Reminders for HPV Vaccine

Recruiting at 1 trial location

Overseen By Ashley Stephens, MD

Age: < 18

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Non-English/Luganda speakers, Previous study participants

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: Unknown

396 Participants Needed

Trial Summary

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

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

What data supports the effectiveness of the treatment HPV Vaccine Reminders?

Research shows that the HPV vaccines Cervarix and Gardasil are highly effective in preventing infections with HPV types that cause cervical cancer. Cervarix, in particular, has shown strong protection against multiple cancer-causing HPV types and has maintained high levels of protective antibodies for over seven years, significantly reducing the risk of cervical precancerous lesions. ^{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 have been reported. Safety data from various sources, including the Vaccine Adverse Event Reporting System (VAERS) and WHO's VigiBase, support their safety profile, but they do contain aluminum adjuvants, which are added to boost the immune response. ^{1 5 6 7 8}

How does the HPV vaccine differ from other treatments for HPV prevention?

The HPV vaccine, particularly the 9-valent version (Gardasil 9), is unique because it covers more HPV types than earlier vaccines, increasing protection from about 70% to 90% against cervical cancer-causing strains. It is administered as a two-dose series for younger individuals, which is simpler and potentially more cost-effective compared to the three-dose regimen for older individuals. ^{2 9 10 11 12}

What is the purpose of this trial?

This RCT will take place at health centres and their affiliated schools and community immunization centers overseen by the Kampala Capital City Authority (KCCA) as well as at the Makerere/Mulago/Columbia Adolescent Health Clinic in Kampala. The investigators will assess the impact of vaccine text message and automated phone reminders on human papillomavirus (HPV) vaccination initiation and completion.

Research Team

Melissa Stockwell, MD MPH

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for parents of girls aged 10-14 in Kampala or nearby, who speak English or Luganda and have a cell phone that can receive texts. Parents already in the study with another child, or involved in past HPV vaccine reminder studies, can't join.

Inclusion Criteria

I am a parent of a girl aged 10-14.

I can understand and agree to the study's requirements.

Reside in Kampala and/or the surrounding districts

Exclusion Criteria

I speak a language other than English or Luganda.

Parenting adult already enrolled in the study for another child

Participation in previous HPV vaccine reminder study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive text message or automated phone reminders for HPV vaccination

12 months

Follow-up

Participants are monitored for timeliness of HPV vaccination completion

12 months

Treatment Details

Interventions

• HPV Vaccine Reminders

Trial Overview The SEARCH II Study is testing if text messages and automated phone reminders increase the start and completion rates of HPV vaccination among adolescent girls at health centers and schools affiliated with KCCA.

Participant Groups

Group I: Text message/automated phone reminders Experimental Treatment 1 Intervention

Text message or automated phone reminders

Group II: Usual Care Active Control 1 Intervention

No reminders

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Makerere University

Collaborator

Trials

297

Recruited

1,862,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

The Gardasil® and Cervarix® vaccines are highly effective and safe in preventing cervical cancer caused by human papillomaviruses (HPV), which is the third most common cancer in women.

Current research is focused on developing more affordable second-generation HPV vaccines using different formulations, as the high cost of existing vaccines limits their global implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic papillomavirus vaccines. Ribeiro-Müller, L., Müller, M.[2022]

HPV-related cancers, including cervical and head and neck cancers, account for a significant portion of global cancer cases, highlighting the urgent need for effective vaccination strategies, especially since over 80% of people are exposed to HPV by age 50.

While prophylactic vaccines like Gardasil® and Cervarix® have successfully reduced HPV infections in young populations, there are currently no FDA-approved therapeutic vaccines for those already infected, indicating a critical gap in treatment options for HPV-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Vaccines for HPV-Associated Malignancies. Smalley Rumfield, C., Roller, N., Pellom, ST., et al.[2020]

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]

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]

The HPV vaccines Gardasil and Cervarix are effective in preventing infection from the most harmful HPV types and are generally considered safe based on data from the U.S. Vaccine Adverse Event Reporting System (VAERS).

While the vaccines are effective, some studies have reported autoimmune side effects, indicating a need for further research to explore the potential link between HPV vaccination and autoimmunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of human papilloma virus-blockers and the risk of triggering autoimmune diseases. Baker, B., Eça Guimarães, L., Tomljenovic, L., et al.[2015]

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 9-valent HPV vaccine (Gardasil 9®) significantly increases protection against cervical cancer by covering 9 oncogenic HPV types, raising potential protection from about 70% to 90%, based on clinical trials involving young women.

Clinical trials demonstrated that the 9vHPV vaccine has a comparable safety profile and immunogenicity to the original 4-valent vaccine, with a 2-dose regimen showing similar effectiveness in younger boys and girls compared to the standard 3-dose regimen for older women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. Zhang, Z., Zhang, J., Xia, N., et al.[2019]

The two-dose HPV vaccine series for pre-adolescent girls (ages 9-15) is effective in providing protection against HPV 16 and other types, with the World Health Organization recommending this schedule since 2015, while older women still require a three-dose series.

Gardasil9 and Cervarix both show strong efficacy in preventing HPV infections, with Cervarix offering a potentially more cost-effective option due to its sustained high antibody levels and the possibility of effective protection with just one dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV vaccines - A review of the first decade. Harper, DM., DeMars, LR.[2022]

Gardasil is a newly available vaccine in the U.S. for girls and women aged 9 to 26 that protects against human papillomavirus (HPV), a major cause of cervical cancer.

These HPV vaccines, including the under-development Cervarix, could potentially lower the incidence of cervical cancer by up to 70%, marking a significant advancement in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the new HPV vaccines in clinical practice. Widdice, LE., Kahn, JA.[2019]

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]

References

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

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

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

Prophylactic papillomavirus vaccines. [2022]

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

Therapeutic Vaccines for HPV-Associated Malignancies. [2020]

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

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

6. 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]

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

The safety of human papilloma virus-blockers and the risk of triggering autoimmune diseases. [2015]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. [2019]

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

HPV vaccines - A review of the first decade. [2022]

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

Using the new HPV vaccines in clinical practice. [2019]

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

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