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RESEARCH QUESTION:

to analyse the immune response in persons living with HIV (PLHIV) to any of the SARS-CoV-2 vaccines that will be implemented for use in the Netherlands

 

HYPOTHESIS:

the immune response in PLHIV will be inferior compared to persons without hiv

 

STUDY DESIGN:

observational cohortstudy with a non-inferiority design

 

STUDY POPULATION:

PLHIV in care of one of the 22 participating hiv centers in The Netherlands, who are invited for the national SARS-CoV2 vaccination program

 

OUTCOME MEASURES

Main study parameter/endpoint:

1. The proportion of participants with a SARS-CoV-2 vaccine induced antibody response with anti-SARS-CoV-2 RBD activity, 4 weeks after the second vaccination (all participants).

Secondary study parameters/endpoints (if applicable)

1. Prevalence of SARS-CoV-2 vaccine related adverse events (all participants)

2. The proportion of participants with a SARS-CoV-2 vaccine induced antibody response with anti-SARS-CoV-2 RBD activity at 3 weeks after first vaccination (subgroup of participants)

3. Duration of antibody immune response with anti-SARS-CoV-2 RBD activity over time (all participants)

4. Factors associated with the (height of the) antibody response with anti-SARS-CoV-2 RBD activity

5. The proportion of participants with a SARS-CoV-2 vaccine induced neutralizing antibody response against SARS-CoV-2 (subgroup of participants).

6. Factors associated with (height of the) the neutralizing antibody response against SARS-CoV-2 (subgroup of participants)

7. Proportion with a SARS-CoV-2 specific T-cell response (subgroup participants)

8. Factors associated with T-cell immune response (subgroup of participants)

9. The incidence of (newly) occurring infections with SARS-CoV2 after vaccination

 

SAMPLE SIZE/DATA-ANALYSIS

In total 550 PLHIV will be included per vaccin type, allowing to analyse the outcome measures per vaccine, but also to analyse the difference in outcomes between the vaccines

 

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