HPV Vaccination Promotion for Young Adults in Texas

Overseen By Qian Lu, MD,PHD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Life-threatening allergy, others

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

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

Compensation: Varies

Number of Visits: 2

1200 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies how to improve the human papillomavirus (HPV) vaccination rate in young adults in Texas. This trial aims to learn more about how researchers and health care providers can increase HPV vaccination among college students.

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the drug Gardasil 9 for HPV prevention?

Research shows that the HPV vaccine, including Gardasil 9, is effective in preventing HPV-related diseases like cervical cancer and genital warts. It is recommended for young adults as a catch-up vaccination to protect against HPV infections. ^{1 2 3 4 5}

Is the HPV vaccine, Gardasil 9, safe for humans?

The HPV vaccine, Gardasil 9, has been shown to be generally safe and well-tolerated in humans, with local reactions like swelling being the most common side effect. It has a safety profile similar to earlier versions of the vaccine, and any adverse events reported are monitored through systems like the Vaccine Adverse Event Reporting System (VAERS). ^{3 6 7 8 9}

How is the HPV vaccine (Gardasil 9) different from other HPV treatments?

The HPV vaccine, Gardasil 9, is unique because it protects against nine types of HPV, including those responsible for about 90% of cervical cancers and genital warts, unlike earlier versions that covered fewer types. It is administered as a preventive measure, not a treatment for existing infections, and is approved for both males and females. ^{3 10 11 12 13}

Research Team

Qian Lu, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for young adults aged 18-26 in Texas who haven't had the HPV vaccine yet. They must read English, have internet access via a smart device, and be enrolled in a participating school for at least 9 months. Pregnant individuals or those with severe allergies to vaccine ingredients cannot join.

Inclusion Criteria

I am between 18 and 26 years old.

I am currently enrolled in a participating school and will be for at least 9 months.

Ability to read and understand English

Exclusion Criteria

Being pregnant

Having a life-threatening allergy to any component of the HPV vaccine

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to receive various interventions including CDC information, video narratives, written narratives, and enhanced access to vaccination

Varies

Follow-up

Participants are monitored for vaccination initiation and completion rates at 3 and 9 months

9 months

2 visits (virtual)

Treatment Details

Interventions

• HPV Vaccine

Trial Overview The study is testing different ways to increase HPV vaccination rates among young adults using a randomized controlled trial (RCT). Participants will be randomly placed into one of five experimental groups to see which method works best over the course of nine months.

Participant Groups

Group I: Group VI (enhanced access to vaccine, written narratives) Experimental Treatment 4 Interventions

Participants receive enhanced access to vaccination and written narratives about HPV vaccination.

Group II: Group V (enhanced access to vaccine, video narratives) Experimental Treatment 4 Interventions

Participants receive enhanced access to vaccination and video narratives about HPV vaccination.

Group III: Group IV (enhanced access to vaccine, CDC information) Experimental Treatment 4 Interventions

Participants receive enhanced access to vaccination and standard CDC information about HPV vaccination.

Group IV: Group III (written narratives) Experimental Treatment 3 Interventions

Participants receive written narratives about HPV vaccination.

Group V: Group II (video narratives) Experimental Treatment 3 Interventions

Participants receive video narratives about HPV vaccination.

Group VI: Group I (standard CDC information) Active Control 3 Interventions

Participants receive standard CDC information about HPV vaccination.

HPV Vaccine is already approved in United States, European Union, Canada, Switzerland for the following indications:

Approved in United States as Gardasil 9 for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

Approved in European Union as Gardasil 9 for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

Approved in Canada as Gardasil 9 for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

Approved in Switzerland as Gardasil 9 for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

The FDA has approved both bivalent and quadrivalent HPV vaccines, which are recommended for routine vaccination in girls aged 11 to 12, and can be given as early as 9 years old, with catch-up vaccination for females aged 13 to 26.

The vaccines are most effective when administered before any sexual activity, but even sexually active individuals can still benefit, as they may not have been exposed to all HPV types covered by the vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Committee opinion no. 467: human papillomavirus vaccination. [2021]

A study involving 215,965 individuals who received the nine-valent HPV vaccine (HPV9) found no new safety concerns, confirming its established safety profile from previous research.

While some elevated event categories were noted, such as skin disorders and ill-defined conditions, most were either previously known or had other causes, and no deaths were linked to the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. Hansen, J., Yee, A., Lewis, N., et al.[2023]

The HPV vaccine is crucial for preventing HPV-related diseases, including cancers and genital warts, and is recommended for adolescents aged 11 to 12, with catch-up vaccination available until age 26.

Young adult women (ages 18 to 26) represent a significant group for catch-up vaccination, but barriers such as parental decisions and lack of provider recommendations hinder timely vaccination; thus, targeted interventions are needed to improve vaccine uptake in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"My mom said it wasn't important": A case for catch-up human papillomavirus vaccination among young adult women in the United States. Thompson, EL., Best, AL., Vamos, CA., et al.[2018]

In a study of 155 women aged 27-45 who tested positive for high-risk HPV and received the Gardasil 9 vaccine, 49% cleared the virus after vaccination, indicating some potential benefit of the vaccine in this age group.

