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Completed

NCT Number: NCT00868218

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.

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Key information

Conditions

Influenza Healthy Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Haukeland Univeristy Hospital

Bergen, N-5021, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

influenza vaccine

Biological

Influenza virus strain:

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

Primary outcomes

  1. 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.

  2. Adverse Events

    Time frame: 42 days

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Rebecca Cox

Other

Collaborators

  • European Commission
  • Haukeland University Hospital

Registry information

Official study title

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

Acronym: PANFLUVAC

Important dates

Study start
2009
Primary completion
2010
Study completion
2013
First posted
Mar 24, 2009
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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