Vaccination Coverage and Level of Protection in Patients at Risk

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT03820752

Collaborator

(none)

2,179

Enrollment

Location

Duration (Months)

30.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine

vaccination coverage of recommended vaccines (routine childhood vaccines and vaccines against seasonal flu and pneumococci) in children with chronic diseases (allergy, cystic fibrosis, diabetes mellitus type 1, congenital heart disease, immunocompromised and solid organ transplant patients)
the level of protection against measles, mumps, rubella and pertussis in children with chronic diseases.
vaccination coverage of recommended vaccines (diphtheria, tetanus, pertussis and vaccines against seasonal flu and pneumococci) in adults with chronic diseases (nephropathy, diabetes mellitus, COPD, heart failure, HIV and solid organ transplant patients)
the level of protection against diphtheria, tetanus and pertussis in adults with chronic diseases.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Chronic Kidney Disease Allergy Cystic Fibrosis Heart Disease

Detailed Description

Chronically ill children

1.1 What is the vaccination status for vaccines recommended by the Superior Health Council in pediatric chronically ill patients (2-16 years of age) who consult within the University hospital of Leuven?

Patients with one of the following chronic conditions will be included:

Cystic fibrosis
Diabetes Mellitus type 1
Allergic constitution
Congenital heart disease
Solid-organ transplantpatients
Immunodeficiency (congenital or acquired)
Cancer

The vaccination coverage for the following vaccines will be determined:

Poliomyelitis
Diphtheria
Tetanus
Pertussis
Haemophilus influenzae type b
Hepatitis B
Measles-Mumps-Rubella
Pneumococci
Meningococcal serogroup C
Rotavirus
Diphtheria-Tetanus-Polio: booster (older than 7 years)
Human papillomavirus (girls of 13 yrs)
Seasonal flu (cystic fibrosis, immunodeficiencies)

Timeliness of the vaccines given will also be determined.

1.2 Is the vaccination coverage of pediatric patients (2-16 years of age) comparable to the data on healthy children in 2012?

1.3 What are possible factors that influence coverage in this specific patient populations?

1.4 If the vaccination coverage is too low (below 90-95 percent), what are possbile solutions to increase the coverage rates within this group?

1.5. Determine antibody titers in this same population for the following vaccine-preventable infectious diseases:

Measles
Mumps
Rubella
Pertussis

1.6 Are antibody titers in this population similar to antibody titers measured in seroprevalence studies of healthy children in the same age group?

Adult patients at risk

2.1 What is the vaccinatiestatus for vaccines recommended by the Superior Health Council of adult patients at risk (over 18 years of age) who consult within the University hospital of Leuven?

Patients with one or more of the following chronic conditions will be included in the study:

Chronic obstructive pulmonary disease (COPD)
Heart failure
Diabetes mellitus (Type 1 and 2)
Chronic kidney disease (stadium IV and V)
Solid organ Transplant patients
HIV
HSCT

The vaccination coverage for the following vaccines will be determined:

Seasonal flu (yearly)
Diphtheria-tetanus (date of last dose)
Pneumococcus (1 dose/last dose before 5 years of age)
Pertussis (1 dose)
Hepatitis B (3 doses in specific risk groups)

2.2 Who immunizes these adult patients at risk?

2.3 What are possible risk factors who influences vaccination status in the adult population?

2.4 If the vaccination coverage is too low (below 90-95 percent), what are possible solutions to improve this coverage in these groups?

2.5 What are the antibody titers measured in the adult risk groups with a chronic condition for the following vaccine-preventable infectious diseases:

Diphtheria
Tetanus
Pertussis

2.6 Are antibody titers measured in this population comparable to those of healthy subjects as measured in previous seroprevalence studies?

Study Design

Study Type:

Observational

Actual Enrollment :

2179 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Study of the Vaccination Coverage and Level of Protection Against Vaccine-preventable Infectious Diseases in Pediatric and Adult Risk Patients in a University Hospital

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Aug 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Pediatric chronically ill patients Through a questionnaire parents of chronically ill patients will be asked about the vaccination status of all recommended vaccines of their child. Also questions on disease, therapy and sociodemographic factors that can influence vaccination coverage will be asked. A blood sample to determine antibodies against measles, mumps, rubella and pertussis will be drawn from children who consent to sampling. The following groups of patients will be questioned: diabetes, allergy, congenital heart disease, cystic fibrosis, immunodeficiency and transplant patients, cancer patients.
Adult chronically ill patients Through a questionnaire chronically ill patients will be asked about their vaccination status of diphtheria, tetanus,pertussis, flu, pneumococcal and hepatitis B vaccine(s). Also questions on disease, therapy and sociodemographic factors that can influence vaccination coverage will be asked. A blood sample to determine antibodies against diphtheria, tetanus and pertussis will be drawn. The following groups of patients will be questioned: diabetes, chronic kidney disease, heart failure, COPD, immunodeficiency and transplant patients, HSCT patients.

Arm

Intervention/Treatment

Pediatric chronically ill patients

Through a questionnaire parents of chronically ill patients will be asked about the vaccination status of all recommended vaccines of their child. Also questions on disease, therapy and sociodemographic factors that can influence vaccination coverage will be asked. A blood sample to determine antibodies against measles, mumps, rubella and pertussis will be drawn from children who consent to sampling. The following groups of patients will be questioned: diabetes, allergy, congenital heart disease, cystic fibrosis, immunodeficiency and transplant patients, cancer patients.

Adult chronically ill patients

Through a questionnaire chronically ill patients will be asked about their vaccination status of diphtheria, tetanus,pertussis, flu, pneumococcal and hepatitis B vaccine(s). Also questions on disease, therapy and sociodemographic factors that can influence vaccination coverage will be asked. A blood sample to determine antibodies against diphtheria, tetanus and pertussis will be drawn. The following groups of patients will be questioned: diabetes, chronic kidney disease, heart failure, COPD, immunodeficiency and transplant patients, HSCT patients.

Outcome Measures

Primary Outcome Measures

Proportion of pediatric chronically ill patients correctly vaccinated with the hexavalent (DTaP-IPV-Hib-HBV), pneumococcal, rotavirus, MMR and MenC vaccine according to the Belgian recommended vaccination schedule. [5 years]
number of patients vaccinated compared to the entire group
Proportion of adult chronically ill patients correctly vaccinated diphtheria, tetanus, pneumococci, hepatitis B and influenza according to Belgian recommended vaccination schedule [5 years]
number of patients vaccinated compared to the entire group

Secondary Outcome Measures

Proportion of pediatric patients with antibodies against measles, mumps, rubella, diphtheria, tetanus and pertussis in children included in the study and who provided a blood sample [5 years]
Determination of antibodies against measles, mumps, rubella and pertussis
Proportion of adult patients with antibodies against diphtheria, tetanus and pertussis. [5 years]
Determination of antibodies against diphtheria, tetanus and pertussis

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

pediatric patients: be at least 2 years of age and maximum 16 ye
adults patients: at least 18 years of age
have a chronic condition

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

Principal Investigator: Corinne Vandermeulen, MD, PhD, KU Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. dr. Corinne Vandermeulen, Principal Investigator, KU Leuven

ClinicalTrials.gov Identifier:

NCT03820752

Other Study ID Numbers:

UZVACC

First Posted:

Jan 29, 2019

Last Update Posted:

Oct 23, 2020

Last Verified:

Oct 1, 2020

Additional relevant MeSH terms:

Cystic Fibrosis

Kidney Diseases

Renal Insufficiency, Chronic

Heart Diseases

Study Results

No Results Posted as of Oct 23, 2020