RECRUITING

Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)

Conditions

Immunization HPV Infection Human Papillomavirus HPV vaccination Gardasil 9 Noninferiority trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to compare a 2-dose and 3-dose series of 9vHPV vaccine among 27-45-year-old females to assess if 2 doses elicit a noninferior immune response. Participants will be randomized 1:1 to either the 2-dose group or the 3-dose group and asked to provide 4 blood samples over a period of 12 months. All 2-dose participants will be offered a 3rd dose after the final blood draw,12 months after their initial vaccination.

Official Title

Comparison of the Immune Response After Administration of 2 vs. 3 Doses of the FDA-approved 9-Valent HPV Vaccine Among Women 27-45 Years of Age

Quick Facts

Study Start:2023-01-18

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05672927

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:27 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Females 27-45 years old. 2. Ability to give informed consent. 3. Has not received any prior doses of the HPV vaccine. This will be verified by the person and state registry (Immtrac), as well as the person's electronic medical record. 4. Reliable telephone access for the duration of the project. 5. Can read and speak in either English or Spanish. 6. Identified source of funding for vaccine such as Medicaid, private health insurance, Texas Healthy Women program, etc. 7. Reports consistent use of reliable birth control and plans to continue its use through study month 13.	1. Currently pregnant or plans to become pregnant or donate eggs in the next 13 months. Any subjects with positive pregnancy tests at the initial visit will be disqualified from the study and advised to seek prenatal care. 2. Has an immunodeficiency or autoimmune disease such as HIV infection, lymphoma, leukemia, lupus, rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition. 3. Currently receiving treatment or medication that can suppress immune function including radiation therapy, chemotherapy, cyclosporin, leflunomide (Arava), TNF-α antagonists, monoclonal antibody therapies (including rituximab \[Rituxan\]), intravenous gamma globulin (IVIG), antilymphocyte sera, other therapy known to interfere with the immune response, or systemic corticosteroids (by mouth or intramuscular injection). Those using or have used steroids that are inhaled, placed in the eye, applied on the skin, or injected into the joint/soft tissue will be considered eligible for the study. 4. History of splenectomy 5. Known allergies to any vaccine components, including aluminum, yeast or Benzonase. 6. Febrile at ≥100°F in the 24 hours prior to vaccination. The patients may be rescheduled for a later date. 7. History of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. 8. History of \>10 sexual partners in their lifetime at time of enrollment 9. Plans to move out of the Galveston/Houston area in the 13 months following study entry.

Inclusion Criteria

Exclusion Criteria

1. Females 27-45 years old.
2. Ability to give informed consent.
3. Has not received any prior doses of the HPV vaccine. This will be verified by the person and state registry (Immtrac), as well as the person's electronic medical record.
4. Reliable telephone access for the duration of the project.
5. Can read and speak in either English or Spanish.
6. Identified source of funding for vaccine such as Medicaid, private health insurance, Texas Healthy Women program, etc.
7. Reports consistent use of reliable birth control and plans to continue its use through study month 13.

1. Currently pregnant or plans to become pregnant or donate eggs in the next 13 months. Any subjects with positive pregnancy tests at the initial visit will be disqualified from the study and advised to seek prenatal care.
2. Has an immunodeficiency or autoimmune disease such as HIV infection, lymphoma, leukemia, lupus, rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
3. Currently receiving treatment or medication that can suppress immune function including radiation therapy, chemotherapy, cyclosporin, leflunomide (Arava), TNF-α antagonists, monoclonal antibody therapies (including rituximab \[Rituxan\]), intravenous gamma globulin (IVIG), antilymphocyte sera, other therapy known to interfere with the immune response, or systemic corticosteroids (by mouth or intramuscular injection). Those using or have used steroids that are inhaled, placed in the eye, applied on the skin, or injected into the joint/soft tissue will be considered eligible for the study.
4. History of splenectomy
5. Known allergies to any vaccine components, including aluminum, yeast or Benzonase.
6. Febrile at ≥100°F in the 24 hours prior to vaccination. The patients may be rescheduled for a later date.
7. History of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
8. History of \>10 sexual partners in their lifetime at time of enrollment
9. Plans to move out of the Galveston/Houston area in the 13 months following study entry.

Contacts and Locations

Study Contact

Abbey B Berenson, MD, PhD

CONTACT

409-772-2417

abberens@utmb.edu

Rosalina M Trujillo

CONTACT

409-747-5594

rmtrujil@utmb.edu

Principal Investigator

Abbey B Berenson, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Texas

Study Locations (Sites)

University of Texas Medical Branch

Galveston, Texas, 77555

United States

Collaborators and Investigators

Sponsor: The University of Texas Medical Branch, Galveston

Abbey B Berenson, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-18

Study Completion Date2027-08

Study Record Updates

Study Start Date2023-01-18

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

HPV vaccination
Gardasil 9
Noninferiority trial

Additional Relevant MeSH Terms

Immunization
HPV Infection
Human Papillomavirus