ArticleInfectious medicine2025
Long-term protective efficacy of the
Article in Infectious medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01735006 (A Phase III Multicenter, Randomized, Double-Blind, Placebo), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III Multicenter, Randomized, Double-Blind, Placebo(Hepatitis E Vaccine)Controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant(E.Coli)Human Papillomavirus Bivalent Vaccine in Healthy Women
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Authors and funding
4 authors.
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Abstract
Background: To assess the enduring protective efficacy of the recombinant human papilloma virus (HPV) 16/18 bivalent vaccine (produced in Methods: A long-term follow-up study was conducted in Xinmi, Henan Province, in September 2022, 9 years post-administration of the initial vaccine dose. This study was grounded in the phase III clinical trial of the vaccine (NCT01735006). Participants were recalled to collect exfoliated cervical cells for HPV DNA genotyping. The long-term protective efficacy of the vaccine against HPV infection was evaluated using Poisson distribution. Results: A total of 1 123 volunteers were recalled, comprising 558 individuals in the experimental group and 565 in the control group, with mean ages of 30.80 ± 7.33 years and 30.64 ± 7.51 years, respectively. At baseline (0 days before vaccination), 147 participants (13.09%) were infected with any type of HPV. By the ninth year of follow-up, the overall HPV infection rate within the entire cohort had increased to 16.65%. In the intention-to-treat analysis, the demonstrated protective efficacy against HPV-16, HPV-18, and HPV-16/18 was 83.12% (95% confidence interval [CI]: 24.20-98.17), 100.00% (95% CI: -10.50 to 100.00) and 87.34% (95% CI: 46.17-98.59), respectively. In the modified intention-to-treat analysis, the protective efficacy of the vaccine against HPV-16, HPV-18, and HPV-16/18 was 82.90% (95% CI: 23.20-98.14), 100.00% (-10.71 to 100.00), and 87.36% (95% CI: 46.20-98.59), respectively. Conclusions: Vaccination with the bivalent HPV vaccine offers long-term protection against HPV-16/18 infections for at least 9 years.
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