Vir Biotechnology HIV Vaccine Candidates

Vir Biotechnology VIR-1111 human immunodeficiency virus (HIV) proof of concept vaccine candidate is based on human cytomegalovirus (HCMV) and has been designed to elicit abundant T cells that recognize human immunodeficiency virus (HIV) epitopes in a way that differs from prior HIV vaccines. Oregon Health & Science University (OHSU) researchers uniquely designed VIR-1111 to elicit abundant and durable CD4 and CD8 T cells programmed to attack virus-infected cells. OHSU's pre-clinical research into the cytomegalovirus-based HIV vaccine has shown it works well in nonhuman primates.

The cytomegalovirus-based vaccine platform's development was supported by the Bill & Melinda Gates Foundation, the National Institute of Allergy and Infectious Diseases, the National Institutes of Health's Office of the Director, and the National Cancer Institute. The vaccine platform was developed by a team of scientists at the OHSU Vaccine and Gene Therapy Institute, including Jay Nelson, Ph.D., Klaus Frueh, Ph.D.; Scott Hansen, Ph.D.; and Louis J. Picker, M.D.

San Francisco-based Vir Biotechnology, Inc. is a clinical-stage immunology company that combines immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.

VIR-1111 Proof of Concept HIV Vaccine Candidate

is a subcutaneously administered HIV T cell vaccine based on HCMV designed to elicit abundant T cells that recognize HIV epitopes in a way that differs from prior HIV vaccines. The investigational vaccine VIR-1111 is being evaluated in humans through a clinical trial sponsored by San Francisco-based Vir Biotechnology. Vir licensed OHSU's cytomegalovirus-based vaccine platform through a merger with OHSU spinoff company TomegaVax in 2017. 

VIR-1388 HIV Vaccine Candidate Indication

On September 20, 2023, Vir Biotechnology announced that the first participant had been dosed in a Phase 1 trial evaluating the safety, reactogenicity, and immunogenicity of VIR-1388, an investigational novel T cell vaccine for the prevention of HIV. VIR-1388 is based on the HCMV vector platform. It is designed to stimulate the body to produce immune cells known as T cells that recognize several HIV proteins in a way that differs from prior investigational HIV vaccines. VIR-1388 was developed using applied learnings from VIR-1111.

The phase 1 clinical trial is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Bill & Melinda Gates Foundation. NIAID has provided funding throughout the product development lifecycle of VIR-1388, and the Foundation has also supported the Company's development of therapies for the treatment of HIV, the prevention of tuberculosis, and the prevention of malaria. The Phase 1 trial of VIR-1388 will take place in domestic and international sites within the federally funded HIV Vaccine Trials Network as study HVTN 142.

Vir Biotechnology HIV Vaccine News

September 20, 2023 - "HIV continues to be a major global public health challenge with no approved vaccines despite decades of research efforts," said Carey Hwang, M.D., Ph.D., Vir's Senior Vice President, Clinical Research, Head of Chronic Infection. "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 1 trial. We are hopeful that our unique approach will help close the longstanding public health gap in HIV prevention."

February 25, 2021 - Vir Biotechnology initiated a Phase 1 clinical trial of VIR-1111, an investigational HIV T-cell vaccine based on human cytomegalovirus.

January 6, 2021 - Vir Biotechnology Announces Initiation of Phase 1 Clinical Trial to Evaluate a Novel Vaccine Platform.

January 6, 2021 - An HIV vaccine candidate that Oregon Health & Science University researchers have been developing for the past two decades is being tested in people for the first time as part of the Phase 1 clinical trial. OHSU's pre-clinical research into the cytomegalovirus-based HIV vaccine has shown it works well in nonhuman primates.

January 25, 2017 - A first-of-its-kind vaccine technology platform developed by renowned scientists at OHSU in Portland, Oregon, has been acquired by Vir Biotechnology, a San Francisco-based biotech startup backed by leading industry investor ARCH Venture Partners and the Bill & Melinda Gates Foundation.

September 11, 2013 -  A study published in Nature found the experimental vaccine completely cleared SIV, a monkey form of HIV, in about half of the rhesus macaques that were vaccinated and exposed to the virus. 'These data provide compelling evidence for progressive clearance of a pathogenic lentiviral infection and suggest that some lentiviral reservoirs may be susceptible to the continuous effector memory T-cell-mediated immune surveillance elicited and maintained by cytomegalovirus vectors.'

VIR-1111 HIV Vaccine Clinical Trials

ClinicalTrials.gov Identifier: NCT05854381 - To Investigate Safety, Reactogenicity, and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV. Last Update Posted: December 15, 2023.

ClinicalTrials.gov Identifier: NCT04725877  VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers - Last Update Posted: January 27, 2021. The randomized, placebo-controlled, Phase 1 clinical trial evaluates the safety and immunogenicity (ability to induce an immune response) of VIR-1111. The trial enrolls healthy adults (ages 18 to 50) who are at low risk of HIV infection and previously infected with human cytomegalovirus. They will receive two doses of VIR-1111 or placebo given by subcutaneous injection and be assessed for safety, reactogenicity (common, expected adverse reactions following vaccination, such as pain and redness), tolerability, and immunogenicity.