RESUMEN
OBJECTIVES: To evaluate the reporting rate of adverse events following immunization (AEFI) of the quadrivalent human papillomavirus vaccine (4vHPV) and to compare the reporting rate of AEFI following 4vHPV with those following other vaccines. METHODS: Review and describe the AEFI reported to national adverse event following immunization surveillance system (NAEFISS) in Zhejiang province from 2018 to 2020. Reporting rates of AEFI were calculated by age, city, severity of AEFI, categories of AEFI, and reaction categories. The data mining algorithm used in this study was reporting odds ratio (ROR). A value of ROR1.96SE >1 (standard error [SE]) was considered as positive signal. RESULTS: NAEFISS received 238 reports after receipt of 4vHPV and 899,282 doses of 4vHPV were administered during the study period, with a crude reporting rate of 2.7/10000 doses. Fever/redness/induration (101 reports) was the most common event reported (1.12/10000 doses). Two cases of anaphylactic shock, three cases of Guillain Barre Syndrome and two cases of acute disseminated encephalomyelitis were reported. ROR showed positive signals for seizure (ROR1.96SE: 2.1), syncope (ROR1.96SE: 1.3), allergic rash (ROR1.96SE: 1.6) and headache (ROR1.96SE: 2.1). CONCLUSION: The present analysis did not identify new/unexpected safety concerns. Further epidemiological studies are required to systematically validate the data provided by NAEFISS.
Asunto(s)
Síndrome de Guillain-Barré , Vacunas contra Papillomavirus , Sistemas de Registro de Reacción Adversa a Medicamentos , Síndrome de Guillain-Barré/inducido químicamente , Humanos , Inmunización/efectos adversos , Vacunas contra Papillomavirus/efectos adversos , Vacunación/efectos adversosRESUMEN
BACKGROUND: The quadrivalent human papillomavirus (qHPV; HPV6/11/16/18) vaccine was approved for use in Chinese women aged 20-45 years in 2017. This Phase 3, open-label study (NCT03493542) aimed to assess immunogenicity and safety of the qHPV vaccine in Chinese girls aged 9-19 years versus Chinese young women aged 20-26 years; we report results from Day 1 through Month 7. The study will continue through Month 60 to assess antibody persistence in Chinese girls aged 9-19 years. METHODS: Participants aged 9-26 years received three doses of the qHPV vaccine (Day 1, Month 2, Month 6). Geometric mean titers (GMTs) and seroconversion percentages for anti-HPV6/11/16/18 antibodies were determined by competitive Luminex immunoassay (cLIA) in serum samples obtained on Day 1 and at Month 7. Injection-site adverse events (AEs) and systemic AEs within 30 days post-vaccination, and serious AEs (SAEs) occurring at any time during the study, were recorded. RESULTS: In total, 766 participants (383 aged 9-19 years; 383 aged 20-26 years) were enrolled and received ≥1 vaccine dose. All participants in the per-protocol immunogenicity population of both age groups seroconverted to each of the vaccine HPV types at Month 7. Anti-HPV6/11/16/18 antibody GMTs at Month 7 in participants aged 9-19 years were non-inferior to those in participants aged 20-26 years. Injection-site AEs and systemic AEs were reported by 36.6% and 49.3% of 9-19-year-olds, and 40.7% and 54.8% of 20-26-year-olds, respectively. There were no vaccine-related SAEs. No participants discontinued the vaccine due to an AE and no deaths were reported. CONCLUSION: Antibody responses induced by the 3-dose qHPV vaccination regimen in Chinese girls aged 9-19 years were non-inferior to those in Chinese young women aged 20-26 years. The vaccine was generally well tolerated in the study population. ClinicalTrials.gov Identifier: NCT03493542.
