vaccination schedule could significantly expand global HPV vaccine coverage.
HPV vaccination is known to be highly effective in preventing infections with high-risk virus types responsible for cervical cancer. Despite this, uptake remains inadequate in many countries, largely due to logistical challenges associated with multidose schedules. Recent observational studies have hinted that even a single dose might generate strong immunity, prompting researchers to test this possibility through a randomized controlled trial rigorously.
The trial enrolled 20,330 girls aged 12 to 16 years, who were randomly assigned to one of four groups: a single dose of the bivalent vaccine, two doses of the bivalent vaccine, a single dose of the nonavalent vaccine, or two doses of the nonavalent vaccine. The primary outcome was the occurrence of new HPV type 16 or 18 infections—two strains most strongly linked to cervical cancer—detected between 12 and 60 months post-vaccination and persisting for at least six months. A prespecified noninferiority margin of 1.25 infections per 100 participants was set to determine whether one dose performed comparably to two.
To strengthen the assessment of effectiveness, the study also incorporated data from a separate nonrandomized survey that included 3005 unvaccinated girls and women, serving as an external comparison group.
According to the authors, these results have significant implications for global immunization efforts. If countries adopt a single-dose schedule, vaccine access could broaden considerably, especially in low- and middle-income regions where cervical cancer remains a major public health burden.
The study concludes that one dose of either the bivalent or nonavalent HPV vaccine offers robust protection against HPV16 and HPV18 infections, performing on par with the traditional two-dose approach. As policymakers update immunization guidelines, this evidence could pave the way for simplified, more accessible HPV vaccination strategies worldwide.
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