HPV Education for HPV
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Children, Prior HPV vaccine
No Placebo Group
Prior Safety Data
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?
This phase IV trial examines the impact of an education program on the human papilloma virus (HPV) and its effects on the acceptance and completion rates of a free HPV vaccination program in underserved adult patients. Participating in the HPV educational program may increase the HPV vaccination rates among low income uninsured adult patients and ultimately prevent HPV related cancers.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment in the HPV Education for HPV clinical trial?
Research shows that the HPV vaccines Cervarix and Gardasil are effective in preventing infections with HPV types that cause most cervical cancers. Cervarix has shown high efficacy in reducing cervical precancerous lesions by over 70% in young girls, and both vaccines have demonstrated strong immune responses and long-lasting protection.12345
Is the HPV vaccine safe for humans?
The HPV vaccines, including Cervarix, Gardasil, and Gardasil 9, have been used widely and are generally considered safe, though some adverse events (unwanted effects) have been reported. These vaccines have undergone extensive safety monitoring through systems like the Vaccine Adverse Event Reporting System (VAERS) and other global databases.16789
How is the HPV vaccination different from other treatments for HPV?
The HPV vaccination, including Gardasil, Cervarix, and Gardasil 9, is unique because it is a preventive measure rather than a treatment for existing HPV infections. These vaccines protect against the most common cancer-causing types of HPV, with Gardasil also preventing genital warts. Unlike treatments that address symptoms or existing infections, these vaccines aim to prevent HPV-related diseases before they occur.1231011
Eligibility Criteria
This trial is for adults who have never had an HPV vaccine, no allergies to its contents, and women without a history of positive HPV tests or abnormal Pap smears. Participants must understand English, be patients at the VIM clinic, and willing to join the study. Those who've already received the HPV vaccine cannot participate.Inclusion Criteria
You are willing to take part in the clinical trial.
I have never had a positive HPV test or abnormal Pap smear.
Patient of VIM clinic
See 3 more
Exclusion Criteria
I have received the HPV vaccine.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Educational Intervention
Participants receive educational materials on HPV and are asked of their willingness to proceed with the first HPV vaccination
1 week
1 visit (in-person)
Vaccination
Participants receive the first dose of the HPV vaccine and the next 2 doses approximately 2 months and 6 months following the initial vaccine
6 months
3 visits (in-person)
Follow-up
Participants are monitored for completion rates and barriers to vaccine series completion
9 months
Treatment Details
Interventions
- Educational Intervention (Behavioural Intervention)
- HPV Vaccination (Cancer Vaccine)
Trial OverviewThe trial is testing whether an educational program can increase acceptance and completion of free HPV vaccinations among underserved adults. It aims to boost vaccination rates in this group which may help prevent HPV-related cancers.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Prevention (HPV educational program)Experimental Treatment2 Interventions
Patients receive educational materials on HPV and are asked of their willingness to proceed with the first HPV vaccination. Patients who express interest in receiving the HPV vaccination, then receive the first dose of the HPV vaccine and the next 2 doses approximately 2 months and 6 months following the initial vaccine.
HPV Vaccination is already approved in United States, European Union, Canada, Japan, Australia for the following indications:
🇺🇸 Approved in United States as Gardasil 9 for:
- Prevention of certain types of cervical, vulvar, vaginal, anal, and oropharyngeal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
🇪🇺 Approved in European Union as Gardasil 9 for:
- Prevention of certain types of cervical, vulvar, vaginal, anal, and oropharyngeal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
🇨🇦 Approved in Canada as Gardasil 9 for:
- Prevention of certain types of cervical, vulvar, vaginal, anal, and oropharyngeal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
🇯🇵 Approved in Japan as Gardasil 9 for:
- Prevention of certain types of cervical, vulvar, vaginal, anal, and oropharyngeal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
🇦🇺 Approved in Australia as Gardasil 9 for:
- Prevention of certain types of cervical, vulvar, vaginal, anal, and oropharyngeal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in FloridaJacksonville, FL
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Human papillomavirus vaccines. [2015]To review the pharmacology, efficacy, safety, tolerability, and pharmacoeconomics of Cervarix and Gardasil, 2 human papillomavirus (HPV) vaccines.
Clinical update of the AS04-adjuvanted human papillomavirus-16/18 cervical cancer vaccine, Cervarix. [2020]Persistent infection with human papillomavirus (HPV) is a necessary cause of cervical cancer, resulting annually in 274,000 deaths worldwide. Two prophylactic HPV vaccines are licensed in >100 countries, and immunization programs in young, adolescent girls have been widely implemented. HPV-16/18 AS04-adjuvanted vaccine (Cervarix; GlaxoSmithKline Biologicals, Rixensart, Belgium) has demonstrated type-specific protection against the five most frequent cancer-causing types (16, 18, 31, 33, and 45) that are responsible for 82% of invasive cervical cancers globally. Cervarix has demonstrated efficacy against HPV-45, which is the third most common HPV type in cervical cancer and adenocarcinoma. Final results of a large phase 3 trial recently showed Cervarix substantially reduced the overall burden of cervical precancerous lesions (cervical intraepithelial neoplasia 2+) by 70.2% in an HPV-naïve population approximating young girls prior to sexual debut, the target of most current vaccination programs. Protection offered by Cervarix against nonvaccine types (mainly 31, 33, and 45) might potentially allow for 11%-16% additional protection against cervical cancers, compared to a vaccine only offering protection against HPV-16/18. Another recent study directly compared the antibody response of Cervarix to that of quadrivalent HPV-6/11/16/18 vaccine (Gardasil; Merck, Whitehouse Station, NJ, USA). Cervarix induced significantly superior neutralizing antibody levels as compared with Gardasil for HPV-16 and HPV-18 in all age groups studied. This may translate into more women having detectable (neutralizing) antibodies in cervicovaginal secretions for HPV-16 and HPV-18 after vaccination with Cervarix when compared with Gardasil. Cervarix induced significantly higher frequencies of antigen-specific memory B-cells and T-cells in responders for HPV-16 and HPV-18 as compared with Gardasil. Cervarix continues to show sustained high levels of total and neutralizing antibodies for HPV-16 and HPV-18, 7.3 years after vaccination. This is associated with high efficacy and no breakthrough cases in the HPV-naïve population, and is the longest duration follow-up for safety, immunogenicity, and efficacy for any licensed HPV vaccine to date.