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Infecciones por Papillomavirus , Vacunas contra Papillomavirus , Adolescente , Adulto , Anticuerpos Antivirales , Niño , China , Femenino , Humanos , Inmunogenicidad Vacunal , Persona de Mediana Edad , Papillomaviridae , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/efectos adversos , Adulto JovenRESUMEN
Post-marketing studies are commonly performed to follow-up on the safety and effectiveness of a drug or vaccine after approval has been obtained. These post-marketing studies may involve the collection of real-world data from registries and clinical biobanks in order to obtain real-world evidence. As this approach can monitor the effects of pharmaceutical products over decades, it is particularly necessary for the development of safe and effective vaccines. A long-term follow-up (LTFU) study was initiated as an extension of a phase 3 clinical study (V501-015; NCT00092534) to assess the effectiveness, immunogenicity and safety of the quadrivalent human papillomavirus (qHPV) vaccine for up to 14â¯years after the start of vaccination. The LTFU study included participants from Denmark, Iceland, Norway, and Sweden, and assessed qHPV vaccine effectiveness against cervical pre-cancers and cancers caused by the oncogenic HPV types 16 and 18. In particular, our study utilized Nordic national health registries, in which individual patient records were linked by a unique Personal Identity Number. Here, we describe the overall implementation and methodology of the qHPV vaccine LTFU study conducted in the Nordic region. The LTFU study format we describe here supported a comprehensive follow-up process, with near-complete retrieval of registry data and specimens from local laboratories achieved in a timely manner; therefore, we have demonstrated that such a collection is feasible and can be used to address stringent post-marketing requirements.
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Vacuna Tetravalente Recombinante contra el Virus del Papiloma Humano Tipos 6, 11 , 16, 18/efectos adversos , Vacuna Tetravalente Recombinante contra el Virus del Papiloma Humano Tipos 6, 11 , 16, 18/inmunología , Infecciones por Papillomavirus/prevención & control , Neoplasias del Cuello Uterino/prevención & control , Adolescente , Adulto , Femenino , Estudios de Seguimiento , Humanos , Infecciones por Papillomavirus/virología , Vigilancia de Productos Comercializados , Sistema de Registros , Países Escandinavos y Nórdicos , Neoplasias del Cuello Uterino/virología , Adulto JovenRESUMEN
BACKGROUND: A quadrivalent human papillomavirus (qHPV) vaccine (HPV6/11/16/18) has demonstrated efficacy and acceptable safety in international studies. However, these studies did not include participants from mainland China, which has a substantial burden of HPV-related disease. This is the first safety report with a follow-up period of up to 90â¯months from a randomized, double-blind, placebo-controlled trial of qHPV vaccine in Chinese women 20-45â¯years of age. METHODS: Participants were randomized 1:1 to receive three doses of qHPV vaccine or placebo (Day1, Month 2, and Month 6). Efficacy outcomes are reported elsewhere. Injection-site and systemic adverse events (AEs) were collected using vaccination report cards (VRCs) for 15â¯days following each vaccination. Serious AEs (SAEs), pregnancy outcomes, new medical conditions, and fetal/infant SAEs were collected during the entire study. RESULTS: Of 3006 participants randomized, AEs were reported by 926 (61.8%) qHPV vaccine recipients and 856 (57.1%) placebo recipients over the entire study. Four participants (two in each group) discontinued the study vaccination due to AEs that were considered vaccination-related. Within 15â¯days following any vaccination, injection-site AEs prompted for on the VRC were more frequent among qHPV vaccine recipients (37.6% vs 27.8%), and systemic AEs prompted for on the VRC were similar in frequency between qHPV vaccine and placebo groups (46.8% vs 45.1%). Thirty-eight and 43 participants reported SAEs in qHPV vaccine and placebo groups, respectively. No SAE was considered qHPV vaccine-related. Pregnancy outcomes, fetal/infant SAEs, and new medical conditions were generally similar in frequency between the qHPV vaccine and placebo groups, and within normal ranges. CONCLUSION: The qHPV vaccine was well tolerated and demonstrated a favorable safety profile in Chinese women 20-45â¯years of age, consistent with findings from global trials and safety surveillance studies. TRIAL REGISTRATION: clinicaltrials.gov; NCT00834106.
