Costiniuk CT, Singer J, Langlois M, Kulic I, Needham J, Burchell A, Jenabian M, Walmsley S, Ostrowski M, Kovacs C, Tan D, Harris M, Hull M, Brumme, Z, Brockman M, Margolese S, Mardarino E, Angel JB, Routy JP, Anis AH, Cooper C, CTN 328: immunogenicity outcomes in people living with HIV in Canada following vaccination for COVID-19 (HIV-COV): protocol for an observational cohort study. BMJ Open 2021;11:e054208. doi: 10.1136/bmjopen-2021-054208
The results and/or conclusions contained in the research do not necessarily reflect the views of all CITF members.
CITF-funded HIV-COV, led by Dr. Aslam Anis from the University of British Columbia, has published the protocols for its pan-Canadian study of people living with HIV who have received, or plan to receive, a COVID-19 vaccine in BMJ Open. The protocol allows for the assessment of how these people’s compromised immune systems respond to vaccination, how long immunity might last, and if the vaccines are safe and well tolerated In this population. Importantly, HIV-COV focuses on how vulnerable groups, such as older people and those with low immune cell counts, respond to vaccines and if they maintain effectiveness against variants of concern.
- Approximately 400 people living with HIV aged 16 and older are being recruited and enrolled in the study across four sites: Montreal, Ottawa, Toronto, and Vancouver.
- Subpopulations that will be targeted include those who:
- are older than 55;
- have CD4+ T cell counts < 350 cell/mm3 (i.e., severely immunodeficient);
- have two or more underlying medical conditions;
- are classified as “stable” or “reference” (defined as a CD4+ T cell count 350 cells/mm3, suppressed viral load for at least six months and with one or no underlying medical condition).
- A group of 1,000 HIV-negative individuals recruited by the Stop the Spread Ottawa study will be used for comparison purposes.
- Participants receiving at least one dose of a COVID-19 vaccine are being invited to five follow-up visits, including pre-vaccination, one month post first dose, followed by three-, six-, and 12-months post second dose.
- The primary objective (endpoint) of the study will be to evaluate the percentage of study participants with COVID-19-specific antibodies at six months following the second dose.
People living with HIV were largely excluded from clinical trials so this study will contribute to the understanding of how to best protect these individuals during the pandemic, and beyond.
The Vancouver HIV-COV group has released preliminary results in preprint, therefore not yet peer-reviewed. Read that summary here.