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Cancer Vaccine

HPV Vaccine for HPV Prevention

Phase 2
Waitlist Available
Led By Hsiao-Hui (Sherry) Chow
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant
Be younger than 18 years old
Must not have
Receiving active treatment for cancer or an autoimmune condition
Previous vaccination against HPV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 6 and 24 months after prime dose and prior to the administration of the second dose
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how well a new HPV vaccine works in preventing HPV infections.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, common ones for vaccines like this may include pain at injection site, fever, headache, fatigue, muscle or joint pain. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I (or my legal representative) can understand and am willing to sign the consent form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently receiving treatment for cancer or an autoimmune disease.
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I have been vaccinated against HPV.
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I have a bleeding disorder that prevents me from getting shots in my muscles.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 6 and 24 months after prime dose and prior to the administration of the second dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and between 6 and 24 months after prime dose and prior to the administration of the second dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Human Papilloma Virus (HPV)16/18 Antibody Titer
Secondary study objectives
Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (Gardasil 9)Experimental Treatment2 Interventions
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,924 Previous Clinical Trials
41,017,750 Total Patients Enrolled
1,437 Trials studying Carcinoma
413,149 Patients Enrolled for Carcinoma
Hsiao-Hui (Sherry) ChowPrincipal InvestigatorThe University of Arizona Medical Center-University Campus
3 Previous Clinical Trials
138 Total Patients Enrolled
Yi ZengPrincipal InvestigatorThe University of Arizona Medical Center-University Campus
1 Previous Clinical Trials
56 Total Patients Enrolled

Media Library

Recombinant Human Papillomavirus Nonavalent Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02568566 — Phase 2
Carcinoma Research Study Groups: Prevention (Gardasil 9)
Carcinoma Clinical Trial 2023: Recombinant Human Papillomavirus Nonavalent Vaccine Highlights & Side Effects. Trial Name: NCT02568566 — Phase 2
Recombinant Human Papillomavirus Nonavalent Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02568566 — Phase 2
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