HPVPhase 4PPVNCT04274153
HPV Vaccination Study in Postpartum Women
A Phase 4 study testing Gardasil9 in people with HPV and Immunization, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (U.S.) and is responsible for a wide range of conditions, including cancers within the anogenital tract and the oropharynx. In just the U.S. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV, Immunization, Human Papilloma Virus
- What is being tested?
- Gardasil9
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Aug 2020to 1 Feb 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants biologically born as females between the ages of 15 through 45 who have delivered a live born baby within the past 72 hours.
Who cannot join
- Pregnancy
- Severe allergic reaction to vaccine components
- Prior receipt of an HPV vaccine dose
- Fetal demise or stillbirth
- Allergy to latex or yeast
- Moderate or severe acute illness (deemed by the investigator to exclude)
- Immunosuppression (e.g., HIV, solid organ transplant).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: A Pilot Study of the Immunogenicity of a Two-dose Protocol for 9-valent Human Papilloma Virus Vaccination in Postpartum Girls and Women (15-45 Years Old) Previously Unvaccinated Against HPV
The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (U.S.) and is responsible for a wide range of conditions, including cancers within the anogenital tract and the oropharynx. In just the U.S. alone, it's estimated that HPV causes 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical cancer. The investigators propose a 2-dose HPV vaccination study in women seeking postpartum care at Johns Hopkins University. The investigators will measure the immunogenicity and acceptability of the vaccine in the postpartum setting.
Read the detailed description
This is a pilot, non-inferiority clinical trial using historical controls. Participants will have whole blood drawn at 0 months, 6 months, and 7 months and receive the HPV vaccine at 0 months, 6 months, and 12 months. Each blood draw will consist of one 15mL red top tube to measure HPV serologies and hormone levels. All blood samples collected will be analyzed at the end of the study.
- Conditions
- HPV, Immunization, Human Papilloma Virus
- Being tested
- Gardasil9
- Keywords
- Human Papilloma Virus, HPV, Immunization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardasil9Biological
Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
| Study group | Role | What they receive |
|---|---|---|
| Gardasil9 | Experimental | Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. Receives: Biological: Gardasil9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer
Measure the immunogenicity of a two-dose 9-valent HPV vaccination regimen in postpartum women previously unvaccinated against the HPV 16 virus. Immunogenicity will be assessed by the antibody responses. The Geometric mean titers will be measured using milli Merck units (mMU)/mL.
Measured: Up to 23 months
Secondary outcomes (5)
Antibody Response to the Other 8 HPV Types
The antibody types that will be measured are HPV types 6, 11, 18, 31, 33, 45, 52, and 58.
The milli Merck units (mMU)/mL of measure will be used to determine antibody response.
Measured: Up to 23 months
Seropositivity for HPV 16 After 1-dose
Calculate the percentage of participants that seroconverted.
Measured: After the first dose, up to 7 months
Seropositivity for HPV 16 After 2-doses
Calculate the percentage of participants that seroconverted.
Measured: After the second dose, up to 2 months
Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16
Running an assay to measure a participants natural inoculation or prior vaccination before administration of the 1st dose.
Measured: Baseline
Percentage of Participants Who Complete 2-dose Vaccination
Calculate the amount of participants that complete 2-dose vaccination.
Measured: At the end of the study, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start3 Aug 2020
- Primary completion1 Jul 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Jenell Coleman, MD, Principal investigator, Johns Hopkins UniversityChailee Moss, MD, Principal investigator, Johns Hopkins UniversityBetty Chou, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274153
- Sponsor's protocol ID
- IRB00227941
- Acronym
- PPV
- Status last verified
- Aug 2023
- First submitted
- 14 Feb 2020
- Last updated
- 29 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Moss CF, Wang R, Sao S, Chou B, Perin J, Lander ME, Thaker SM, Mann M, Coleman JS. Immunogenicity of 2-Dose HPV Vaccine Series for Postpartum Women: An Open-Label, Nonrandomized, Noninferiority Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352996. doi: 10.1001/jamanetworkopen.2023.52996.
PubMed 38285445
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Immunogenicity of a Two-dose Protocol for 9-valent Human Papilloma Virus Vaccination in Postpartum Girls and Women (15-45 Years Old) Previously Unvaccinated Against HPV
- ClinicalTrials.gov ID
- NCT04274153
- Acronym / sponsor ID
- PPV / IRB00227941
- Conditions
- HPV, Immunization, Human Papilloma Virus
- Keywords
- Human Papilloma Virus, HPV, Immunization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Posted 29 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (U.S.) and is responsible for a wide range of conditions, including cancers within the anogenital tract and the oropharynx. In just the U.S. alone, it's estimated that HPV causes 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical cancer. The investigators propose a 2-dose HPV vaccination study in women seeking postpartum care at Johns Hopkins University. The investigators will measure the immunogenicity and acceptability of the vaccine in the postpartum setting.
Detailed description
This is a pilot, non-inferiority clinical trial using historical controls. Participants will have whole blood drawn at 0 months, 6 months, and 7 months and receive the HPV vaccine at 0 months, 6 months, and 12 months. Each blood draw will consist of one 15mL red top tube to measure HPV serologies and hormone levels. All blood samples collected will be analyzed at the end of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gardasil9 | Experimental | Biological: Gardasil9Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants biologically born as females between the ages of 15 through 45 who have delivered a live born baby within the past 72 hours.
Key exclusion criteria (7 listed)
- Pregnancy
- Severe allergic reaction to vaccine components
- Prior receipt of an HPV vaccine dose
- Fetal demise or stillbirth
- Allergy to latex or yeast
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 |
|---|---|---|
| Gardasil9Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL). | Biological | Gardasil9 |
Primary outcome
Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer
Time frame: Up to 23 months
Measure the immunogenicity of a two-dose 9-valent HPV vaccination regimen in postpartum women previously unvaccinated against the HPV 16 virus. Immunogenicity will be assessed by the antibody responses. The Geometric mean titers will be measured using milli Merck units (mMU)/mL.
5 secondary outcomes
Antibody Response to the Other 8 HPV Types
Time frame: Up to 23 months
Seropositivity for HPV 16 After 1-dose
Time frame: After the first dose, up to 7 months
Seropositivity for HPV 16 After 2-doses
Time frame: After the second dose, up to 2 months
Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16
Time frame: Baseline
Percentage of Participants Who Complete 2-dose Vaccination
Time frame: At the end of the study, up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38285445Moss CF, Wang R, Sao S, Chou B, Perin J, Lander ME, Thaker SM, Mann M, Coleman JS. Immunogenicity of 2-Dose HPV Vaccine Series for Postpartum Women: An Open-Label, Nonrandomized, Noninferiority Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352996. doi: 10.1001/jamanetworkopen.2023.52996.
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HPV Vaccination
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.
Jenell Coleman, MD principal investigator
Johns Hopkins University
Chailee Moss, MD principal investigator
Johns Hopkins University
Betty Chou, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gardasil9 in people with HPV and Immunization, run by Johns Hopkins University at 2 sites 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 29 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer (time frame: Up to 23 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04274153, which also lists 1 linked publication.
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 29 Aug 2023.