Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults (PANFLUVAC)

November 1, 2019 updated by: Rebecca Cox

Preparing for an Influenza Pandemic: A Phase I Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults

The safety and tolerability of the pandemic A/H5N1 virosomal vaccine formulated with or without the 3rd generation ISCOM™ adjuvant for parenteral administration will be investigated locally and systemically and by using haematological, biochemical and immunological screening tests. The immunogenicity of the H5N1 vaccine will be assessed through the induction of local and systemic antibody and cellular immune responses. In a pandemic situation, an important aspect is the rapidity of the immune response to the H5N1 vaccine so the detailed kinetics of the immune response will be investigated. The capacity of the vaccine to elicit long lasting immunity and cross reactive immunity to H5 viruses will also be evaluated. Furthermore, the quality of the immune response induced by the vaccine will be studied. The vaccine will be administered as twice the normal human dose (30μg HA) with and without adjuvant, and in a dose sparing manor of half (7.5μg HA) and one tenth (1.5μg HA) of the normal human dose with adjuvant. Sixty subjects will receive two doses of virosomal H5N1 influenza vaccine (separated by 21 ± 4 days) by intramuscular injection into the deltoid muscle. Escalating doses will be separated by a period of one week. Four groups each containing 15 subjects will receive two doses of the pandemic virosomal A/H5N1 influenza vaccine containing:

Group 1 30µg HA IM, Group 2 1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM, Group 3 7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM, Group 4 30µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, N-5021
        • Haukeland Univeristy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers (as concluded from the medical history, physical examination, and clinical judgment) aged 19 to 50 years old
  • Females using a reliable method of contraception (from 4 weeks prior to the first vaccination until 4 weeks after the second vaccination) and a negative urine pregnancy test will be required before administration of each dose of vaccine
  • Signed informed consent
  • Subjects able to understand and comply with the study protocol and complete the Adverse Event Form
  • Subjects able to attend the scheduled visits
  • Subjects with normal pre-screening values. If a subjects prescreening samples lie outside the reference values he/she will only be included in the study based upon the medical evaluation of the clinical investigator

Exclusion Criteria:

  • Persons with a history of anaphylaxis or serious reactions to any vaccine
  • Persons with known hypersensitivity to any of the vaccine components
  • Persons who have had a temperature >38oC during the previous 72 hours
  • Persons who have had an acute respiratory infection during the last 7 days
  • Women who are pregnant or breast-feeding
  • Persons with chronic illness at any stage that could interfere with trial conduct or compliance
  • Persons who have received blood products or immunoglobulins parenterally during the previous 3 months
  • Persons who have been vaccinated with any vaccine during the 4 weeks preceding the first trial vaccination
  • Persons with known or suspected immunosuppressive disease or who use systemic immunosuppressive drugs
  • Persons taking immunostimulant therapy
  • Persons involved in another clinical trial during the last month.
  • Suspected non-compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
30µg HA vaccine Intramuscularly administered
Biological: Influenza vaccine

Influenza virus strain:

avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
Active Comparator: 2
1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Biological: Influenza vaccine

Influenza virus strain:

avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
Active Comparator: 3
7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Biological: Influenza vaccine

Influenza virus strain:

avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
Active Comparator: 4
30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Biological: Influenza vaccine

Influenza virus strain:

avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Solicted Adverse Events
Time Frame: three months
The primary endpoints of the trial are the local and systemic adverse events and tolerability of parenterally administered virosomal H5N1 influenza vaccine with or without 3rd generation ISCOM™ adjuvant.
three months
Adverse Events
Time Frame: 42 days
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of a Non-adjuvanted and 3rd Generation ISCOM™ Adjuvanted Virosomal H5N1 Influenza Vaccine
Time Frame: one year
Number of participants with haemagglutination inhibition tigers >= 32 at the long term time point (1 year post vaccination).
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rebecca Cox

Collaborators

Haukeland University Hospital
European Commission

Investigators

  • Study Director: Haakon Sjursen, MD, Haukeland Univeristy Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 23, 2009

First Posted (Estimate)

March 24, 2009

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANFLUVAC-2008, Version 2
  • EU PANFLUVAC 44115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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