Merck to start trials investigating single dosing regimen of HPV vaccine

2024-03-13

上市批准疫苗临床1期

Merck to start trials investigating single dosing regimen of HPV vaccine

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来源: Pharmaceutical Technology

Gardasil 9 was approved by the US FDA to prevent certain cancers, such as cervical, anal, oropharyngeal, and head and neck cancers, caused by nine different HPV in 2014. Image Credit: Katherine Welles / Shutterstock.

Merck & Co (MSD) plans to start two prospective clinical trials evaluating the safety and efficacy of a single-dose regimen of its multivalent human papillomavirus (HPV) vaccine, Gardasil 9 (recombinant Human Papillomavirus 9-valent).

The company plans to conduct two separate trials investigating Gardasil 9 in men and women aged 16-26 years to evaluate whether a single dose of the vaccine provides comparable long-term protection, compared to the approved three-dose regimen. The study is expected to start enrolment in Q4 of this year.

Gardasil 9 was approved by the US Food and Drug Administration (FDA) to prevent certain cancers, such as cervical, anal, oropharyngeal, and head and neck cancers, caused by nine different HPV types in 2014. The vaccine is indicated for individuals aged 9-45 years. It is administered in a three-dose schedule for people aged 15-45 years but it can be given in a two or three-dose schedule for children aged 9-14 years.

The vaccine coverage for HPV remains low worldwide. As per the World Health Organization’s (WHO) latest vaccine coverage statistics, global coverage by full dose in 2022 was 15% and 5% in females and males, respectively. First dosage coverage was higher at 21% and 6% in females and males, respectively, during the same period.

In a push to boost coverage, the WHO updated its scheduling recommendations in December 2022. The new recommendations say that one dose of vaccine can adequately protect women aged 9-14 years against cervical cancer caused by HPV, specifically, HPV 16 and HPV 18 strains.