ImmunizationPhase 4NCT05672927
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
A Phase 4 study testing 9-valent HPV vaccine, 2 doses alternate timing and 9-valent HPV vaccine, 3 doses standard timing in people with Immunization and HPV Infection, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 27 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Immunization, HPV Infection, Human Papillomavirus
- What is being tested?
- 9-valent HPV vaccine, 2 doses alternate timing and 9-valent HPV vaccine, 3 doses standard timing
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 618 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to Aug 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females 27-45 years old.
- Ability to give informed consent.
- 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.
- Reliable telephone access for the duration of the project.
- Can read and speak in either English or Spanish.
- Identified source of funding for vaccine such as Medicaid, private health insurance, Texas Healthy Women program, etc.
- Reports consistent use of reliable birth control and plans to continue its use through study month 13.
Who cannot join
- 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.
- Has an immunodeficiency or autoimmune disease such as HIV infection, lymphoma, leukemia, lupus, rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
- 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.
- History of splenectomy
- Known allergies to any vaccine components, including aluminum, yeast or Benzonase.
- Febrile at ≥100°F in the 24 hours prior to vaccination. The patients may be rescheduled for a later date.
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- History of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- History of >10 sexual partners in their lifetime at time of enrollment
- Plans to move out of the Galveston/Houston area in the 13 months following study entry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical Branch
Galveston, Texas, 77555
Rosalina M Trujillo, 409-747-5594, rmtrujil@UTMB.EDU
About this study
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
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.
Read the detailed description
The investigators are studying an alternate dosing regimen of an approved drug (9vHPV vaccine) in the population for which it is approved. The vaccine is approved for individuals ages 9-45 years old and participants in this study will be 27-45 years of age. The purpose of the study is to examine the immune response of 2 doses of 9vHPV vaccine. The current recommendation is to administer the vaccine in 3 doses (administered at 0, 1-2 months and 6 months) to those 15-45 years of age, but only 2 doses (administered at 0 and 6 months) if the vaccine series is initiated before age 15. The investigators will conduct a randomized study to determine if 2 doses of elicit a similar immune response to that of a standard 3 dose series in individuals 27-45 years of age. Participants in the study group will receive 2 doses of at 0 and 6 months. Participants in the control group will receive 3 doses of 9vHPV vaccine at 0, 2 months, and 6 months. All participants (target accrual n=618) will have 5 mLs of blood drawn at 0, 1, 7, and 12 months. Following the 12-month blood draw, participants randomized to 2-doses will be offered the 3rd dose. Potential participants will be recruited through the University of Texas Medical Branch (UTMB) clinics and surrounding community, and will be screened for inclusion/exclusion criteria. Eligible patients will sign an informed written consent. At their baseline visit, participants will have their blood drawn, be randomized into either the study or control group, and receive their first dose of the HPV vaccine. All participants will receive compensation administered through a ClinCard following each of the 4 blood draws.
- Conditions
- Immunization, HPV Infection, Human Papillomavirus
- Being tested
- 9-valent HPV vaccine, 2 doses alternate timing, 9-valent HPV vaccine, 3 doses standard timing
- Keywords
- HPV vaccination, Gardasil 9, Noninferiority trial
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9-valent HPV vaccine, 2 doses alternate timingBiological
Evaluate 2 doses of the 9-valent HPV vaccine across a 12-month period following the 1st dose among 27-45-year-old females.
9-valent HPV vaccine, 3 doses standard timingBiological
This will be the comparison group for the 2-dose group.
| Study group | Role | What they receive |
|---|---|---|
| Females, 3-dose standard | Active comparator | 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. Receives: Biological: 9-valent HPV vaccine, 3 doses standard timing |
| Females, 2-dose alternative | Experimental | 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. Receives: Biological: 9-valent HPV vaccine, 2 doses alternate timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.
Measured: Month 1
Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.
Measured: Month 7
Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.
Measured: Month 12
Short-term HPV type-specific antibody response for type HPV-11
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-11, measured as number of participants.
Measured: Month 1
Short-term HPV type-specific antibody response for type HPV-11
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-11, measured as number of participants.
Measured: Month 7
Short-term HPV type-specific antibody response for type HPV-11
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-11, measured as number of participants.
Measured: Month 12
Short-term HPV type-specific antibody response for type HPV-16
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-16, measured as number of participants.
Measured: Month 1
Short-term HPV type-specific antibody response for type HPV-16
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-16, measured as number of participants.
Measured: Month 7
Short-term HPV type-specific antibody response for type HPV-16
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-16, measured as number of participants.
Measured: Month 12
Short-term HPV type-specific antibody response for type HPV-18
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-18, measured as number of participants.
Measured: Month 1
Short-term HPV type-specific antibody response for type HPV-18
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-18, measured as number of participants.
Measured: Month 7
Short-term HPV type-specific antibody response for type HPV-18
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-18, measured as number of participants.
Measured: Month 12
Short-term HPV type-specific antibody response for type HPV-31
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-31, measured as number of participants.
Measured: Month 1
Short-term HPV type-specific antibody response for type HPV-31
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-31, measured as number of participants.
Measured: Month 7
Short-term HPV type-specific antibody response for type HPV-31
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-31, measured as number of participants.
Measured: Month 12
Short-term HPV type-specific antibody response for type HPV-33
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-33, measured as number of participants.
Measured: Month 1
Short-term HPV type-specific antibody response for type HPV-33
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-33, measured as number of participants.
Measured: Month 7
Short-term HPV type-specific antibody response for type HPV-33
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-33, measured as number of participants.
Measured: Month 12
Short-term HPV type-specific antibody response for type HPV-45
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-45, measured as number of participants.
Measured: Month 1
Short-term HPV type-specific antibody response for type HPV-45
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-45, measured as number of participants.
Measured: Month 7
Short-term HPV type-specific antibody response for type HPV-45
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-45, measured as number of participants.
Measured: Month 12
Short-term HPV type-specific antibody response for type HPV-52
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-52, measured as number of participants.
Measured: Month 1
Short-term HPV type-specific antibody response for type HPV-52
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-52, measured as number of participants.
Measured: Month 7
Short-term HPV type-specific antibody response for type HPV-52
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-52, measured as number of participants.
Measured: Month 12
Short-term HPV type-specific antibody response for type HPV-58
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-58, measured as number of participants.
Measured: Month 1
Short-term HPV type-specific antibody response for type HPV-58
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-58, measured as number of participants.
Measured: Month 7
Short-term HPV type-specific antibody response for type HPV-58
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-58, measured as number of participants.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start18 Jan 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 618 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Responsible party
- Sponsor
- Investigators
- Abbey B Berenson, MD, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672927
- Sponsor's protocol ID
- 22-0243
- Status last verified
- Oct 2025
- First submitted
- 19 Dec 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PubMed 41276263