Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

NCT02605538 | Withdrawn

• 1 other identifier: 2012/251-31/2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients according to European consensus. The aim of the study is to vaccinate as many patients as possible and to follow up whether immunization has been complete.

Conditions

Cystic Fibrosis; Hepatitis A; Hepatitis B; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers

  6 months for vaccination

Study Arms (2)

Cystic Fibrosis

ACTIVE COMPARATOR

Vaccination with Twinrix (TM), 3 doses within 6 months according to the manufacturer's instruction. The response will be studied in a time frame of 6 months.

Biological: Vaccination with vaccine against hepatitis A and B

Healthy volunteers

ACTIVE COMPARATOR

Vaccination with Twinrix (TM), 3 doses within 6 months according to the manufacturer's instruction. The response will be studied in a time frame of 6 months.

Biological: Vaccination with vaccine against hepatitis A and B

Interventions

Vaccination with vaccine against hepatitis A and B BIOLOGICAL

Vaccination against hepatitis A and B

Also known as: Twinrix (TM)

Cystic Fibrosis; Healthy volunteers

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• CF patients not previously immunized against hepatitis A or B
• Healthy volunteers not previously immunized against hepatitis A or B
• Age over 1 year

You may not qualify if:

• Previously transplanted patients
• Previous vaccination with hepatitis vaccine
• Known allergy against components in Twinrix (TM)

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Stockholm CF Center, KArolinska University Hospital

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Cystic Fibrosis; Hepatitis A; Hepatitis B; Tuberculosis

Interventions

Vaccination; twinrix

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Ferenc Karpati, MD, PhD

  Stockholm CF Center, Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: November 16, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

SE (1)