Gardasil9 Vaccine for Human Papillomavirus

Overseen By Natalie Pierre-Joseph, MD

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: Boston Medical Center

Disqualifiers: Severe allergies, Immunocompromised, Thrombocytopenia, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vaccine called Gardasil9 to evaluate its effectiveness in preventing human papillomavirus (HPV) infections in children. The study administers two doses of the vaccine one year apart to assess the body's response over four years. It seeks children aged 4 to 8 who have not yet received an HPV vaccine and are cared for at Boston Medical Center. As an Early Phase 1 trial, this research aims to understand how the vaccine works in young children, offering participants a chance to contribute to important medical knowledge.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Earlier studies have shown Gardasil 9 to be safe. Researchers tested it in clinical trials with over 15,000 people and found no unexpected safety issues. The most common side effects were minor, including pain, swelling, and redness at the injection site. Some participants also experienced itching, bruising, or a small lump where the shot was given. Approved since 2014 to prevent HPV-related illnesses, this HPV vaccine has demonstrated its safety for use in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard HPV vaccines, Gardasil9 offers broader protection by targeting nine HPV strains, including those most commonly linked to cervical cancer and other HPV-related diseases. The excitement around Gardasil9 stems from its potential to significantly reduce the incidence of HPV-related cancers with just two doses, given over a year apart, which is a more convenient schedule compared to the typical three-dose regimens. This streamlined dosing schedule could improve vaccine compliance and accessibility, making it easier for more people to complete the series and gain full protection.

What evidence suggests that Gardasil9 might be an effective treatment for HPV?

Research has shown that Gardasil9 effectively creates an immune response. Over 98% of those who receive the full series of this vaccine develop antibodies against the targeted HPV types. Studies have found it to be nearly 99% effective in preventing serious HPV-related conditions, such as severe forms of cervical precancer. Long-term evidence indicates that the vaccine remains effective for at least ten years. Overall, Gardasil9 has proven to be a strong tool in preventing HPV infections and related diseases. ^{6 7 8 9 10}

Who Is on the Research Team?

Elisha Wachman, MD

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

This trial is for children aged 4-8 who get care at Boston Medical Center or its community health centers and have never had an HPV vaccine. It's not for kids with blood clotting issues, severe allergies (especially to yeast), or weakened immune systems.

Inclusion Criteria

Receives care at the Boston Medical Center or one of the affiliated Community Health Centers

My child is between 4 and 8 years old.

I have never received the HPV vaccine.

Exclusion Criteria

History of severe allergic reaction, including known allergy to any vaccine component, especially severe allergic reaction to yeast

I have a weakened immune system or have been on drugs that lower my immunity.

I have a blood clotting disorder or low platelet count.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 doses of the 9vHPV vaccine at 0 and 12 months

12 months

2 visits (in-person)

Follow-up

Participants are monitored for immunogenicity and safety after the second dose

48 months

Multiple visits for serology testing

What Are the Treatments Tested in This Trial?

Interventions

• Gardasil9

Trial Overview

The study tests the effectiveness of a two-dose regimen of Gardasil9, an HPV vaccine, given over one year to prevent warts and human papillomavirus in young children.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

HPV 9-valent human papillomavirus vaccine (Gardasil 9) - 0.5mL intramuscular dose - 2 doses (Month 0, 12)

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

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]

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]

In a study of 266,647 doses of Gardasil-9® administered in Puglia, Italy, only 22 adverse events following immunization (AEFIs) were reported, resulting in a low reporting rate of 8.25 per 100,000 doses, indicating a favorable safety profile for the vaccine.

Out of the 22 reported AEFIs, only 5 were classified as serious, with 2 leading to hospitalization; however, only 2 serious AEFIs were consistently associated with the vaccine, suggesting that the benefits of Gardasil-9® outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Life Safety Profile of the 9-Valent HPV Vaccine Based on Data from the Puglia Region of Southern Italy. Di Lorenzo, A., Berardi, P., Martinelli, A., et al.[2022]

The nine-valent HPV vaccine, Gardasil9, significantly increases the efficacy against cervical cancer from 70% to 90% compared to the quadrivalent vaccine, covering a broader range of HPV types.

