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Cancer Vaccine
Adjuvanted HPV Vaccine for HPV Prevention
Phase 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
Study Summary
This trial is testing the safety of a new HPV vaccine.
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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Anti-HPV immunoglobulin G (IgG) antibody concentrations
Anti-HPV neutralizing antibody titers
Correlation between anti-HPV IgG antibody concentration and anti-HPV neutralizing antibody titers
+7 moreTrial 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.
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,758 Previous Clinical Trials
8,103,065 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman aged 18 to 26 and about to start the study treatment.I am a woman aged 16 to 26 and ready for the first study treatment.I am a woman not planning to use birth control or trying to get pregnant.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.I am a woman aged 16 to 26 and ready for the first study treatment.I have had 4 or fewer sexual partners in my lifetime.I have had 4 or fewer sexual partners in my lifetime.I am a woman aged 18 to 26 and about to receive my first study treatment.I am a woman who cannot become pregnant.You were born with a serious physical defect, as determined by the study doctor.You have a history of or currently struggle with chronic alcohol consumption or drug abuse.You are allergic to latex.I have been previously treated with MPL or AS04 adjuvant.I have or had an autoimmune disease.You have a history of a severe reaction or allergy to any of the study treatments.I am a woman who cannot become pregnant.I have been vaccinated against HPV.The investigator believes that your health condition may put you at risk if you participate in the study.I have had genital or vaginal warts in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Human Papilloma Virus 9-valent (HPV9) Low Group
- Group 2: Human Papilloma Virus 9-valent (HPV9) Med Group
- Group 3: Gardasil 9 (Gar9) Group
- Group 4: Human Papilloma Virus 9-valent (HPV9) High Group
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are young adults eligible for this particular research program?
"This clinical trial is looking for patients who are young adults aged 16-26."
Answered by AI
To sign up for this experiment, who does one have to be?
"This clinical trial is seeking 1080 participants between the ages of 16 and 26 who have been diagnosed with cervical intraepithelial neoplasia. In addition to meeting this age and diagnosis criteria, potential participants must also: Be in generally good health as determined by medical history and physical examination before entering the study., For Step 2: Be female, between the ages of 16 and 26 at the time of first study intervention administration,, Have had no more than 4 sexual partners prior to enrollment,, Be a non-childbearing female or agree to use contraception throughout the duration of the study and for 2 months after completion of study intervention administration series.,"
Answered by AI
Are there any open positions in this clinical trial for new patients?
"Yes, the trial is currently recruiting patients. The study was originally posted on 8/22/2022 and has been updated as recently as 8/30/2022 according to clinicaltrials.gov"
Answered by AI
How many test subjects are currently a part of this clinical trial?
"Based on the information available from clinicaltrials.gov, this study is still recruiting patients. The trial was originally posted on 8/22/2022 and was most recently edited on 8/30/2022. They are searching for a total of 1080 patients from 1 location."
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
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