This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
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: October 19, 2016
Last verified: October 2016
  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
Intervention Model: Factorial Assignment
Masking: None (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:


Further study details as provided by Rebecca Cox, University of Bergen:

Primary Outcome Measures:
  • 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.

  • Adverse Events [ Time Frame: 42 days ]

Secondary Outcome Measures:
  • 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).


Enrollment: 60
Study Start Date: March 2009
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 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


  Eligibility

Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: June 6, 2015
Last Updated: October 19, 2016

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

Additional relevant MeSH terms:
Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017