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

Primary Purpose

Influenza, Virus Diseases

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for Influenza focused on measuring Bird Flu

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Immunogenicity, determined by anti-H5N1 antibody titer

Full Information

NCT ID

NCT00488046

First Posted

June 18, 2007

Last Updated

November 19, 2007

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Johns Hopkins Bloomberg School of Public Health

1. Study Identification

Unique Protocol Identification Number

NCT00488046

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Johns Hopkins Bloomberg School of Public Health

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Virus Diseases

Keywords

Bird Flu

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

Intranasal vaccine

Primary Outcome Measure Information:

Title

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Immunogenicity, determined by anti-H5N1 antibody titer

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ruth A. Karron, MD

Organizational Affiliation

Johns Hopkins Bloomberg School of Public Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17541633

Citation

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.

Results Reference

background

PubMed Identifier

17519856

Citation

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

Results Reference

background

PubMed Identifier

14987888

Citation

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.

Results Reference

background

PubMed Identifier

17458770

Citation

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

Results Reference

background

PubMed Identifier

15668219

Citation

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.

Results Reference

background

PubMed Identifier

19540952

Citation

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.

Results Reference

derived

Links:

URL

http://www.jhsph.edu/cir

Description

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

Learn more about this trial

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

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