HPV SeroconversionGININCT01924754
Gardasil Immunogenicity With Needle-Free Injection
An observational study of HPV Seroconversion, run by University of California, San Francisco at 2 sites in 2 countries.
Trial summary
Using biospecimens collected in a trial by the Thai Red Cross AIDS Research Center that studied two new human papillomavirus (HPV) vaccine delivery regimens, the investigators at UCSF will be testing the serum for antibodies to measure the strength of their response to the vaccine. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Seroconversion
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2014to 31 May 2016
- Phase
- Observational
- 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 18 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study was for women and focused on the safety and immunogenicity of the HPV vaccine. Separate studies will be done in men if the dosing regimens in Groups II or III are shown to be non-inferior to the standard regimen
Who may be able to join
- Thai women age 18-26 years
- No more than 5 lifetime sexual partners
- HIV-uninfected
- No history of HPV vaccination
- Judged able to complete all of the protocol visits
- No contraindications to vaccination with Gardasil
Who cannot join
- Does not satisfy all of the inclusion criteria
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of California, San Francisco
San Francisco, California, 94062
About this study
Official title: GINI: Gardasil Immunogenicity With Needle-free Injection-Safety and Immunogenicity of Gardasil Using IM and ID Needle-free Injection Delivery
Using biospecimens collected in a trial by the Thai Red Cross AIDS Research Center that studied two new human papillomavirus (HPV) vaccine delivery regimens, the investigators at UCSF will be testing the serum for antibodies to measure the strength of their response to the vaccine.
Read the detailed description
Primary Objectives
- Compared rates of seroconversion and geometric mean titers (GMTs) generated following a 3-dose series of vaccine in women given low doses of vaccine by the intradermal (ID) route with the needle-free injector (NFI) (Group III) to those women given standard doses by the intramuscular (IM) route with a needle and syringe (Group I) at 1 month, 6 months and 12 months following completion of the vaccination series.
- Compared rates of seroconversion and GMTs generated following a 3-dose series of vaccine in women given standard doses of vaccine by the IM route with the NFI (Group II) to those women given standard doses by the IM route with a needle and syringe (Group I) at 1 month, 6 months and 12 months following completion of the vaccination series.
Serum samples were collected on 4 successive occasions: (1) day zero, prior to the first immunization, (2) at visit 4, one month following the third and final immunization, (3) at visit 5 (12 months) and (4) and at visit 6 (24 months after enrollment). Samples were split, stored and transferred in batch for analysis.
Merck received samples for processing and determined the geometric mean titer of antibodies specific to HPV (types 6, 11, 16, and 18) and results were transferred to the principal investigator. The University of California, San Francisco (UCSF) used a portion of the collected blood samples for pseudovirion-based neutralisation assay (PBNA) analysis conducted at UCSF.
- Conditions
- HPV Seroconversion
- Keywords
- HPV, Gardasil, seroconversion
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard intramuscular injection (NS-IM) | HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe (NS-IM) | |
| PharmaJet needle-free Stratis device (JI-IM) | HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device (JI-IM) | |
| PharmaJet needle-free Tropis device (JI-ID) | HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device (JI-ID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Geometric Mean Antibody Concentrations by HPV Type
Geometric mean antibody concentrations above the lower limit of assay detection at baseline were assessed by HPV type
Measured: Baseline, up to 1 day
Percentage of Participants With a Demonstrated Seroconversion for HPV 6
The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 6 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Measured: Up to 7 months
Percentage of Participants With a Demonstrated Seroconversion for HPV 11
The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 11 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Measured: Up to 7 months
Percentage of Participants With a Demonstrated Seroconversion for HPV 16
The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 16 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Measured: Up to 7 months
Percentage of Participants With a Demonstrated Seroconversion for HPV 18
The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 18 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Measured: Up to 7 months
Median Concentration for HPV 6 Over Time
The median (mMU/mL) for HPV 6 at month 7 for the intent to treat population was calculated
Measured: Up to 7 months
Median Concentration for HPV 11 Over Time
The median concentration (mMU/mL) for HPV 11 at month 7 for the intent to treat population was calculated
Measured: Up to 7 months
Median Concentration for HPV 16 Over Time
The median concentration (mMU/mL) for HPV 16 at month 7 for the intent to treat population was calculated
Measured: Up to 7 months
Median Concentration for HPV 18 Over Time
The median concentration (mMU/mL) for HPV 18 at month 7 for the intent to treat population was calculated
Measured: Up to 7 months
Geometric Mean Concentration Ratio of NS-IM Versus the PharmaJet Groups by HPV Type
The Geometric Mean Concentration Ratio (GMCR) and 95% confidence interval for both NS-IM versus JI-IM and NS-IM versus JI-ID was computed for the intent to treat population. Non-inferiority for arms JI-IM and JI-ID was defined as geometric mean concentration ratio (GMCR) <1.5 of NS-IM at month 7
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study start1 Jan 2014
- Primary completion31 May 2016
- Study completion31 May 2016
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.
