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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase the number of children receiving the HPV vaccine by testing a program designed for families and healthcare providers. The program includes education for parents and children, assistance with appointment scheduling, and training for medical teams. The trial will compare clinics using this program to those providing standard care. Children aged 10-12 who have not yet received the HPV vaccine are ideal participants. As an unphased trial, this study offers families the opportunity to contribute to important research that could enhance vaccination rates and protect children's health.

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 prior data suggests that the HPV vaccine is safe?

Research shows that the HPV vaccine is very safe. Studies have found that serious health problems after receiving the HPV vaccine are extremely rare, occurring in about 1.8 cases per 100,000 doses, or just 0.0018%.

Common side effects include soreness at the injection site, reported by 18% of people after the first dose, 17% after the second, and 12% after the third. These side effects are usually mild and resolve on their own.

There is also a very low risk of a severe allergic reaction called anaphylaxis, occurring in about 1.7 cases per million doses. Overall, the HPV vaccine is well-tolerated and has a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to boost HPV vaccination rates through a comprehensive, multilevel intervention. Unlike standard approaches that solely focus on recommending the vaccine during routine check-ups, this intervention arm offers tailored education for parents and patients, assists with scheduling vaccination appointments, and provides specialized training for primary care teams. This holistic strategy is designed to address barriers to vaccination and make the process smoother and more accessible, potentially leading to higher vaccination rates and better protection against HPV-related diseases.

What is the effectiveness track record for the HPV vaccine?

Studies have shown that the HPV vaccine effectively protects against infections caused by the human papillomavirus, which can lead to certain types of cancer. Research indicates that the vaccine works best when administered at younger ages, providing strong protection before virus exposure. This trial will compare two approaches: an intervention arm, where clinics receive a multilevel intervention including tailored parent/patient education, appointment scheduling assistance, and primary care team training, and a control arm, where clinics continue with usual care. A review of studies found that efforts like education and reminders have successfully increased vaccination rates, with some studies showing coverage rising from 12.5% to 65.5%. In 2023, about 57.3% of adolescents aged 13-15 received the HPV vaccine as recommended. This vaccination effort has notably improved the number of up-to-date vaccinations among both girls and boys in recent years. ^{6 7 8 9 10}

Who Is on the Research Team?

Julie HT Dang, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8310215/

A Systematic Review of Interventions to Improve HPV ... Our review found that various evaluated interventions have improved HPV vaccination coverage, including narrative education, outreach plus reminders, reminders ...

2. thelancet.com thelancet.com/journals/lanam/article/PIIS2667-193X(25)00235-2/fulltext

Clinical effectiveness of HPV vaccine by age at vaccination These data demonstrate that the full benefit of HPV vaccines may not be realized when administered at older ages. Continued and strengthened ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25006565

Review Effective strategies in human papillomavirus (HPV) ... Around 70 % of these studies (n = 7) yielded statistically significant results with an increase in HPV vaccination from 12.5 to 65.5 % [33,40,42 ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823251

Human Papillomavirus Vaccination and ... The up-to-date HPV vaccination status also increased for female participants from 0% in 2006 to 17.1% in 2022 and from 2.2% to 16.6% for male ...

5. progressreport.cancer.gov progressreport.cancer.gov/prevention/hpv_immunization

HPV Vaccination - Cancer Trends Progress Report In 2023, 57.3% of adolescents aged 13-15 had received human papilloma virus vaccine as recommended (HPV). Summary graph for HPV Vaccination- Click to see ...

6. cdc.gov cdc.gov/hpv/hcp/vaccination-considerations/safety-and-effectiveness-data.html

HPV Vaccine Safety and Effectiveness Data Learn about the scientific data showing HPV vaccine effectiveness and safety.

7. cancer.gov cancer.gov/news-events/cancer-currents-blog/2021/hpv-vaccine-parents-safety-concerns

Parent Concerns About HPV Vaccine Safety Increasing - NCI Reports of serious health issues after HPV vaccination were consistently rare—around 1.8 per 100,000 HPV vaccine doses, or 0.0018%. A total of ...

8. who.int who.int/groups/global-advisory-committee-on-vaccine-safety/topics/human-papillomavirus-vaccines/safety

Safety of HPV vaccines The risk of anaphylaxis has been characterized as approximately 1.7 cases per million doses, and syncope was established as a common anxiety or stress-related ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4964727/

Quadrivalent HPV vaccine safety review and safety monitoring ... No severe adverse events related to vaccination were found, however, injection site reactions occurred in 18%, 17%, and 12% after the first, second, and third ...

10. hpvroundtable.org hpvroundtable.org/wp-content/uploads/2024/10/Epidemiologic-Evidence-Effectiveness-and-Safety-of-the-HPV-Vaccine.pdf

Epidemiologic-Evidence-Effectiveness-and-Safety-of-the- ... Data have shown that HPV vaccination is safe and effective in preventing precancers and genital warts. Data from long-term observational studies continue to ...