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| ID | Type | Description | Link |
|---|---|---|---|
| EU PANFLUVAC 44115 |
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| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
| European Commission | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 30µg HA vaccine Intramuscularly administered |
|
| 2 | Active Comparator | 1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered |
|
| 3 | Active Comparator | 7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered |
|
| 4 | Active Comparator | 30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine | Biological | Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | three months |
| Adverse Events | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haakon Sjursen, MD | Haukeland Univeristy Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland Univeristy Hospital | Bergen | N-5021 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22551811 | Result | 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. | |
| 21864624 | Result | 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. |
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Haelthy person were randomly assigned to one of 4 vaccine groups
Haukeland University hospital recrutiment in 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | 30µg HA Vaccine | 30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 |
| FG001 | 1.5µg HA Adjuvanted | 1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 |
| FG002 | 7.5µg HA Adjuvanted | 7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 |
| FG003 | 30µg HA Adjuvanted | 30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Healthy adults willing to join phase I trial
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| ID | Title | Description |
|---|---|---|
| BG000 | 30µg HA Vaccine | 30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 |
| BG001 | 1.5µg HA Adjuvanted |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | three months |
|
AE were solicited for 42 days after vaccination
Each participant received an AE form which was returned to the clinic 21 days after each vaccination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 30µg HA Vaccine | 30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| local or systemic reactions | Infections and infestations | Non-systematic Assessment | Local: redness, local itching, oedema/local swelling, pain at the injection site, ecchymosis, hardness/induration; Systemic: fever, malaise, shivering/chills, fatigue, headache, sweating, myalgia, arthralgia, respiratory symptoms and diarrhoea. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Rebecca Jane Cox | University of Bergen | +4755974668 | rebecca.cox@uib.no |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 25424948 | Result | 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. |
| 24950357 | Result | 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. |
| 26147369 | Result | 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. |
| 25210189 | Result | 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. |
1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
| BG002 | 7.5µg HA Adjuvanted | 7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 |
| BG003 | 30µg HA Adjuvanted | 30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 7.5µg HA Adjuvanted | 7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 |
| OG003 | 30µg HA Adjuvanted | 30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 |
|
|
| Primary | Adverse Events | Posted | Number | participants | 42 days |
|
|
|
| Secondary | 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). | Posted | Number | participants | one year |
|
|
|
| 0 |
| 15 |
| 8 |
| 15 |
| EG001 | 1.5µg HA Adjuvanted | 1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 | 0 | 15 | 13 | 15 |
| EG002 | 7.5µg HA Adjuvanted | 7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 | 0 | 15 | 12 | 15 |
| EG003 | 30µg HA Adjuvanted | 30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14 | 0 | 15 | 13 | 15 |
|
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| D012140 | Respiratory Tract Diseases |