N/A
Completed N=150
Gardasil Immunogenicity With Needle-Free Injection
HPV Seroconversion
Source: ClinicalTrials.gov NCT01924754 ↗
Enrolled (actual)
150
Serious AEs
4.7%
Results posted
Oct 2021
Primary outcomePrimary: Number of Participants With Geometric Mean Antibody Concentrations by HPV Type — 15; 12; 8; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Geometric Mean Antibody Concentrations by HPV Type |
15; 12; 8; 4; 2; 6 | — |
| PRIMARY Percentage of Participants With a Demonstrated Seroconversion for HPV 6 |
100; 97.2; 100 | — |
| PRIMARY Percentage of Participants With a Demonstrated Seroconversion for HPV 11 |
100; 100; 100 | — |
| PRIMARY Percentage of Participants With a Demonstrated Seroconversion for HPV 16 |
100; 97.4; 100 | — |
| PRIMARY Percentage of Participants With a Demonstrated Seroconversion for HPV 18 |
100; 97.6; 97.6 | — |
| PRIMARY Median Concentration for HPV 6 Over Time |
11; 11; 11; 449.5; 311; 259.5 | — |
| PRIMARY Median Concentration for HPV 11 Over Time |
8; 8; 8; 517.5; 484; 387 | — |
| PRIMARY Median Concentration for HPV 16 Over Time |
11; 11; 11; 2243.5; 2054.5; 1482 | — |
| PRIMARY Median Concentration for HPV 18 Over Time |
10; 10; 10; 412.5; 414.5; 372.5 | — |
| PRIMARY Geometric Mean Concentration Ratio of NS-IM Versus the PharmaJet Groups by HPV Type |
1.37; 1.84; 1.36; 1.61; 1.47; 1.97 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Does not satisfy all of the inclusion criteria
Data sourced from ClinicalTrials.gov (NCT01924754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.