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An open-label pilot study on the effects of trivalent inactivated influenza vaccination (InfluvacŪ) in patients with hypo- and dysgammaglobulinemia.


- candidate number2239
- NTR NumberNTR767
- ISRCTNISRCTN31814323
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR8-sep-2006
- Secondary IDsN/A 
- Public TitleAn open-label pilot study on the effects of trivalent inactivated influenza vaccination (InfluvacŪ) in patients with hypo- and dysgammaglobulinemia.
- Scientific TitleAn open-label pilot study on the effects of trivalent inactivated influenza vaccination (InfluvacŪ) in patients with hypo- and dysgammaglobulinemia.
- ACRONYMVIPID
- hypothesisPatients with hypo- or dysgammaglobulinemia have comparable cellular immun respons to influenza vaccin as matched healthy volunteers.
- Healt Condition(s) or Problem(s) studiedDysgammaglobulinemia
- Inclusion criteria1. Patients have to fulfil the diagnostic criteria for primary immunodeficiency as defined by the Pan-American Group for Immunodeficiency and the European Society for immunodeficiencies;
2. Informed consent.
- Exclusion criteria1. Age under 18 years;
2. Current infection, defined as fever in combination with clinical focal signs of infection and the need for therapeutic antibiotic treatment;
3. Pregnancy;
4. Malignancy;
5. Continuous use of immunosuppressive drugs;
6. Known allergy to any substance of InfluvacŪ.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-okt-2006
- planned closingdate30-jun-2007
- Target number of participants100
- InterventionsVaccination with trivalent inactivated influenza vaccin (InfluvacŪ).
- Primary outcomeCellular immune responses.
- Secondary outcome1. Humoral immune responses;
2. Side effects.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES S. Assen, van
- CONTACT for SCIENTIFIC QUERIES S. Assen, van
- Sponsor/Initiator University Medical Center Groningen (UMCG), department of Internal medicine
- Funding
(Source(s) of Monetary or Material Support)
under construction
- PublicationsN/A
- Brief summaryHypo- or dysgammaglobulinemia, caused by several primary immunodeficiency syndromes, usually leads to recurrent infections. Vaccination to prevent these infections in general does not result in an adequate generation of protective antibodies in this category of patients. However, for prevention of influenza virus infection, besides protective antibodies T-cell responses have been shown to prevent this infection or to reduce the severity of influenza virus infection.
Although in a number of the primary immunodeficiency syndromes causing hypo- or dysgammaglobulinemia B-cell dysfunction may accompanied by reduced T-cell responses, and treatment with intravenous immunoglobulins alters cellular immunity, no studies have been performed on vaccination against influenza with the currently used subunit vaccines in this category of patients.
In this context, of patients unable to produce protective antibodies, but possibly capable of eliciting protective T-cell responses to influenza virus, we designed a study protocol to determine the cellular immune response following influenza vaccination in patients with hypo- or dysgammaglobulinemia and to determine the usefulness of administering influenza vaccine to this category of patients.
Humoral and T-cell responses will be determined by several proven methods in patients with hypo- or dysgammaglobulinemia at three time points following vaccination with influenza virus subunit vaccine for the season 2006-2007, and compared with the responses measured in healthy controls. A number of 50 patients and 50 matched healthy controls will be included. Patients will be stratified according to the treatment with intravenous immunoglobulins. The two questions to be answered are:
1. Is vaccination with trivalent inactivated influenza vaccine in hypo- and dysgammaglobulinemic patients useful; elicit these patients adequate T-cell responses after influenza vaccination?
2. Is the cellular response dependent on IVIG substitution therapy?
- Main changes (audit trail)
- RECORD8-sep-2006 - 1-dec-2009


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