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Cancer Vaccine

HPV Vaccination Immune Response Study

Phase 4

Recruiting

Led By Erin Scherer, Ph.D.

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Individuals aged 18-45 years old (inclusive), as the HPV vaccine is approved for this age range in adults

Must be willing to undergo lymph node fine needle aspiration and bone marrow aspiration

Must not have

Has history of active malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure

Had major surgery (per the investigator's judgment) within 4 weeks before study entry or planned major surgery during this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 0), day 14, day 30, day 60, day 67, day 90, day 180, day 187, day 210, day 365, day 730 post-intervention

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will assess the immune response in different parts of the body to the HPV vaccine in order to better understand how the vaccine works.

Who is the study for?

Adults aged 18-45 with a BMI ≤ 32, in good health, and able to give informed consent can join this HPV vaccine study. They must be willing to undergo lymph node and bone marrow sampling and not have any history of genital warts, abnormal pap smears, positive HPV tests, or certain cancers. Participants should not have received blood products recently or plan major surgery during the study.

What is being tested?

The trial is testing immune responses to the Gardasil HPV vaccine through blood, saliva, bone marrow, and lymph node samples over two years. Participants will receive three doses of the vaccine at specific intervals followed by multiple assessments.

What are the potential side effects?

Possible side effects include discomfort from lidocaine injections used for numbing before procedures like fine needle aspiration of lymph nodes and bone marrow sampling. There may also be general vaccine-related side effects such as soreness at injection site.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 45 years old.

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I am willing to have needle tests on my lymph nodes and bone marrow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer other than skin cancer, but it was surgically removed and considered cured.

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I haven't had, nor plan to have, major surgery within 4 weeks of joining this study.

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I have had an organ, bone marrow, or stem cell transplant.

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I have diabetes and need insulin to manage it.

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I have not received blood products or immunoglobulin in the last 3 months.

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I have a history of genital warts, an abnormal pap smear, or a positive HPV test.

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I have tested positive for one of the HPV types listed.

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I have received an HPV vaccine dose.

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I do not have chronic infections like HIV, TB, or hepatitis.

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I have a bleeding disorder or am currently on blood thinners or NSAIDs.

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I have a weak immune system due to a condition or medication.

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I have an infection, swollen lymph nodes, or rash in the area to be treated.

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I have not had a fever of 100.4 F or higher in the last 3 days.

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I am currently immunosuppressed due to cancer treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 0), day 14, day 30, day 60, day 67, day 90, day 180, day 187, day 210, day 365, day 730 post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 0), day 14, day 30, day 60, day 67, day 90, day 180, day 187, day 210, day 365, day 730 post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 0), day 14, day 30, day 60, day 67, day 90, day 180, day 187, day 210, day 365, day 730 post-intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with a minimum four-fold rise in post-vaccination HPV-16 and HPV-18 neutralizing antibody titers

Secondary study objectives

Change in number of HPV-specific memory B cell (Bmem) response from Baseline

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3: Lymph node sampling at D180, D194 and D210Experimental Treatment2 Interventions

Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180. Group 3 will have lymph node sampling D180, D194 and D210. Bone marrow sampling will be done for all groups at D730.

Group II: Group 2: Lymph node sampling at D60, D74 and D90Experimental Treatment2 Interventions

Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180. Group 2 will have lymph node sampling done at D60, D74 and D90. Bone marrow sampling will be done for all groups at D730.

Group III: Group 1: Lymph node sampling at D-30 to D0, D14 and D30Experimental Treatment2 Interventions

Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180. Group 1 will have lymph node sampling done D-30 to D0, D14 and D30. Bone marrow sampling will be done for all groups at D730.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lidocaine injections

2014

N/A

~110

Gardasil

2011

Completed Phase 4

~5000