Asunto(s)
Anticuerpos Antivirales/sangre , Vacuna Tetravalente Recombinante contra el Virus del Papiloma Humano Tipos 6, 11 , 16, 18/administración & dosificación , Infecciones por Papillomavirus/prevención & control , Adulto , Pueblo Asiatico , China , Método Doble Ciego , Femenino , Estudios de Seguimiento , Vacuna Tetravalente Recombinante contra el Virus del Papiloma Humano Tipos 6, 11 , 16, 18/inmunología , Humanos , Persona de Mediana Edad , Vacunación/efectos adversos , Vacunación/estadística & datos numéricos , Potencia de la Vacuna , Adulto JovenRESUMEN
BACKGROUND: A quadrivalent human papillomavirus vaccine (qHPV; HPV6/11/16/18) has demonstrated efficacy and effectiveness worldwide. We report qHPV vaccine efficacy for up to 6.5â¯years after first administration among Chinese women 20-45â¯years of age. METHODS: In this randomized, double-blind, placebo-controlled, multicenter, Phase 3 study (NCT00834106), women were randomized 1:1 to receive 3 doses of qHPV vaccine or placebo (Day 1, Month 2, Month 6). Endo-ecto-cervical and external genital swabs were collected for HPV testing and gynecologic examinations, and cervical cytology testing were performed at Day 1 and Months 7, 12, 18, 24, 30, 42, 54, 66, and 78. Any abnormality in cytology testing would trigger colposcopy examination and cervical biopsy, if necessary. Efficacy against genital disease, persistent infection, and the composite endpoint was assessed. Primary efficacy analyses were conducted in the per-protocol efficacy (PPE) population. RESULTS: Of 3006 participants randomized, 2759 (91.8%) and 2374 (79%) completed the Month 30 and Month 78 visits, respectively. At Month 78, efficacy among women aged 20-45â¯years was 100% (95% CI: 32.3, 100; 0 vs 7 cases) and 100% (95% CI: 70.9, 100; 0 vs 14 cases) against HPV16/18-related cervical intraepithelial neoplasia Grade 2 or 3, adenocarcinoma in situ, and cervical cancer (CIN 2+) and HPV6/11/16/18-related CIN 1+, respectively, in the PPE population. The efficacy against cervical 6-month and 12-month persistent infection was 91.6% (95% CI: 66.0, 99.0) and 97.5% (95% CI: 85.1, 99.9) at Month 30 and Month 78, respectively, in the PPE population. The vaccine also reduced the rate of cervical cytology abnormalities associated with HPV6/11/16/18, with an efficacy of 94.0% (95% CI: 81.5, 98.8). The vaccine was generally well tolerated (reported separately). CONCLUSION: The qHPV vaccine is efficacious against endpoints of persistent infection and genital precancerous lesions in Chinese women aged 20-45â¯years.
Asunto(s)
Vacuna Tetravalente Recombinante contra el Virus del Papiloma Humano Tipos 6, 11 , 16, 18/inmunología , Infecciones por Papillomavirus/complicaciones , Infecciones por Papillomavirus/prevención & control , Neoplasias del Cuello Uterino/prevención & control , Adulto , Pueblo Asiatico , China , Método Doble Ciego , Femenino , Estudios de Seguimiento , Genitales Femeninos/patología , Genitales Femeninos/virología , Vacuna Tetravalente Recombinante contra el Virus del Papiloma Humano Tipos 6, 11 , 16, 18/administración & dosificación , Humanos , Esquemas de Inmunización , Persona de Mediana Edad , Placebos/administración & dosificación , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: The Food and Drug Administration (FDA) approved quadrivalent human papillomavirus vaccine (4vHPV) for use in females and males aged 9-26â¯years, since 2006 and 2009 respectively. We characterized reports to the Vaccine Adverse Event Reporting System (VAERS), a US spontaneous reporting system, in females and males who received 4vHPV vaccination. METHODS: We searched VAERS for US reports of adverse events (AEs) following 4vHPV from January 2009 through December 2015. Signs and symptoms were coded using Medical Dictionary for Regulatory Activities (MedDRA). We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reports. Clinicians reviewed available information, including medical records, and reports of selected pre-specified conditions. FINDINGS: VAERS received 19,760 reports following 4vHPV; 60.2% in females, 17.2% in males, and in 22.6% sex was missing. Overall, 94.2% of reports were non-serious; dizziness, syncope and injection site reactions were commonly reported in both males and females. Headache, fatigue and nausea were commonly reported serious AEs. More than 60 million 4vHPV doses were distributed during the study period. Crude AE reporting rates were 327 reports per million 4vHPV doses distributed for all reports, and 19 per million for serious reports. Among 29 verified reports of death, there was no pattern of clustering of deaths by diagnosis, co-morbidities, age, or interval from vaccination to death. INTERPRETATION: No new or unexpected safety concerns or reporting patterns of 4vHPV with clinically important AEs were detected. Safety profile of 4vHPV is consistent with data from pre-licensure trials and postmarketing safety data.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Alphapapillomavirus/inmunología , Infecciones por Papillomavirus/epidemiología , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/efectos adversos , Vacunas contra Papillomavirus/inmunología , Vigilancia de Productos Comercializados , Adolescente , Adulto , Teorema de Bayes , Niño , Preescolar , Femenino , Humanos , Masculino , Vigilancia en Salud Pública , Estados Unidos/epidemiología , Vacunación , Adulto JovenRESUMEN
