About the Study

CTNPT 045 aims to understand the effect of COVID-19 vaccines on immune response in people living with HIV, and whether these vaccines may increase systemic immune activation and chronic inflammation or negatively affect the viral reservoir. Researchers will determine whether these vaccines induce a protective response in people living with HIV, both in the short- and long-term, and whether this response differs in people living with HIV who have suppressed immune function.

This study is complimentary to CTN 328, which is also focused on COVID-19 vaccines in people living with HIV; CTNPT 045 will provide a detailed look at the immune system and viral reservoir, while CTN 328 aims to understand overall vaccine effectiveness in a large population.

About The Disease

People living with HIV may be at an increased risk of complications related to COVID-19. Only a limited number of people with HIV were included in the initial clinical trials to test the effectiveness of COVID-19 vaccines. This means that we don’t know how the immune systems of people living with HIV will respond to the vaccine, especially in those with diminished immune responses and chronic inflammation. Research in non-COVID-19 vaccines shows that shows some vaccines may temporarily increase HIV activity, suggesting that vaccination may affect the HIV reservoir. The viral reservoir refers to the collection of immune cells in the body that may be infected with HIV but are not actively producing new HIV, effectively hiding them from the rest of the immune system and contributing to HIV persistence.

Study Approach

This study is enrolling people living with HIV and 12 HIV-negative controls in Toronto. The study involves one screening visit, one baseline visit, and at least eight follow-up visits. The screening and baseline visits will take place before the first vaccine dose. The follow-up visits will take place periodically following each of the two vaccine doses, up to 48 weeks after the first dose. Public health officials are currently discussing the rollout of a booster (third) dose in some or all of the eligible population. If a booster is approved for people living with HIV, three additional study visits will be added. Each study visit involves collection of blood and saliva samples.

Participants in this study will learn about their antibody levels, what those antibodies mean, and whether they are from natural infection or the vaccine. Participants will be given $35 for each visit. Researchers will compare the vaccine-induced immune response between participants living with HIV and HIV-negative controls. They will also compare how people living with HIV who have differing levels of immune function respond to the vaccine over the study period.

Eligibility Requirements

Required

Participants living with HIV:

  • Ability to provide signed written informed consent
  • Documented HIV diagnosis for 1+ year
  • Antiretroviral therapy for 1+ year
  • 55 years of age or older
  • Good general health as shown by medical history and screening laboratory tests at the screening visit

Participants without HIV:

  • Ability to provide signed written informed consent
  • Negative HIV test at the screening visit
  • 55 years of age or older
  • Stable clinical status and absence of acute illnesses as shown by medical history and screening laboratory tests at the screening visit

Please contact participating site for more information about eligibility criteria.

Additional Information

If you would like to take part in this study or want more information, please contact the participating site.

Principal Investigators

Here’s who is leading this study.

Can’t find what you’re looking for? Email ctninfo@hivnet.ubc.ca.

Dr. Vitaliy Matveev

Postdoctoral Fellow, Ostrowski Lab

Participating Site

Here’s where this study is being conducted.