The objective of this study is to determine the immune response after hepatitis A and pneumococcal vaccination in different groups of ICPs. The overarching aim of the study is to improve vaccine regimens and to optimize guideline recommendations…
ID
Source
Brief title
Condition
- Immune disorders NEC
- Infections - pathogen unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of ICPs and controls with protective antibody titers
(seroconversion rate) after rabiës/hepatitis A/pneumococcal vaccination.
Secondary outcome
- 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.
Background summary
Immunocompromised patients (ICPs) are at increased risk of infections, some of
which are preventable by vaccination. However, ICPs are also less likely to
mount effective post-vaccination immune responses, leading to a clinical
paradox: precisely this patient group that most needs protection is least
likely to produce a protective immune response. Although guidelines advice
vaccination of this patient group, data on immunogenicity of current rabiës,
hepatitis A an pneumococcal vaccination schedules are scare and heterogeneous.
Study objective
The objective of this study is to determine the immune response after hepatitis
A and pneumococcal vaccination in different groups of ICPs. The overarching aim
of the study is to improve vaccine regimens and to optimize guideline
recommendations specifically targeted to ICPs. In addition a well-defined
cohort of ICPs and controls will be established to allow long term follow up of
the immune respons after vaccination
Study design
Prospective cohort study
Study burden and risks
Since rabiës, hepatitis A and pneumococcal vaccines will only be administered
to people with an indication for vaccination according to national and local
guidelines, no additional risk or benefit related to the vaccine is posed by
study participation. Apart from the visits to the clinic to receive
vaccination, participating subjects have to make a maximum of 6 extra shorts
visits to the vaccination clinic for blood sampling for the purpose of antibody
measurement. Antibody measurements in ICPs after hepatitis A and pneumococcal
vaccination are indicated by local guidelines, but not as often as proposed in
this study. However, venous blood sample collection is a low risk intervention.
The benefit of participation in this study is closer monitoring of vaccination
status against common potentially life-threatening infections.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
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 <5 years before enrollment.
- Age <18 years or >70 years
- Donor lymfocyte infusion < 28 days
- Pregnancy
- No indication for hepatitis A/pneumococcal vaccination
- In ICPs only: Steroids < 10 mg prednisolone or its equivalent as only
immunosuppressant (low dose corticosteroids).
- Not being able or willing to consent
- Previous vaccination against rabies
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | 7385 (NTR) |
| CCMO | NL65687.018.18 |
| OMON | NL-OMON24856 |