Gardasil9 also provides high efficacy (97%) against lesions associated with HPV types 31, 33, 45, 52, and 58, while maintaining similar effectiveness against HPV types 6, 11, 16, and 18 as the quadrivalent vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nine-valent HPV vaccine - new generation of HPV vaccine]. Fait, T., Dvořák, V., Pilka, R.[2018]

The Gardasil vaccine significantly increased the intersurgical interval (ISI) by an average of 3.1 months in patients with recurrent respiratory papillomatosis (RRP), indicating a positive effect on disease management.

40% of patients achieved complete remission and 25% experienced partial remission, with males showing a greater response compared to females, suggesting that the vaccine can effectively modulate the severity of RRP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of the quadrivalent human papillomavirus vaccine (gardasil) as adjuvant therapy in the treatment of recurrent respiratory papilloma. Young, DL., Moore, MM., Halstead, LA.[2015]

The introduction of the quadrivalent vaccine Gardasil and the bivalent vaccine Cervarix has significantly advanced the prevention of HPV-related diseases, including various cancers and benign conditions like genital warts.

A new multivalent vaccine, Gardasil 9, has been approved and shows promise in providing broader protection against nine HPV subtypes, with ongoing efforts to improve vaccine accessibility and reduce production costs, especially in developing countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-generation prophylactic HPV vaccines: current options and future strategies for vaccines development. Fruscalzo, A., Londero, AP., Bertozzi, S., et al.[2016]

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 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 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]

Citations

1.

cdc.gov

cdc.gov/vaccines/vpd/hpv/hcp/vaccines.html

HPV Vaccine Efficacy

More than 98% of recipients develop an antibody response to HPV types included in the respective vaccines 1 month after completing a full vaccination series.

2.

merckvaccines.com

merckvaccines.com/gardasil9/efficacy/

Efficacy of GARDASIL®9 (Human Papillomavirus 9-valent ...

Efficacy and effectiveness of GARDASIL are relevant to GARDASIL 9 since the vaccines are manufactured similarly and contain 4 of the same HPV L1 VLPs. In men ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8706722/

Human Papillomavirus Vaccine Efficacy and Effectiveness ...

For CIN2+ and CIN3+ associated with HPV 6/11/16/18, the vaccine efficacy was 99% (95% CI = 91% to 100%) and 99% (95% CI = 82% to 100%). The quadrivalent ...

4.

publications.aap.org

publications.aap.org/pediatrics/article/152/4/e2022060993/193886/Ten-Year-Follow-up-of-9-Valent-Human

Ten-Year Follow-up of 9-Valent Human Papillomavirus ...

Immunogenicity, effectiveness, and safety were demonstrated through 10 years postvaccination. Rates of persistent infection and disease related ...

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/21645515.2024.2377903

Long-term effectiveness of the nine-valent human ...

The results of the control chart method have demonstrated statistically significant vaccine effectiveness of at least 90% through at least 10 ...

6.

cdc.gov

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

HPV Vaccine Safety and Effectiveness Data

Each vaccine was found to be safe and effective in clinical trials. Gardasil 9 was studied in clinical trials with more than 15,000 females and ...

7.

gardasil9.com

gardasil9.com/patient-pd/what-is-gardasil-9/safety-and-side-effects/

GARDASIL 9 safety and side effects

The most common side effects of GARDASIL 9 include: pain, swelling, redness, itching, bruising, bleeding, and a lump where your child got the shot.

8.

fda.gov

fda.gov/media/90064/download

Package Insert - GARDASIL 9

GARDASIL 9, Human Papillomavirus 9-valent Vaccine, Recombinant, is a non-infectious recombinant. 9-valent vaccine prepared from the purified virus-like ...

9.

cdc.gov

cdc.gov/vaccine-safety/vaccines/hpv.html

Human Papillomavirus (HPV) Vaccine Safety

Gardasil 9 (human papillomavirus 9-valent ... Both included multiple years of data, and did not identify any unexpected safety problems with Gardasil 9.

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40662677/

Adverse events following 9-valent human papillomavirus ...

GARDASIL 9, a 9-valent HPV vaccine approved in 2014, is widely administered for the prevention of HPV-related malignancies.