AzTrials
AzTrials

InfluenzaPhase 1NCT00488046

Single Group Study of the Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults

A Phase 1 study testing H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/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.

Completed

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

Official record
Search all trials

Trial summary

Over the past decade, avian influenza (AI) has become a major health concern. The development of a safe and effective vaccine against H5N1 infection is important. The purpose of this study is to determine the safety of a new AI vaccine in healthy adults. 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?
H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Jun 2007to Sep 2007
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

  • Good general health
  • Available for the duration of the study
  • Willing to use acceptable forms of contraception for the duration of the study

Who cannot join

  • Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
  • Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may affect study participation
  • Medical, work, or family problems as a result of alcohol or illicit drug use within 12 months prior to study entry
  • Previously enrolled in an H5N1 influenza vaccine trial or in any study of an avian influenza vaccine
  • Seropositive to the H5N1 influenza A virus (serum hemagglutination inhibitor [HI] titer greater than 1:8)
  • Illegal drug use or dependency determined by urine test
Show all 29Show fewer
  • History of severe allergic reaction
  • Allergy to oseltamivir
  • Asthma or reactive airways disease within 2 years prior to study entry
  • History of Guillain-Barre syndrome
  • HIV infected
  • Hepatitis C virus infected
  • Positive for hepatitis B surface antigen (HBsAg)
  • Known immunodeficiency syndrome
  • Use of corticosteroid or immunosuppressive drugs within 30 days prior to vaccination. Participants who have used topical corticosteroids are not excluded.
  • Live vaccines within 4 weeks prior to study vaccination
  • Killed vaccines within 2 weeks prior to study vaccination
  • Absence of spleen
  • Blood products within 6 months prior to study vaccination
  • Current smoker unwilling to stop smoking for the duration of the study
  • Have traveled to the Southern Hemisphere or Asia within 14 days prior to study vaccination
  • Have traveled on a cruise ship within 14 days prior to study vaccination
  • Work in the poultry industry
  • Other investigational vaccine or drug within 30 days prior to study vaccination
  • Allergy to eggs or egg products
  • Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
  • Have family member with immunodeficiency-related condition
  • Other condition that, in the opinion of the investigator, may interfere with the study
  • Pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health

    Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: Phase I Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine Modified H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H5N1 Infection in the Event of a Pandemic

Over the past decade, avian influenza (AI) has become a major health concern. The development of a safe and effective vaccine against H5N1 infection is important. The purpose of this study is to determine the safety of a new AI vaccine in healthy adults.

Read the detailed description

According to the World Health Organization, the current pandemic risk associated with avian influenza H5N1 infection is serious, as an increasing number of humans are infected. Currently, H5N1 influenza transmission occurs in humans when they are exposed through direct contact to infected poultry or surfaces and objects contaminated by infected poultry feces. A pandemic occurs when a new influenza subtype emerges that infects humans, causes serious illness, and spreads easily among humans. The development of a safe and effective vaccine is necessary, should a pandemic occur. The purpose of this study is to evaluate the safety and immunogenicity of a live, attenuated A1 virus vaccine, H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca).

This study will last approximately 16 weeks. Participation in this study includes a hospital stay in an isolation unit at the Johns Hopkins Bayview Medical Center. All participants will receive two doses of vaccine in nasal spray form, at study entry and sometime between 4 and 8 weeks after initial vaccination. Participants will be admitted to the isolation unit 2 days prior to each vaccination. A targeted physical exam will occur daily following each vaccination until discharge. Participants will not be discharged until nasal washes are negative. Vital signs measurement will be done at least twice daily for the duration of the inpatient stay. A follow-up outpatient visit will occur approximately 4 weeks following each vaccination. Blood and urine collection will occur at selected timepoints throughout the study.

Being tested
H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/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.

  • H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca)Biological

    Intranasal vaccine

Study groups in NCT00488046
Study groupRoleWhat they receive
1ExperimentalTwo, 0.5 ml doses of vaccine in nasal spray form administered at study entry and sometime between 4 and 8 weeks after initial vaccination
Receives: Biological: H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca)

What is being measured

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

  1. Safety, defined as the frequency of vaccine-related reactogenicity events

    Measured: During the acute monitoring (in-patient) phase of the study

Secondary outcomes (1)

  1. Immunogenicity, determined by anti-H5N1 antibody titer

    Measured: At Days 0, 7, 9, and 28 with respect to vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Study completionSep 2007

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00488046
Sponsor's protocol ID
CIR 239
Status last verified
Nov 2007
First submitted
18 Jun 2007
Last updated
20 Nov 2007
Results posted
No

Publications

  • Cinatl J Jr, Michaelis M, Doerr HW. The threat of avian influenza A (H5N1). Part IV: Development of vaccines. Med Microbiol Immunol. 2007 Dec;196(4):213-25. doi: 10.1007/s00430-007-0052-3. Epub 2007 Jun 1.

    PubMed 17541633

  • Cox MM. Vaccines in development against avian influenza. Minerva Med. 2007 Apr;98(2):145-53.

    PubMed 17519856

  • Peiris JS, Yu WC, Leung CW, Cheung CY, Ng WF, Nicholls JM, Ng TK, Chan KH, Lai ST, Lim WL, Yuen KY, Guan Y. Re-emergence of fatal human influenza A subtype H5N1 disease. Lancet. 2004 Feb 21;363(9409):617-9. doi: 10.1016/S0140-6736(04)15595-5.

    PubMed 14987888

  • Rajagopal S, Treanor J. Pandemic (avian) influenza. Semin Respir Crit Care Med. 2007 Apr;28(2):159-70. doi: 10.1055/s-2007-976488.

    PubMed 17458770

  • Ungchusak K, Auewarakul P, Dowell SF, Kitphati R, Auwanit W, Puthavathana P, Uiprasertkul M, Boonnak K, Pittayawonganon C, Cox NJ, Zaki SR, Thawatsupha P, Chittaganpitch M, Khontong R, Simmerman JM, Chunsutthiwat S. Probable person-to-person transmission of avian influenza A (H5N1). N Engl J Med. 2005 Jan 27;352(4):333-40. doi: 10.1056/NEJMoa044021. Epub 2005 Jan 24.

    PubMed 15668219

  • Karron RA, Talaat K, Luke C, Callahan K, Thumar B, Dilorenzo S, McAuliffe J, Schappell E, Suguitan A, Mills K, Chen G, Lamirande E, Coelingh K, Jin H, Murphy BR, Kemble G, Subbarao K. Evaluation of two live attenuated cold-adapted H5N1 influenza virus vaccines in healthy adults. Vaccine. 2009 Aug 6;27(36):4953-60. doi: 10.1016/j.vaccine.2009.05.099. Epub 2009 Jun 21.

    PubMed 19540952

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/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 29 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 20 Nov 2007. 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?

Safety, defined as the frequency of vaccine-related reactogenicity events (time frame: During the acute monitoring (in-patient) phase of the study). 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 NCT00488046, which also lists 6 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 20 Nov 2007.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in