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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52193

Enrollment

1650

Registered

2021-01-20

Start date

2021-06-14

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

coronavirus SARS-CoV-2 virus

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

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

Exclusion criteria

Exclusion criteria: a history of a previous SARS-CoV2 infection (proven by PCR or positive serology). For participation in substudy previous SARS-CoV2 is no reason for exclusion

Design outcomes

Primary

Measure	Time frame
Main study: primary vaccination regimen Primary Outcome: 1. Antibody response against SARS-CoV-2 in PLWH 4 weeks after the completed vaccination schedule with one of the two available mRNA vaccines (BNT162b2 or mRNA-1273) compared to non-HIV healthy controls.	—

Secondary

Measure	Time frame
Secondary Outcomes: 1. HIV-related (e.g. actual and nadir CD4 counts, plasma HIV-RNA) and HIV-unrelated variables (age, sex) that are associated with antibody response 4 weeks after the completed vaccination schedule with one of the two mRNA vaccines (BNT162b2 or mRNA-1273) in PLWH. 2. Antibody response in PLWH 4 weeks after the completed vaccination schedule with one of the two vector vaccines (AZD1222 and Ad26.COV2.S) compared to healthy controls. 3. HIV-related and HIV-unrelated factors that are associated with a week 4 post-vaccination response (Trimeric Spike IgG >=300 BAU/mL as well as non-response (IgG =33.8 BAU/mL after the primary vaccination regimen) and primary vaccine type (vector vs. mRNA). 1. To assess HIV-related (e.g. actual and nadir CD4+ T-cell counts, plasma HIV-RNA) and HIV-unrelated variables (age, sex, primary vaccine type) that are associated with the mean increase in antibody response in the 28 days after each booster vaccination. 2. To measure SARS-CoV-2-specific neutralizing antibodies and SARS-CoV-2-specific B/T-cell responses at day 0,7, 28, 90 and 180 in PLWH, all against relevant variants and according to primary vaccine type, and in comparison to HIV-negative controls. 3. To assess HIV-related (e.g. actual and nadir CD4+ T-cell counts, plasma HIV-RNA) and HIV-unrelated variables (age, sex, primary vaccine type, timing and type of booster vaccinations, breakthrough infections) that are associated with the magnitude of the SARS-CoV-2-specific neutralizing antibodies and B/T-cell responses. 4. To assess the correlation between the SARS-CoV-2 antibodies and the SARS-CoV-2-specific neutralizing antibodies, and the correlation between the SARS-CoV-2 antibodies and the B/T-cell responses, both comparing these correlations to the ones found in HIV-negative controls. 5. To compare the SARS-CoV-2-specific antibodies between day 7 post boost and day 28 post boost and vice versa for the neutralizing antibodies, and B/	—

Measure

Time frame

Secondary Outcomes: 1. HIV-related (e.g. actual and nadir CD4 counts, plasma HIV-RNA) and HIV-unrelated variables (age, sex) that are associated with antibody response 4 weeks after the completed vaccination schedule with one of the two mRNA vaccines (BNT162b2 or mRNA-1273) in PLWH. 2. Antibody response in PLWH 4 weeks after the completed vaccination schedule with one of the two vector vaccines (AZD1222 and Ad26.COV2.S) compared to healthy controls. 3. HIV-related and HIV-unrelated factors that are associated with a week 4 post-vaccination response (Trimeric Spike IgG >=300 BAU/mL as well as non-response (IgG =33.8 BAU/mL after the primary vaccination regimen) and primary vaccine type (vector vs. mRNA). 1. To assess HIV-related (e.g. actual and nadir CD4+ T-cell counts, plasma HIV-RNA) and HIV-unrelated variables (age, sex, primary vaccine type) that are associated with the mean increase in antibody response in the 28 days after each booster vaccination. 2. To measure SARS-CoV-2-specific neutralizing antibodies and SARS-CoV-2-specific B/T-cell responses at day 0,7, 28, 90 and 180 in PLWH, all against relevant variants and according to primary vaccine type, and in comparison to HIV-negative controls. 3. To assess HIV-related (e.g. actual and nadir CD4+ T-cell counts, plasma HIV-RNA) and HIV-unrelated variables (age, sex, primary vaccine type, timing and type of booster vaccinations, breakthrough infections) that are associated with the magnitude of the SARS-CoV-2-specific neutralizing antibodies and B/T-cell responses. 4. To assess the correlation between the SARS-CoV-2 antibodies and the SARS-CoV-2-specific neutralizing antibodies, and the correlation between the SARS-CoV-2 antibodies and the B/T-cell responses, both comparing these correlations to the ones found in HIV-negative controls. 5. To compare the SARS-CoV-2-specific antibodies between day 7 post boost and day 28 post boost and vice versa for the neutralizing antibodies, and B/

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Countries

Netherlands

Outcome results