Safety and Efficacy of Single-Dose versus Multiple-Dose HPV Vaccination in Women: A Systematic Review of Randomized Controlled Trials
Papillomavirus vaccines; cervical cancer prevention; female; HPV vaccination; single-dose regimen.
Objective: To evaluate the safety and efficacy of single-dose HPV vaccines compared to multiple-dose regimens, other vaccines, or no vaccination. Study selection: This systematic review of randomized controlled trials compared to safety and efficacy of the single-dose HPV vaccine in women. Studies evaluating only multiple dose regimens were excluded; there were no restrictions regarding language or publication date. The PubMed, Embase, Web of Science, Scopus, Cochrane, ClinicalTrails.gov, and SciELO databases were searched from inception to March 2026, using the terms "Woman," "human papillomavirus," and "papillomavirus vaccines." The primary outcome was local, systemic, and serious adverse events and Efficacy of the single-dose vaccine and incidence of HPV types 16 and 18. Data collection: Analyses followed Cochrane and PRISMA guidelines. Data synthesis: Initial search resulted in 1,058 articles. After removing duplicates, 545 studies were evaluated by title and abstract. Of these, 20 were retrieved and evaluated in full. Finally, seven randomized controlled trials (RCTs) met the inclusion criteria, totaling 26,719 participants aged between 9 and 45 years. Analysis of clinical trials indicates that single-dose vaccination presents a favorable safety profile, with self-limited adverse events, and rates of serious events comparable to those of multiple-dose schedules. The single dose schedules demonstrated efficacy against HPV types 16 and 18 similar to two- or three-dose schedules, establishing itself as a potential efficient and safe strategy for the prevention of cervical cancer. Conclusion: Single-dose HPV vaccination is capable of providing sustained safety and efficacy when compared to multiple-dose schedules.