Fortress Biotech and its partner Helocyte have commenced a Phase II clinical trial of the cytomegalovirus (CMV) vaccine, Triplex, in adult subjects co-infected with human immunodeficiency virus (HIV) and CMV.
Triplex is a universal recombinant Modified Vaccinia Ankara viral vector vaccine.
Developed by City of Hope, the vaccine’s intellectual property was exclusively licenced to Helocyte in 2015.
It can potentially elicit a strong and long-lasting virus-specific T cell response to three immuno-dominant proteins associated with CMV events in infected people.
The double-blind, placebo-controlled, randomised trial is designed to analyse the safety and immunogenicity of two intramuscular deltoid doses of the Triplex vaccine in adult subjects aged 18 to 65 years co-infected with HIV and CMV.
Carried out by the AIDS Clinical Trials Group, the trial is funded by the US National Institutes of Health unit National Institute of Allergy and Infectious Diseases and partnering institutes.
It will enrol 90 subjects, who will be categorised to receive either Triplex (60) or placebo (30) on days zero and 28.
Subsequently, the subjects will be followed up for another 92 weeks after the second dose.
At least 25% of the subjects in the trial will be cisgender or transgender women while all the patients should have undetectable HIV on antiretroviral treatment.
Fortress Biotech chairman, president and CEO Lindsay Rosenwald said: “We are pleased to further study Triplex in adults co-infected with CMV and HIV, as it has already demonstrated safety, immunogenicity and efficacy in previous clinical trials.
“This clinical trial will evaluate Triplex’s potential ability to reduce systemic inflammation among adults living with HIV, which can be linked to a number of health issues that complicate their care and impact their quality of life.”
In various Phase I and II trials enrolling more than 100 participants, Triplex was found to be safe, well-tolerated, effective and immunogenic.
Earlier this month, Takeda Pharmaceutical reported that the Phase III SOLSTICE trial of Livtencity in people with post-transplant refractory CMV infections with or without resistance, met the primary goal.