HPV Education for HPV

Overseen By Clinical Trials Referral Office

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Children, Prior HPV vaccine

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 2 3 10 11}

Research Team

Gerardo Colon-Otero

Principal Investigator

Mayo Clinic

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

Exclusion Criteria

I have received the HPV vaccine.

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
• HPV Vaccination

Trial Overview The 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

Group I: Prevention (HPV educational program) Experimental Treatment 2 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 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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Cervarix and Gardasil are effective HPV vaccines that prevent infections from HPV types 16 and 18, which cause 70% of cervical cancers, with Gardasil also protecting against HPV types 6 and 11, responsible for most genital warts.

Both vaccines are well tolerated with minimal side effects, primarily at the injection site, and ongoing Phase III trials aim to further assess their long-term efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccines. Schmiedeskamp, MR., Kockler, DR.[2015]

Cervarix, an HPV vaccine, has shown a 70.2% reduction in cervical precancerous lesions in HPV-naïve young girls, indicating its strong efficacy in preventing cervical cancer caused by HPV types 16, 18, 31, 33, and 45.

Cervarix induces significantly higher levels of neutralizing antibodies and memory immune cells compared to Gardasil, with sustained protection lasting over 7 years, demonstrating its long-term effectiveness and safety in preventing HPV-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical update of the AS04-adjuvanted human papillomavirus-16/18 cervical cancer vaccine, Cervarix. Schwarz, TF.[2020]

Cervarix and Gardasil are effective prophylactic HPV vaccines that help prevent cervical cancer by targeting different cancer-causing HPV types, with Cervarix covering five types and Gardasil covering three types plus two that cause genital warts.

Cervarix has demonstrated efficacy for 6.4 years, while Gardasil has shown efficacy for 5 years, highlighting the importance of vaccine duration in reducing cervical cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Currently approved prophylactic HPV vaccines. Harper, DM.[2022]

Both Gardasil and Cervarix HPV vaccines have shown outstanding efficacy in preventing infections and related conditions in young women, with excellent safety profiles and only mild to moderate side effects reported.

Neither vaccine is effective in treating existing HPV infections or lesions, but they provide strong protection against specific HPV types for at least four years, with Gardasil also preventing genital warts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update of prophylactic human papillomavirus L1 virus-like particle vaccine clinical trial results. Schiller, JT., Castellsagué, X., Villa, LL., et al.[2022]

Both Cervarix and Gardasil HPV vaccines show over 90% efficacy in preventing cervical intraepithelial neoplasia grade 2+ (CIN 2+) caused by HPV 16 and 18 in women aged 16-26 who were initially HPV-negative, indicating strong potential to reduce cervical cancer incidence.

Cervarix not only provides higher efficacy against HPV 31 and 33 compared to Gardasil but also induces a stronger immune response, with significantly higher antibody levels and memory cell responses, while both vaccines have similar safety profiles with mostly mild injection site reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current prophylactic HPV vaccines and gynecologic premalignancies. Harper, DM.[2022]

A comprehensive analysis of adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) identified 3,112 AEs for Cervarix, 31,606 for Gardasil, and 6,872 for Gardasil 9, highlighting the need for ongoing monitoring of vaccine safety.

The study found 46 unique serious adverse events (SAEs) associated with the HPV vaccines, clustered around behavioral, neurological, immune, nervous, and reproductive systems, indicating that while the vaccines are effective, further research is needed to understand the cause-and-effect relationships of these AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. Zi, W., Yang, Q., Su, J., et al.[2022]

Over 4 years of post-licensure safety surveillance of the HPV-16/18 vaccine (Cervarix) showed that the most commonly reported adverse events were consistent with those expected in the general population, indicating a favorable safety profile.

No significant patterns of serious immune-mediated diseases were found, and the incidences of conditions like Bell's palsy and Guillain-Barré syndrome were within expected ranges, reinforcing the vaccine's acceptable benefit-risk profile for adolescent girls and women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. Angelo, MG., Zima, J., Tavares Da Silva, F., et al.[2021]

In a study involving 12,066 women aged 9 to 26 years who received the HPV vaccines Gardasil® and Cervarix® over three years, 61% reported experiencing mild and transient adverse events after the first dose.

The high rate of reported adverse events is attributed to the study's design, which encouraged participants to document all occurrences, highlighting the importance of ongoing surveillance for vaccine safety, especially for newly marketed vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Human papillomavirus vaccine register]. Spila-Alegiani, S., Da Cas, R., Giambi, C., et al.[2013]

The post-licensure safety profile of HPV vaccines Gardasil and Cervarix was evaluated using data from three sources, including VigiBase and VAERS, confirming that the reported adverse events align with existing safety data.

The analysis showed that the safety profiles of both vaccines are consistent with the information provided in their Summary of Product Characteristics (SPC), indicating that they are safe for public use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. Labadie, J.[2015]

The nine-valent HPV vaccine, Gardasil9, significantly increases the efficacy against cervical cancer from 70% to 90% compared to the quadrivalent vaccine, covering a broader range of HPV types.

Gardasil9 also provides high efficacy (97%) against lesions associated with HPV types 31, 33, 45, 52, and 58, while maintaining similar effectiveness against HPV types 6, 11, 16, and 18 as the quadrivalent vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nine-valent HPV vaccine - new generation of HPV vaccine]. Fait, T., Dvořák, V., Pilka, R.[2018]

Following the French High Committee of Public Health's recommendation change on January 25, 2011, there was a significant increase in the prescription of Cervarix(®) compared to Gardasil(®), indicating that medical recommendations can directly influence prescribing behavior.

The study suggests that the rapid response of prescribers to the new guidelines may be influenced by the strong involvement of pharmaceutical companies in medical education, highlighting the importance of how information is communicated to healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Did the recommendation of the French public health council modify the antipapillomavirus vaccines' prescription level?]. Birebent, J., Dupouy, J., Lempégnat, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccines. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical update of the AS04-adjuvanted human papillomavirus-16/18 cervical cancer vaccine, Cervarix. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Currently approved prophylactic HPV vaccines. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

An update of prophylactic human papillomavirus L1 virus-like particle vaccine clinical trial results. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Current prophylactic HPV vaccines and gynecologic premalignancies. [2022]

6. England pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. [2021]

8. Italy pubmed.ncbi.nlm.nih.gov

[Human papillomavirus vaccine register]. [2013]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. [2015]

10. Czech Republic pubmed.ncbi.nlm.nih.gov

[Nine-valent HPV vaccine - new generation of HPV vaccine]. [2018]

11. France pubmed.ncbi.nlm.nih.gov

[Did the recommendation of the French public health council modify the antipapillomavirus vaccines' prescription level?]. [2022]