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

Merck & Co., Inc., Rahway, N.J., USA Announces Fourth-Quarter and Full-Year 2025 Financial Results… (Merck (MSD) Press Release) - "Full-Year Worldwide Sales Were $65.0 Billion (1% Growth; 2% Growth ex-FX): KEYTRUDA/KEYTRUDA QLEX Sales Were $31.7 Billion (7% Growth Both Nominally and ex-FX); Includes KEYTRUDA QLEX Sales of $40 Million; WINREVAIR Sales Were $1.4 Billion; CAPVAXIVE Sales Were $759 Million; GARDASIL/GARDASIL 9 Sales Were $5.2 Billion (39% Decline Both Nominally and ex-FX)."

Sales • Anal Carcinoma • Bladder Cancer • Cholangiocarcinoma • Colorectal Cancer • Cutaneous Melanoma • Endometrial Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Negative Breast Cancer • Hormone Receptor Negative Breast Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Merkel Cell Carcinoma • Microsatellite Instability • Neuroendocrine Carcinoma • Oropharyngeal Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Vaginal Cancer

From knowledge to action: HPV vaccine awareness and acceptance in georgia (ESGO 2026) - "Although safe and effective vaccines (Gardasil 9) are available, vaccine uptake varies widely across populations and is influenced by social, cultural, and informational factors... Despite generally good knowledge about HPV and the benefits of vaccination, uptake among adults remains low, with only 19% fully vaccinated. Barriers include insufficient information, fear of side effects, and uncertainty about the need for vaccination. Physicians are key sources of information, highlighting the importance of targeted education and counseling to improve vaccine coverage."

Cervical Cancer • Oncology • Solid Tumor

Combined effect of conization and HPV vaccination ( gardasil 9 ) in patients with high-grade cervical intraepithelial lesions in azerbaijan: A three-year follow - up study (ESGO 2026) - "These results support the inclusion of postoperative HPV vaccination in standard management protocols, especially in low-income countries where HPV-related disease burden is high. In Azerbaijan, where national HPV vaccination and cervical screening programs are not yet implemented, such preventive strategies are essential to reduce the high incidence of cervical cancer."

Clinical • Cervical Cancer • Oncology • Solid Tumor

NOVA-HIV: A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV (clinicaltrials.gov) - P4 | N=275 | Recruiting | Sponsor: University of British Columbia | N=450 ➔ 275

Enrollment change • Human Immunodeficiency Virus • Infectious Disease • Oncology

Post-licensure safety surveillance of 9-valent human papillomavirus vaccine using the vaccine adverse event reporting system, 2014-2024. (PubMed, Front Public Health) - "Disproportionality analysis identified potential safety signals warranting further investigation but did not confirm causality. Continuous surveillance is necessary to further evaluate these rare events and ensure the ongoing safety of 9vHPV."

Adverse events • Journal • Cardiovascular • CNS Disorders • Dermatology • Multiple Sclerosis • Musculoskeletal Pain • Oncology • Pain • Women's Health

Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative The NOVEL Trial (clinicaltrials.gov) - P3 | N=1099 | Completed | Sponsor: Imperial College London | Active, not recruiting ➔ Completed

Trial completion • Gynecology • Oncology

Public Health Impact and Cost-Effectiveness of Routine and Catch-Up Human Papillomavirus Vaccination in Girls and Women in Selected Regions of China: A Model-Based Study. (PubMed, Pharmacoeconomics) - "The routine 9vHPV strategy may be cost-effective compared with the 2vHPV strategy in China. However, a 9vHPV catch-up strategy varies in cost-effectiveness by regional socioeconomic development."

HEOR • Journal • Cervical Cancer • Oncology • Solid Tumor

COVENANT: HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV (clinicaltrials.gov) - P3 | N=536 | Completed | Sponsor: AIDS Malignancy Consortium | Active, not recruiting ➔ Completed | Trial completion date: Mar 2027 ➔ Aug 2025

Trial completion • Trial completion date • Human Immunodeficiency Virus • Human Papillomavirus Infection • Infectious Disease • Oncology

Epidemiology and prevention of HPV-driven cervical cancer in urban-rural China: a population-based study of 60,280 women. (PubMed, Sci Rep) - "Only 1.33% of women participated in self-screening initiatives. Urban-rural disparities in HPV 52/58/33 prevalence persist alongside low screening rates, underscoring the urgency of implementing targeted vaccination strategies, particularly the 9-valent HPV vaccine, and adopting advanced triage methods such as methylation testing in Putian."

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

Human Papillomavirus Genotype Landscape Across Cervical Cytology Grades and Impact of HIV Among Women of Eastern Cape Province, South Africa. (PubMed, Viruses) - "HPV types targeted by Gardasil-9® were detected in 36.0% of women with normal cervical cytology, 83.0% of those with HSIL, and 81.0% of those with cervical cancer...While HPV prevalence did not significantly increase with HIV co-infection, distinct differences were observed in the HPV genotype patterns when stratified by HIV status. The dominance of non-HPV vaccine types in HSIL and cervical cancer cases underscores a critical gap in current prevention strategies."