IMPORTANCE: Outcomes of treating high-grade squamous intraepithelial lesions (HSIL), a precursor to anal cancer, remain uncertain. Emerging evidence shows that post HSIL treatment adjuvant quadrivalent human papillomavirus (qHPV) vaccination improves the effectiveness of treatment. However, no recommendations exist regarding the use of qHPV vaccine as an adjuvant form of therapy. Our objective was to determine whether post-treatment adjuvant vaccination should be adopted in HIV-infected MSM (individuals at highest risk for anal cancer) on the basis of cost-effectiveness determined using existing evidence or whether future research is needed. METHODS: We developed a Markov (state-transition) cohort model to assess the cost-effectiveness of post-treatment adjuvant HPV vaccination of 27years or older HIV-infected MSM. We first estimated cost-effectiveness and then performed value-of-information (VOI) analysis to determine whether future research is required by estimating the expected value of perfect information (EVPI). We also estimated expected value of partial perfect information (EVPPI) to determine what new evidences should have highest priority. RESULTS: With the incremental cost-effectiveness ratio (ICER) of $71,937/QALY, "treatment plus vaccination" was the most cost-effective HSIL management strategy using the willingness-to-pay threshold of 100,000/QALY. We found that population-level EVPI for conducting future clinical research evaluating HSIL management approaches was US$12 million (range $6-$20 million). The EVPPI associated with adjuvant qHPV vaccination efficacy estimated in terms of hazards of decreasing HSIL recurrence was $0 implying that additional data from a future study evaluating efficacy of adjuvant qHPV vaccination will not change our policy conclusion that "treatment plus vaccination" was cost-effective. Both the ICER and EVPI were sensitive to HSIL treatment compliance. CONCLUSION: Post-treatment adjuvant qHPV vaccination in HIV-infected MSM aged 27 or above is likely to be cost-effective. Use of adjuvant qHPV vaccination could be considered as a potential strategy to reduce rising anal cancer burden among these high-risk individuals.
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Neoplasias del Ano/prevención & control , Recurrencia Local de Neoplasia/prevención & control , Vacunas contra Papillomavirus/uso terapéutico , Neoplasias del Ano/inmunología , Análisis Costo-Beneficio , Infecciones por VIH/inmunología , Infecciones por VIH/prevención & control , Homosexualidad Masculina , Humanos , Masculino , Recurrencia Local de Neoplasia/inmunología , Infecciones por Papillomavirus/inmunología , Infecciones por Papillomavirus/prevención & controlRESUMEN
BACKGROUND: Recent evidence shows that quadrivalent human papillomavirus (qHPV) vaccination in men who have sex with men (MSM) who have a history of high-grade anal intraepithelial neoplasia (HGAIN) was associated with a 50% reduction in the risk of recurrent HGAIN. We evaluated the long-term clinical and economic outcomes of adding the qHPV vaccine to the treatment regimen for HGAIN in human immunodeficiency virus (HIV)-positive MSM aged ≥27 years. METHODS: We constructed a Markov model based on anal histology in HIV-positive MSM comparing qHPV vaccination with no vaccination after treatment for HGAIN, the current practice. The model parameters, including baseline prevalence, disease transitions, costs, and utilities, were either obtained from the literature or calibrated using a natural history model of anal carcinogenesis. The model outputs included lifetime costs, quality-adjusted life years, and lifetime risk of developing anal cancer. We estimated the incremental cost-effectiveness ratio of qHPV vaccination compared to no qHPV vaccination and decrease in lifetime risk of anal cancer. We also conducted deterministic and probabilistic sensitivity analyses to evaluate the robustness of the results. RESULTS: Use of qHPV vaccination after treatment for HGAIN decreased the lifetime risk of anal cancer by 63% compared with no vaccination. The qHPV vaccination strategy was cost saving; it decreased lifetime costs by $419 and increased quality-adjusted life years by 0.16. Results were robust to the sensitivity analysis. CONCLUSIONS: Vaccinating HIV-positive MSM aged ≥27 years with qHPV vaccine after treatment for HGAIN is a cost-saving strategy. Therefore, expansion of current vaccination guidelines to include this population should be a high priority.
