Implementation challenges and immunogenicity outcomes of single-dose vs multi-dose hpv vaccination programs in low- and middle-income area in ahmedabad city

Background and Objective: Cervical cancer remains a leading cause of cancer mortality among women in low- and middle-income countries (LMICs), driven primarily by delayed screening and constrained access to multi-dose Human Papillomavirus (HPV) prophylactic vaccination. The World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) recently endorsed single-dose HPV vaccination regimens to mitigate global supply shortfalls and reduce delivery barriers. However, real-world data combining immunogenicity persistence with implementation logistics in hospital-affiliated gynecologic oncology outreach networks remain sparse. Methods: We conducted a pragmatic implementation study evaluated within the Department of Gynecologic Oncology community screening network. A pilot cohort of 20 adolescent girls (aged 9–14 years) enrolled across rural outreach screening hubs was stratified into a Single-Dose (SD, n=10) arm and a Multi-Dose (MD, 2-dose, n=10) arm. Primary outcomes included 12-month Anti-HPV 16 and Anti-HPV 18 antibody titers (measured via ELISA in IU/mL), program completion rates, delivery cost per fully immunized individual, and cold-chain adherence metrics. Results: Both single-dose and multi-dose schedules demonstrated 100% seroconversion at Month 12. Geometric mean antibody titers for Anti-HPV 16 were 182.4 ± 24.1 IU/mL in the SD group compared to 198.6 ± 28.3 IU/mL in the MD group, fulfilling predefined statistical non-inferiority criteria (p = 0.185). Anti-HPV 18 titers similarly displayed non-inferior responses (108.3 ± 15.6 vs. 119.5 ± 18.2 IU/mL, p = 0.158). Crucially, the Single-Dose regimen achieved a 100% protocol completion rate compared to 70% in the Multi-Dose arm (p = 0.070, Fisher's exact), while significantly reducing the mean delivery cost per fully protected participant from $32.40 to $14.20 (p < 0.001) and lowering cold-chain breach vulnerabilities by 64%. Conclusion: A single-dose HPV vaccination strategy provides robust, non-inferior short-term immunogenicity while removing the substantial drop-off and financial burden associated with second-dose delivery in LMIC settings. Integrating single-dose campaigns into Gynecologic Oncology preventive outreach offers a scalable path toward achieving global cervical cancer elimination goals.