COVID-19 Vaccination among People Living with HIV: Immunogenicity, Effectiveness, and Safety [COVAXHIV, study data contributed to the CITF Databank]

Objectives of the CITF-funded study: The first aim of the funded study, from which data for the PLWH cohort was shared, was to compare the immunogenicity of COVID-19 vaccines among PLWH compared to people who are HIV-negative, particularly regarding the necessity for additional doses.

Methods

COVAXHIV used a cohort design with the treated group followed from second dose of SARS-CoV-2 vaccination. Outcome measures included SARS-CoV-2 serology and neutralization capacity[, and hospitalization due to COVID-19] up to 12 months post third dose. PLWH 16 years and older were recruited from clinics in Montreal, Ottawa, Toronto, and Vancouver, Canada, and through social media.

Enrollment was between April 2021 and January 2022. Participants were excluded if they had an active COVID infection or three doses prior to enrollment. (HIV negative participants 18 years and older were recruited through an existing research project, Stop the Spread Ottawa, and are not in the contributed data.) Data were collected through a standardized questionnaire capturing health behaviors, medical history, and serological samples to evaluate COVID-19-specific antibodies, with a focus on post-third and fourth vaccine doses.

Lab collaboration with the Integrating Longitudinal Epidemiologic, Virologic and Immunologic Analyses to Understand COVID-19 Immunity and Infection Outcomes in Long Term Care [ILEVIA, study data contributed to the CITF Databank] Contributed dataset contents: The contributed data include baseline and follow-up visit questionnaire data for 375 participants living with HIV (346 with follow-up) variables. Serology and neutralisation results for 50 participants among 99 participants with blood samples of the participants are stored with the Romney dataset, linked by participant ID.

Study protocol states that clinical chart review was used to supplement participant-reported information when needed. The contributed data included 375 participants living with HIV who completed baseline visits between January 2021 and May 2022 (344 participants with follow-up). All participants gave one or more blood samples for SARS-CoV-2 serology between April 2021 and August 2023.

Two additional participants provided a blood sample without completing a questionnaire. A total of 1,534 blood samples were collected. ACE2 displacement and live virus neutralization results for 699 blood samples from 99 participants were collected.

Cellular immunity test results for 169 blood samples from 50 participants are stored with the Romney T-cell mediated immunity dataset, linked by participant ID. Variables include data in the following areas of information: demographics (age, sex and gender, race and indigeneity), general health (tobacco use, chronic conditions, height and weight, flu vaccine), exposure risk factors (travel, occupation, gathering, compliance to COVID-19 preventive behaviors), longitudinal follow-up for COVID infections (COVID tests, symptoms, hospitalization), COVID vaccination history (number of vaccine doses, vaccination during pregnancy), SARS-CoV-2 serology (IgG against spike, nucleocapsid and RBD, ACE2 displacement, live virus neutralization) and cellular immunity (CD4+ and CD8+ T-cell responses against spike).

This study was in collaboration with Romney et al [doi.org/10.5683/SP3/V68T4B]]