Currently approved prophylactic HPV vaccines. [2022]Cervarix and Gardasil are two prophylactic HPV vaccines designed primarily for cervical cancer prevention. Cervarix is effective against HPV-16, -18, -31, -33 and -45, the five most common cancer-causing types, including most causes of adenocarcinoma for which we cannot screen adequately. Gardasil is effective against HPV-16, 18 and 31, three common squamous cell cancer-causing types. In addition, Gardasil is effective against HPV-6 and -11, causes of genital warts and respiratory papillomatosis. The most important determinant of vaccine impact to reduce cervical cancer is its duration of efficacy. To date, Cervarix's efficacy is proven for 6.4 years and Gardasil's for 5 years.
An update of prophylactic human papillomavirus L1 virus-like particle vaccine clinical trial results. [2022]This review focuses on recent publications of clinical trials of two prophylactic human papillomavirus (HPV) vaccines: Gardasil (Merck & Co., Inc., Whitehouse Station, NJ USA), a quadrivalent vaccine containing L1 virus-like particles (VLPs) of types -6, 11, 16, and 18, and Cervarix (GlaxoSmithKline Biologicals, Rixensart, Belgium), a bivalent vaccine containing VLPs of types -16 and 18. In efficacy trials involving young women, both vaccines produced outstanding efficacy against primary and secondary endpoints associated with the vaccine type HPVs and were highly and consistently immunogenic. Both had excellent safety records and, as expected, the most frequent vaccine-related adverse were mild to moderate injection site sequelae. No evidence of waning protection was observed after four years for endpoints examined ranging from incident infection to cervical intraepithelial neoplasia grade 3 associated with the vaccine type HPVs. Gardasil was also highly efficacious at preventing vaginal/vulvar lesions and genital warts. However, neither vaccine demonstrated therapeutic efficacy against prevalent infections or lesions, regardless of the associated HPV type. Cervarix has shown limited cross-protection against infection with specific closely related types while preliminary results of limited cross-protection have been presented for Gardasil. As expected, more limited efficacy was noted for both vaccines when women with prevalent infection were included or endpoints associated with any HPV type were evaluated. Immunological bridging trials involving adolescent girls and boys were also recently published. For both vaccines, serum VLP antibody levels in girls were non-inferior to those generated in young women and antibody response to Gardasil was also non-inferior in boys. The results of these studies have led to the approval of Gardasil and Cervarix by national regulatory agencies in a number of countries.
Current prophylactic HPV vaccines and gynecologic premalignancies. [2022]Studies of the human papillomavirus (HPV) vaccines, Cervarix and Gardasil provide strong evidence for the recommendation that HPV vaccines may minimize the incidence of cervical cancer over time.
OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]Three licensed human papillomavirus (HPV) vaccines (Cervarix, Gardasil, and Gardasil 9) have been effectively used to prevent infection with oncogenic HPV types; however, many adverse events (AEs) have also been reported following their vaccinations. We assessed AE profiles after receiving the HPV vaccines based on the reported data from Vaccine Adverse Event Reporting System (VAERS).
Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. [2021]To summarise post-licensure safety surveillance over more than 4 years of routine use of the human papillomavirus-16/18-AS04-adjuvanted vaccine (HPV-16/18 vaccine: Cervarix®, GlaxoSmithKline, Belgium).
[Human papillomavirus vaccine register]. [2013]We carried out an active surveillance of common adverse events occurring among women (9 to 26 years old) receiving human papillomavirus vaccine (Gardasil® and Cervarix®) in 9 Italian Regions.
Postlicensure safety evaluation of human papilloma virus vaccines. [2015]A summary of postlicensure safety information of HPV vaccines from three sources: VigiBase, the global database of WHO's Programme for International Drug Monitoring, the VAERS report on Gardasil and the RIVM report on Cervarix.
[Nine-valent HPV vaccine - new generation of HPV vaccine]. [2018]To evaluate current knowledge about new generation of HPV vaccine - nine-valent vaccine Gardasil9.
[Did the recommendation of the French public health council modify the antipapillomavirus vaccines' prescription level?]. [2022]In France, two vaccines are approved for prevention of papillomavirus infection: Cervarix(®) and Gardasil(®). The 17th of December 2010 the French High Committee of Public Hearth changed its recommendation about Cervarix(®) and decided that no scientific element justified a preference using Gardasil(®). This notification was published the 25th of January 2011. Our study aimed to determine whether this decision changed medical prescriptions.