European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) SARS-CoV-2 Antibody Study Protocol. Covid-19

Launched by PENTA FOUNDATION · Jan 26, 2021

Keywords

ClinConnect Summary

The study will be conducted within existing cohorts of children, adolescents and young adults living with HIV being followed up in several European countries and South Africa: the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) Paediatric Study and the Cape Town Adolescent Antiretroviral Cohort (CTAAC). In CTAAC, adolescents without HIV are also enrolled and will be included in this study. For all participants, two blood samples will be taken at routine clinic visits approximately six months apart and tested for antibodies to SARS-CoV-2; clinical data and data on ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \< 18 years at HIV diagnosis
• • Current age under 25 years
• • Attending routine HIV care in a participating clinic
• • Currently in follow-up in CTAAC, a cohort which contributes to EPPICC, or another collaborating cohort
• • If aged ≥16 years (or local legal adult age), willing and able to give informed consent to participate in the study
• • If aged \<16 years (or local legal adult age), a parent/carer able to give informed consent for participating in the study (and, depending on local requirements, those aged ≥10 years, with capacity, to also provide assent).
• In addition, in South Africa HIV-uninfected adolescents will be eligible to participate in the study during planned study visits if they meet the following inclusion criteria:
• • Current age under 25 years
• • In follow-up in the CTAAC study
• • If aged ≥18 years, willing and able to give informed consent to participate in the study
• • If aged \<18 years, a parent/carer is able to give informed consent for participating in the study and participant willing and able to provide assent.
• Exclusion Criteria:
• • Children and adolescents are ineligible if they are taking part in a COVID-19 / SARS-CoV-2 vaccine study at enrollment.
• • However, should a participant who is enrolled in the EPPICC-SARS-CoV-2 study subsequently join a COVID-19 / SARS-CoV-2 vaccine study or receive a COVID-19 / SARS-CoV-2 vaccine, these are not reasons for exclusion from this study. Data will be collected on vaccine receipt and participation in vaccine studies.