|- candidate number||2239|
|- NTR Number||NTR767|
|- Date ISRCTN created||28-dec-2006|
|- date ISRCTN requested||18-dec-2006|
|- Date Registered NTR||8-sep-2006|
|- Secondary IDs||N/A |
|- Public Title||An open-label pilot study on the effects of trivalent inactivated influenza vaccination (InfluvacŪ) in patients with hypo- and dysgammaglobulinemia. |
|- Scientific Title||An open-label pilot study on the effects of trivalent inactivated influenza vaccination (InfluvacŪ) in patients with hypo- and dysgammaglobulinemia.|
|- hypothesis||Patients with hypo- or dysgammaglobulinemia have comparable cellular immun respons to influenza vaccin as matched healthy volunteers.|
|- Healt Condition(s) or Problem(s) studied||Dysgammaglobulinemia|
|- Inclusion criteria||1. 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 criteria||1. 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;
5. Continuous use of immunosuppressive drugs;
6. Known allergy to any substance of InfluvacŪ.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-okt-2006|
|- planned closingdate||30-jun-2007|
|- Target number of participants||100|
|- Interventions||Vaccination with trivalent inactivated influenza vaccin (InfluvacŪ).|
|- Primary outcome||Cellular immune responses. |
|- Secondary outcome||1. Humoral immune responses;|
2. Side effects.
|- Trial web site||N/A|
|- status||inclusion 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|
(Source(s) of Monetary or Material Support)
|- Brief summary||Hypo- 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)|
|- RECORD||8-sep-2006 - 1-dec-2009|