Clinical stage immunology company conducts a clinical trial of a Prototype Human CMV-based Vaccine (VIR-1111) for Human Immunodeficiency Virus (HIV)
Photo by Markus Spiske
Vir Biotechnology, Inc is recruiting patients for the clinical trial of VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers.
This is first in human study in which healthy adult participants who are considered to be at low-risk for HIV infection and are seropositive for cytomegalovirus (CMV) will receive two doses of VIR-1111 or placebo. These participants will be assessed for safety, reactogenicity, tolerability and immunogenicity. There is an optional long-term follow-up study that would lengthen study participation for up to 3 years post-first dose.
Among primary outcome measures are the Number of participants with any local site reactogenicity event after first dose and Signs and symptoms will be captured at the injection site (e.g., pain/tenderness, swelling, redness and induration) through self-assessment via participant diaries and in-person clinical assessments.
The study will take place in Boston, Massachusetts; Seattle, Washington; Madison, Wisconsin, United States.
There are a number of conditions that do not allow participation, such as:
- Live in a home with children under the age of 6
- Routine provision of child care to children under the age of 6
- Have close contact with immunocompromised individuals
- Have close contact with pregnant women or a partner planning to become pregnant during the course of the study
- Health care provider who routinely comes into contact with immunosuppressed patients or pregnant women
- Participant is immunocompromised
- Participant has an autoimmune disorder
- Positive HIV test at the time of study screening
- Receipt of another investigational HIV or CMV vaccine candidate
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04725877
