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AzTrials

InfluenzaPhase 1NCT00734175

Safety of and Immune Response to Recombinant Live-Attenuated Influenza H6N1 Virus Vaccine Vaccine

A Phase 1 study testing H6N1 Teal HK 97/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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 49 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Virus Diseases
What is being tested?
H6N1 Teal HK 97/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
Sep 2008to Dec 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 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Adult males and non-pregnant females 18-49 years old
  • 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 H6N1 influenza vaccine trial or in any study of an avian influenza vaccine
  • Seropositive to the H6N1 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

Other trials in United States

About this study

Official title: Phase I Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine H6N1 (6-2) AA ca Recombinant (A/Teal/Hong Kong/W312/1997 (H6N1) x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H6N1 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 H6N1 influenza vaccine candidate.

Read the detailed description

H6 influenza viruses are of the low pathogenicity phenotype in poultry, and in the last decade, outbreaks of H6 influenza infection have been reported both in the United States and South Africa. The prevalence of H6 influenza viruses in a wide range of domestic and wild birds, and their propensity for reassortment has raised concerns regarding the pandemic potential of these viruses. 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 inpatient 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 on the day of admission, the following day, and day 7 after vaccination. 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.

Being tested
H6N1 Teal HK 97/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.

  • H6N1 Teal HK 97/AA ca recombinant vaccineBiological

    Approximately 0.2 ml of 10^7 TCID50 doses of vaccine administered intranasally

Study groups in NCT00734175
Study groupRoleWhat they receive
1ExperimentalParticipants will receive 2 doses of vaccine 4 to 8 weeks (28-62 days) apart
Receives: Biological: H6N1 Teal HK 97/AA ca recombinant vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of vaccine-related reactogenicity events and other adverse events

    Measured: Throughout study

  2. Amount of vaccine virus shed by each participant

    Measured: Throughout study

  3. Amount of serum and nasal wash antibody induced by the vaccine

    Measured: Throughout study

Secondary outcomes (5)

  1. Number of participants infected with the H6N1 Teal HK 97/AA ca recombinant vaccine

    Measured: Throughout study

  2. Phenotypic stability of vaccine virus shed

    Measured: Throughout study

  3. 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

  4. T-cell mediated and innate immune responses against the H6N1 Teal HK 97/AA ca recombinant vaccine

    Measured: Throughout study

  5. Development of serum bank so that the capacity of the H6N1 Teal HK 97/AA ca recombinant vaccine to elicit HA1 and neutralizing antibodies to future H6 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.

  1. First posted14 Aug 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionDec 2008

Resources

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00734175
Sponsor's protocol ID
CIR 251
Status last verified
Sep 2008
First submitted
12 Aug 2008
Last updated
7 Aug 2009
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 18582523

  • Hampson 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 18618064

  • Wright 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

  • Talaat KR, Karron RA, Luke CJ, Thumar B, McMahon BA, Chen GL, Lamirande EW, Jin H, Coelingh KL, Kemble G, Subbarao K. An open label Phase I trial of a live attenuated H6N1 influenza virus vaccine in healthy adults. Vaccine. 2011 Apr 12;29(17):3144-8. doi: 10.1016/j.vaccine.2011.02.043. Epub 2011 Mar 4.

    PubMed 21377509

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing H6N1 Teal HK 97/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 4 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 7 Aug 2009. 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 NCT00734175, which also lists 4 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 7 Aug 2009.

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