HPV InfectionPhase 4NCT04235257
Intradermal, Fractional Dose of HPV Vaccines:
A Phase 4 study testing HPV vaccine in people with HPV Infection and HPV Vaccine, run by University of Washington at 1 site in United States.
Trial summary
This randomized phase IV trial compares fractional dose of bivalent HPV vaccine to fractional dose of nonavalent HPV vaccine among men and women aged 27-45 years in Seattle, Washington. Participants will have immune response assessed at baseline, 4 weeks, 6 months, 12 months, and 24 months. Read more about this study
- Who is it for?
- Ages 27 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, HPV Vaccine
- What is being tested?
- HPV vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 27-45 years at enrollment
- Not intending to receive the HPV vaccine series for the duration of the study participation
- Willing and able to provide written informed consent, undergo clinical evaluation, and adhere to follow-up schedule
Who cannot join
- Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)
- Currently pregnant or breastfeeding
- Immune deficiency or other immune disorder
- HIV infection or continued high risk for HIV; patients at risk for HIV who do not have a negative HIV test in the last 6 months will be excluded
- Cancer or chemotherapy (current, within 6 months, or anticipated in the future) except for fully excised non-melanoma skin cancer)
- Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes,
- Known allergy to vaccine components
- Prior history of HPV-associated cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Virology Research Clinic
Seattle, Washington, 98104
About this study
Official title: Immunogenicity of Fractional Dose of the Bivalent and Nonavalent Intradermal HPV Vaccines.
This randomized phase IV trial compares fractional dose of bivalent HPV vaccine to fractional dose of nonavalent HPV vaccine among men and women aged 27-45 years in Seattle, Washington. Participants will have immune response assessed at baseline, 4 weeks, 6 months, 12 months, and 24 months.
- Conditions
- HPV Infection, HPV Vaccine
- Being tested
- HPV vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV vaccineBiological
Gardasil 9 Bivalent HPV VLP Vaccine, one-fifth dose Nonavalent HPV VLP Vaccine, one-fifth dose
| Study group | Role | What they receive |
|---|---|---|
| Bivalent HPV vaccine | Experimental | One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously Receives: Biological: HPV vaccine |
| Nonavalent HPV vaccine | Experimental | One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously Receives: Biological: HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV antibody detection after fractional HPV vaccination
HPV antibody response after delivery of a single, intradermal, fractional dose of the HPV-2 or HPV-9 vaccines
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Wald, University of Washington
- Investigators
- Anna Wald, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235257
- Sponsor's protocol ID
- STUDY00008961
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2020
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Fractional Dose of the Bivalent and Nonavalent Intradermal HPV Vaccines.
- ClinicalTrials.gov ID
- NCT04235257
- Acronym / sponsor ID
- STUDY00008961
- Conditions
- HPV Infection, HPV Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase IV trial compares fractional dose of bivalent HPV vaccine to fractional dose of nonavalent HPV vaccine among men and women aged 27-45 years in Seattle, Washington. Participants will have immune response assessed at baseline, 4 weeks, 6 months, 12 months, and 24 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bivalent HPV vaccine | Experimental | Biological: HPV vaccineOne-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously |
| Nonavalent HPV vaccine | Experimental | Biological: HPV vaccineOne-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously |
Who may qualify
- Ages
- 27 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 27-45 years at enrollment
- Not intending to receive the HPV vaccine series for the duration of the study participation
- Willing and able to provide written informed consent, undergo clinical evaluation, and adhere to follow-up schedule
Key exclusion criteria (8 listed)
- Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)
- Currently pregnant or breastfeeding
- Immune deficiency or other immune disorder
- HIV infection or continued high risk for HIV; patients at risk for HIV who do not have a negative HIV test in the last 6 months will be excluded
- Cancer or chemotherapy (current, within 6 months, or anticipated in the future) except for fully excised non-melanoma skin cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV vaccineGardasil 9 Bivalent HPV VLP Vaccine, one-fifth dose Nonavalent HPV VLP Vaccine, one-fifth dose | Biological | Bivalent HPV vaccine, Nonavalent HPV vaccine |
Primary outcome
HPV antibody detection after fractional HPV vaccination
Time frame: 12 months
HPV antibody response after delivery of a single, intradermal, fractional dose of the HPV-2 or HPV-9 vaccines
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Wald, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HPV vaccine in people with HPV Infection and HPV Vaccine, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV antibody detection after fractional HPV vaccination (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.