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DRUG:

Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)

i
Other names: V501, 4vHPV
Associations
Company:
UniQuest
Drug class:
Immunostimulant
Related drugs:
Associations
2ms
New P2 trial
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) • Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
3ms
Prospective Trial of Vaccine Responses in Childhood Cancer Survivors (clinicaltrials.gov)
P2, N=75, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
Trial completion date • Trial primary completion date
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
4ms
Trial completion
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
5ms
CHASE: Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis (clinicaltrials.gov)
P=N/A, N=43, Completed, University Hospitals Cleveland Medical Center | Phase classification: P4 --> P=N/A
Phase classification
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
6ms
Enrollment change • Trial withdrawal
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
7ms
TheraVACCS: Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts (clinicaltrials.gov)
P3, N=75, Active, not recruiting, University of Pretoria | Trial completion date: Jul 2023 --> Jul 2025 | Trial primary completion date: May 2023 --> May 2025
Trial completion date • Trial primary completion date
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CD4 (CD4 Molecule)
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
7ms
Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine (clinicaltrials.gov)
P=N/A, N=600, Recruiting, Shanghai Bovax Biotechnology Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
7ms
Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years (clinicaltrials.gov)
P3, N=1348, Recruiting, Shanghai Bovax Biotechnology Co., Ltd. | Trial primary completion date: May 2022 --> Nov 2023
Trial primary completion date
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
8ms
Immunogenicity and Safety of One Dose of HPV Vaccine (clinicaltrials.gov)
P4, N=200, Completed, Xiamen Innovax Biotech Co., Ltd
New P4 trial
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Cecolin (recombinant human papillomavirus bivalent (types 16, 18) vaccine (Escherichia coli)) • Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
8ms
Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System (clinicaltrials.gov)
P2, N=480, Not yet recruiting, PharmaJet, Inc. | Trial completion date: Dec 2024 --> Apr 2025 | Initiation date: Jan 2024 --> May 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
Trial completion date • Trial initiation date • Trial primary completion date
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
9ms
Assessing Durable Antibody Response to HPV Vaccination (clinicaltrials.gov)
P4, N=50, Recruiting, Emory University | N=32 --> 50 | Trial completion date: Oct 2024 --> May 2026
Enrollment change • Trial completion date
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
9ms
New P3 trial
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CD4 (CD4 Molecule)
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
11ms
Phase 3 Trial of a Bivalent HPV Vaccine (Cecolin®) in Young Girls (clinicaltrials.gov)
P3, N=1025, Completed, PATH | Active, not recruiting --> Completed
Trial completion
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Cecolin (recombinant human papillomavirus bivalent (types 16, 18) vaccine (Escherichia coli)) • Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
11ms
HPV vaccines induce trained immunity and modulate pro-inflammatory cytokine expression in response to secondary Toll-like receptor stimulations. (PubMed, Microbiol Immunol)
In this work, we explored the innate immune responses and trained immunity caused by two HPV vaccines, Cervarix and Gardasil. Moreover, Gardasil injection into mice resulted in enhanced TNF-α production in sera following secondary TLR stimulation. Our findings suggest that HPV vaccinations have the ability to induce trained immunity that modulate TLR ligand responses.
Journal • IO biomarker
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IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL1B (Interleukin 1, beta) • IFNB1 (Interferon Beta 1)
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IL6 expression
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Cervarix (recombinant human papillomavirus bivalent vaccine) • Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
12ms
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
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) • Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
12ms
Effectiveness of the Q-HPV Vaccine 9-years Post Vaccination Among HIV Positive Adolescents (clinicaltrials.gov)
P4, N=158, Completed, University of Washington | Active, not recruiting --> Completed
Trial completion
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
1year
New P2 trial
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
1year
Trial completion • Trial completion date
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
1year
Human papillomavirus prevalence and vaccine effectiveness in young women in Germany, 2017/2018: results from a nationwide study. (PubMed, Front Public Health)
Confounder-adjusted VE was 46.4% (95% CI 4.2-70.1) against HPV16/18 infection and 49.1% (95% CI 8.2-71.8) against infection with at least one HPV genotype covered by the quadrivalent HPV vaccine...A decrease of HPV16 and HPV18 was even observed in unvaccinated participants, compared to 2010-2012 data, suggesting indirect protection of unvaccinated women. Low VE against HPV16/18 and HPV6/11/16/18 in our study might be attributable to study design in combination with the endpoint selection of (mainly transient) HPV DNA positivity.