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Neoplasias del Ano/prevención & control , Carcinoma in Situ/prevención & control , Infecciones por VIH/complicaciones , Infecciones por VIH/terapia , Homosexualidad Masculina , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/administración & dosificación , Adulto , Anciano de 80 o más Años , Neoplasias del Ano/epidemiología , Carcinoma in Situ/epidemiología , Costos y Análisis de Costo , Humanos , Masculino , Persona de Mediana Edad , Infecciones por Papillomavirus/epidemiología , Vacunas contra Papillomavirus/economía , Resultado del TratamientoRESUMEN
Focal epithelial hyperplasia (FEH) or Heck's disease is a rare, benign and asymptomatic mucosal proliferation associated with human papillomavirus (HPV) infection, mainly with genotypes 13 and 32. We report a florid case of FEH in an 11-year-old Haitian girl with systemic lupus erythematosus receiving immunosuppressive therapy. Cryotherapy was previously performed on numerous occasions with no results. We decided to prescribe a non-invasive and more comfortable treatment. A combination of topical retinoid and imiquimod cream was well tolerated and led to an important improvement. The evidence of infection by HPV-16 detected by polymerase chain reaction (PCR) technique, prompted us to prescribe the quadrivalent HPV vaccine (types 6, 11,16 and 18). Subsequent PCR sequencing with generic primers GP5-GP6 and further BLAST comparative analysis confirmed that genomic viral sequence in our case truly corresponded with HPV-32. This molecular misdiagnosis can be explained by the similarity between genomic sequences of both HPV-16 and -32 genotypes. At the 1-year follow up, we observed total clinical improvement and no recurrences of the disease. Complete healing in this case may correspond to a potential action of topical retinoid, imiquimod and the cross-protection mechanism of the quadrivalent HPV vaccine.
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Hiperplasia Epitelial Focal/diagnóstico , Papillomavirus Humano 16 , Papillomaviridae , Infecciones por Papillomavirus/diagnóstico , Infecciones por Papillomavirus/terapia , Adyuvantes Inmunológicos/administración & dosificación , Aminoquinolinas/administración & dosificación , Niño , Terapia Combinada , Errores Diagnósticos , Femenino , Hiperplasia Epitelial Focal/terapia , Hiperplasia Epitelial Focal/virología , Vacuna Tetravalente Recombinante contra el Virus del Papiloma Humano Tipos 6, 11 , 16, 18/administración & dosificación , Papillomavirus Humano 16/genética , Papillomavirus Humano 16/aislamiento & purificación , Humanos , Imiquimod , Papillomaviridae/clasificación , Papillomaviridae/genética , Papillomaviridae/aislamiento & purificación , Infecciones por Papillomavirus/virología , Retinoides/administración & dosificaciónRESUMEN
Adolescent immunization rates for human papillomavirus (HPV) are low and interventions within school-based health centers (SBHCs) may increase HPV uptake and series completion. We examined the effect of a parent health message intervention on HPV vaccination intent, first dose uptake and series completion among adolescents who received care at SBHCs. Via computer-assisted telephone interviews (CATI), 445 parents of young adolescents were randomly assigned to 2 two-level interventions using a 2 × 2 design (rhetorical question (RQ) or no-RQ and one-sided or two-sided message). The RQ intervention involved asking the parent a question they were likely to endorse (e.g., "Do you want to protect your daughter from cervical cancer?") with the expectation that they would then behave in a manner consistent with their endorsement (i.e., agree to vaccinate). For the one-sided message, parents were given information that emphasized the safety and effectiveness of HPV vaccine, whereas the two-sided message acknowledged that some parents might have concerns about the vaccine, followed by reassurance regarding the safety and effectiveness. At CATI conclusion, parents indicated intentions to have their adolescents vaccinated. Parents who endorsed any intent were sent a consent form to return and all adolescents with signed returned consents were vaccinated at SBHCs. Medical records were reviewed for uptake/completion. Parents were 87% female; adolescents were 66% male and racially/ethnically diverse. 42.5% of parents indicated some intention to immunize, 51.4% were unsure, and 6.1% were not interested. 34% (n = 151) of adolescents received their first dose with series completion rates of 67% (n = 101). The RQ component of the intervention increased intention to vaccinate (RR = 1.45; 95%CI 1.16,1.81), but not first dose uptake or series completion. The 1-sided and 2-sided messages had no effect. This brief, RQ health intervention enhanced intent, but did not impact vaccination rates, likely due to the time delay between the intervention and consent form receipt.
