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Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501)

Primary Purpose

Influenza

Status

Completed

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

H5N1 influenza vaccine (whole virion, Vero cell-derived), 7.5 µg HA antigen, non-adjuvanted

About this trial

This is an interventional prevention trial for Influenza focused on measuring Pandemic influenza

Eligibility Criteria

18 Years - 46 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects who participated in Study 810501 will be eligible for participation in the study if they:

Completed the Day 42 visit in study 810501
Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
Are clinically healthy, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination
Agree to keep a daily record of symptoms for the duration of the study
If female and capable of bearing children, have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

Have a history of vaccination with an H5N1 influenza virus since the second vaccination in study 810501
Have had an allergic reaction to one of the components of the vaccine since the second vaccination in Study 810501
Have been diagnosed with a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, renal or metabolic disorder since the second vaccination in Study 810501
Are unable to lead an independent life as a result of either physical or mental handicap
Suffer from any kind of immunodeficiency since the second vaccination in Study 810501
Suffer from a disease or were undergoing a treatment within 30 days prior to the scheduled booster vaccination or are currently undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
Have had severe allergic reactions or anaphylaxis since the second vaccination in Study 810501
Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
Have undergone systemic corticoid therapy within 30 days prior to study entry
Have a functional or surgical asplenia
Have a known or suspected problem with alcohol or drug abuse
Were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator If female, are pregnant or lactating

Sites / Locations

University Hospital, Department of Clinical Pharmacology, General Hospital Vienna

Outcomes

Primary Outcome Measures

Number of subjects with antibody response to the vaccine strain (A/Indonesia/05/2005) associated with protection 21 days after the booster vaccination (HI antibody titer >= 1:40 or MN titer >= 1:20)

Secondary Outcome Measures

Full Information

NCT ID

NCT00530660

First Posted

September 14, 2007

Last Updated

October 7, 2015

Sponsor

Ology Bioservices

1. Study Identification

Unique Protocol Identification Number

NCT00530660

Brief Title

Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501)

Official Title

An Open-label Phase II Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Heterologous Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Healthy Young Adult Population (Follow Up to Study 810501)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ology Bioservices

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this Phase II follow-up study (to study 810501) is to assess the immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza vaccine administered 12 to 17 months after a two-dose regimen of different doses of an adjuvanted or non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. A data safety monitoring board will review the safety data after the booster vaccination. The H5N1 influenza antibody persistence 180 days after the booster vaccination will also be assessed.

6. Conditions and Keywords

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

Influenza

Keywords

Pandemic influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

141 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

H5N1 influenza vaccine (whole virion, Vero cell-derived), 7.5 µg HA antigen, non-adjuvanted

Intervention Description

All subjects who have completed the Day 42 visit at the Austrian study site in Study 810501 will be invited to receive a booster vaccination, 12 to 17 months after the first vaccination with the A/Vietnam/1203/2004 influenza vaccine administered in Study 810501, with a heterologous whole virion, Vero cell-derived influenza vaccine containing 7.5 mg A/H5N1/Indonesia/05/2005 hemagglutinin (HA) antigen in a non-adjuvanted formulation.

Primary Outcome Measure Information:

Title

Number of subjects with antibody response to the vaccine strain (A/Indonesia/05/2005) associated with protection 21 days after the booster vaccination (HI antibody titer >= 1:40 or MN titer >= 1:20)

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

46 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who participated in Study 810501 will be eligible for participation in the study if they: Completed the Day 42 visit in study 810501 Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry Are clinically healthy, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination Agree to keep a daily record of symptoms for the duration of the study If female and capable of bearing children, have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study Exclusion Criteria: Have a history of vaccination with an H5N1 influenza virus since the second vaccination in study 810501 Have had an allergic reaction to one of the components of the vaccine since the second vaccination in Study 810501 Have been diagnosed with a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, renal or metabolic disorder since the second vaccination in Study 810501 Are unable to lead an independent life as a result of either physical or mental handicap Suffer from any kind of immunodeficiency since the second vaccination in Study 810501 Suffer from a disease or were undergoing a treatment within 30 days prior to the scheduled booster vaccination or are currently undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs Have had severe allergic reactions or anaphylaxis since the second vaccination in Study 810501 Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating Have undergone systemic corticoid therapy within 30 days prior to study entry Have a functional or surgical asplenia Have a known or suspected problem with alcohol or drug abuse Were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator If female, are pregnant or lactating

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baxter BioScience Investigator

Organizational Affiliation

Baxter Healthcare Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital, Department of Clinical Pharmacology, General Hospital Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

19712040

Citation

Ehrlich HJ, Muller M, Fritsch S, Zeitlinger M, Berezuk G, Low-Baselli A, van der Velden MV, Pollabauer EM, Maritsch F, Pavlova BG, Tambyah PA, Oh HM, Montomoli E, Kistner O, Noel Barrett P. A cell culture (Vero)-derived H5N1 whole-virus vaccine induces cross-reactive memory responses. J Infect Dis. 2009 Oct 1;200(7):1113-8. doi: 10.1086/605608.

Results Reference

derived

Learn more about this trial

Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501)

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