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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 belowSelect...
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:Select...
I am currently receiving treatment for cancer or an autoimmune disease.
Select...
I have been vaccinated against HPV.
Select...
I have a bleeding disorder that prevents me from getting shots in my muscles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between 6 and 24 months after prime dose and prior to the administration of the second dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 6 and 24 months after prime dose and prior to the administration of the second dose
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
13,938 Previous Clinical Trials
41,022,987 Total Patients Enrolled
1,438 Trials studying Carcinoma
412,919 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition that weakens your immune system or makes it less effective.I am a healthy child with no medical issues.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.I (or my legal representative) can understand and am willing to sign the consent form.You have a history of allergic reactions to similar vaccines or substances used in GARDASIL 9, including yeast.I am currently receiving treatment for cancer or an autoimmune disease.I have been vaccinated against HPV.I have a bleeding disorder that prevents me from getting shots in my muscles.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (Gardasil 9)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.