NCT00347672

Brief Summary

Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and other parts of the world. The need for a vaccine to prevent the spread of AI among livestock and to humans is sorely needed. The purpose of this study is to test the safety of and immune response to a new AI vaccine in healthy adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 21, 2008

Status Verified

January 1, 2008

Enrollment Period

1.1 years

First QC Date

July 3, 2006

Last Update Submit

January 18, 2008

Conditions

InfluenzaVirus Diseases

Keywords

Bird Flu

Outcome Measures

Primary Outcomes (2)

  • Frequency of vaccine-related reactogenicity events

    During the acute monitoring phase of the study

  • Anti-H5N1 antibody levels and seroconversion, defined as a greater than fourfold rise in serum hemagglutination inhibiting (HI) and/or neutralizing antibody titer compared to Day 0

    Throughout study

Secondary Outcomes (6)

  • To determine the number of vaccinees infected with the H5N1 VN 2004/AA ca recombinant vaccine candidate

    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

    At study completion

  • To determine the phenotypic stability of vaccine virus shed

    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

    Throughout study

  • To evaluate T-cell mediated and innate immune responses against the H5N1 VN 2004/AA ca recombinant vaccine candidate

    Throughout study

  • +1 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

Two vaccinations of H5N1 VN 2004/AA vaccine at the highest dose

Biological: H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca)

2

EXPERIMENTAL

One vaccination of H5N1 VN 2004/AA vaccine at a dose in-between the lowest and highest doses

Biological: H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca)

3

EXPERIMENTAL

One vaccination of H5N1 VN 2004/AA vaccine at the lowest dose

Biological: H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca)

Interventions

H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca)BIOLOGICAL

Live, attenuated recombinant H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca) vaccine (one of three doses)

123

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • Medical, work-related, or family problems as a result of alcohol or illicit drug use in the 12 months prior to study entry
  • History of severe allergic reaction or anaphylaxis
  • Current asthma or reactive airway disease
  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Baltimore, Maryland, 21205, United States

Location

Related Publications (6)

  • Ferguson NM, Cummings DA, Cauchemez S, Fraser C, Riley S, Meeyai A, Iamsirithaworn S, Burke DS. Strategies for containing an emerging influenza pandemic in Southeast Asia. Nature. 2005 Sep 8;437(7056):209-14. doi: 10.1038/nature04017. Epub 2005 Aug 3.

    PMID: 16079797BACKGROUND

  • Joseph T, Subbarao K. Human infections with avian influenza viruses. Md Med. 2005 Winter;6(1):30-2.

    PMID: 15869106BACKGROUND

  • Sims LD, Domenech J, Benigno C, Kahn S, Kamata A, Lubroth J, Martin V, Roeder P. Origin and evolution of highly pathogenic H5N1 avian influenza in Asia. Vet Rec. 2005 Aug 6;157(6):159-64. doi: 10.1136/vr.157.6.159.

    PMID: 16085721BACKGROUND

  • Stephenson 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.

    PMID: 15288823BACKGROUND

  • Webby RJ, Perez DR, Coleman JS, Guan Y, Knight JH, Govorkova EA, McClain-Moss LR, Peiris JS, Rehg JE, Tuomanen EI, Webster RG. Responsiveness to a pandemic alert: use of reverse genetics for rapid development of influenza vaccines. Lancet. 2004 Apr 3;363(9415):1099-103. doi: 10.1016/S0140-6736(04)15892-3.

    PMID: 15064027BACKGROUND

  • 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.

    PMID: 19540952DERIVED

MeSH Terms

Conditions

Influenza, HumanVirus DiseasesInfluenza in Birds

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsRespiratory Tract DiseasesBird DiseasesAnimal Diseases

Study Officials

  • Ruth A. Karron, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

June 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

January 21, 2008

Record last verified: 2008-01

Locations

US(1)