No registrations found.
ID
Source
Brief title
Health condition
COVID-19, HIV
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the humoral vaccine efficacy against SARS-CoV-2 in PLWHIV 2 weeks after the completed vaccination schedule (all participants)
Secondary outcome
1. To find factors associated with intensity of immune response and/or related adverse events (all participants)
2. To determine the humoral vaccine efficacy against SARS-CoV-2 in PLWHIV 3 weeks after the first vaccination (subgroup participants)
3. To measure anti-SARS-CoV-2 neutralising antibody response (subgroup participants)
4. To determine the duration of serologic anti-SARS-CoV-2 immune responses over time (all participants)
5. To evaluate anti-SARS-CoV-2 specific T-cell responses (subgroup participants)
Background summary
Rationale: The immune response in people living with HIV (PLWHIV) to any of the SARS-CoV-2 vaccines that are to be implemented for use in the Netherlands used is currently unknown. As observed with other vaccines, this immune response could be hampered by the immune status of PLWHIV.
Objective: To assess the immune response and the reactogenicity to SARS-CoV-2 vaccines in people living with HIV in the Netherlands.
Study design: Observational study (the vaccination is performed by the family doctor or at the municipal health center)
Study population: People living with HIV (in care in one of the 20 participating centers) who will receive a SARS-CoV2 vaccination in 2021
Sample size: we aim to include minimally 550 participants per vaccine, and are planning to target women and older patients
Intervention: An extra blood sample before and 2 weeks after the last SARS-CoV-2 vaccination (maximally 2 blood samples in total, main study). A standardized adverse event dairy post-vaccination.
Main study parameters/endpoints: Proportion of all participants with a protective antibody response to SARS-CoV-2 vaccine overall and according to CD4 nadir
Study objective
We calculated the sample size on the assumption that the antibody response in HIV positive patients (p) is 90% and the response in HIV negative historical controls of (p0) is 95%, for the SARS-CoV-2 vaccines that are approved at this point in the Netherlands
Study design
1st blood sampling 1-3 weeks before vaccination, subgroup: before second vaccination, 2nd blood sampling 7-21 days after second vaccination, long term response: follow up at regular outpatient monitoring every 6 months until 12 months after vaccination
Intervention
Blood sampling before the first and after the second SARS-CoV-2 vaccination (vaccinations are performed by the family doctor of municipal health center)
Inclusion criteria
18 years or older, confirmed HIV-infection, selected by national regulations for SARS-CoV-2 vaccination
Exclusion criteria
none
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9214 |
| CCMO | NL76562.100.21 |
| OMON | NL-OMON52193 |