Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) / Merck (MSD), Chongqing Zhifei - LARVOL DELTA

HUMAN PAPILLOMAVIRUS GENOTYPE DISTRIBUTION AMONG ADULT WOMEN IN THE RABAT REGION (MOROCCO): A RETROSPECTIVE AND ANALYTICAL STUDY WITH IMPLICATIONS FOR HPV VACCINATION STRATEGIES. (PubMed, Intervirology) - "This study provides the first detailed characterization of HR-HPV prevalence and genotype distribution in Moroccan women attending a tertiary hospital. HPV16 remains the predominant genotype. A significant proportion of infections are preventable by the 9-valent vaccine. These findings highlight the urgent need for expanded HPV vaccination and molecular-based screening programs in Morocco and provide a critical baseline for monitoring vaccine impact and guiding public health strategies."

Journal • Retrospective data • Cervical Cancer • Diabetes • Human Papillomavirus Infection • Infectious Disease • Metabolic Disorders • Oncology • Solid Tumor

p16 Overexpression and Human Papillomavirus Positivity in More Than 1000 Penile Cancers. (PubMed, Int J Cancer) - "hrHPV genotypes covered by the 9-valent HPV-vaccine (HPV16/18/31/33/45/52/58) were detected in 97.9% of double positive SCCs. Based on this large population-based study, we demonstrate a good correlation between p16 and hrHPV DNA and no substantial changes in the prevalences over time (1995-2020). Nearly all double positive SCCs harbored a hrHPV genotype that could potentially be prevented by vaccination, pointing to a likely future decrease in penile cancer in Denmark."

Journal • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma

Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old) (clinicaltrials.gov) - P4 | N=618 | Recruiting | Sponsor: The University of Texas Medical Branch, Galveston | Trial completion date: Aug 2027 ➔ Aug 2028 | Trial primary completion date: Aug 2026 ➔ Aug 2027

Trial completion date • Trial primary completion date • Human Papillomavirus Infection • Infectious Disease • Oncology

HPV antibody concentrations among male and female adolescents after single-dose 9-valent HPV vaccination. (PubMed, J Infect Dis) - "One to four years after single-dose 9vHPV vaccination, males had similar detection but lower antibody concentrations than females. Because very low levels of antibody are thought to protect against HPV, the clinical significance of these sex differences is unknown."

Journal • Oncology

Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV (clinicaltrials.gov) - P3 | N=700 | Active, not recruiting | Sponsor: Weill Medical College of Cornell University | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Human Papillomavirus Infection • Infectious Disease • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Follow up immunogenicity of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccines 36 months post-vaccination among boys and girls. (PubMed, Vaccine) - P3 | "Serological responses of mixed-HPV vaccination schedules are sustained for at least 36 months post-vaccination and comparable to a 2-dose 9vHPV schedule, for HPV16/18. These findings provide immunogenicity evidence supporting the feasibility of mixed 2-dose HPV schedules, while further research on clinical effectiveness and implementation is needed to inform policy decisions."

Journal • Oncology

Rationale and design of a clinical trial of a reduced dosing schedule for the nonavalent human papillomavirus vaccine in women living with HIV: The NOVA-HIV study. (PubMed, Contemp Clin Trials) - "Although the approved nonavalent HPV (9vHPV) vaccine is highly safe, immunogenic, and efficacious in those without HIV, there are very few data in women with HIV...Over 24 months, participants attend six or seven visits, where clinical data, blood, and vaginal samples are collected. Data generated could support the implementation of reduced-dose schedules in women with HIV, making vaccination more feasible, contributing to the elimination of cervical cancer, and accelerating global health equity."

Journal • Cervical Cancer • Human Immunodeficiency Virus • Human Papillomavirus Infection • Infectious Disease • Oncology • Solid Tumor

ESCUDDO Long Term Follow Up (clinicaltrials.gov) - P4 | N=13700 | Enrolling by invitation | Sponsor: National Cancer Institute (NCI) | Phase classification: P ➔ P4 | N=9700 ➔ 13700

Enrollment change • Phase classification • Human Papillomavirus Infection • Infectious Disease • Oncology

Intralesional Gardasil-9 for the Treatment of Recalcitrant Warts (clinicaltrials.gov) - P2 | N=55 | Recruiting | Sponsor: Rush University Medical Center

New P2 trial • Dermatology

VulVaccin: Adjuvant Nonavalent HPV Vaccination in Women Treated for Vulvar HSIL (clinicaltrials.gov) - P4 | N=500 | Recruiting | Sponsor: Erasmus Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open

Intralesional Gardasil-9 for the Treatment of Recalcitrant Warts (clinicaltrials.gov) - P2 | N=55 | Active, not recruiting | Sponsor: Rush University Medical Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology

Immunogenicity and Safety of the 9-valent Human Papillomavirus (HPV) Vaccine Administered as 2-Dose or 3-Dose Regimens in Japanese Boys and Girls Aged 9-15 Years. (PubMed, Jpn J Infect Dis) - "These results support immunobridging of efficacy findings in Japanese men and women to Japanese boys and girls. The 9vHPV vaccine was generally well tolerated."

Journal • Oncology

The Role of Adjuvant Nonavalent HPV Vaccination After LLETZ in Patients with Isolated CIN2: A Controlled Cohort Study. (PubMed, Pathogens) - "Adjuvant 9vHPV administration after LLETZ for isolated CIN2 was associated with a clinically substantial lower absolute recurrence rate (2.03% vs. 5.71%, corresponding to a 64.6% relative risk reduction). Although this reduction did not achieve statistical significance (p=0.165) due to our small sample size and a low baseline recurrence rate in this isolated cohort, the effect size is highly comparable to broader CIN2+ studies. The study was likely underpowered to prove statistical significance, and larger multi-center studies are required to confirm the statistical value of adjuvant vaccination specifically in isolated CIN2 lesions."

