Human Papilloma VirusEarly Phase 1NCT05329961
Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old
A Early Phase 1 study testing Gardasil9 in people with Human Papilloma Virus, run by Boston Medical Center at 1 site in United States.
Trial summary
This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12). Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- Gardasil9
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2022to Dec 2028
- Phase
- Early Phase 1
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4-8 years old
- Receives care at the Boston Medical Center or one of the affiliated Community heath centers
- Naïve to HPV Vaccine
Who cannot join
- A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic reaction to yeast
- Immunocompromised/previous immunosuppressive therapy
- Thrombocytopenia or other coagulation disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Over a Four-year Follow up Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study
This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12).
Read the detailed description
Study participants will include 150 boys and girls aged 4-8 years (total, 75 boys and 75 girls) to receive 2 doses of the 9vHPV vaccine at 0 and 12 months. Patients will be recruited by age-group to achieve balanced enrollment of 15 girls and 15 boys per year of age. The investigators will examine the immunogenicity profile in this cohort, for which titers will be analyzed one month after dose 2 (Month 13).
Though clinical efficacy cannot be assessed in young children because of limited exposure to human papillomavirus (HPV), this descriptive study will allow the investigators to understand whether the 9vHPV vaccine in younger patients provides immunogenicity similar to that shown for the 9-14 and 16-26 age groups who have received the 9vHPV vaccine. This study will require an IND for the use of the HPV vaccine in children younger than 9 years.
Immunogenicity will be measured by examining serum antibodies of all participants using a competitive Luminex immunoassay (cLIA). The antibody response testing will be performed at Merck Research Laboratory.
The goal of this study is to explore whether a 2-dose 9vHPV vaccine regimen with dosage separated by 12 months is immunogenic among children aged 4-8 years. The primary outcome will be geometric mean titers (GMT) for HPV6, HPV11, HPV16, HPV18, HPV31, HPV33, HPV45, HPV52, and HPV58 antibodies at month 13. Results will allow the investigators to qualitatively compare immunogenicity in individuals vaccinated at age 4-8 years to known immunogenicity in 9vHPV recipients vaccinated at ages 9-14. Knowledge of whether vaccination in this age group is sufficient to induce high-level protective antibody titers after the second dose will support further efficacy studies in a larger randomized trial of a 2-dose 9vHPV regimen for children aged 4-8 years.
- Conditions
- Human Papilloma Virus
- Being tested
- Gardasil9
- Keywords
- Gardasil 9, Immunogenicity, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardasil9Drug
Also called GARDASIL®
The Gardasil 9 vaccine is a recombinant L 1 VLP vaccine containing HPV types 6, 11,16,18, 31, 33, 45, 52 and 58 VLP. The vaccine is not currently licensed for children under 9 years of age but it is licensed in the USA for males and females ages 9 to 45 years old.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | HPV 9-valent human papillomavirus vaccine (Gardasil 9) - 0.5mL intramuscular dose - 2 doses (Month 0, 12) Receives: Drug: Gardasil9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV6 antibodies at 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV6 if it is >30mMu.
Measured: 13 months
HPV11 antibodies at 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV11 if it is >16mMu.
Measured: 13 months
HPV16 antibodies at 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV16 if it is >20mMu.
Measured: 13 months
HPV18 antibodies at 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV18 if it is >24 mMU.
Measured: 13 months
HPV31 antibodies at 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV31 if it is >10 mMU.
Measured: 13 months
HPV33 antibodies at 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV33 if it is >8 mMU.
Measured: 13 months
HPV45 antibodies at 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV45 if it is >8 mMU.
Measured: 13 months
HPV52 antibodies at 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV52 if it is >8 mMU.
Measured: 13 months
HPV58 antibodies at 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV58 if it is >8 mMU.
Measured: 13 months
HPV6 antibodies at 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV6 if it is >30mMU.
Measured: 60 months
HPV11 antibodies at 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV11 if it is >16 mMU.
Measured: 60 months
HPV16 antibodies at 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV16 if it is >20 mMU.
Measured: 60 months
HPV18 antibodies at 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV18 if it is >24mMU.
Measured: 60 months
HPV31 antibodies at 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV31 if it is >10 mMU.
Measured: 60 months
HPV33 antibodies at 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV33 if it is >8 mMU.
Measured: 60 months
HPV45 antibodies at 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV45 if it is >8 mMU.
Measured: 60 months
HPV52 antibodies at 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV52 if it is >8 mMU.
Measured: 60 months
HPV58 antibodies at 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV58 if it is >8 mMU.
Measured: 60 months
Secondary outcomes (4)
Injection site swelling after first injection
Solicited local swelling will be graded from 0-4 where 0 is no swelling and 4 is severe swelling.
Measured: day 3 after injection
Injection site swelling after second injection
Solicited local swelling will be graded from 0-4 where 0 is no swelling and 4 is severe swelling.
Measured: day 3 after injection
Injection site redness after first injection
Solicited local redness will be graded from 0-4 where 0 is no redness and 4 is severe redness.
Measured: day 3 after injection
Injection site redness after second injection
Solicited local redness will be graded from 0-4 where 0 is no redness and 4 is severe redness.