Journal
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
1year
Factors Affecting Human Papillomavirus Vaccine Trends in the United States of America. (PubMed, Cureus)
In the most recent survey of 2017-2020, the highest number of vaccination series completion was achieved for Gardasil®. Conclusions Improved physician efforts and strategies to vaccinate males, low socioeconomic strata patients, and ethnic minorities in more numbers are needed.
Journal
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
over1year
Quadrivalent HPV vaccine effectiveness against anogenital warts: A registry-based study of 2,2 million individuals. (PubMed, Vaccine)
When administered before 14 years of age, qHPV vaccination reduced the probability of AGW about fivefold. The effect decreased sharply with vaccination age, and was not significant among women vaccinated after age 20 years. QHPV administered after the first AGW episode did not protect against a second AGW episode. Herd effects were indicated in unvaccinated males, as we observed a gradual decrease in AGW rates from the 1993 male birth cohort and onwards.
Journal
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
over1year
Health and economic impact of delaying large-scale HPV vaccination and screening implementation on cervical cancer in China: a modelling study. (PubMed, Lancet Reg Health West Pac)
Even with immediate vaccination, the gradual scale-up of LBC-based screening to 70% coverage in 2070 would result in 2,530,000-3,060,000 additional cases, 909,000-1,040,000 deaths, and $5098-5714 million costs compared with no-delay scenario, and could not achieve elimination if domestic 2vHPV or 4vHPV vaccines are used (4.09-4.21 cases per 100,000 woman in 2100)...These findings should spur health authorities to expedite large-scale vaccine rollout and improve screening. Bill & Melinda Gates Foundation (INV-031449 and INV-003174) and CAMS Innovation Fund for Medical Sciences (CIFMS) (2021-I2M-1-004).
Journal • HEOR
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
over1year
A Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant Vaccine in Chinese Healthy Females (clinicaltrials.gov)
P3, N=3131, Terminated, Shanghai Bovax Biotechnology Co., Ltd. | N=10000 --> 3131 | Trial completion date: Dec 2027 --> Mar 2023 | Not yet recruiting --> Terminated | Trial primary completion date: Jun 2023 --> Mar 2023; Strategic adjustment
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
over1year
Impact and Cost-Effectiveness of Alternative Human Papillomavirus Vaccines for Preadolescent Girls in Mozambique: A Modelling Study. (PubMed, Vaccines (Basel))
This study evaluated the health and economic impact of the current HPV vaccine (GARDASIL hereafter referred to as GARDASIL-4) and two other vaccines (CECOLIN and CERVARIX) that could be used in the future. At a willingness-to-pay (WTP) threshold set at 35% of Gross Domestic Product (GDP) per capita, HPV vaccination is cost-effective in Mozambique. The optimal vaccine choice depends on cross-protection assumptions.
Journal • HEOR • Cost-effectiveness • Cost effectiveness
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Cecolin (recombinant human papillomavirus bivalent (types 16, 18) vaccine (Escherichia coli)) • Cervarix (recombinant human papillomavirus bivalent vaccine) • Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
over1year
Efficacy of HPV Vaccination Regarding Vulvar and Vaginal Recurrences in Previously Treated Women: The Need for Further Evidence. (PubMed, Vaccines (Basel))
From 2006 to November 2022, only one study evaluated the efficacy of HPV vaccination with respect to preventing vulvovaginal recurrences in treated women and showed that a quadrivalent HPV vaccine administered after the surgical treatment of vulvar high-grade squamous intraepithelial lesion (HSIL) can reduce vulvar recurrence of the disease. Therefore, the efficacy of HPV vaccination with respect to vulvovaginal recurrence is still an unexplored field. Further studies are needed to produce stronger evidence in order to appropriately support interventions to protect women's health.
