Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

Healthy Clinical Trial

— H1N1VAC  

Official title:

Safety and Immunogenicity Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003288
• Other study ID #: H1N1VAC-2009, Version 1
• Secondary ID: 2009-016456-43
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: December 2014

Study information

• Verified date: November 2019
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The investigators will conduct a safety and immunogenicity study in health employees as detailed below:

• Examine adverse events of all employees after vaccination using adverse events form

• Examine the immunogenicity of the vaccine by collecting blood samples at days 0, 21 & 42 after vaccination (up to 500 people)

• Provide a detailed time course of the immune response to vaccination with a novel influenza H1N1 virus including the kinetics of the T-cell, B-cell and antibody responses in 50 volunteers

• Investigate the long lasting immunity induced by the vaccine

• Examine the ability of the vaccine to induce cross-reactive immunity to H1N1 strains.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: December 2014
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Adjuvanted influenza H1N1split virion vaccine
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)

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (9)

Eidem S, Tete SM, Jul-Larsen Å, 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 — View Citation

Jul-Larsen Å, 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. — View Citation

Lartey S, Pathirana RD, Zhou F, Jul-Larsen Å, 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 s — View Citation

Madhun AS, Akselsen PE, Sjursen H, Pedersen G, Svindland S, Nøstbakken 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. Vacc — View Citation

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 201 — View Citation

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 — View Citation

Trieu MC, Jul-Larsen Å, Sævik M, Madsen A, Nøstbakken 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 — View Citation

Trieu MC, Zhou F, Lartey S, Jul-Larsen Å, 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. — View Citation

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/s4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay	Antibody responses were measured using the HI assay to evaluate the rapidity and long term duration of the response	7, 14, 21 days post vaccination and long term follow up for 5 years