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Bij mensen die leven met hiv (PLWH) werken vaccinaties vaak minder goed; het effect van de nieuwe SARS-CoV2 vaccins bij PLWH was niet bekend.

In de COVIH studie werd prospectief de immuunrespons geanalyseerd van het reguliere RIVM vaccinatieschema bij PLWH in 22 hiv-centra in Nederland.

In totaal werden 1154 deelnemers geincludeerd (884 ontvingen Pfizer, 100 Moderna, 150 AstraZeneca en 20 Janssen).

In vergelijking met hiv negatieve controle groep, bleken PLWH significant lagere concentraties antistoffen te maken. Een te lage antistofreactie vond plaats bij 14,2% van de studiepopulatie. Lage antistofrespons was geassocieerd met CD4 waarden 250/mm3, hiv load > 50 copies/ml en leeftijd >65 jaar. Een extra vaccinatie na primaire cyclus bij mensen met te lage antistofwaarden liet een significante stijging van antistofwaarden zien. Er deden zich geen bijzondere bijwerkingen voor

 

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Samenvatting
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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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