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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Haukeland University Hospital
European Commission
Information provided by (Responsible Party):
Rebecca Cox, University of Bergen
ClinicalTrials.gov Identifier:
NCT00868218
First received: March 23, 2009
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza
Healthy
 Biological: Influenza vaccine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Preparing for an Influenza Pandemic: A Phase I Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu
U.S. FDA Resources

Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • 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. [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary endpoints are the evaluation of the immunogenicity of a non-adjuvanted and 3rd generation ISCOM™ adjuvanted virosomal H5N1 influenza vaccine and the ability of the vaccine to meet the CHMP evaluation criteria. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: November 2013
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
30µg HA IM
 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™ IM
 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™ IM
 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™ IM
 Biological: Influenza vaccine

Influenza virus strain:

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

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868218

Locations
Norway
Haukeland Univeristy Hospital
Bergen, Norway, N-5021
Sponsors and Collaborators
Rebecca Cox
Haukeland University Hospital
European Commission
Investigators
Study Director: Haakon Sjursen, MD Haukeland Univeristy Hospital
  More Information

Publications:

Responsible Party: Rebecca Cox, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT00868218     History of Changes
Other Study ID Numbers: PANFLUVAC-2008, Version 2, EU PANFLUVAC 44115
Study First Received: March 23, 2009
Last Updated: June 12, 2012
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University of Bergen:
Influenza A
pandemic
vaccine
 immunogenicity
Virus
H5N1

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013