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Virus Therapy
HPV Vaccine Dosing Schedules for Human Papillomavirus
Phase 4
Recruiting
Led By Abbey B Berenson, MD, PhD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
Study Summary
This trial aims to compare two and three doses of the HPV vaccine in adult women. Blood samples will be taken over 12 months. All 2-dose participants will get a 3rd dose.
Who is the study for?
This trial is for females aged 27-45 who haven't had the HPV vaccine, use reliable birth control, and can consent. They must have a way to pay for the vaccine, speak English or Spanish, and have phone access. Pregnant women or those planning pregnancy soon, with suppressed immune systems or certain medical conditions are excluded.Check my eligibility
What is being tested?
The study compares two schedules of the HPV vaccine: one group will receive two doses at different times while another gets three doses at standard intervals. The goal is to see if fewer doses still provide strong immunity against HPV over a year.See study design
What are the potential side effects?
Possible side effects from the HPV vaccine include pain at injection site, swelling, redness, headaches, nausea, fever or dizziness. Severe allergic reactions are rare but may occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Short-term HPV type-specific antibody response for type HPV-11
Short-term HPV type-specific antibody response for type HPV-16
Short-term HPV type-specific antibody response for type HPV-18
+6 moreSide effects data
From 2012 Phase 3 trial • 6104 Patients • NCT0134659227%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Females, 2-dose alternativeExperimental Treatment1 Intervention
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (27-45 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
Group II: Females, 3-dose standardActive Control1 Intervention
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (27-45 years of age) at 0, 2, and 6 months.
Find a Location
Who is running the clinical trial?
The University of Texas Medical Branch, GalvestonLead Sponsor
243 Previous Clinical Trials
56,053 Total Patients Enrolled
Cancer Prevention Research Institute of TexasOTHER
50 Previous Clinical Trials
97,820 Total Patients Enrolled
Abbey B Berenson, MD, PhDPrincipal InvestigatorUniversity of Texas
1 Previous Clinical Trials
757 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had more than 10 sexual partners in my lifetime.I am a woman aged between 27 and 45.I have a blood condition that makes injections unsafe for me.I have had my spleen removed.I have never received the HPV vaccine.I have not had a fever of 100°F or higher in the last 24 hours.I can read and speak English or Spanish.I have an immune system disorder like HIV, lupus, or rheumatoid arthritis.I am currently on treatments that could weaken my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Females, 3-dose standard
- Group 2: Females, 2-dose alternative
Awards:
This trial has 3 awards, including:- 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.
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.
Is the enrollment for this trial limited to those under 45 years of age?
"According to the prerequisites for this medical trial, applicants must be between 27 and 45 years of age."
Answered by AI
How secure is the 2-dose regimen for women?
"The safety of the two-dose treatment for females has been established, garnering it a score of 3. This is because this drug has already completed Phase 4 trials and thus been approved by our team at Power."
Answered by AI
Is recruitment for this investigation currently underway?
"According to the information hosted on clinicaltrials.gov, this medical trial is no longer actively recruiting patients as it was last updated on December 21st 2022. However, there are currently 110 other studies that are in need of volunteers."
Answered by AI
Who is eligible to participate in this clinical investigation?
"For this trial, 618 immunized individuals aged 27-45 are being recruited. Criteria for eligibility include: female gender, informed consent given, lack of prior HPV vaccination (verified through Immtrac and electronic medical record), reliable telephone access throughout the study period, fluency in either English or Spanish language, available funding options such as Medicaid/private insurance/Texas Healthy Women program , and a commitment to consistent birth control usage up until month 13."
Answered by AI
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