HPV Vaccine and Screening Strategy for Cervical Cancer

Recruiting at 1 trial location

Overseen By Jane Montealegre, M D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Language barrier, others

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

Compensation: Varies

Number of Visits: Unknown

920 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 treatment PRECEDE-PROCEED in the clinical trial for cervical cancer?

Research shows that HPV vaccination, a key component of the treatment strategy, can prevent about 80% of cervical cancer precursors and significantly reduce new cancer cases when combined with screening. This suggests that the treatment could be effective in reducing cervical cancer incidence. ^{1 2 3 4 5}

Is the HPV vaccine safe for humans?

The HPV vaccines, Gardasil® and Cervarix®, have been studied in over 60,000 women and are considered safe, with ongoing monitoring to ensure their safety. Some adverse events have been reported, but serious ones are rare, and the vaccines are important for preventing cervical cancer. ^{6 7 8 9 10}

How does the HPV vaccine and screening strategy differ from other treatments for cervical cancer?

The HPV vaccine and screening strategy is unique because it combines vaccination to prevent HPV infections, which cause most cervical cancers, with a risk-based screening approach that reduces the frequency of tests needed. This strategy aims to nearly eradicate cervical cancer by preventing the development of precancerous lesions and reducing unnecessary treatments and anxiety associated with traditional screening methods. ^{2 4 11 12 13}

What is the purpose of this trial?

Cervical cancer is a disease that is preventable through vaccination against the virus that causes it, human papillomavirus (HPV), and through screening and treatment of cervical disease before it becomes cancet.

Research Team

Jane Montealegre

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women aged 30 or older living in RGV who haven't had a Pap test in the last 3.5 years or a Pap/HPV co-test in the past 5.5 years, and have not been diagnosed with cervical cancer or severe cervical dysplasia. Participants must be able to understand English or Spanish, are not pregnant, and do not belong to vulnerable populations.

Inclusion Criteria

I am a woman aged 30 or older.

I have not had a hysterectomy that removed my cervix.

Have not had a Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years.

Exclusion Criteria

Vulnerable Populations

I cannot communicate in English or Spanish.

Lack valid telephone contact information

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Community-Based Intervention

Community Health Workers (CHW) deliver self-sample HPV testing to increase cervical cancer screening among women

8 weeks

Follow-up

Participants who test positive for HR-HPV are monitored for clinical follow-up and further diagnostic procedures

4 weeks

Treatment Details

Interventions

• PRECEDE-PROCEED

Trial Overview The study tests a community-based strategy called PRECEDE-PROCEED aimed at improving access to cervical cancer screening for early detection of potential disease caused by HPV.

Participant Groups

Group I: PRECEDE-PROCEED Experimental Treatment 1 Intervention

To identify predisposing, enabling, and reinforcing factors that could influence women's decision to participate in self-sample HPV testing and diagnostic follow-up.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

In a study of 4632 women aged 25-36, HPV vaccination did not significantly change the sensitivity and specificity of cervical screening methods for detecting high-grade precancers, indicating that vaccinated women still benefit from regular screening.

While HPV-based screening led to lower colposcopy referral rates in vaccinated women, the positive predictive value remained similar between vaccinated and unvaccinated groups, suggesting that non-vaccine HPV types may still contribute to high-grade lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of Cervical Screening a Decade Following HPV Vaccination: The Costa Rica Vaccine Trial. Hu, SY., Kreimer, AR., Porras, C., et al.[2023]

HPV vaccination in sexually naïve women is expected to reduce the proportion of positive cervical screening tests from 8.7% to 6.5%, indicating a modest improvement in screening outcomes.

The reduction in false-positive rates is also minimal, decreasing from 5.5% to 4.3% for CIN2+ and from 6.2% to 4.7% for CIN3+, suggesting that while vaccination has benefits, the overall impact on screening effectiveness remains limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of HPV vaccination on future cervical screening: a simulation study of two birth cohorts in Denmark. Hestbech, MS., Lynge, E., Kragstrup, J., et al.[2018]

A study of 44 women diagnosed with cervical cancer after a Pap-negative, high-risk HPV-positive screen showed that most cases were early-stage and potentially curable, highlighting the importance of HPV testing in early detection.

The majority of cancers were adenocarcinomas, which are often missed by cytology, suggesting that immediate triage to colposcopy after a Pap-/HPV+ result may be more effective than the current recommendation of retesting in one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of 44 cervical cancers diagnosed following Pap-negative, high risk HPV-positive screening in routine clinical practice. Kinney, W., Fetterman, B., Cox, JT., et al.[2021]

Cervical cancer is the second most common cancer among women, primarily caused by persistent infection with human papillomavirus (HPV), but it is highly preventable through HPV vaccination and effective screening methods.

