Safety, Tolerability, and Immunogenicity of GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV… (NCT02689726) | Clinical Trial Compass
TerminatedPhase 1
Safety, Tolerability, and Immunogenicity of GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged 25 to 65 Years, With Normal Cytology, ASCUS, or LSIL
Stopped: Lack of efficacy in European Phase 2 study
United States13 participantsStarted 2015-08
Plain-language summary
A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged 25 to 65 Years, With Normal Cytology, ASCUS, or LSIL.
Who can participate
Age range
25 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Females between the ages of 25 and 65 years, inclusive, at the time of screening.
. Subject is in generally good health based on medical history and on clinically acceptable results, in the judgment of the investigator, on the following assessments: physical examination, vital signs, clinical chemistry, and hematology.
. Cervical HPV 16 and/or 18 infection confirmed by cobas® HPV Test (Roche Molecular Systems, Inc) real-time polymerase chain reaction (RT PCR) assay at screening.
. Cervical cytological evaluation with a normal, ASCUS, or LSIL result.
. Subjects of childbearing potential must use effective contraception at the time of GTL001 injection and for at least 12 months after the first vaccination. Effective methods of birth control include those that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as implants, injectable, combined oral contraceptives, desogestrel only pill, levonorgestrel-releasing intrauterine system, intrauterine devices, vasectomized partner, and true sexual abstinence. Subjects not of childbearing potential include those who are surgically sterile or postmenopausal (no menses for the previous 12 months).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of local and systemic reactions recorded on diary cards as a measure of safety and tolerability
. Subject is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
. In the opinion of the investigator, the subject is able to comply with the protocol and has a high probability of completing the study.
Exclusion criteria
. Current or history of untreated high-grade cervical lesion (either CIN2 or CIN3).
. Current or history of cervical, vulvar, or vaginal cancer.
. Prior exposure to HPV prophylactic vaccine, regardless of number of doses received, or participation in another HPV vaccination clinical trial.
. Current acute or chronic disease, other than HPV 16/18 infection, which would be expected to interfere with the protocol-defined evaluations.
. Clinically significant gynecological abnormalities that could interfere with study procedures (eg, prolapse, severe vaginal atrophy, myoma, hysterectomy) in the judgment of the investigator.
. Malignancy, or treatment for malignancy, within the previous 2 years, with the exception of basal cell or squamous cell carcinoma of the skin.
. Clinically important abnormalities in the physical examination or laboratory tests during the screening period (ie, hemoglobin level \<9.5 g/dL, white blood cells \<2500 cells/mm3, aspartate aminotransferase and/or alanine aminotransferase ≥1.5 × the upper limit of normal \[ULN\], creatinine ≥1.25 × ULN, alkaline phosphatase ≥2 × ULN, and total bilirubin \>ULN).
. Administration of any live viral vaccine within 3 months or any inactivated (nonlive) vaccine within 2 weeks prior to screening.