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Terapia Conductista/métodos , Educación en Salud/métodos , Inmunización/métodos , Inmunización/estadística & datos numéricos , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/administración & dosificación , Adolescente , Adulto , Niño , Femenino , Humanos , Entrevistas como Asunto , Masculino , Aceptación de la Atención de SaludRESUMEN
BACKGROUND: In 2006, quadrivalent human papillomavirus (HPV4; Gardasil, Merck & Co., Inc.) vaccine was licensed in the US for use in females aged 9-26 years. HPV4 is not recommended during pregnancy; however, inadvertent administration during pregnancy may occur. OBJECTIVES: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received HPV4 vaccine and assess for potentially concerning adverse events among non-manufacturer reports. METHODS: We searched the VAERS database for non-manufacturer reports of adverse events (AEs) in pregnant women who received HPV4 vaccine from 6/1/2006 to 12/31/2013. We conducted clinical review of reports and available medical records. RESULTS: We found 147 reports after HPV4 vaccine administered to pregnant women. The most frequent pregnancy-specific AE was spontaneous abortion in 15 (10.2%) reports, followed by elective terminations in 6 (4.1%). Maternal fever was the most frequent non-pregnancy-specific AE in 3 reports. Two reports of major birth defects were received. No maternal deaths were noted. One hundred-three (70.1%) reports did not describe an AE. CONCLUSIONS: This review of VAERS non-manufacturer reports following vaccination with HPV4 in pregnancy did not find any unexpected patterns in maternal or fetal outcomes.
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Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/patología , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/efectos adversos , Adolescente , Adulto , Femenino , Vacuna Tetravalente Recombinante contra el Virus del Papiloma Humano Tipos 6, 11 , 16, 18 , Humanos , Recién Nacido , Vacunas contra Papillomavirus/administración & dosificación , Embarazo , Resultado del Embarazo , Adulto JovenRESUMEN
We examined the long-term clinical and economic benefits of quadrivalent human papillomavirus (qHPV) vaccine as a secondary/adjunct prevention strategy in the prevention of recurrent high-grade intraepithelial neoplasia (HGAIN) in HIV-negative men who have sex with men (MSM) and are 27 years or older. We constructed a Markov model to evaluate the clinical effectiveness and cost-effectiveness of two strategies: (1) no qHPV vaccine after treatment for HGAIN versus (2) qHPV vaccine after treatment for HGAIN. Model parameters, including natural history of anal cancer, vaccine efficacy measured in terms of hazard ratio (HR) (decrease in the risk of recurrent HGAIN), HGAIN treatment efficacy, utilities, and costs, were obtained from the literature. The outcomes were measured in terms of lifetime risk of anal cancer, lifetime cost, quality-adjusted life years, and incremental cost-effectiveness ratios (ICERs). Sensitivity analysis was conducted on all model parameters. We found that vaccinating HIV-negative MSM reduced the lifetime risk of anal cancer by 60.77% at an ICER of US$87,240 per quality-adjusted life-year. The results were highly sensitive to vaccine efficacy, transition of HGAIN to anal cancer, cost of treatment for HGAIN, vaccine degree of protection over time, and the vaccine duration of protection and less sensitive to HPV clearance, cost of qHPV vaccine, and the transitions from normal to low-grade anal intraepithelial neoplasia (LGAIN) and normal to HGAIN. With an HR of 0.3, the ICER was well below a $50,000 willingness-to-pay threshold; with an HR of 0.5, the ICER was still below a threshold of $100,000. The most critical disease-related factor influencing the cost-effectiveness was the progression of HGAIN to anal cancer. At an annual transition probability below 0.001, the ICER was below $50,000. Vaccinating HIV-negative MSM treated for HGAIN decreases the lifetime risk of anal cancer and is likely to be a cost-effective intervention.