Shifting to HPV screening for women aged 30 and older could reduce new cervical cancer cases by 70-80%, especially when combined with HPV vaccination, which prevents about 80% of precursor lesions, potentially leading to the near eradication of cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV and cervical cancer. Petry, KU.[2015]

All three HPV vaccines (bivalent, quadrivalent, and 9vHPV) show high efficacy in preventing infections from specific HPV types and associated high-grade cervical dysplasia in women who have not been previously exposed to HPV.

While the bivalent and quadrivalent vaccines have demonstrated early clinical effectiveness in reducing HPV 16 and 18 prevalence, the overall benefits of HPV vaccination in reducing cervical cancer are still largely theoretical, highlighting the need for large-scale studies to confirm long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of 2-, 4- and 9-valent HPV vaccines on morbidity and mortality from cervical cancer. Luckett, R., Feldman, S.[2018]

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 two available HPV vaccines have been shown to be safe and effective in preventing cervical cancer, based on trials involving over 60,000 women before their approval.

Post-licensure surveillance confirms the safety of these vaccines, and ongoing monitoring is essential to ensure continued confidence in their use for women's health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of human papillomavirus (HPV) vaccines: a review of the international experience so far. Agorastos, T., Chatzigeorgiou, K., Brotherton, JM., et al.[2009]

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]

In a study involving 192,119 girls aged 13-16, the bivalent HPV vaccine showed a safety profile with no unexpected serious side effects, indicating it is generally safe for this age group.

While side effects were reported, with 92.1% experiencing local effects and 91.7% systemic effects, most were mild and short-lived, aligning with findings from other studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety of the bivalent human papillomavirus vaccine--results following administration of more than 192,000 doses]. van der Maas, NA., Kemmeren, JM., de Melker, HE.[2009]

A review of VAERS reports identified four cases of cervical cancer and three cases of carcinoma in situ among women who received the quadrivalent HPV vaccine, indicating that some cervical cancer cases can still occur post-vaccination.

The findings emphasize the importance of continued cervical cancer screening for vaccinated women, as the vaccine does not eliminate the risk of cervical cancer or precancerous conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Invasive and in situ cervical cancer reported to the vaccine adverse event reporting system (VAERS). Wong, C., Krashin, J., Rue-Cover, A., et al.[2022]

As HPV vaccination rates increase, the prevalence of cervical precancers and cancers is expected to decrease significantly, leading to a need for updated screening guidelines.

New risk-based management guidelines for cervical cancer screening are being developed to reduce the number of tests women undergo while maximizing benefits and minimizing potential harms like overdiagnosis and overtreatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical Cancer Screening Guidelines in the Postvaccination Era: Review of the Literature. Liverani, CA., Di Giuseppe, J., Giannella, L., et al.[2023]

Cervical cancer-related mortality in the US has significantly decreased over the past 50 years due to effective screening programs, with guidelines recommending screening to start around age 21 or three years after sexual activity begins.

Combining HPV testing with cytology screening every three years for women aged 30 and older is not only as sensitive as annual screenings but also more cost-effective, highlighting the importance of tailored screening strategies for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening and management of women and girls with human papillomavirus infection. Spitzer, M.[2022]

Prophylactic HPV vaccines have shown to provide over 90% protection against persistent HPV 16 and 18 infections, which are responsible for 70% of cervical cancers, with minimal side effects reported in clinical trials.

Vaccination against HPV 16 and 18 could significantly reduce the incidence of abnormal Pap tests by 90% and overall abnormal Pap results by about 50%, potentially decreasing the need for invasive procedures and reducing cervical cancer mortality by over 95%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cervical cancer prevention: the impact of HPV vaccination]. Monsonégo, J.[2007]

References

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

Performance of Cervical Screening a Decade Following HPV Vaccination: The Costa Rica Vaccine Trial. [2023]

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

The impact of HPV vaccination on future cervical screening: a simulation study of two birth cohorts in Denmark. [2018]

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

Characteristics of 44 cervical cancers diagnosed following Pap-negative, high risk HPV-positive screening in routine clinical practice. [2021]

4. Norway pubmed.ncbi.nlm.nih.gov

HPV and cervical cancer. [2015]

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

Impact of 2-, 4- and 9-valent HPV vaccines on morbidity and mortality from cervical cancer. [2018]

6. Italy pubmed.ncbi.nlm.nih.gov

[Human papillomavirus vaccine register]. [2013]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of human papillomavirus (HPV) vaccines: a review of the international experience so far. [2009]

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

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

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

[Safety of the bivalent human papillomavirus vaccine--results following administration of more than 192,000 doses]. [2009]

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

Invasive and in situ cervical cancer reported to the vaccine adverse event reporting system (VAERS). [2022]

11. Egypt pubmed.ncbi.nlm.nih.gov

Cervical Cancer Screening Guidelines in the Postvaccination Era: Review of the Literature. [2023]

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

Screening and management of women and girls with human papillomavirus infection. [2022]

13. France pubmed.ncbi.nlm.nih.gov

[Cervical cancer prevention: the impact of HPV vaccination]. [2007]