However, the study found no significant differences in risk factors or outcomes between those who cleared the virus and those who did not, suggesting that the vaccine's role as a treatment for existing HPV infections remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic human papilloma virus vaccination in patients at risk for cervical dysplasia. Florence, AM., Fogel, J., Mozey, M., et al.[2022]

The 9-valent HPV vaccine (9vHPV) was well tolerated in over 15,000 participants aged 9 to 26, with a safety profile similar to the quadrivalent HPV vaccine, showing mostly mild-to-moderate adverse events like injection-site pain and headaches.

Serious adverse events were very rare (0.1%), and the vaccine did not show any significant safety concerns related to pregnancy outcomes, supporting its widespread use for HPV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Moreira, ED., Block, SL., Ferris, D., et al.[2019]

The new nonavalent HPV vaccine (9vHPV) shows a very strong immune response with nearly 100% seroconversion rates and has a safety profile similar to the quadrivalent vaccine (qHPV), although it may cause more local reactions like swelling, especially when given with other vaccines.

The 9vHPV vaccine offers additional protection against HPV-related cancers, potentially preventing 8% to 18% more cases compared to previous vaccines, but its overall impact will depend on various factors such as duration of protection and population-specific HPV type distribution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on the 9-valent HPV vaccine. Lopalco, PL.[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]

The 9-valent HPV vaccine (9vHPV) is as effective as the quadrivalent HPV vaccine (qHPV) in generating immune responses against HPV types 6, 11, 16, and 18, while also providing a 96.7% risk reduction against high-grade cervical, vulvar, or vaginal diseases related to five additional HPV types in females aged 16-26.

The 9vHPV vaccine has been shown to be safe and well tolerated, with evidence supporting its efficacy in both males and females aged 9-26, indicating its potential to significantly expand protection against HPV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus 9-valent vaccine for cancer prevention: a systematic review of the available evidence. Signorelli, C., Odone, A., Ciorba, V., et al.[2022]

The Gardasil(®) vaccine, licensed in 2006, effectively prevents cervical cancer and genital warts by targeting HPV types 6, 11, 16, and 18, which are responsible for a significant percentage of these conditions.

Since its introduction, Gardasil(®) has expanded its indications to include males and has evolved into Gardasil 9 (9vHPV), which offers broader protection against additional HPV types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of cervical cancer: journey to develop the first human papillomavirus virus-like particle vaccine and the next generation vaccine. Bryan, JT., Buckland, B., Hammond, J., et al.[2022]

A pharmacist-led intervention at Grady Health System significantly increased the administration of the first doses of the 9-valent HPV vaccine, with 89 doses given to young adults aged 18-26 during the intervention period, compared to none in the pre-intervention phase.

The initiative not only improved vaccination rates but also demonstrated the potential of pharmacists to enhance health literacy and access to immunization services, as evidenced by the administration of a total of 166 doses during the project.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Human Papillomavirus Vaccination After Pharmacist-Led Intervention: A Pilot Project in an Ambulatory Clinic at a Large Academic Urban Medical Center. Cebollero, J., Walton, SM., Cavendish, L., et al.[2020]

The nine-valent HPV (9vHPV) vaccine demonstrated comparable immune responses to the quadrivalent HPV (qHPV) vaccine for HPV types 6/11/16/18, while also effectively eliciting immune responses for five additional oncogenic HPV types (31/33/45/52/58) in a study of 500 men aged 16-26.

Both the 9vHPV and qHPV vaccines exhibited similar safety profiles, indicating that the 9vHPV vaccine is a safe and effective option for preventing a broader range of HPV-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men. Van Damme, P., Meijer, CJLM., Kieninger, D., et al.[2017]

The HPV 9-valent vaccine is now approved for adults aged 27-45, but vaccination rates in this age group remain very low, with only 0.00 to 5.56% of respondents vaccinated, despite some individuals potentially benefiting from it.

Women aged 27-45 showed a higher prevalence of unprotected sex and a greater number of sexual partners, yet they had lower awareness of HPV-related cancers, indicating a need for improved education and outreach about HPV vaccination and its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Papilloma Virus Vaccination Knowledge, Prevalence, Risk Factors, and HPV Detection in 18-26 and 27-45-year-old Men and Women. Chernyshov, PV., Semushyna, T., Verbytska, L., et al.[2023]

References

1. 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]

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

Committee opinion no. 467: human papillomavirus vaccination. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. [2023]

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

"My mom said it wasn't important": A case for catch-up human papillomavirus vaccination among young adult women in the United States. [2018]

5. Italy pubmed.ncbi.nlm.nih.gov

Therapeutic human papilloma virus vaccination in patients at risk for cervical dysplasia. [2022]

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

Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. [2019]

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

Spotlight on the 9-valent HPV vaccine. [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. England pubmed.ncbi.nlm.nih.gov

Human papillomavirus 9-valent vaccine for cancer prevention: a systematic review of the available evidence. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Prevention of cervical cancer: journey to develop the first human papillomavirus virus-like particle vaccine and the next generation vaccine. [2022]

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

Evaluation of Human Papillomavirus Vaccination After Pharmacist-Led Intervention: A Pilot Project in an Ambulatory Clinic at a Large Academic Urban Medical Center. [2020]

12. Netherlands pubmed.ncbi.nlm.nih.gov

A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men. [2017]

13. Croatia pubmed.ncbi.nlm.nih.gov

Human Papilloma Virus Vaccination Knowledge, Prevalence, Risk Factors, and HPV Detection in 18-26 and 27-45-year-old Men and Women. [2023]