InfluenzaPhase 1NCT00722774
Safety and Immune Response to Recombinant Live-Attenuated Influenza H2N2 Virus Vaccine
A Phase 1 study testing H2N2 1960 AA ca recombinant vaccine 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
In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Virus Diseases
- What is being tested?
- H2N2 1960 AA ca recombinant vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Sep 2008
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- General good health
- Available for the duration of the trial
- If female, 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
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease. More information on this criterion can be found in the protocol.
- Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, intereferes with the study
- Previous receipt of FluMist or any intranasal live attenuated influenza vaccine
- Previous enrollment in an H2N2 influenza vaccine trial or in any study of an avian influenza vaccine
- Seropositive to the H2N2 influenza A virus (serum HAI titer >1:8)
- Positive urine drug toxicology test indicating narcotic use and/or dependency as defined by the Drug Enforcement Agency
Show all 27Show fewer
- Medical, occupational, or family problems as a result of alcohol or illicit drug use within the 12 months prior to study entry
- Any condition that, in the opinion of the investigator, would interfere with the study
- History of anaphylaxis
- Allergy to oseltamivir as determined by subject report
- Current diagnosis of asthma or reactive airway disease within 2 years prior to study entry
- History of Guillain-Barre Syndrome
- HIV-1-infected
- Hepatitis C-infected
- Positive hepatitis B virus surface antigen
- Known immunodeficiency syndrome
- Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to study entry
- Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study entry
- History of a surgical splenectomy
- Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study entry
- 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 entry
- Travel on a cruise ship within 14 days prior to study entry
- Direct contact with live poultry within the 14 days prior to the study or after study completion.
- Receipt of another investigational vaccine or drug within 30 days prior to study entry
- Allergy to eggs or egg products
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center, CIR Unit at the Mason F Lord Building
Baltimore, Maryland, 21205
About this study
Official title: Phase I Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine H2N2 (A/Ann Arbor/6/60 ca Recombinant), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H2N2 Infection in the Event of a Pandemic
In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Thus, the development of a vaccine against potential influenza strains has become a priority. The purpose of this study is to determine the safety and immune response to an H2N2 influenza vaccine candidate.
Read the detailed description
H2N2 influenza viruses emerged in the 1950s replacing the then circulating H1N1 human influenza virus. The first cases occurred in China in 1956, and disease became widespread in 1956-1957, resulting in the "Asian Influenza" pandemic that was responsible for between 1 and 4 million deaths worldwide. H2N2 viruses have not circulated since 1968, when they were replaced by H3N2 influenza viruses and the resurgence of H1N1 viruses. For this reason, a large proportion of the population is now susceptible to infection with H2N2 influenza. If this subtype re-emerges, it could potentially cause the next pandemic. This vaccine, therefore, is an important priority in the development of vaccines against potential pandemic influenza strains.
This vaccine trial will be conducted in the Center for Immunization Research isolation unit in the Mason F. Lord Building at the Johns Hopkins Bayview Medical Center (Baltimore, MD). The study will be initiated between April 1st and December 20th, 2008, when wild-type influenza is unlikely to be circulating in the Baltimore area.
An individual's participation in the study will last approximately 90 days. All participants will receive two vaccinations approximately 4 - 8 weeks apart. After each vaccination, participants will remain in isolation at the study site for at least nine days or until rRT-PCR assays for influenza are negative for 2 consecutive days. A physical examination and nasal wash will occur each day during the isolation period. Blood collection will occur in isolation beginning on Day 7 until release. Follow-up outpatient visits are scheduled on Days 28 and 56 after the first vaccination and on Day 28 after the second vaccination. Follow-up visits will include serum collection, nasal wash, and interim medical history.
- Conditions
- Influenza, Virus Diseases
- Being tested
- H2N2 1960 AA ca recombinant vaccine
- Keywords
- Vaccine, Influenza
- Medical subject headings
- Influenza, Human, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H2N2 1960 AA ca recombinant vaccineBiological
Approximately 0.2 ml of 10^7 TCID50 doses of vaccine administered intranasally
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive 2 doses of vaccine 4 to 8 weeks (28-62 days) apart Receives: Biological: H2N2 1960 AA ca recombinant vaccine |
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 events
Measured: Throughout study
Amount of vaccine virus shed by each participant
Measured: Throughout study
Amount of serum and nasal wash antibody induced by the vaccine
Measured: Throughout study
Secondary outcomes (4)
Number of participants infected with the H2N2 1960 AA ca recombinant vaccine
Measured: Throughout study
Phenotypic stability of vaccine virus shed
Measured: Throughout study
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: Throughout study
T-cell mediated and innate immune responses against the H2N2 1960 AA ca recombinant vaccine
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 posted28 Jul 2008 (estimated)
- Primary completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 22 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Investigators
- Kawsar Talaat, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722774
- Sponsor's protocol ID
- CIR 247
- Status last verified
- Jul 2008
- First submitted
- 25 Jul 2008
- Last updated
- 10 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Eichelberger M, Golding H, Hess M, Weir J, Subbarao K, Luke CJ, Friede M, Wood D. FDA/NIH/WHO public workshop on immune correlates of protection against influenza A viruses in support of pandemic vaccine development, Bethesda, Maryland, US, December 10-11, 2007. Vaccine. 2008 Aug 12;26(34):4299-303. doi: 10.1016/j.vaccine.2008.06.012. Epub 2008 Jun 26.
