1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab. 2. breast and lung cancer undertreated by chemotherapy 3. HIV 4. Haematopoietic progenitor cell transplantation (TCPH). MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Orga
Conditions
Interventions
Trade Name: Fendrix suspension for injection
Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Product Name: Fendrix
Product Code: Fendrix
Pharmaceutical Form: Suspension for injection
INN or Propose
Sponsors
FUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients over 18 years of age, and diagnosed of: - Autoimmune rheumatologic diseases under treatment with Rituximab or Infliximab - Primary breast cancer or primary lung cancer - Human Immunodeficiency Virus (HIV) - Hematopoietic stem cell transplantation patients (HSCT), time since transplantation = 6 months • Negative result of markers of hepatitis B virus infection (anti-core HBV antibody, hepatitis B virus surface antigen, anti-HBV surface antigen antibody) in the last 3 months • Life expectancy exceeding 1 year • Written consent of the patient to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 740 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Hypersensitivity to the active ingredients or to any of the excipients of vaccines • Documented history of infection or previous vaccination against HBV • Infection with HIV (except in the subproject with HIV patients) • Rejection of vaccination against HBV • Difficulty of the patient to go to the study visits • Presence of any other immune disorder different than the primary diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the proportion of patients with protective levels of antibodies against HBV at 3 months after the first dose, in immunosuppressed patients, between those vaccinated with an anti-hepatitis B vaccine adjuvanted with AS04C versus those vaccinated with anti-hepatitis B vaccine with increased antigenic load.;Secondary Objective: To compare the proportion of patients with protective levels of antibodies against HBV at 3 months after the first dose, in immunosuppressed patients, between those vaccinated with an anti-hepatitis B vaccine adjuvanted with 1. To compare the proportion of patients with protective levels of antibodies against HBV at 7 and 12 months after the first dose, in immunosuppressed patients, between those vaccinated with anti-hepatitis B vaccine adjuvanted with AS04C and those vaccinated with an increased antigenic load. 2. To compare the levels of antibodies against HBV at 3, 7 and 12 months of the first dose, in immunosuppressed patients, between patients vaccinated with anti-hepatitis B vaccine adjuvanted with AS04C and those vaccinated with an increased antigenic load vaccine. 3. To describe all adverse events that could appear during research.;Primary end point(s): Main variable for vaccine response assessment (immunogenicity): Level of antibodies against HBV surface antigen (HBsAg) one month after the third dose =10UI, which will be determined by enzyme-immunoassay.;Timepoint(s) of evaluation of this end point: During the clinical trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints of immunogenicity: • Level of antibodies against HBV surface antigen at the end of the vaccination schedule, which will be determined by enzyme-immunoassay between 1 and 2 months after the last dose. • Level of antibodies against HBV surface antigen one year after the end of the vaccination schedule, which will be determined by enzyme-immunoassay (Patients will be considered responders to the vaccine when the antibody titer against HBsAg is equal to or greater than 10IU/l. In the patients who don’t respond after the last dose of vaccination the determination at 12 months won’t be performed. These non-responding patients will receive the usual clinical pattern, revaccination with a second complete series, and there would be no more follow-up from the study). Descriptive variables of subgroups: - HIV patients: • Level of CD4 lymphocytes and determination of viral load one month before the first dose, one month after the third dose, between one and two months after the last dose, and 12 months after the first dose. -HSCT patients: • Follow up to detect any evidence of Graft-Versus-Host-Disease (GVHD) • Type of transplant, autologous or allogeneic • Clinical condition that cause the transplant -Rheumatologic patients: • Main clinical condition • Date of diagnosis • Other immunosuppressive treatment (besides Rituximab or Infliximab: type of drug, start and end time) -Cancer patients: • Stage of cancer • Date of diagnosis • Histological type of cancer • Treatment (chemotherapy): start and end time;Timepoint(s) of evaluation of this end point: During the clinical trial. | — |
Countries
Spain
Contacts
Public ContactARO
FUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)
Outcome results
None listed