Skip to content

Vaccinations in the Immunocompromised population: paramount and paradox.

Vaccinations in the Immunocompromised population: paramount and paradox. - VIPPP-study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56421
Enrollment
980
Registered
2018-06-25
Start date
2018-08-06
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunocompromising conditions impaired immune system

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient group: - Indication for rabies/hepatitis A and/or or pneumococcal vaccination - Age 18-70 years old; - At least of the following criteria 1. Diagnosed with HIV; and/or 2. Treated with one or more immunosuppressive agents for underlying disease/organ transplant; and/or 3. Hematopoietic stem cell transplant (HSCT) recipients 3-24 months after HSCT. - Able and willing to consent Control group: - Immunocompetent individuals aged 18-70 years. - Indication for hepatitis A and/or or pneumococcal vaccination - Able and willing to consent.

Exclusion criteria

Exclusion criteria: Diagnosis of one of the following 1. Primary immune deficiency disorder 2. Active malignancy 3. Hemophilic disorder precluding intramuscular vaccination. 4. Functional asplenia - Receiving chemotherapy - An allergy to any of the components of the hepatitis A or pneumococcal vaccines. - Naturally acquired hepatitis A immunity (either assessed in the medical history or at first antibody concentration measurement) - Previous vaccination with any pneumococcal conjugate vaccine - Previous vaccination with Pneumovax 23 70 years - Donor lymfocyte infusion

Design outcomes

Primary

MeasureTime frame
The proportion of ICPs and controls with protective antibody titers (seroconversion rate) after rabiës/hepatitis A/pneumococcal vaccination.

Secondary

MeasureTime frame
- Strength of the humoral immune response measured in geometric mean concentrations (GMCs) of antibodies in ICPs and controls before and at different time points (7 days, 1,2,4, 6, 8, 10,12 months, 3 years) after rabiës, hepatitis A and pneumococcal vaccination. - In vitro post-vaccination cellular immune response measured after pneumococcal vaccination. - The differences in immune response after hepatitis A and pneumococcal vaccination between ICPs and non-ICP controls. - The long term immune response after vaccination. - The immune response after hepatitis A booster vaccination in participants with low antibodies 1-5 years after primary vaccination - Boostability three years after PCV13 + PPSV23 (T36), defined as the proportion of ICPs who had seroreverted at T36 and , who seroconvert again 7 days after booster vaccination with PCV20. - The influence of age, gender, time between vaccination and antibody measurment, intoxications, group and dose of immunosuppressive medication and CD4+ count (in HIV patients) on the seroconversion rate and GMCc of antibodies after rabiës, hepatitis A and pneumococcal vaccination.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)