What side effects are associated with this type of intervention?

Common treatments for cervical neoplasia include surgery, radiation therapy, and chemotherapy, each with distinct side effects. Surgery may cause infection, bleeding, and anesthesia-related issues. Radiation therapy often leads to fatigue, skin irritation, and long-term gastrointestinal and urinary problems. Chemotherapy is associated with nausea, vomiting, hair loss, and increased infection risk. Investigational adjuvanted HPV vaccines, designed to enhance immune response, typically have side effects like injection site reactions, mild fever, and fatigue.

What prior FDA approvals exist?

FDA-approved treatments for cervical neoplasia include pembrolizumab, an immune checkpoint inhibitor used for PD-L1 positive recurrent or metastatic cervical cancer, and tisotumab vedotin-tftv, a tissue factor-directed antibody-drug conjugate for recurrent or metastatic cervical cancer. These treatments enhance the immune response, similar to the investigational adjuvanted HPV vaccine being studied to boost immune response to HPV antigens.

What other types of research exist?

Promising novel alternatives for cervical neoplasia patients include: 1) Pembrolizumab, an immune checkpoint inhibitor, which has shown efficacy in advanced cervical cancer (KEYNOTE-158 and KEYNOTE-028 trials). 2) Cemiplimab, another immune checkpoint inhibitor, which has demonstrated survival benefits in recurrent cervical cancer. 3) Targeted therapies such as bevacizumab, which has been effective in combination with chemotherapy for advanced cervical cancer. These treatments offer new avenues for patients, especially those with advanced or recurrent disease.

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Cancer Vaccine

Adjuvanted HPV Vaccine for HPV Prevention

Phase 1 & 2

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy participants as established by medical history and clinical examination before entering into the study.

For Step 1 only: Female between and including 18 and 26 years of age at the time of the first study intervention administration.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at month 3 and month 7

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new HPV vaccine with an added ingredient to help the immune system fight the virus better. It aims to ensure the vaccine is safe and effective for people who need protection against HPV. HPV vaccines have been proven effective in preventing cervical cancer and other HPV-related malignancies.

Who is the study for?

Healthy women aged 16-26, with no more than four lifetime sexual partners and not planning pregnancy. They must use effective contraception, have a negative pregnancy test before receiving the vaccine, and agree to follow-up requirements. Women with major congenital defects, drug abuse history, previous HPV vaccination or exposure to certain adjuvants are excluded.

What is being tested?

The trial is testing different formulations of GSK's investigational HPV vaccine (low, medium, high doses) against Gardasil 9 for safety and immune response in young women at risk of cervical dysplasia/neoplasia.

What are the potential side effects?

Possible side effects include reactions at the injection site like pain or swelling, general symptoms such as fever or fatigue. There may also be allergic responses due to ingredients in the vaccines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 18 to 26 and about to start the study treatment.

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I am a woman aged 16 to 26 and ready for the first study treatment.

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I have had 4 or fewer sexual partners in my lifetime.

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I am a woman who cannot become pregnant.

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I am a woman who can have children, using effective birth control, not pregnant, and agree to continue birth control during and 2 months after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at month 3 and month 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at month 3 and month 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 3 and month 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants with Grade 3 solicited administration site events after dose 1

Percentage of participants with Grade 3 solicited administration site events after dose 2

Percentage of participants with Grade 3 solicited administration site events after dose 3

+8 more

Secondary study objectives

Correlation between anti-HPV IgG antibody concentration and anti-HPV neutralizing antibody titers

Number of seroconverted participants for anti-HPV IgG antibodies

Number of seroconverted participants with anti-HPV neutralizing antibodies

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Human Papilloma Virus 9-valent (HPV9) Med GroupExperimental Treatment1 Intervention

Healthy females aged 16 to 26 years receive 3 doses of the HPV9-Medium formulation of the investigational adjuvanted HPV vaccine on Day 1, Month 2, and Month 6.

Group II: Human Papilloma Virus 9-valent (HPV9) Low GroupExperimental Treatment1 Intervention

Healthy females aged 16 to 26 years receive 3 doses of the HPV9-Low formulation of the investigational adjuvanted HPV vaccine on Day 1, Month 2, and Month 6.

Group III: Human Papilloma Virus 9-valent (HPV9) High GroupExperimental Treatment1 Intervention

Healthy females aged 16 to 26 years receive 3 doses of the HPV9-High formulation of the investigational adjuvanted HPV vaccine on Day 1, Month 2, and Month 6.

Group IV: Gardasil 9 (Gar9) GroupActive Control1 Intervention

Healthy females aged 16 to 26 years receive 3 doses of the marketed HPV vaccine on Day 1, Month 2, and Month 6.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HPV9 High formulation

2022

Completed Phase 2

~1080

HPV9 Low formulation

2022

Completed Phase 2

~1080

HPV9 Medium formulation

2022

Completed Phase 2

~1080

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The investigational adjuvanted HPV vaccine enhances the immune response to HPV antigens, helping the body to recognize and fight off the virus that can lead to cervical neoplasia. Surgery physically removes neoplastic tissue, directly eliminating abnormal cells. Radiation therapy uses high-energy rays to kill cancer cells or shrink tumors, and chemotherapy employs drugs to target and kill rapidly dividing cells, including cancer cells. These treatments are essential for cervical neoplasia patients as they aim to eradicate cancerous cells, prevent disease progression, and reduce recurrence risk.