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DRUG:

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)

i
Other names: V503, 9vHPV
Associations
Company:
Merck (MSD)
Drug class:
Immunostimulant
Related drugs:
Associations
15d
NCI-2018-02606: Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov)
P4, N=48, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025
Trial completion date • Trial primary completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
17d
Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV (clinicaltrials.gov)
P3, N=700, Active, not recruiting, Weill Medical College of Cornell University | Recruiting --> Active, not recruiting
Enrollment closed
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
18d
Trial completion
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
24d
Testing RG1-VLP Vaccine to Prevent HPV-related Cancers (clinicaltrials.gov)
P1, N=33, Not yet recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2026 --> Jun 2027
Trial completion date
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
1m
Randomized Phase II Trial of Imiquimod with or without 9-Valent HPV Vaccine versus Observation in Patients with High-grade Pre-neoplastic Cervical Lesions (NCT02864147). (PubMed, Clin Cancer Res)
A higher regression rate than expected was observed in the surveillance arm of this prospective trial. Future clinical trials with imiquimod targeting CIN3 patients are warranted.
P2 data • Journal
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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Zyclara (imiquimod) • Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
1m
Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department (clinicaltrials.gov)
P=N/A, N=610, Not yet recruiting, University of Alabama at Birmingham | Initiation date: Mar 2024 --> Sep 2024
Trial initiation date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen (clinicaltrials.gov)
P4, N=360, Recruiting, Boston Medical Center | Trial completion date: Mar 2025 --> Sep 2025 | Trial primary completion date: Mar 2024 --> Sep 2024
Trial completion date • Trial primary completion date
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts (clinicaltrials.gov)
P2/3, N=120, Recruiting, Western Institute for Veterans Research | Not yet recruiting --> Recruiting
Enrollment open
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
Immunogenicity of 9-valent HPV Vaccine (clinicaltrials.gov)
P4, N=120, Recruiting, Talia Sainz Costa | Not yet recruiting --> Recruiting
Enrollment open
|
CD4 (CD4 Molecule)
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose (clinicaltrials.gov)
P4, N=757, Active, not recruiting, The University of Texas Medical Branch, Galveston | Recruiting --> Active, not recruiting | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Feb 2024 --> Mar 2025
Enrollment closed • Trial completion date • Trial primary completion date
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients (clinicaltrials.gov)
P2, N=52, Active, not recruiting, National Cancer Institute (NCI) | N=180 --> 52 | Trial completion date: Dec 2023 --> Mar 2025
Enrollment change • Trial completion date
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants (clinicaltrials.gov)
P2, N=201, Active, not recruiting, National Cancer Institute (NCI) | Phase classification: P2a --> P2 | Trial completion date: Feb 2024 --> Feb 2025
Phase classification • Trial completion date
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
3ms
HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini (clinicaltrials.gov)
P4, N=1403, Active, not recruiting, Columbia University | Trial completion date: Oct 2023 --> Sep 2024
Trial completion date • Head-to-Head
|
IFNG (Interferon, gamma) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • IL2 (Interleukin 2)
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
3ms
Immunogenicity of HPV Vaccine in Transplant Recipients. (clinicaltrials.gov)
P4, N=100, Recruiting, Medical College of Wisconsin | Phase classification: P=N/A --> P4
Phase classification
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
3ms
Establishing Optimal Number of Doses for HPV Vaccination in Children and Adolescents Living With HIV, OPTIMO Trial (clinicaltrials.gov)
P4, N=97, Active, not recruiting, Fred Hutchinson Cancer Center | Recruiting --> Active, not recruiting
Enrollment closed
|
CD4 (CD4 Molecule)
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
3ms
New trial
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
4ms
COVENANT: HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV (clinicaltrials.gov)
P3, N=536, Active, not recruiting, AIDS Malignancy Consortium | Trial primary completion date: Dec 2025 --> Dec 2024
Trial primary completion date
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
4ms
A Study to Evaluate the Immunogenicity and Safety of Nonavalent Human Papillomavirus (HPV) Vaccine (clinicaltrials.gov)
P3, N=1260, Active, not recruiting, Beijing Health Guard Biotechnology, Inc | Recruiting --> Active, not recruiting
Enrollment closed
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
4ms
Testing RG1-VLP Vaccine to Prevent HPV-related Cancers (clinicaltrials.gov)
P1, N=33, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Nov 2023 --> Apr 2024 | Trial primary completion date: Nov 2025 --> Apr 2026
Trial initiation date • Trial primary completion date
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
4ms
A Phase III Trial to Evaluate the Immunogenicity and Safety of HPV Vaccine (clinicaltrials.gov)
P3, N=1260, Recruiting, Beijing Health Guard Biotechnology, Inc
New P3 trial
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
4ms
Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women (clinicaltrials.gov)
P=N/A, N=392, Not yet recruiting, Xiamen Ophthalmology Center Affiliated to Xiamen University
New trial
