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Expanding access to HPV vaccines: PATH to evaluate safety and immunogenicity of new HPV vaccine

August 31, 2020 by Tara Newton

PATH, Innovax, KfW, and the Bill & Melinda Gates Foundation are partnering to expand options for human papillomavirus (HPV) vaccines in the countries that need them most.

Cervical cancer is a leading cause of cancer deaths among women in low- and middle-income countries (LMICs). More than 570,000 new cases and 311,000 deaths occur annually, with more than 85 percent of deaths occurring in LMICs, according to the World Health Organization (WHO).

HPV vaccines are highly effective and have significantly decreased HPV infections and precancerous cervical lesions in countries where they have been introduced. However, uptake in LMICs has been slower than expected due to financial and logistical barriers, including global supply constraints.

The entry of new HPV vaccines into the global market, such as CecolinĀ®, an HPV vaccine manufactured by Xiamen Innovax Biotech Co., Ltd (Innovax), and recently approved in China, may help to address these obstacles. This new HPV vaccine is designed to protect against HPV types 16 and 18, the most common virus types that lead to cervical cancer. WHO recently accepted Cecolin for prequalification evaluation. This is an important milestone in expanding the reach of this new vaccine and in the global fight against cervical cancer.

While pre-licensure trials to date have proven Cecolin to be safe and efficacious, additional data can facilitate further confidence in the vaccine for global recommending bodies and individual countries. These data include direct immunological comparison with a WHO-prequalified HPV vaccine; evidence of safety and immunogenicity in populations from outside China and in countries of highest potential impact; data on the use of flexible schedules to permit extended-interval vaccination; and country-specific health economic analyses of HPV vaccination to help governments assess the true value of the intervention.

To generate this evidence, PATH will conduct a phase 3 randomized controlled trial of Cecolin comparing three different two-dose regimens against GardasilĀ®, the most widely used HPV vaccine. The trial, known as CHOISE (Comparing HPV Vaccine Options: Immunogenicity and Safety Evaluation), will take place in Bangladesh and Ghana. Enrollment is anticipated to start in Fourth Quarter 2020. The schedule is subject to change depending on the current COVID-19 pandemic.

In parallel, PATH will also conduct a set of economic evaluations, including country-specific cost-effectiveness analyses and assessments of the costs of and barriers to HPV vaccination and treatment to inform evidence gaps at the global and country levels.

Financial support for this project is provided to PATH by the German government through KfW, a German state-owned development bank, and by the Bill & Melinda Gates Foundation. Innovax will donate the vaccine for the trial and will provide additional technical and regulatory support as needed, but it will have no influence on the collection, interpretation, or reporting of the results.

WHO recommends two doses of HPV vaccine for girls aged 9 to 14 years and three doses for girls aged 15 years and older and those who are immune compromised or HIV positive (regardless of age).