Journal
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
over1year
Evaluation of the Therapeutic Effect of Quadrivalent Human Papillomavirus (HPV) Vaccination on Cervical Intraepithelial Neoplasia Lesions. (PubMed, Indian J Surg Oncol)
150 patients were classified into the control group (without HPV vaccination) and the other 150 patients were in the Gardasil group (with HPV vaccination)...Between two groups in 1 and 2 years' follow-up examinations, the high-grade lesions in both Pap smear and pathology were significantly diminished in patients in the HPV vaccinated group in comparison with the control group with p-values 0.001 and 0.004 in 1 year follow-up respectively and 0.00 after 2 years follow-up. HPV vaccination can prevent the progression of CIN lesions in 2-year follow-up examination.
Journal
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
over1year
The efficacy of human papillomavirus prophylactic vaccination after conization in preventing cervical intraepithelial neoplasia recurrence: A prospective observational study in China. (PubMed, Eur J Obstet Gynecol Reprod Biol)
148 patients after loop electrosurgical excision procedure (LEEP) for CIN2+ disease received HPV prophylactic vaccination (6/11/16/18 vaccine, Gardasil®, Merck) after surgery (V-group) and 273 didn't get vaccination (NV-group)...Our study showed the quadrivalent prophylactic HPV vaccination after LEEP had a significantly protective role in the prevention of high-grade squamous intraepithelial lesion recurrence. Further randomized, controlled trials are required in elucidating the efficacy of the prophylactic HPV vaccines using shortly after LEEP in patients with CIN disease.
Observational data • Journal
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
over2years
A community-based approach to cervical cancer prevention in western Kenya: An AMPATH feasibility project. (PubMed, SAGE Open Med)
Women were offered the quadrivalent HPV vaccine for their children if and when it became available for the study...HR-HPV was prevalent, especially in HIV-infected women. As a result of this pilot study, this community-based strategy to prevent cervical cancer will be continued in western Kenya.
Journal
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cobas® HPV test
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
over3years
HPV vaccination to prevent recurrence of Anal Intraepithelial Neoplasia in HIV+ MSM: a randomised, placebo-controlled multicentre trial. (PubMed, AIDS)
Despite adequate serological responses to qHPV vaccination, short-term recurrence of HGAIN was not prevented. These findings do not support qHPV vaccination as a treatment adjuvant to prevent HGAIN recurrence in HIV+MSM.
Clinical • Journal
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CD4 (CD4 Molecule)
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
over3years
Effectiveness of the Quadrivalent HPV Vaccine in Preventing Anal ≥ HSILs in a Spanish Population of HIV+ MSM Aged > 26 Years. (PubMed, Viruses)
A long-lasting immune response was observed in almost all the vaccinated men. The main protective factor against ≥ HSIL was to have completed the vaccination regimen more than 6 months earlier.
Clinical • Journal
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
almost4years
AIDS Malignancy Consortium 054: Safety and Immunogenicity of the Quadrivalent vaccine in Indian Women Living with HIV. (PubMed, J Acquir Immune Defic Syndr)
The quadrivalent HPV vaccine (qHPV) is effective in prevention of initial infection with HPV-6/11/16/18 in HIV-negative women...There were no qHPV-related serious adverse events and no change in CD4 level or HIV VL among women on ART. qHPV vaccine was safe and immunogenic in Indian WLWH. A high proportion were naïve to HPV-6/11/16/18 and may benefit from vaccination even though many were married and several years post-initiation of sexual activity.
Clinical • Journal
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CD4 (CD4 Molecule)
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
almost4years
Immune responses against autologous tumor and human papilloma virus in lymph nodes from patients with penile cancer. (PubMed, Investig Clin Urol)
LN-derived T cells from patients with penile cancer recognize tumor antigen(s) and in HPV-positive cases, there is a response against L1 (late) HPV proteins, being constituents of the Gardasil vaccine.
Clinical • Journal
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CD8 (cluster of differentiation 8)
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)