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Polyvalent meningococcal conjugate vaccine enters late-stage clinical study

A meningococcal conjugate vaccine using chemistry developed at Fina Biosolutions has entered a pivotal phase III trial. FinaBio patents for CPIP conjugation were exclusively licensed to the Serum Institute of India. This license allowed the Serum Institute of India to circumvent a big big pharma patent thicket and will pave the way for a low cost pentavalent meningococcal conjugate vaccine.

The story is detailed in the PATH newsletter, “Moving the Needle”:

Africa’s meningitis story reached an important milestone in August, when a meningococcal serogroups ACWXY conjugate vaccine developed and manufactured by Serum Institute of India Pvt. Ltd. (SIIPL) entered a pivotal Phase 3 clinical study (NCT03964012). Supported by PATH, SIIPL, and the UK Department for International Development, sites in Banjul, The Gambia, and Bamako, Mali, will enroll a total of about 1,800 participants 2 to 29 years of age. The study will investigate the vaccine’s safety and immunogenicity to generate data in support of licensure and World Health Organization (WHO) prequalification.

Africa’s meningitis belt—26 countries stretching from Senegal to Ethiopia—has long been plagued by annual meningitis epidemics. That changed in 2010 when MenAfriVac®, a meningitis A conjugate vaccine, was introduced. MenAfriVac has since been delivered to more than 305 million people and has virtually eliminated meningitis A wherever it has been used. However, other meningococcal serogroups can cause epidemics, including C, W, X, and Y. Globally, meningococcal serogroups ACWY conjugate vaccines exist, but there is no vaccine against meningococcal serogroup X; and, the meningococcal ACWY conjugate vaccines that do exist are too expensive for African nations. An affordable meningococcal ACWXY conjugate vaccine could end epidemic meningococcal meningitis in Africa once and for all.

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