- Other trials for HPV SeroconversionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Joel Palefsky, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924754
- Sponsor's protocol ID
- 13366
- Acronym
- GINI
- Status last verified
- Aug 2021
- First submitted
- 14 Aug 2013
- Last updated
- 13 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GINI: Gardasil Immunogenicity With Needle-free Injection-Safety and Immunogenicity of Gardasil Using IM and ID Needle-free Injection Delivery
- ClinicalTrials.gov ID
- NCT01924754
- Acronym / sponsor ID
- GINI / 13366
- Conditions
- HPV Seroconversion
- Keywords
- HPV, Gardasil, seroconversion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Posted 13 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using biospecimens collected in a trial by the Thai Red Cross AIDS Research Center that studied two new human papillomavirus (HPV) vaccine delivery regimens, the investigators at UCSF will be testing the serum for antibodies to measure the strength of their response to the vaccine.
Detailed description
Primary Objectives
- Compared rates of seroconversion and geometric mean titers (GMTs) generated following a 3-dose series of vaccine in women given low doses of vaccine by the intradermal (ID) route with the needle-free injector (NFI) (Group III) to those women given standard doses by the intramuscular (IM) route with a needle and syringe (Group I) at 1 month, 6 months and 12 months following completion of the vaccination series.
- Compared rates of seroconversion and GMTs generated following a 3-dose series of vaccine in women given standard doses of vaccine by the IM route with the NFI (Group II) to those women given standard doses by the IM route with a needle and syringe (Group I) at 1 month, 6 months and 12 months following completion of the vaccination series.
Serum samples were collected on 4 successive occasions: (1) day zero, prior to the first immunization, (2) at visit 4, one month following the third and final immunization, (3) at visit 5 (12 months) and (4) and at visit 6 (24 months after enrollment). Samples were split, stored and transferred in batch for analysis.
Merck received samples for processing and determined the geometric mean titer of antibodies specific to HPV (types 6, 11, 16, and 18) and results were transferred to the principal investigator. The University of California, San Francisco (UCSF) used a portion of the collected blood samples for pseudovirion-based neutralisation assay (PBNA) analysis conducted at UCSF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard intramuscular injection (NS-IM) | – | –HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe (NS-IM) |
| PharmaJet needle-free Stratis device (JI-IM) | – | –HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device (JI-IM) |
| PharmaJet needle-free Tropis device (JI-ID) | – | –HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device (JI-ID) |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study was for women and focused on the safety and immunogenicity of the HPV vaccine. Separate studies will be done in men if the dosing regimens in Groups II or III are shown to be non-inferior to the standard regimen
Key inclusion criteria (6 listed)
- Thai women age 18-26 years
- No more than 5 lifetime sexual partners
- HIV-uninfected
- No history of HPV vaccination
- Judged able to complete all of the protocol visits
Key exclusion criteria (1 listed)
- Does not satisfy all of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Geometric Mean Antibody Concentrations by HPV Type
Time frame: Baseline, up to 1 day
Geometric mean antibody concentrations above the lower limit of assay detection at baseline were assessed by HPV type
Percentage of Participants With a Demonstrated Seroconversion for HPV 6
Time frame: Up to 7 months
The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 6 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Percentage of Participants With a Demonstrated Seroconversion for HPV 11
Time frame: Up to 7 months
The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 11 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Percentage of Participants With a Demonstrated Seroconversion for HPV 16
Time frame: Up to 7 months
The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 16 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Percentage of Participants With a Demonstrated Seroconversion for HPV 18
Time frame: Up to 7 months
The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 18 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Median Concentration for HPV 6 Over Time
Time frame: Up to 7 months
The median (mMU/mL) for HPV 6 at month 7 for the intent to treat population was calculated
Median Concentration for HPV 11 Over Time
Time frame: Up to 7 months
The median concentration (mMU/mL) for HPV 11 at month 7 for the intent to treat population was calculated
Median Concentration for HPV 16 Over Time
Time frame: Up to 7 months
The median concentration (mMU/mL) for HPV 16 at month 7 for the intent to treat population was calculated
Median Concentration for HPV 18 Over Time
Time frame: Up to 7 months
The median concentration (mMU/mL) for HPV 18 at month 7 for the intent to treat population was calculated
Geometric Mean Concentration Ratio of NS-IM Versus the PharmaJet Groups by HPV Type
Time frame: Up to 7 months
The Geometric Mean Concentration Ratio (GMCR) and 95% confidence interval for both NS-IM versus JI-IM and NS-IM versus JI-ID was computed for the intent to treat population. Non-inferiority for arms JI-IM and JI-ID was defined as geometric mean concentration ratio (GMCR) <1.5 of NS-IM at month 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Joel Palefsky, M.D. principal investigator
University of California, San Francisco
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Seroconversion, run by University of California, San Francisco at 2 sites in 2 countries.
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 6 inclusion and 1 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 13 Oct 2021. 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, Thailand. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2021). 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?
Number of Participants With Geometric Mean Antibody Concentrations by HPV Type (time frame: Baseline, up to 1 day). The study lists 10 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 13 Oct 2021; AzTrials last refreshed its copy on 29 Oct 2026.