Infect Dis. 2009 Mar 1;199(5):711-6. doi: 10.1086/596558.
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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.
Ruth A. Karron, MD principal investigator
Center of Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health
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 H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) in people with Influenza and Virus Diseases, 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 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2008. 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 and other adverse effects for each dose of the H9N2 G9/AA ca reassortant vaccine (time frame: Throughout study). 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 NCT00110279, which also lists 5 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 21 Jan 2008.