HPV Vaccine for Increasing Vaccination Rates

(HPV Trial)

Overseen By Ramneek Kahlon, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Received HPV vaccine, contraindication

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

Compensation: Varies

Number of Visits: Unknown

2232 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the HPV vaccine treatment?

Research shows that HPV vaccines are highly effective, with close to 100% efficacy in preventing HPV infections and cervical cancer when given in a three-dose schedule to young women who have not been previously infected with HPV. ^{1 2 3 4 5}

Is the HPV vaccine generally safe for humans?

The HPV vaccine has been linked to some adverse events, with a small percentage being serious. However, most studies have not found these events to be directly caused by the vaccine, and it is generally considered safe based on pre-licensure and post-marketing data. ^{6 7 8 9 10}

How is the HPV vaccine treatment unique compared to other treatments for HPV-related conditions?

The HPV vaccine is unique because it is a preventive measure that effectively stops the transmission of HPV, which can lead to cancers, rather than treating existing infections. It is recommended for individuals aged 9 to 26 and has a strong safety profile, but it does not offer therapeutic benefits for those already infected. ^{11 12 13 14 15}

What is the purpose of this trial?

Develop, implement, and evaluate a culturally tailored multilevel intervention to increase uptake of the HPV vaccine among eligible patients ages 10-12 of the University of California, Davis Health Community Physician (UCDH CP) primary care practices using a randomized controlled trial design.

Research Team

Julie HT Dang, PhD

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for eligible patients aged 10-12 within the UC Davis Health Community Physician primary care practices, aiming to increase HPV vaccine uptake. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am between 10-12 years old and eligible for the HPV vaccine.

Exclusion Criteria

I have received the HPV vaccine.

I cannot receive the HPV vaccine due to health reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of a multilevel intervention including tailored education, appointment scheduling assistance, and primary care team trainings

12 months

Follow-up

Participants are monitored for the completion of the HPV vaccine series

12 months

Treatment Details

Interventions

• HPV Vaccine

Trial Overview The study is testing a culturally tailored intervention designed to boost HPV vaccination rates among young patients. It's set up as a randomized controlled trial, meaning participants will be randomly assigned to receive this new approach or continue with standard practices.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

These clinics will receive the multilevel intervention which will include tailored parent/patient education, appointment scheduling assistance, and primary care team trainings.

Group II: Control Arm Active Control 1 Intervention

These clinics will not receive any intervention and will continue with care as usual.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

While clinical trials have shown that HPV vaccines are highly effective, their effectiveness in the general population is still not fully understood, highlighting the need for further research.

A comprehensive review of HPV-related clinical outcomes suggests that tracking these outcomes at the population level is crucial for evaluating the real-world effectiveness of HPV vaccines, as many large trials are nearing completion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the impact of human papillomavirus vaccines. Chang, Y., Brewer, NT., Rinas, AC., et al.[2009]

A study involving 22,486 girls aged 11 to 17 showed that a combined intervention targeting both clinicians and families significantly increased HPV vaccination rates by 9, 8, and 13 percentage points for doses 1, 2, and 3, respectively.

The clinician-focused approach was particularly effective for starting the HPV vaccination series, while the family-focused approach helped in completing the series, highlighting the importance of a dual strategy for optimal vaccination outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt. Fiks, AG., Grundmeier, RW., Mayne, S., et al.[2022]

Expanding HPV vaccination to adults, particularly at cervical cancer screening visits for women and during STI consultations for both sexes, could lead to significant reductions in HPV infection rates, with reductions of about 20% for women and even greater reductions (63% for HPV-16 and 84% for HPV-18) when including male vaccination.

The study suggests that while the impact of vaccinating adult women alone is modest, combining vaccination strategies for both genders during key health consultations is a highly efficient approach to improve HPV prevention and reduce the incidence of related cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public Health Benefits of Routine Human Papillomavirus Vaccination for Adults in the Netherlands: A Mathematical Modeling Study. Matthijsse, SM., Hontelez, JA., Naber, SK., et al.[2018]

A total of 3174 adverse events (AEs) were reported in children and adolescents aged 6-17 after receiving the HPV vaccine, with 191 (6%) classified as serious.

While these serious AEs raise concerns, further research is necessary to establish a direct link between these events and the HPV vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccine safety in pediatric patients: an evaluation of the Vaccine Adverse Event Reporting System. Borja-Hart, NL., Benavides, S., Christensen, C.[2019]

There are three licensed HPV vaccines: bivalent, quadrivalent, and nonavalent, with the nonavalent vaccine introduced in 2014, yet vaccination coverage remains low in many developed countries due to safety concerns.

This review aims to clarify the safety profiles of all three HPV vaccines by summarizing data from both pre- and post-licensure studies, particularly focusing on the newer nonavalent vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of HPV vaccines in the age of nonavalent vaccination. Quattrone, F., Canale, A., Filippetti, E., et al.[2018]

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]

HPV vaccines are highly effective in preventing the transmission of HPV and related cancers, with a strong safety profile demonstrated in both prelicensure and postlicensure studies, making them recommended for everyone aged 9 to 26.

While current HPV vaccines provide limited therapeutic benefits, ongoing research into new DNA vaccines shows promise in treating existing HPV infections and precancerous lesions, highlighting the need for continued efforts to combat vaccination hesitancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Papillomavirus Vaccines. Conageski, C.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluating the impact of human papillomavirus vaccines. [2009]

2. England pubmed.ncbi.nlm.nih.gov

Human papillomavirus (HPV) vaccination: from clinical studies to immunization programs. [2020]

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

Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt. [2022]

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

HPV and HPV vaccine education intervention: effects on parents, healthcare staff, and school staff. [2022]

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

Public Health Benefits of Routine Human Papillomavirus Vaccination for Adults in the Netherlands: A Mathematical Modeling Study. [2018]

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

Human papillomavirus vaccine safety in pediatric patients: an evaluation of the Vaccine Adverse Event Reporting System. [2019]

7. Italy pubmed.ncbi.nlm.nih.gov

Safety of HPV vaccines in the age of nonavalent vaccination. [2018]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series. [2022]

10. India pubmed.ncbi.nlm.nih.gov

Lessons learnt in Japan from adverse reactions to the HPV vaccine: a medical ethics perspective. [2019]

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

Human Papillomavirus Vaccines. [2023]

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

Implementing a Multipartner HPV Vaccination Assessment and Feedback Intervention in an Integrated Health System. [2018]

13. New Zealand pubmed.ncbi.nlm.nih.gov

The Role of Physician Recommendations and Public Policy in Human Papillomavirus Vaccinations. [2017]

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

Increasing HPV vaccination through policy for public health benefit. [2018]

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

Interventions to Improve HPV Vaccine Uptake: A Systematic Review. [2018]