Journal • Cervical Cancer • Gynecology • Human Papillomavirus Infection • Infectious Disease • Oncology

ESCUDDO Long Term Follow Up (clinicaltrials.gov) - P=N/A | N=9700 | Enrolling by invitation | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Human Papillomavirus Infection • Infectious Disease • Oncology

Developing an Interactive Human Papillomavirus Vaccination Education Program for Oropharyngeal Cancer Patients and Healthcare Providers: Lessons Learned from the Target Users' Feedback. (PubMed, Vaccines (Basel)) - "Background: Human papillomavirus (HPV) is associated with multiple head and neck cancers, many of which are preventable with the 9-valent HPV vaccine... Findings suggest that effective digital health interventions may benefit from incorporating training in evaluating health information, ensuring intuitive design and navigation, and including content featuring real individuals. These results will inform further refinement of IHVEP and the development of future digital health interventions."

Journal • Cervical Cancer • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor

A Clinical Study of V503 in Chinese Females Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine (V503-108) (clinicaltrials.gov) - P3 | N=930 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Infectious Disease • Oncology

Real-World Effectiveness and Impact of Human Papillomavirus Vaccination in Males: A Comprehensive Review. (PubMed, Int J Infect Dis) - "Real-world evidence indicates that HPV vaccination substantially reduces anogenital and oral HPV infections and AGW in males. GNV programs further reduce HPV-related disease burden, reinforcing the public health significance of universal HPV vaccination programs worldwide."

Journal • Real-world evidence • Review • Dermatology • Gastrointestinal Disorder • Human Papillomavirus Infection • Infectious Disease • Oncology

Assessing Human Papillomavirus Knowledge and Vaccination Intentions Following a Virtual Educational Intervention for Parents and Guardians. (PubMed, WMJ) - "A virtual educational intervention significantly improved parental knowledge and positively influenced their intent to vaccinate against HPV. Addressing vaccine hesitancy through structured, accessible educational programs may help increase HPV vaccination rates and reduce the burden of HPV-related cancers."

Journal • Cervical Cancer • Infectious Disease • Oncology

Assessing Durable Antibody Response to HPV Vaccination (clinicaltrials.gov) - P4 | N=17 | Completed | Sponsor: Emory University | Active, not recruiting ➔ Completed

Trial completion

Patient and provider knowledge and attitudes regarding vaccination with the 9-valent HPV vaccine during pregnancy. (PubMed, Am J Perinatol) - "Patient and providers report significant uncertainty about the safety and efficacy of the HPV vaccine in pregnancy. More research, and permissive language from professional organizations, are needed before patients and providers would feel comfortable with antepartum vaccination."

Journal • Cervical Cancer • Obstetrics • Oncology • Solid Tumor

Efficacy, immunogenicity, and safety of the 9-valent human papillomavirus vaccine in males aged 16-26 years in Japan: a randomised, double-blind, placebo-controlled trial. (PubMed, Lancet Infect Dis) - P3 | "The 9vHPV vaccine prevents anogenital persistent infection related to vaccine-targeted HPV types in males and has an acceptable safety profile. These findings support the use of the 9vHPV vaccine in males to prevent HPV-related anogenital diseases."

Journal • Infectious Disease • Oncology

A Dynamic Prediction Study of Persistent Nine-valent Human Papillomavirus Infection Among HIV-negative Men Who Have Sex With Men in Urumqi, China: a Longitudinal and Time-to-event-based Joint Model. (PubMed, Open Forum Infect Dis) - "This study aimed to develop a dynamic prediction model to assess whether longitudinal sexual-behavior-related and exposure-related indicators could predict persistent 9vHPV infection among human immunodeficiency virus type 1 (HIV-1)-negative MSM...The partner-based model demonstrated superior predictive accuracy (AUC = 0.727). The Bayesian joint model provides accurate dynamic predictions of persistent 9v-HPV infection in MSM, supporting personalized prevention strategies."

Journal • Human Immunodeficiency Virus • Human Papillomavirus Infection • Infectious Disease • Oncology

Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers and Mental Health. (clinicaltrials.gov) - P4 | N=2140 | Not yet recruiting | Sponsor: Eunice Dube | Trial completion date: Dec 2031 ➔ Dec 2032 | Trial primary completion date: Sep 2031 ➔ Dec 2032

Trial completion date • Trial primary completion date • Cervical Cancer • CNS Disorders • Depression • Hepatitis B • Infectious Disease • Liver Cancer • Oncology • Psychiatry • Solid Tumor

Assessment of the impact of nonavalent human papillomavirus vaccine on disease clearance time in women with active infection. (PubMed, Rev Bras Ginecol Obstet) - "Main findings suggest a negligible effect of 9vHPV in significantly reducing time to clearance in patients with active infection. Further research is needed to clarify its role in secondary prevention strategies."

Journal • Retrospective data • Cervical Cancer • Infectious Disease • Oncology • Solid Tumor

A Study on the Safety and Long-lasting Immunogenicity of a Domestic 9-Valent HPV Vaccine in HIV-Infected Male Recipients with Varying Degrees of Immune Reconstitution (ChiCTR) - P3 | N=90 | Recruiting | Sponsor: Beijing Ditan Hospital, Capital Medical University; Beijing Ditan Hospital, Capital Medical University

New P3 trial • Human Immunodeficiency Virus • Human Papillomavirus Infection • Infectious Disease • Oncology • CD4