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

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) Center for Immunization Research (CIR)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00488046

Purpose

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.

Condition	Intervention	Phase
Influenza Virus Diseases	Biological: H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca)	Phase I

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety 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

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Safety, defined as the frequency of vaccine-related reactogenicity events [ Time Frame: During the acute monitoring (in-patient) phase of the study ]

Secondary Outcome Measures:

Immunogenicity, determined by anti-H5N1 antibody titer [ Time Frame: At Days 0, 7, 9, and 28 with respect to vaccination ]

Enrollment:	16
Study Start Date:	June 2007
Study Completion Date:	September 2007

Arms	Assigned Interventions
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) Intranasal vaccine

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.

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488046

Locations

United States, Maryland
Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Center for Immunization Research (CIR)

Investigators

Principal Investigator:

Ruth A. Karron, MD

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

More Information

Additional Information:

Click here for the Johns Hopkins Bloomberg School of Public Health - Center for Immunization Research (CIR) Web site This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Cinatl Jr J, Michaelis M, Doerr HW. The threat of avian influenza A (H5N1). Part IV: development of vaccines. Med Microbiol Immunol. 2007 Jun 1; [Epub ahead of print]

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

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.

Rajagopal S, Treanor J. Pandemic (avian) influenza. Semin Respir Crit Care Med. 2007 Apr;28(2):159-70. Review.

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. Epub 2005 Jan 24.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2009 Jun 21.

Study ID Numbers:	CIR 239
Study First Received:	June 18, 2007
Last Updated:	November 19, 2007
ClinicalTrials.gov Identifier:	NCT00488046 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Bird Flu

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human

Influenza in Birds
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on September 01, 2009