To assess immunogenicity and safety of SARS-CoV-2 vaccination in patients with isolated antibody deficiencies, i.e. patients with immunoglobulin G (IgG) subclass deficiency and patients with selective antibody deficiency with normal immunoglobulins…
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the antibody response in patients with an isolated
antibody deficiency (selective IgG subclass deficiency or SADNI) on day 28
after vaccination
Secondary outcome
Safety is a secondary endpoint which will be reported in terms of percentage of
solicited local and systemic adverse events (AEs) graded according to severity.
Other secondary endpoints include monitoring of occurrence of infection despite
vaccination, development of vaccine escape variants of the virus, mounting of
response after 1st vaccination, durability of the immune response at 6 and 12
months and levels of SARS-CoV-2 specific T and B cell responses.
Evaluation of the antibody response in patients with CVID, CID, CGD or XLA on
day 28 after vaccination will be a secondary endpoint of this study. Other
secondary endpoints for patients with CVID, CID, CGD or XLA include safety,
occurrence of infection despite vaccination, development of vaccine escape
variants of the virus, mounting of response after 1st vaccination, durability
of the immune response at 6 and 12 months and levels of SARS-CoV-2 specific T
and B cell responses.
Evaluation of the antibody and cellular response in a group of subjects that
receive a 3rd SARS-CoV-2 vaccination, not part of this protocol, by the
Municipal Public Health Services (GGDs), at day 28-42 after 3rd vaccination.
Background summary
Primary immune deficiencies (PIDs), also known as Inborn Errors of Immunity
(IEI), are clinically characterized by an increased risk of severe infections.
Primary antibody deficiencies (PADs) are the most prevalent PIDs, accounting
for approximately 60-70% of PID patients. Other categories include combined (T
and B cell) deficiencies (CIDs) and neutrophilic granulocyte defects. Because
of the increased risk of infectious complications in PIDs, these patients may
also have an increased risk of adverse outcome of COVID-19 or may experience
protracted course of disease. Effective SARS-CoV-2 vaccination would therefore
be of great clinical importance in PID patients. However, until now not much is
known about the efficacy and safety of SARS-CoV-2 vaccination in these
vulnerable patients. In PID patients, the underlying disease may have a
significant impact on the ability to develop an effective immune response after
SARS-CoV-2 vaccination
Study objective
To assess immunogenicity and safety of SARS-CoV-2 vaccination in patients with
isolated antibody deficiencies, i.e. patients with immunoglobulin G (IgG)
subclass deficiency and patients with selective antibody deficiency with normal
immunoglobulins (SADNI), which are clinically characterized by an increased
risk of infections.
To explore immunogenicity and safety of SARS-CoV-2 vaccination in patients with
Common Variable Immune Deficiency (CVID), Combined Immunodeficiency (CID),
Chronic Granulomatous Disease (CGD) and X-linked agammaglobulinemia (XLA),
which are clinically characterized by an increased risk of infections and
immune dysregulation
Study design
Prospective, controlled multicenter study
Intervention
Study participants will receive the COVID-19 Vaccine Moderna ccording to
manufacturer's protocol, which requires two injections of 0.5 mL each, by
intramuscular injection, with interval of 28 days
Study burden and risks
Burden:
- Vaccination with COVID-19 Vaccine Moderna, twice 0.5 mL (intramuscular
injection)
- Extra visits to the hospital (4-5 in total)
- Drawing of blood at 6-7 time points x 55-60 ml
- Collection of questionnaires at 5-6 time points x 5 minutes (questionnaire 1)
- Collection of questionnaires at 2 time points x 5 minutes (questionnaire 2)
Oropharyngeal and nasopharyngeal swab (once)
Risks:
Side effects vaccination:
Pain or swelling at injection site, swelling of axillary lymph nodes at side of
injection, headache, nausea, vomiting, myalgia, arthralgia, fatigue, chills,
fever, itching rash and redness at injection site or skin rash.
Very rare (2 to 3 cases per million doses administered): anaphylactic reaction
after vaccination, within 15 minutes after administration of vaccine,
necessitating medical intervention
After blood drawing:
Local hematoma after blood collection
Benefit:
- Evaluation of vaccination immunogenicity in vulnerable patients will provide
new data to be used for application of group-specific vaccination regimens
Dr Molewaterplein 40
Rotterdam 3015GD
NL
Dr Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Subjects must meet the Inclusion Criteria for enrollment into the study.
Inclusion criteria:
Subjects are eligible for the study if all of the following apply:
1. All patients should be eligible for COVID-19 vaccination as described by the
instructions of the manufacturer.
2. Age of 18 years or older
3. Capable of understanding the purpose and risks of the study, fully informed
and given written informed consent (signed informed consent form has been
obtained)
4. A diagnosis of either one of the IUIS criteria based diagnoses below:
- CVID, with or without use of immunosuppressive therapy
- CID
- CGD
- XLA
- Selective IgG subclass deficiency
- SADNI
- Partners, sibling or other family member from patient (not suffering from a
PID)
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (e.g., anaphylaxis) to any component of the study
intervention(s).
Women who are pregnant or breastfeeding
Active (hematological) malignancy
HIV (Human Immunodeficiency Virus)
Bleeding diathesis or condition associated with prolonged bleeding that would,
in the opinion of the investigator, contraindicate intramuscular injection.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-000515-24-NL |
| CCMO | NL76470.078.21 |