Clinical trial NCT03820752: Vaccination Coverage and Level of Protection in Patients at Risk
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Chronic Kidney Disease
Allergy
Cystic Fibrosis
Heart Disease
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 2179
Sex: ALL
Minimum age (years): 2
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronically ill patients (pediatric and adult) in follow-up at the University Hospital Leuven, Belgium

Brief summary: The purpose of this study is to determine

1. 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)
2. the level of protection against measles, mumps, rubella and pertussis in children with chronic diseases.
3. 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)
4. the level of protection against diphtheria, tetanus and pertussis in adults with chronic diseases.

Detailed description: 1. 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?
2. 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?

Eligibility criteria: 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:

-

Primary outcomes:
measure: 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.
timeFrame: 5 years
measure: Proportion of adult chronically ill patients correctly vaccinated diphtheria, tetanus, pneumococci, hepatitis B and influenza according to Belgian recommended vaccination schedule
timeFrame: 5 years
Secondary outcomes:
measure: 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
timeFrame: 5 years
measure: Proportion of adult patients with antibodies against diphtheria, tetanus and pertussis.
timeFrame: 5 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: KU Leuven
name: Corinne Vandermeulen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vandermeulen C, Roelants M, Theeten H, Depoorter AM, Van Damme P, Hoppenbrouwers K. Vaccination coverage in 14-year-old adolescents: documentation, timeliness, and sociodemographic determinants. Pediatrics. 2008 Mar;121(3):e428-34. doi: 10.1542/peds.2007-1415.