Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

NCT01003288 | Completed Results

• 2 other identifiers: H1N1VAC-2009, Version 12009-016456-43
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

Haukeland University Hospital has approximately 8000 employees many of whom will be in the front line to receive the pandemic A/H1N1 vaccine. We propose to conduct a safety and immunogenicity study in these subjects

Conditions

Healthy

Keywords

H1N1 pandemic vaccine immunogenicity safety; Health employees

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Local and Systemic Adverse Events

  Solicited adverse events were collected on side reactions form which were filled in for 21 days after pandemic or seasonal vaccination.

  21 days after vaccination

Secondary Outcomes (1)

• Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay

  7, 14, 21 days post vaccination and long term follow up for 5 years

Study Arms (1)

Pandemic influenza H1N1 vaccine

EXPERIMENTAL

Influenza vaccine

Biological: Adjuvanted influenza H1N1split virion vaccine

Interventions

Adjuvanted influenza H1N1split virion vaccine BIOLOGICAL

Vaccination Pandemrix suspension and emulsion for emulsion for injection. 1 dose (0.5 ml) contains Split influenza virus, inactivated, containing antigen 3.75 micrograms of A/California/7/2009 (H1N1)v-like strain (X-179A) \* Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

Also known as: Pandemrix

Pandemic influenza H1N1 vaccine

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 for the kinetic study

You may not qualify if:

• Persons with a history of anaphylaxis or serious reactions to any vaccine
• Person 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
• Suspected non-compliance

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, N5021, Norway

Location

Related Publications (11)

• Madhun AS, Akselsen PE, Sjursen H, Pedersen G, Svindland S, Nostbakken JK, Nilsen M, Mohn K, Jul-Larsen A, Smith I, Major D, Wood J, Cox RJ. An adjuvanted pandemic influenza H1N1 vaccine provides early and long term protection in health care workers. Vaccine. 2010 Dec 16;29(2):266-73. doi: 10.1016/j.vaccine.2010.10.038. Epub 2010 Oct 27.

  PMID: 21034828 RESULT

• Pedersen G, Halstensen A, Sjursen H, Naess A, Kristoffersen EK, Cox RJ. Pandemic influenza vaccination elicits influenza-specific CD4+ Th1-cell responses in hypogammaglobulinaemic patients: four case reports. Scand J Immunol. 2011 Aug;74(2):210-8. doi: 10.1111/j.1365-3083.2011.02561.x.

  PMID: 21438900 RESULT

• Jul-Larsen A, Madhun AS, Brokstad KA, Montomoli E, Yusibov V, Cox RJ. The human potential of a recombinant pandemic influenza vaccine produced in tobacco plants. Hum Vaccin Immunother. 2012 May;8(5):653-61. doi: 10.4161/hv.19503. Epub 2012 May 1.

  PMID: 22634440 RESULT

• Pathirana RD, Bredholt G, Akselsen PE, Pedersen GK, Cox RJ. A(H1N1)pdm09 vaccination of health care workers: improved immune responses in low responders following revaccination. J Infect Dis. 2012 Dec 1;206(11):1660-9. doi: 10.1093/infdis/jis589. Epub 2012 Sep 11.

  PMID: 22969149 RESULT

• Lartey S, Pathirana RD, Zhou F, Jul-Larsen A, Montomoli E, Wood J, Cox RJ. Single dose vaccination of the ASO3-adjuvanted A(H1N1)pdm09 monovalent vaccine in health care workers elicits homologous and cross-reactive cellular and humoral responses to H1N1 strains. Hum Vaccin Immunother. 2015;11(7):1654-62. doi: 10.1080/21645515.2015.1048939.

  PMID: 26009966 RESULT

• Eidem S, Tete SM, Jul-Larsen A, Hoschler K, Montomoli E, Brokstad KA, Cox RJ. Persistence and avidity maturation of antibodies to A(H1N1)pdm09 in healthcare workers following repeated annual vaccinations. Vaccine. 2015 Aug 7;33(33):4146-54. doi: 10.1016/j.vaccine.2015.05.081. Epub 2015 Jun 7.

  PMID: 26057137 RESULT

• Trieu MC, Zhou F, Lartey SL, Sridhar S, Mjaaland S, Cox RJ. Augmented CD4+ T-cell and humoral responses after repeated annual influenza vaccination with the same vaccine component A/H1N1pdm09 over 5 years. NPJ Vaccines. 2018 Aug 14;3:37. doi: 10.1038/s41541-018-0069-1. eCollection 2018.

  PMID: 30131880 RESULT

• Trieu MC, Zhou F, Lartey S, Jul-Larsen A, Mjaaland S, Sridhar S, Cox RJ. Long-term Maintenance of the Influenza-Specific Cross-Reactive Memory CD4+ T-Cell Responses Following Repeated Annual Influenza Vaccination. J Infect Dis. 2017 Mar 1;215(5):740-749. doi: 10.1093/infdis/jiw619.

  PMID: 28007925 RESULT

• Trieu MC, Jul-Larsen A, Saevik M, Madsen A, Nostbakken JK, Zhou F, Skrede S, Cox RJ. Antibody Responses to Influenza A/H1N1pdm09 Virus After Pandemic and Seasonal Influenza Vaccination in Healthcare Workers: A 5-Year Follow-up Study. Clin Infect Dis. 2019 Jan 18;68(3):382-392. doi: 10.1093/cid/ciy487.

  PMID: 29893797 RESULT

• Amdam H, Madsen A, Zhou F, Bansal A, Trieu MC, Cox RJ. Functional and Binding H1N1pdm09-Specific Antibody Responses in Occasionally and Repeatedly Vaccinated Healthcare Workers: A Five-Year Study (2009-2014). Front Immunol. 2021 Dec 6;12:748281. doi: 10.3389/fimmu.2021.748281. eCollection 2021.

  PMID: 34938285 DERIVED

• Manenti A, Tete SM, Mohn KG, Jul-Larsen A, Gianchecchi E, Montomoli E, Brokstad KA, Cox RJ. Comparative analysis of influenza A(H3N2) virus hemagglutinin specific IgG subclass and IgA responses in children and adults after influenza vaccination. Vaccine. 2017 Jan 3;35(1):191-198. doi: 10.1016/j.vaccine.2016.10.024. Epub 2016 Oct 24.

  PMID: 27789145 DERIVED

MeSH Terms

Interventions

pandemrix

Results Point of Contact

• Title: Professor Rebecca Cox
• Organization: University of Bergen

rebecca.cox@uib.no

+4755974668

Study Officials

• Per Espen Akselsen, MD

  Haukeland University Hospital

  STUDY CHAIR

• Haakon Sjursen, MD PhD

  Haukeland University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 28, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: December 1, 2014
• Last Updated: November 18, 2019
• Results First Posted: August 24, 2016

Record last verified: 2019-11

Locations

NO (1)