Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
150 participants
OBSERVATIONAL
2014-01-01
2016-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. 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.
2. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
No interventions assigned to this group
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)
No interventions assigned to this group
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)
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
26 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joel Palefsky, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Francisco
San Francisco, California, United States
Thai Red Cross AIDS Research Centre
Bangkok, , Thailand
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13366
Identifier Type: -
Identifier Source: org_study_id