Vaccination Response in ImmunoCompromised Host. Immune Response After Vaccination Against Pandemic A/H1N1 Influenza

NCT01066169 | Completed DMC

• 1 other identifier: P09.187
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

As recommended by the Dutch Health Council, certain risk groups and health care workers in The Netherlands were vaccinated to prevent morbidity due to pandemic influenza A/H1N1. Adults were vaccinated twice with the monovalent influenza A/California/2009(H1N1) MF59-adjuvanted surface-antigen vaccine Focetria® (Novartis). The vaccination campaign was executed by general practitioners. The aim of the study is to verify whether HIV-infected individuals generate an adequate immune response after the first and after the second vaccination.

Conditions

HIV

Keywords

Pandemic Influenza A/H1N1; HIV; Antibodies; Replicaton

Outcome Measures

Primary Outcomes (1)

• Antibody titer after second vaccination

  day 55-60

Secondary Outcomes (3)

• Antibody titer after second vaccination

  day 17-20

• Antibody titer shortly after first vaccination (day 5-7)

  day 5-7

• HIV replication after vaccination

  day 5-7

Study Arms (2)

Healthy volunteers

Healthy subjects without HIV, vaccinated with Pandemic Influenza A/H1N1

Biological: Foceteria® (Novartis)

HIV-infected patients

HIV-infected patients, vaccinated with Pandemic Influenza A/H1N1

Biological: Foceteria® (Novartis)

Interventions

Foceteria® (Novartis) BIOLOGICAL

This is not an interventional study. In this observational study we monitored the immune response in a cohort of people who were vaccinated during the national vaccination campaign. The vaccine that was used in The Netherlands is the monovalent influenza A/California/2009(H1N1) MF59-adjuvanted surface-antigen vaccine. It contains 7,5 µg hemagglutinine and the MF59C.1 adjuvant, which is an oil-in-water emulsion, composed of Squalene 9.75 mg, Polysorbate 80 1.175 mg and Sorbitan trioleate 1.175 mg. This vaccine has been approved for use according to a two dose schedule.

HIV-infected patients; Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV patients at the department 'Infectious Diseases' of the Leiden University Medical Centre and healthy volunteers (hospital employees of the Leiden University Medical Centre)

You may qualify if:

• Above 18 years of age
• Stable antiretroviral regimen or not yet in need of treatment (in case of HIV-infected patients)

You may not qualify if:

• Use of systemic immunosuppressive medication
• An ongoing infection
• Recent flu-like symptoms and pregnancy

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Erasmus Medical Center: collaborator

Study Sites (1)

Leiden University Medical Centre

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (1)

• Soonawala D, Rimmelzwaan GF, Gelinck LB, Visser LG, Kroon FP. Response to 2009 pandemic influenza A (H1N1) vaccine in HIV-infected patients and the influence of prior seasonal influenza vaccination. PLoS One. 2011 Jan 31;6(1):e16496. doi: 10.1371/journal.pone.0016496.

  PMID: 21304982 DERIVED

Related Links

• Publication of results

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Plasma, Peripheral blood mononuclear cells

MeSH Terms

Interventions

lactitol

Study Officials

• Frank P Kroon, MD PhD

  Leiden University Medical Centre

  PRINCIPAL INVESTIGATOR

• Leo G Visser, MD PhD

  Leiden University Medical Centre

  STUDY CHAIR

• Luc BS Gelinck, MD

  Leiden University Medical Centre

  STUDY CHAIR

• A F Rimmelzwaan, Prof PhD

  Leiden University Medical Centre

  STUDY CHAIR

• Darius Soonawala, MD

  Leiden University Medical Centre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: November 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: January 30, 2012

Record last verified: 2010-02

Locations

NL (1)