The Phase I/IIa trial will assess the safety, reactogenicity and immunogenicity of the vaccine regimen. Credit: Marco Verch.

Denmark-based biotechnology firm Bavarian Nordic has initiated and started dosing patients in a Phase I/IIa clinical trial of MVA-BN HPV prime-boost vaccine regimen for chronic infections with high-risk subtypes of the human papillomavirus (HPV) of the cervix.

The clinical trial is part of Bavarian Nordic’s strategic alliance with Janssen Vaccines & Prevention for the development of new vaccination methods to treat HPV, HIV and Hepatitis B.

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Under the HPV programme, the partners are working on developing a therapeutic vaccine for women with persistent HPV types 16 or 18 infection.

MVA-BN HPV vaccine is based on Bavarian Nordic’s MVA-BN and Janssen’s AdVac technologies. It has been licensed to Janssen Vaccines & Prevention, which is sponsoring the product’s clinical development.

The randomised, double-blind, placebo-controlled, Phase I/IIa trial will assess the safety, reactogenicity, and immunogenicity of the vaccine regimen in 66 patients with persistent HPV16 or 18 infection of the cervix.

“While preventative HPV vaccines have become widely available since their launch only a little over a decade ago, HPV remains the most common sexually transmitted infection.”

In specific, the study will evaluate monovalent HPV16 and HPV18 Ad26-vectored vaccine components and an MVA-vectored HPV16/18 vaccine component (MVA-BN HPV).

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Primary outcome measures of the trial are the proportion of subjects with solicited local and systemic adverse events (AEs), unsolicited AEs and serious adverse events (SAEs).

Bavarian Nordic president and CEO Paul Chaplin said: “While preventative HPV vaccines have become widely available since their launch only a little over a decade ago, HPV remains the most common sexually transmitted infection resulting in a continued high incidence rate of cervical cancer.

“Building on our strong clinical experience with the AdVac/MVA-BN vaccine platform from the development of an Ebola vaccine with Janssen, we are excited to explore this new approach, which might represent a significant opportunity to transform the treatment paradigm in cervical and other HPV-induced cancers.”

The agreement will mean the initiation of the Phase II portion of the Phase I/IIa trial triggers a milestone payment of $12.5m to Bavarian Nordic.