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

P3, N=75, Active, not recruiting, University of Pretoria | Trial completion date: Jul 2023 --> Jul 2025 | Trial primary completion date: May 2023 --> May 2025

P=N/A, N=600, Recruiting, Shanghai Bovax Biotechnology Co., Ltd. | Not yet recruiting --> Recruiting

P3, N=1348, Recruiting, Shanghai Bovax Biotechnology Co., Ltd. | Trial primary completion date: May 2022 --> Nov 2023

P4, N=200, Completed, Xiamen Innovax Biotech Co., Ltd

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

P4, N=50, Recruiting, Emory University | N=32 --> 50 | Trial completion date: Oct 2024 --> May 2026

P3, N=450, Not yet recruiting, Serum Institute of India Pvt. Ltd.

P3, N=1025, Completed, PATH | Active, not recruiting --> Completed

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.

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

P4, N=158, Completed, University of Washington | Active, not recruiting --> Completed

P2, N=480, Not yet recruiting, PharmaJet, Inc.

P3, N=766, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed | Trial completion date: Jan 2024 --> Oct 2023

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.

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.

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.

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).

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

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.

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.

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.

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.

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.

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.

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.

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.

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.