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

Primary Purpose

Influenza, Healthy

Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Influenza vaccine
Sponsored by
Rebecca Cox
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Influenza focused on measuring Influenza A, pandemic, vaccine, immunogenicity, Virus, H5N1

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Haukeland Univeristy Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

30µg HA vaccine Intramuscularly administered

1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered

7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered

30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered

Outcomes

Primary Outcome Measures

Solicted Adverse Events
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

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2009
Last Updated
November 1, 2019
Sponsor
Rebecca Cox
Collaborators
Haukeland University Hospital, European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT00868218
Brief Title
Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults
Acronym
PANFLUVAC
Official Title
Preparing for an Influenza Pandemic: A Phase I Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rebecca Cox
Collaborators
Haukeland University Hospital, European Commission

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Healthy
Keywords
Influenza A, pandemic, vaccine, immunogenicity, Virus, H5N1

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
30µg HA vaccine Intramuscularly administered
Arm Title
2
Arm Type
Active Comparator
Arm Description
1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Arm Title
3
Arm Type
Active Comparator
Arm Description
7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Arm Title
4
Arm Type
Active Comparator
Arm Description
30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine
Intervention Description
Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
Primary Outcome Measure Information:
Title
Solicted Adverse Events
Description
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
Title
Adverse Events
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Immunogenicity of a Non-adjuvanted and 3rd Generation ISCOM™ Adjuvanted Virosomal H5N1 Influenza Vaccine
Description
Number of participants with haemagglutination inhibition tigers >= 32 at the long term time point (1 year post vaccination).
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haakon Sjursen, MD
Organizational Affiliation
Haukeland Univeristy Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland Univeristy Hospital
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22551811
Citation
Pedersen GK, Madhun AS, Breakwell L, Hoschler K, Sjursen H, Pathirana RD, Goudsmit J, Cox RJ. T-helper 1 cells elicited by H5N1 vaccination predict seroprotection. J Infect Dis. 2012 Jul 15;206(2):158-66. doi: 10.1093/infdis/jis330. Epub 2012 May 2.
Results Reference
result
PubMed Identifier
21864624
Citation
Cox RJ, Pedersen G, Madhun AS, Svindland S, Saevik M, Breakwell L, Hoschler K, Willemsen M, Campitelli L, Nostbakken JK, Weverling GJ, Klap J, McCullough KC, Zambon M, Kompier R, Sjursen H. Evaluation of a virosomal H5N1 vaccine formulated with Matrix M adjuvant in a phase I clinical trial. Vaccine. 2011 Oct 19;29(45):8049-59. doi: 10.1016/j.vaccine.2011.08.042. Epub 2011 Aug 22.
Results Reference
result
PubMed Identifier
25424948
Citation
Pedersen GK, Sjursen H, Nostbakken JK, Jul-Larsen A, Hoschler K, Cox RJ. Matrix M(TM) adjuvanted virosomal H5N1 vaccine induces balanced Th1/Th2 CD4(+) T cell responses in man. Hum Vaccin Immunother. 2014;10(8):2408-16. doi: 10.4161/hv.29583.
Results Reference
result
PubMed Identifier
24950357
Citation
Pedersen GK, Hoschler K, Oie Solbak SM, Bredholt G, Pathirana RD, Afsar A, Breakwell L, Nostbakken JK, Raae AJ, Brokstad KA, Sjursen H, Zambon M, Cox RJ. Serum IgG titres, but not avidity, correlates with neutralizing antibody response after H5N1 vaccination. Vaccine. 2014 Jul 31;32(35):4550-4557. doi: 10.1016/j.vaccine.2014.06.009. Epub 2014 Jun 18.
Results Reference
result
PubMed Identifier
26147369
Citation
Cox RJ, Major D, Pedersen G, Pathirana RD, Hoschler K, Guilfoyle K, Roseby S, Bredholt G, Assmus J, Breakwell L, Campitelli L, Sjursen H. Matrix M H5N1 Vaccine Induces Cross-H5 Clade Humoral Immune Responses in a Randomized Clinical Trial and Provides Protection from Highly Pathogenic Influenza Challenge in Ferrets. PLoS One. 2015 Jul 6;10(7):e0131652. doi: 10.1371/journal.pone.0131652. eCollection 2015.
Results Reference
result
PubMed Identifier
25210189
Citation
Nachbagauer R, Wohlbold TJ, Hirsh A, Hai R, Sjursen H, Palese P, Cox RJ, Krammer F. Induction of broadly reactive anti-hemagglutinin stalk antibodies by an H5N1 vaccine in humans. J Virol. 2014 Nov;88(22):13260-8. doi: 10.1128/JVI.02133-14. Epub 2014 Sep 10.
Results Reference
result

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Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults

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