Measured: day 3 after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start26 Sep 2022
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Eilsha Wachman, Boston Medical Center
- Investigators
- Elisha Wachman, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329961
- Sponsor's protocol ID
- H-41686
- Status last verified
- Jun 2026
- First submitted
- 21 Mar 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Over a Four-year Follow up Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study
- ClinicalTrials.gov ID
- NCT05329961
- Acronym / sponsor ID
- H-41686
- Conditions
- Human Papilloma Virus
- Keywords
- Gardasil 9, Immunogenicity, Children
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Apr 2022 (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 study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12).
Detailed description
Study participants will include 150 boys and girls aged 4-8 years (total, 75 boys and 75 girls) to receive 2 doses of the 9vHPV vaccine at 0 and 12 months. Patients will be recruited by age-group to achieve balanced enrollment of 15 girls and 15 boys per year of age. The investigators will examine the immunogenicity profile in this cohort, for which titers will be analyzed one month after dose 2 (Month 13).
Though clinical efficacy cannot be assessed in young children because of limited exposure to human papillomavirus (HPV), this descriptive study will allow the investigators to understand whether the 9vHPV vaccine in younger patients provides immunogenicity similar to that shown for the 9-14 and 16-26 age groups who have received the 9vHPV vaccine. This study will require an IND for the use of the HPV vaccine in children younger than 9 years.
Immunogenicity will be measured by examining serum antibodies of all participants using a competitive Luminex immunoassay (cLIA). The antibody response testing will be performed at Merck Research Laboratory.
The goal of this study is to explore whether a 2-dose 9vHPV vaccine regimen with dosage separated by 12 months is immunogenic among children aged 4-8 years. The primary outcome will be geometric mean titers (GMT) for HPV6, HPV11, HPV16, HPV18, HPV31, HPV33, HPV45, HPV52, and HPV58 antibodies at month 13. Results will allow the investigators to qualitatively compare immunogenicity in individuals vaccinated at age 4-8 years to known immunogenicity in 9vHPV recipients vaccinated at ages 9-14. Knowledge of whether vaccination in this age group is sufficient to induce high-level protective antibody titers after the second dose will support further efficacy studies in a larger randomized trial of a 2-dose 9vHPV regimen for children aged 4-8 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Gardasil9HPV 9-valent human papillomavirus vaccine (Gardasil 9) - 0.5mL intramuscular dose - 2 doses (Month 0, 12) |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 4-8 years old
- Receives care at the Boston Medical Center or one of the affiliated Community heath centers
- Naïve to HPV Vaccine
Key exclusion criteria (3 listed)
- A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic reaction to yeast
- Immunocompromised/previous immunosuppressive therapy
- Thrombocytopenia or other coagulation disorder
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 |
|---|---|---|
| Gardasil9Also: GARDASIL®The Gardasil 9 vaccine is a recombinant L 1 VLP vaccine containing HPV types 6, 11,16,18, 31, 33, 45, 52 and 58 VLP. The vaccine is not currently licensed for children under 9 years of age but it is licensed in the USA for males and females ages 9 to 45 years old. | Drug | Single Arm |
Primary outcome
HPV6 antibodies at 13 months
Time frame: 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV6 if it is >30mMu.
HPV11 antibodies at 13 months
Time frame: 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV11 if it is >16mMu.
HPV16 antibodies at 13 months
Time frame: 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV16 if it is >20mMu.
HPV18 antibodies at 13 months
Time frame: 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV18 if it is >24 mMU.
HPV31 antibodies at 13 months
Time frame: 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV31 if it is >10 mMU.
HPV33 antibodies at 13 months
Time frame: 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV33 if it is >8 mMU.
HPV45 antibodies at 13 months
Time frame: 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV45 if it is >8 mMU.
HPV52 antibodies at 13 months
Time frame: 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV52 if it is >8 mMU.
HPV58 antibodies at 13 months
Time frame: 13 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV58 if it is >8 mMU.
HPV6 antibodies at 60 months
Time frame: 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV6 if it is >30mMU.
HPV11 antibodies at 60 months
Time frame: 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV11 if it is >16 mMU.
HPV16 antibodies at 60 months
Time frame: 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV16 if it is >20 mMU.
HPV18 antibodies at 60 months
Time frame: 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV18 if it is >24mMU.
HPV31 antibodies at 60 months
Time frame: 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV31 if it is >10 mMU.
HPV33 antibodies at 60 months
Time frame: 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV33 if it is >8 mMU.
HPV45 antibodies at 60 months
Time frame: 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV45 if it is >8 mMU.
HPV52 antibodies at 60 months
Time frame: 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV52 if it is >8 mMU.
HPV58 antibodies at 60 months
Time frame: 60 months
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV58 if it is >8 mMU.
4 secondary outcomes
Injection site swelling after first injection
Time frame: day 3 after injection
Injection site swelling after second injection
Time frame: day 3 after injection
Injection site redness after first injection
Time frame: day 3 after injection
Injection site redness after second injection
Time frame: day 3 after injection
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 1 Jul 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.
Elisha Wachman, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gardasil9 in people with Human Papilloma Virus, run by Boston Medical Center 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 3 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 1 Jul 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
HPV6 antibodies at 13 months (time frame: 13 months). The study lists 18 primary outcomes in all. 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 1 Jul 2026.