9-valent HPV vaccine, 2 dose efficacy for Human Papillomavirus

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Texas Medical Branch, Galveston, TXHuman Papillomavirus+2 More9-valent HPV vaccine, 2 dose efficacy - Biological
Eligibility
15 - 26
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to see if a third dose of the HPV vaccine is necessary for people aged 15-26, or if two doses provide enough protection against the nine types of HPV it vaccinates against.

Eligible Conditions
  • Human Papillomavirus
  • Effectiveness
  • Immunizations

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

18 Primary · 0 Secondary · Reporting Duration: Month 12

Month 12
HPV type-specific antibody response for type HPV-11
HPV type-specific antibody response for type HPV-16
HPV type-specific antibody response for type HPV-18
HPV type-specific antibody response for type HPV-31
HPV type-specific antibody response for type HPV-33
HPV type-specific antibody response for type HPV-45
HPV type-specific antibody response for type HPV-52
HPV type-specific antibody response for type HPV-58
HPV type-specific antibody response for type HPV-6
Month 7
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
Short-term HPV type-specific antibody response for type HPV-31
Short-term HPV type-specific antibody response for type HPV-33
Short-term HPV type-specific antibody response for type HPV-45
Short-term HPV type-specific antibody response for type HPV-52
Short-term HPV type-specific antibody response for type HPV-58
Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Females, 3 dose standard
1 of 4
Males, 3 dose standard
1 of 4
Females, 2 dose with delayed 3rd dose
1 of 4
Males, 2 dose with delayed 3rd dose
1 of 4

Active Control

Experimental Treatment

800 Total Participants · 4 Treatment Groups

Primary Treatment: 9-valent HPV vaccine, 2 dose efficacy · No Placebo Group · Phase 4

Females, 2 dose with delayed 3rd dose
Biological
Experimental Group · 1 Intervention: 9-valent HPV vaccine, 2 dose efficacy · Intervention Types: Biological
Males, 2 dose with delayed 3rd dose
Biological
Experimental Group · 1 Intervention: 9-valent HPV vaccine, 2 dose efficacy · Intervention Types: Biological
Females, 3 dose standard
Biological
ActiveComparator Group · 1 Intervention: 9-valent HPV vaccine, 3 doses standard timing · Intervention Types: Biological
Males, 3 dose standard
Biological
ActiveComparator Group · 1 Intervention: 9-valent HPV vaccine, 3 doses standard timing · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 12

Who is running the clinical trial?

Cancer Prevention Research Institute of TexasOTHER
44 Previous Clinical Trials
79,137 Total Patients Enrolled
The University of Texas Medical Branch, GalvestonLead Sponsor
224 Previous Clinical Trials
54,469 Total Patients Enrolled
Abbey B Berenson, MD, PhDPrincipal InvestigatorUniversity of Texas
1 Previous Clinical Trials
618 Total Patients Enrolled

Eligibility Criteria

Age 15 - 26 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

How many participants are currently receiving treatments as part of this experiment?

"Affirmative. Research hosted on clinicaltrials.gov reveals that this medical research project, which was first published on June 17th 2019, is actively recruiting patients at present. The trial necessitates the enrollment of 700 participants from 1 location." - Anonymous Online Contributor

Unverified Answer

Has the two-dose 9-valent HPV vaccine been verified by the FDA for efficacy?

"The 9-valent HPV vaccine, 2 dose efficacy has gotten a score of 3 due to the Phase 4 classification; which denotes that it is officially approved." - Anonymous Online Contributor

Unverified Answer

What are the eligibility requirements for this research trial?

"This clinical trial is enrolling 700 participants aged between 15-26 that have yet to receive any immunizations. Furthermore, applicants must possess reliable telephone access and an identified source of funding for the vaccine such as Texas Vaccines for Children (VFC) program, Medicaid, the Children's Health Insurance Plan (CHIP), Texas Healthy Women programme or other public or private health insurance. To verify prior vaccination history we will consult with patients' primary care provider in addition to Immtrac and UTMB electronic medical record if they had been seen at UTMB before." - Anonymous Online Contributor

Unverified Answer

Does the trial permit individuals of younger ages to participate?

"This clinical trial seeks participants aged between 15 and 26 years old." - Anonymous Online Contributor

Unverified Answer

Is there still room for participants in this clinical experiment?

"Per the information presented on clinicaltrials.gov, this trial is currently seeking participants. The study had its inception on June 17th 2019 and has been recently amended as of October 5th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.