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

An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen (clinicaltrials.gov) - P4 | N=352 | Active, not recruiting | Sponsor: Boston Medical Center | Trial completion date: Jan 2026 ➔ Jun 2026 | Trial primary completion date: Jan 2026 ➔ Apr 2026

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

Dynamics of anal HPV infection after 9vHPV vaccination in men who have sex with men (MSM) with HIV: A prospective, controlled cohort study. (PubMed, Hum Vaccin Immunother) - "No significant differences were observed in anal dysplasia regression or anal microbiota composition over 12 months. Given the lack of short-term secondary benefit and persistence of HPV incidence, MSM with HIV require continued routine anal cancer screening."

Journal • Human Immunodeficiency Virus • Human Papillomavirus Infection • Infectious Disease • CD4

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: Jan 2026 ➔ Jul 2026 | Trial primary completion date: Nov 2025 ➔ May 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

Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers and Mental Health. (clinicaltrials.gov) - P4 | N=1800 | Not yet recruiting | Sponsor: Eunice Dube | Trial completion date: Sep 2030 ➔ Dec 2031 | Trial primary completion date: Sep 2030 ➔ Sep 2031

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

The Mother-Daughter Project: Merck-4 (clinicaltrials.gov) - P=N/A | N=2500 | Not yet recruiting | Sponsor: Indiana University | Trial primary completion date: Feb 2028 ➔ Aug 2028

Trial primary completion date • Gynecology

Anal HPV shedding assessed by self-sampling and multiplex real-time PCR among men who have sex with men in N'Djamena, Chad: a feasibility and acceptability study. (PubMed, PLoS One) - "Taken together, these observations point the MSM population in N'Djamena as a very particular core group of HIV and HPV transmission. HIV prevalence was higher than that of general adult population, but limited to only one MSM of twenty. The RDS method of recruitment allowed to include MSM likely belonging to the same sexual network of HPV transmission leading to the selection of an atypical and specific profile of anal HPV distribution. The potential efficacy of HPV prophylactic vaccination in this population can be estimated at relatively weak."

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

*ISI *RRP: Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval* for Adults With Recurrent Respiratory Papillomatosis* (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: Ohio State University

New P1/2 trial • Oncology

Cost-effectiveness of female-only and gender-neutral HPV vaccination strategies in Japan. (PubMed, J Med Econ) - "Both female-only 4vHPV and 9vHPV strategies are cost-effective under Japan's economic standards. Furthermore, GNV with 9vHPV provides greater health benefits and cost-effectiveness."

HEOR • Journal • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor

Therapeutic Limitations of the Human Papillomavirus Vaccine in Conjunctival Papilloma: A Case Series. (PubMed, Ocul Oncol Pathol) - "We present 3 patients with CP who demonstrated no clinical response to 9-valent HPV vaccination. These findings highlight some of the limitations of the vaccine in the context of CP."

Journal • Eye Cancer • Human Papillomavirus Infection • Infectious Disease • Oncology • Solid Tumor

Evaluating the Role of the 9-Valent HPV Vaccine in Preventing Recurrence of Genital Warts (EAU 2026) - No abstract available

Dermatology

HPV Prevalence and Genotype Distribution Among Infertile and Fertile Women of Turkish Nationality and Association with Cytology and Vaccination Status. (PubMed, Biomedicines) - "The 9-valent HPV vaccine covered 56.2% (18/32) of genotypes detected in infertile women and 45.1% (23/51) of those detected in fertile women. In this study, no significant differences were observed between the groups in terms of HPV prevalence, genotype distribution, or cytology findings. These results suggest that HPV is not an independent risk factor for infertility and highlight the need for further studies focusing on genotype-specific patterns, viral persistence, and biological mechanisms that may influence reproductive outcomes."

Journal • Gynecology • Human Papillomavirus Infection • Infectious Disease • Infertility • Oncology • Sexual Disorders

FASTER1DOSE: Vaccine Effectiveness of One Dose of the Nonavalent Human Papillomavirus (HPV) Vaccine Among Young-adult Women in Sweden Among Women Participating in a Clinical Trial of Concomitant HPV Vaccination and Screening (clinicaltrials.gov) - P4 | N=150000 | Active, not recruiting | Sponsor: Karolinska Institutet

New P4 trial • Infectious Disease • Oncology

HOPE II: Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV. (clinicaltrials.gov) - P4 | N=750 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Trial primary completion date: Apr 2026 ➔ Dec 2026 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Oncology

Human papilloma virus genotypes associated with non-cervical HPV positive cancer development in UK and Ireland cohorts: a systematic review. (PubMed, BMC Infect Dis) - "This systematic review confirms HPV16 as the dominant genotype in HPV-positive cancers and highlights the genotypic diversity in non-cervical HPV-positive cancers. Moreover, while HPV vaccination using Gardasil-9 provides limited genotype-specific protection, it could have prevented nearly all HPV-positive cancers reported in eligible studies. Regional differences were minimal, but London had the highest proportion of unprotected genotypes. This suggests that while vaccination is highly effective in preventing HPV-related cancers, gaps in protection remain, particularly for less common genotypes."

Journal • Review • Cervical Cancer • Genito-urinary Cancer • Gynecologic Cancers • Novel Coronavirus Disease • Oncology • Penile Cancer • Solid Tumor • Vulvar Cancer

RIFT-SSA: Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Miquel Angel Pavon Ribas

New P2 trial • Human Papillomavirus Infection • Infectious Disease • Oncology