Bivalent HPV vaccine Cecolin® demonstrates strong safety and immunogenicity in low- and middle-income country populations and in various dosing schedules
Results from a Phase 3 clinical study of Innovax’s WHO prequalified vaccine can help expand access globally and give countries another option for affordable, sustainable HPV vaccine.
Detailed results from a Phase 3 study of Cecolin® were published in The Lancet Infectious Diseases. Cecolin is manufactured by Xiamen Innovax Biotech Co. Ltd. (Innovax), a wholly owned subsidiary of Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. and is designed to protect against human papillomavirus (HPV) types 16 and 18, the most common virus types that lead to cervical cancer.
Cecolin achieved World Health Organization (WHO) prequalification in 2021, a designation that ensures a vaccine meets strict international quality, safety, and efficacy standards and that allows it to be procured by United Nations agencies and Gavi, the Vaccine Alliance. Though prequalification is a critical step for expanding access, Cecolin’s efficacy had only been studied in populations in China up to that point. To build a broader evidence base for its use, and to help countries feel confident in considering it for their vaccination programs, PATH supported a Phase 3 study of Cecolin that examined its performance in low- and middle-income countries and in extended and alternative dosing schedules, including single-dose administration.
With funding from the Federal Ministry of Education and Research in Germany via KfW Development Bank and the Gates Foundation, PATH sponsored the study that took place between March 2021 and December 2023 in Bangladesh and Ghana. A total of 1,025 girls between the ages of 9 and 14 were enrolled across the two sites and received either a two-dose regimen of Cecolin 6, 12, or 24 months apart; a two-dose regimen of the comparator vaccine Gardasil® 6 months apart; or a single dose of Gardasil followed 24 months later by a single dose of Cecolin.
Study results demonstrated that Cecolin is highly immunogenic in extended and alternative dosing schedules, including as a single dose, and generated immune responses comparable to Gardasil® (which has been available since 2006 and is the most commonly used HPV vaccine in low- and middle-income countries).
Based on the study data, in October 2024, WHO revised its Considerations for HPV Vaccine Product Choice document and added Cecolin to the list of HPV vaccines that can be administered on a single-dose schedule. Single-dose vaccination can improve HPV vaccine coverage and help alleviate global HPV vaccine supply challenges—giving more countries options for affordable HPV vaccination and helping to protect them against cervical cancer.
About HPV
HPV is extremely common worldwide. Of the more than 200 types of the virus, at least 12 are cancer causing—including types 16 and 18, which cause about 70 percent of cervical cancers globally. Cervical cancer is a leading cause of cancer death among women in countries with low- and middle-income economies.
HPV vaccines are highly effective. Since their introduction, they have significantly reduced vaccine-type HPV infections and precancerous cervical lesions. The WHO’s global strategy to accelerate the elimination of cervical cancer calls on countries to, by the year 2030, fully vaccinate 90 percent of girls against HPV by age 15. WHO recommends one or two doses of HPV vaccine in girls and women between 9 and 20 years of age.
About PATH
PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing health challenges. For more information, visit https://www.path.org.
About Xiamen Innovax Biotech Co. Ltd.
Innovax is a wholly owned subsidiary of Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. under the YangShengTang Group. Established in 2005, Innovax is dedicated to providing innovative, reliable, and affordable vaccines to combat infectious diseases. Innovax established a core platform using recombinant technology to express protein in Escherichia coli for vaccine production. Based on this platform, the world’s first hepatitis E vaccine, Hecolin®, was launched in China in October 2012. Cecolin was licensed in China in December 2019. In addition, Innovax initiated a Phase 3 clinical trial with its 9-valent HPV candidate vaccine and the clinical trial is proceeding as planned.