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

Influenza Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530660
• Other study ID #: 810703
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2007
• Last updated: October 7, 2015
• Start date: September 2007
• Est. completion date: October 2008

Study information

• Verified date: December 2008
• Source: Nanotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: October 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 46 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
Austria	University Hospital, Department of Clinical Pharmacology, General Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Nanotherapeutics, Inc.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		9 months	No