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) • nonavalent HPV vaccine
5ms
COVENANT: HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV (clinicaltrials.gov)
P3, N=536, Active, not recruiting, AIDS Malignancy Consortium | Trial primary completion date: Mar 2025 --> Dec 2025 | Recruiting --> Active, not recruiting
Enrollment closed • Trial primary completion date
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
5ms
Trial completion
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
5ms
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia (clinicaltrials.gov)
P2, N=100, Recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Feb 2024 --> Dec 2025
Trial completion date
|
CD4 (CD4 Molecule)
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
5ms
Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021) (clinicaltrials.gov)
P=N/A, N=4453, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Jan 2024 --> Jan 2040 | Trial primary completion date: Jan 2024 --> Jan 2040
Trial completion date • Trial primary completion date
|
Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) • Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
7ms
Establishing Optimal Number of Doses for HPV Vaccination in Children and Adolescents Living With HIV, OPTIMO Trial (clinicaltrials.gov)
P4, N=100, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: Apr 2026 --> Jul 2026 | Trial primary completion date: Mar 2026 --> Jun 2026
Trial completion date • Trial primary completion date
|
CD4 (CD4 Molecule)
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
7ms
Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts (clinicaltrials.gov)
P2/3, N=120, Not yet recruiting, Western Institute for Veterans Research | Trial completion date: Dec 2025 --> Dec 2026 | Initiation date: Jun 2023 --> Dec 2023 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial initiation date • Trial primary completion date
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
7ms
HPV Vaccination in Immunosuppressed Patients with Established Skin Warts and Non-Melanoma Skin Cancer: A Single-Institutional Cohort Study. (PubMed, Vaccines (Basel))
Gardasil-9 vaccination showed good efficacy in reducing major dermatologic interventions even after correction of relevant cofactors and national COVID-19 caseloads during the observational period. Alpha-HPV vaccination may potentially cause a significant decrease in dermatologic interventions and overall mortality as well as healthcare costs in immunosuppressed patients with high skin tumor burden.
Journal
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
7ms
HPV Opportunistic Vaccination: A Literature Review and a Single-Center Experience in Northern Italy through the COVID-19 Pandemic. (PubMed, Vaccines (Basel))
Opportunistic vaccination offers the possibility of including individuals excluded from the free vaccination campaigns, often already affected by lesions caused by HPV, providing increased viral clearance and faster lesion regression. The main limit remains the economic burden.
Review • Journal
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
Provision of screening services for cervical and breast cancer - A scientific study commissioned by the European Board & College of Obstetrics and Gynaecology (EBCOG). (PubMed, Eur J Obstet Gynecol Reprod Biol)
There are discrepancies around gynaecological cancer screenings provision among EBCOG member countries. It is important to establish European recommendations about screening for gynaecological cancers, in order to standardize the access to equitable better health care in gynaecological cancers within Europe.
Journal
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
Oral Human Papillomavirus Prevalence and Genotyping Among a Healthy Adult Population in the US. (PubMed, JAMA Otolaryngol Head Neck Surg)
Oral HPV prevalence was 6.6% (95% CI, 5.7%-7.4%) for any HPV genotype, and 2.0% (95% CI, 1.5%-2.5%), 0.7% (95% CI, 0.4%-1.0%), and 1.5% (95% CI, 1.1%-1.9%) for HR, HPV-16, and 9-valent-HPV vaccine types, respectively...In this cross-sectional study, oral HPV burden was highest among older men who may be at higher risk of developing oropharyngeal cancer. In addition to male sex and older age, HR oral HPV infection was also associated with sexual behaviors, including increasing number of male sex partners and female oral sex partners.
Journal
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
Micronutrients and prevention of cervical pre-cancer in HPV vaccinated women: a cross-sectional study. (PubMed, Korean J Community Nutr)
Prophylactic vaccines against high-risk human papillomaviruses (HR-HPVs) hold promise to prevent the development of higher grade cervical intraepithelial neoplasia (CIN 2+) and cervical cancer (CC) that develop due to HR-HPV genotypes that are included, in HPV vaccines, but women will continue to develop CIN 2+ and CC due to HR-HPV genotypes that are not included in the quadrivalent HPV vaccine (qHPV) and 9-valent HPV vaccine (9VHPV)...We identified vitamin B12 status and smoking as independent modifiable factors and ethnicity as a factor that needs attention to reduce the risk of developing CIN 2+ in the post vaccination era. Continuation of tailored screening programs combined with non-vaccine-based approaches are needed to manage the residual risk of developing HPV-related CIN 2+ and CC in vaccinated women.
Observational data • Journal
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
The efficacy of human papillomavirus vaccination in the prevention of recurrence of severe cervical lesions. (PubMed, Ceska Gynekol)
Adjuvant HPV vaccination in the setting of surgical treatment for cervical precancerous lesion is significantly associated with a reduced risk of recurrence. HPV vaccination should be strongly considered as adjuvant therapy, especially in young patients undergoing conisation for a severe cervical lesion.