PubMed 18582523Hampson AW. Vaccines for pandemic influenza. The history of our current vaccines, their limitations and the requirements to deal with a pandemic threat. Ann Acad Med Singap. 2008 Jun;37(6):510-7.
PubMed 18618064Wright PF. Vaccine preparedness--are we ready for the next influenza pandemic? N Engl J Med. 2008 Jun 12;358(24):2540-3. doi: 10.1056/NEJMp0803650. No abstract available.
PubMed 18550873
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 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 Live Influenza A Vaccine H2N2 (A/Ann Arbor/6/60 ca Recombinant), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H2N2 Infection in the Event of a Pandemic
- ClinicalTrials.gov ID
- NCT00722774
- Acronym / sponsor ID
- CIR 247
- Conditions
- Influenza, Virus Diseases
- Keywords
- Vaccine, Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Sep 2008 (actual)
- First posted
- 28 Jul 2008 (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 the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Thus, the development of a vaccine against potential influenza strains has become a priority. The purpose of this study is to determine the safety and immune response to an H2N2 influenza vaccine candidate.
Detailed description
H2N2 influenza viruses emerged in the 1950s replacing the then circulating H1N1 human influenza virus. The first cases occurred in China in 1956, and disease became widespread in 1956-1957, resulting in the "Asian Influenza" pandemic that was responsible for between 1 and 4 million deaths worldwide. H2N2 viruses have not circulated since 1968, when they were replaced by H3N2 influenza viruses and the resurgence of H1N1 viruses. For this reason, a large proportion of the population is now susceptible to infection with H2N2 influenza. If this subtype re-emerges, it could potentially cause the next pandemic. This vaccine, therefore, is an important priority in the development of vaccines against potential pandemic influenza strains.
This vaccine trial will be conducted in the Center for Immunization Research isolation unit in the Mason F. Lord Building at the Johns Hopkins Bayview Medical Center (Baltimore, MD). The study will be initiated between April 1st and December 20th, 2008, when wild-type influenza is unlikely to be circulating in the Baltimore area.
An individual's participation in the study will last approximately 90 days. All participants will receive two vaccinations approximately 4 - 8 weeks apart. After each vaccination, participants will remain in isolation at the study site for at least nine days or until rRT-PCR assays for influenza are negative for 2 consecutive days. A physical examination and nasal wash will occur each day during the isolation period. Blood collection will occur in isolation beginning on Day 7 until release. Follow-up outpatient visits are scheduled on Days 28 and 56 after the first vaccination and on Day 28 after the second vaccination. Follow-up visits will include serum collection, nasal wash, and interim medical history.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: H2N2 1960 AA ca recombinant vaccineParticipants will receive 2 doses of vaccine 4 to 8 weeks (28-62 days) apart |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- General good health
- Available for the duration of the trial
- If female, 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 (27 listed)
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease. More information on this criterion can be found in the protocol.
- Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, intereferes with the study
- Previous receipt of FluMist or any intranasal live attenuated influenza vaccine
- Previous enrollment in an H2N2 influenza vaccine trial or in any study of an avian influenza vaccine
- Seropositive to the H2N2 influenza A virus (serum HAI titer >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 |
|---|---|---|
| H2N2 1960 AA ca recombinant vaccineApproximately 0.2 ml of 10^7 TCID50 doses of vaccine administered intranasally | Biological | 1 |
Primary outcome
Frequency of vaccine-related reactogenicity events and other adverse events
Time frame: Throughout study
Amount of vaccine virus shed by each participant
Time frame: Throughout study
Amount of serum and nasal wash antibody induced by the vaccine
Time frame: Throughout study
4 secondary outcomes
Number of participants infected with the H2N2 1960 AA ca recombinant vaccine
Time frame: Throughout study
Phenotypic stability of vaccine virus shed
Time frame: Throughout study
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: Throughout study
T-cell mediated and innate immune responses against the H2N2 1960 AA ca recombinant vaccine
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 10 Nov 2008.
- Background: PubMed 18582523Eichelberger M, Golding H, Hess M, Weir J, Subbarao K, Luke CJ, Friede M, Wood D. FDA/NIH/WHO public workshop on immune correlates of protection against influenza A viruses in support of pandemic vaccine development, Bethesda, Maryland, US, December 10-11, 2007. Vaccine. 2008 Aug 12;26(34):4299-303. doi: 10.1016/j.vaccine.2008.06.012. Epub 2008 Jun 26.
- Background: PubMed 18618064Hampson AW. Vaccines for pandemic influenza. The history of our current vaccines, their limitations and the requirements to deal with a pandemic threat. Ann Acad Med Singap. 2008 Jun;37(6):510-7.
- Background: PubMed 18550873Wright PF. Vaccine preparedness--are we ready for the next influenza pandemic? N Engl J Med. 2008 Jun 12;358(24):2540-3. doi: 10.1056/NEJMp0803650. No abstract available.
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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.
Kawsar Talaat, MD principal investigator
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 H2N2 1960 AA ca recombinant vaccine 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 27 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 10 Nov 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 events (time frame: Throughout study). 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 NCT00722774, which also lists 3 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 10 Nov 2008.