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

NCT00488046 | Completed Phase 1

• 1 other identifier: CIR 239
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza; Virus Diseases

Keywords

Bird Flu

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (1)

• Immunogenicity, determined by anti-H5N1 antibody titer

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

Study Arms (1)

1

EXPERIMENTAL

Two, 0.5 ml doses of vaccine in nasal spray form administered at study entry and sometime between 4 and 8 weeks after initial vaccination

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

Interventions

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

Intranasal vaccine

1

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

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

Baltimore, Maryland, 21205, United States

Location

Related Publications (6)

• 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.

  PMID: 17541633 BACKGROUND

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

  PMID: 17519856 BACKGROUND

• 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.

  PMID: 14987888 BACKGROUND

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

  PMID: 17458770 BACKGROUND

• 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.

  PMID: 15668219 BACKGROUND

• 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: 19540952 DERIVED

Related Links

• Click here for the Johns Hopkins Bloomberg School of Public Health - Center for Immunization Research (CIR) Web site

MeSH Terms

Conditions

Influenza, Human; Virus Diseases; Influenza in Birds

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases; Bird Diseases; Animal Diseases

Study Officials

• Ruth A. Karron, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 19, 2007
• Study Start: June 1, 2007
• Study Completion: September 1, 2007
• Last Updated: November 20, 2007

Record last verified: 2007-11

Locations

US (1)