Journal
|
Cervarix (recombinant human papillomavirus bivalent vaccine) • Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
Myasthenia gravis after the third dose of human papillomavirus 9-valent vaccine: A case report. (PubMed, Hum Vaccin Immunother)
To our knowledge, this is the first documented case report of 9vHPV-associated MG in China. Although ocular MG may be a rare adverse event after vaccination with 9vHPV, there is currently no direct evidence establishing a causal relationship; therefore, the safety of 9vHPV remains unquestioned.
Journal
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
Underlying background of the current trend of increasing HPV vaccination coverage in Japan. (PubMed, Glob Health Med)
Additionally, in July 2020, the Japanese government approved the updated 9-valent HPV vaccine and resumed recommendations in November 2021. As a result, 30.1% of those eligible for routine HPV vaccination received at least one dose of the vaccine from April to September, 2022. However, the HPV vaccine coverage in Japan is still far from the 90% recommended by the World Health Organization, and continued communication and education on the vaccines benefits are necessary to achieve optimal coverage.
Journal
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
Global impact and cost-effectiveness of one-dose versus two-dose human papillomavirus vaccination schedules: a comparative modelling analysis. (PubMed, BMC Med)
Results were consistent across the three independent models and suggest that one-dose vaccination has similar health benefits to a two-dose programme while simplifying vaccine delivery, reducing costs, and alleviating vaccine supply constraints. The second dose may become cost-effective if there is a shorter duration of protection from one dose, cheaper vaccine and vaccination delivery strategies, and high burden of cervical cancer.
Journal • HEOR • Cost-effectiveness • Cost effectiveness
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
9ms
HPV Vaccination Behavior, Vaccine Preference, and Health Beliefs in Chinese Female Health Care Workers: A Nationwide Cross-Sectional Study. (PubMed, Vaccines (Basel))
Regardless of actual vaccination status, respondents mostly preferred the 9-valent HPV vaccine (58.6%), followed by 4-valent (15.6%) and 2-valent vaccines (3.1%); additionally, 17.9% did not have a preference...In conclusion, HPV vaccine uptake is high in Chinese female health care workers. HBM constructs may be effective in facilitating the improvement and delivery of targeted intervention programs to increase HPV vaccine uptake.
Observational data • Journal
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
10ms
Head-to-head immunogenicity comparison of an Escherichia coli-produced 9-valent human papillomavirus vaccine and Gardasil 9 in women aged 18-26 years in China: a randomised blinded clinical trial. (PubMed, Lancet Infect Dis)
Cecolin 9 induced non-inferior HPV type-specific immune responses compared with Gardasil 9 and is a potential candidate to accelerate the elimination of cervical cancer by allowing for global accessibility to 9-valent HPV vaccinations, especially in low-income and middle-income countries.
Journal • Head-to-Head
|
Cecolin (recombinant human papillomavirus bivalent (types 16, 18) vaccine (Escherichia coli)) • Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
10ms
Human papillomavirus genotype distribution by cytological status and associated risk factors in the general population of Congolese women living in urban and rural areas: Implications for cervical cancer prevention. (PubMed, Infect Dis Now)
Cervical HR-HPV infection is particularly frequent in young or HIV-infected Congolese women. Prophylactic HPV vaccination combined with primary molecular screening of HR-HPV infection in this country should be extended.
Journal
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
10ms
Diagnostic accuracy of extended HPV DNA genotyping and its application for risk-based cervical cancer screening strategy. (PubMed, Clin Chem Lab Med)
Extended HPV genotyping had good agreement with a well-validated partial HPV genotyping CC primary screening kit in hr-HPV detection. Extended HPV genotyping could facilitate risk-based stratified management strategy and improve the diagnostic accuracy of primary CC screening.
Journal
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
10ms
NCI-2018-02606: Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov)
P4, N=48, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2023 --> May 2024 | Trial primary completion date: May 2023 --> May 2024
Trial completion date • Trial primary completion date
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
11ms
Oral HPV Infection in Women with HPV-Positive Cervix Is Closely Related to Oral Sex. (PubMed, Diagnostics (Basel))
In contrast, oral HPV infections were significantly associated with women aged 36 to 50 years (OR 27.38, 95% CI: 4.37-171.37; p = 0.000202) and oral sex (OR 95.5, 95% CI: 5.13-1782.75, p = 0.001126).Additionally, being separate, being cohabitant, lifetime sexual partners of >10, 3-5 lifetime sexual partners, 10 sexual intercourse per month, occasional and regular anal sex, >20 cigarettes per day, a history of sexually transmitted disease (herpes and multiple), and having a history of genital warts were significant. Screening and early diagnosis are considered to be practically unfeasible for this category of cancer, given the lack of visible lesions; the 9-valent HPV vaccine remains the only means that could help to successfully counter the growing incidence of oral squamous cell carcinoma.
Journal
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)