SARS-CoV-2 vaccination study in people living with HIV

SARS-CoV-2 vaccination response in people living with HIV - COVIH

Status

Not yet recruiting

Phases

Phase 1Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001054-57-NL

Enrollment

1650

Registered

2021-03-08

Start date

2021-03-08

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

COVID-19 vaccine response in people living with HIV MedDRA version: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 100000004865

Interventions

Trade Name: COVID-19 Vaccine Moderna Product Name: COVID-19 mRNA Vaccine (nucleoside modified) Product Code: EMEA/H/C/005791 Pharmaceutical Form: Dispersion for injection Trade Name: Comirnaty Produc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 18 years or older - Confirmed HIV infection - Selected by national regulations for SARS-CoV2 vaccination - Active participant in the follow-up of the Stichting HIV monitoring Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: - A history of a previous SARS-CoV2 infection (proven by PCR or positive serology)

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the humoral vaccine efficacy against SARS-CoV-2 in PLWHIV 4 weeks after vaccination;Secondary Objective: 1. To find factors associated with intensity of immune response and/or related adverse events 2. To determine the humoral vaccine efficacy against SARS-CoV-2 in PLWHIV 3 weeks after the first vaccination 3. To measure anti-SARS-CoV-2 neutralising antibody response 4. To determine the duration of serologic anti-SARS-CoV-2 immune responses over time 5. To evaluate anti-SARS-CoV-2 specific T-cell responses 6. To estimate the incidence of new SARS-CoV2 infections postvaccination;Primary end point(s): - SARS- CoV-2 serologic response;Timepoint(s) of evaluation of this end point: - Before vaccination (1-42 days) (T0) -4 weeks after final vaccination (T2)	—

Measure

Time frame

Main Objective: To determine the humoral vaccine efficacy against SARS-CoV-2 in PLWHIV 4 weeks after vaccination;Secondary Objective: 1. To find factors associated with intensity of immune response and/or related adverse events 2. To determine the humoral vaccine efficacy against SARS-CoV-2 in PLWHIV 3 weeks after the first vaccination 3. To measure anti-SARS-CoV-2 neutralising antibody response 4. To determine the duration of serologic anti-SARS-CoV-2 immune responses over time 5. To evaluate anti-SARS-CoV-2 specific T-cell responses 6. To estimate the incidence of new SARS-CoV2 infections postvaccination;Primary end point(s): - SARS- CoV-2 serologic response;Timepoint(s) of evaluation of this end point: - Before vaccination (1-42 days) (T0) -4 weeks after final vaccination (T2)

—

Secondary

Measure	Time frame
Secondary end point(s): - Adverse events - Serologic response in between vaccination - Immune response before and after vaccination;Timepoint(s) of evaluation of this end point: - Adverse events diary one week after each vaccination - Extra serologic measurement 3 weeks after first vaccination (T1) - Extra blood for immune response same time points as primary endpoints (T0 and T2)	—

Countries

Netherlands

Contacts

Public ContactKees Brinkman

OLVG

K.Brinkman@olvg.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 11, 2026