Vir Biotechnology has dosed the first patient in the Phase I HVTN 142 clinical trial of the new T cell vaccine VIR-1388 to prevent human immunodeficiency virus (HIV).
The Bill & Melinda Gates Foundation supported the development of VIR-1388 while the National Institute of Allergy and Infectious Diseases provided funds throughout the development lifecycle.
The two-part, placebo-controlled, double-blind, randomised study will be carried out at both domestic and international sites, within the federally funded HIV Vaccine Trials Network (HVTN).
It will compare the immunogenicity, safety, and reactogenicity of VIR-1388 against placebo.
The trial enrolled nearly 95 patients aged 18 to 55 years who will receive three different doses of VIR-1388 subcutaneously.
Participants with existing antibodies specific to human cytomegalovirus (HCMV), overall good health and without HIV are included in the study.
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In the lead-in phase, Part A will enrol a limited number of HCMV-positive participants without childbearing possibility while Part B will enrol a broader population of HCMV-positive persons with childbearing potential.
After the first dose, the company plans to conduct an optional long-term follow-up study for up to three years.
Initial data from the study is anticipated in the second half of next year.
Vir Biotechnology Clinical Research senior vice-president and chronic infection head Carey Hwang said: “The initiation of our first clinical trial evaluating VIR-1388 is an important clinical milestone in our pursuit of developing an HIV vaccine and we are grateful to all our partners for their support of this Phase I trial.”
The company developed VIR-1388 using the applied learnings from VIR-1111, an initial investigational proof-of-concept HIV T cell vaccine based on HCMV.
HCMV, a weakened version of the virus, delivers the HIV vaccine material to the immune system without causing disease in the study subjects.
Vir Biotechnology is also engaged in developing therapeutics targeting Covid-19, influenza A and B, and hepatitis B and hepatitis delta viruses.