HPV Vaccine for HPV Prevention

Not currently recruiting at 1 trial location

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Immunosuppressants, Chemotherapy, Anticoagulants, others

Disqualifiers: Cancer, Autoimmune, Immunodeficient, Bleeding disorders, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a vaccine can prevent various types of HPV, a virus that can lead to certain cancers if infections persist. The study tests a new schedule for administering the nonavalent HPV vaccine (Recombinant Human Papillomavirus Nonavalent Vaccine), which targets nine virus types. This trial may suit healthy boys and girls who have not previously received an HPV vaccine. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressive drugs, chemotherapy, or certain other treatments. It's best to discuss your specific medications with the trial team.

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

Research has shown that the Gardasil 9 vaccine, which protects against nine types of HPV, is generally safe and well-tolerated. HPV can lead to certain cancers and diseases.

Common side effects include pain, redness, and swelling at the injection site. Some people might also experience itching, bruising, or a small lump there. These effects are usually mild and resolve on their own.

Gardasil 9 is recommended for individuals aged 9 to 45 to help prevent HPV-related diseases. However, it is not suitable for those with severe allergies to any of its ingredients.

Overall, extensive studies have confirmed the vaccine's safety for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the recombinant human papillomavirus nonavalent vaccine, known as Gardasil 9, because it offers broader protection against HPV compared to earlier vaccines. Unlike previous vaccines that targeted fewer strains, Gardasil 9 covers nine HPV types, including the ones most commonly associated with cancer and genital warts. This increased coverage means it has the potential to prevent more cases of HPV-related diseases. Additionally, the vaccine's schedule includes a priming injection and booster doses, which may enhance and prolong its protective effects.

What evidence suggests that this vaccine might be an effective treatment for HPV prevention?

Research has shown that the HPV vaccine, administered to participants in this trial, is highly effective. It prevents serious diseases of the cervix, vulva, or vagina in over 96% of cases. The vaccine protects against nine types of HPV, offering broad protection. Studies have found that it significantly reduces the risk of infections that can lead to cancer. Health experts widely recommend it for teenagers and young adults to prevent HPV-related health issues. ^{6 7 8 9 10}

Who Is on the Research Team?

Hsiao-Hui (Sherry) Chow

Principal Investigator

The University of Arizona Medical Center-University Campus

Are You a Good Fit for This Trial?

This trial is for healthy, medically well boys and girls who can understand and agree to participate. They must not have had an HPV vaccine before, be on immunosuppressive drugs, or have significant health issues like heart or kidney problems. Pregnant individuals or those with a history of allergic reactions to similar vaccines are excluded.

Inclusion Criteria

I am a healthy child with no medical issues.

Ability to understand and the willingness to sign a written assent document by the participant

I (or my legal representative) can understand and am willing to sign the consent form.

Exclusion Criteria

You have a condition that weakens your immune system or makes it less effective.

I haven't taken immune-weakening drugs in the last 6 months, except for inhaled steroids, nasal sprays, or topical creams.

I do not have severe lung, heart, liver, or kidney problems that would stop me from getting the study vaccine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Priming Injection

Participants receive the recombinant human papillomavirus nonavalent vaccine intramuscularly at baseline

Baseline

1 visit (in-person)

Booster Injection

Participants receive booster injections of the vaccine at 24 and 30 months

6 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Recombinant Human Papillomavirus Nonavalent Vaccine

Trial Overview The study is testing the effectiveness of the nonavalent HPV vaccine given in a different dosing schedule to prevent nine types of HPV in young participants. It also involves laboratory analysis to monitor biomarkers related to the vaccine's effect.

How Is the Trial Designed?

Group I: Prevention (Gardasil 9) Experimental Treatment 2 Interventions

Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

In a study of 167 HIV-infected women, the prevalence of high-risk HPV types was found to be significantly higher in the anus (90%) compared to the cervix (83%), indicating a need for targeted screening and prevention in this population.

The nonavalent HPV vaccine, which targets both high-risk and low-risk HPV types, is supported by the findings as 9v HR-HPV types were prevalent (67% in the anus and 51% in the cervix), highlighting its potential effectiveness in reducing HPV-related disease in HIV-infected women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and Incidence of Anal and Cervical High-Risk Human Papillomavirus (HPV) Types Covered by Current HPV Vaccines Among HIV-Infected Women in the SUN Study. Kojic, EM., Conley, L., Bush, T., et al.[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]

Vaccinating 12-year-old girls with the quadrivalent HPV vaccine is predicted to significantly reduce the incidence of anogenital warts by 72.1% and cervical intraepithelial neoplasia lesions (CIN2 and -3) by 46.1% over 70 years, while the bivalent vaccine shows no reduction in AGWs but a 51.0% reduction in CIN2 and -3.

Switching from bivalent or quadrivalent vaccines to a nonavalent vaccine could further enhance protection, potentially reducing AGW episodes by an additional 66.7% and CIN2 and -3 cases by an additional 9.3%, indicating a greater long-term effectiveness against precancerous lesions and cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population-level impact of the bivalent, quadrivalent, and nonavalent human papillomavirus vaccines: a model-based analysis. Van de Velde, N., Boily, MC., Drolet, M., et al.[2022]

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]

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]

The study analyzed 23 randomized controlled trials and found that the bivalent HPV vaccine (2vHPV) was associated with significantly more systemic adverse events compared to the quadrivalent (4vHPV) and 9-valent (9vHPV) vaccines, as well as placebo.

Despite the increased systemic adverse events linked to the 2vHPV vaccine, there were no significant differences in serious adverse events between vaccinated individuals and those receiving a placebo, suggesting overall safety in terms of severe reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparative safety of human papillomavirus vaccines: A Bayesian network meta-analysis. Huang, R., Gan, R., Zhang, D., et al.[2022]

Citations

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

Human Papillomavirus Vaccine Efficacy and Effectiveness ... HPV vaccination has been shown to be highly effective against oral HPV type 16/18 infection, with a significant percentage of participants developing IgG ...

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

HPV Vaccine Efficacy Quadrivalent vaccine was also found to have high efficacy (99%) for prevention of genital warts. Among men who have sex with men (MSM), quadrivalent vaccine had ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6613616/

Recombinant human papillomavirus nonavalent vaccine in ... The study reported greater than 96% vaccine efficacy against high-grade cervical, vulvar, or vaginal disease as well as six-month persistent ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03180034

Study Details | NCT03180034 | Comparing One or Two ... This phase IV trial investigates whether one dose of a human papillomavirus vaccine works as well as two doses in preventing human papillomavirus (HPV) ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1684118225000714

Recommendations and guidance for human ... Adjuvanted, non-live, HPV recombinant vaccines, including the bivalent, quadrivalent, and 9-valent vaccines, are widely recommended for adolescents and young ...

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

Human Papillomavirus (HPV) Vaccine Safety The 9vHPV vaccine adds 5 additional antigens, providing protection against 9 types of cancer-causing human papillomaviruses.

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. merckvaccines.com merckvaccines.com/gardasil9/

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, ... GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is contraindicated in individuals with hypersensitivity, including severe allergic reactions to ...

10. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK562186/

Human Papilloma Virus Vaccine - StatPearls - NCBI Bookshelf The 9vHPV vaccine is routinely recommended for males and females aged 9 to 45 to prevent various diseases and dysplastic lesions caused by HPV.