HPV 16- and/or HPV 18-Infected Women With Normal Cytology, ASCUS, or LSILPhase 1NCT02689726
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
A Phase 1 study testing GTL001+ and Aldara in people with HPV 16- and/or HPV 18-Infected Women With Normal Cytology, ASCUS, or LSIL, run by Genticel at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- HPV 16- and/or HPV 18-Infected Women With Normal Cytology, ASCUS, or LSIL
- What is being tested?
- GTL001+ and Aldara
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2015to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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.
Who cannot join
- 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.
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- 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.
- Primary or secondary systemic immunosuppression (defined as prolonged [≥7 days] use of corticosteroids that is ≥20 mg/day of prednisone equivalent or any other immunosuppressive drug).
- History of severe allergy requiring hospital care or history of severe asthma requiring oral or parenteral drug management in the last year.
- Known hypersensitivity to imiquimod.
- History of a severe reaction to any drug or vaccination.
- Medical condition with clinical and/or biological consequences judged by the investigator to be incompatible with ID vaccination.
- History of, or positive test results at screening for, human immunodeficiency virus, hepatitis B virus surface Ag, or hepatitis C virus.
- Current episode of symptomatic vaginal or genital infection.
- Current episode or history of genital herpes.
- Subject is pregnant or lactating/breastfeeding.
- Use of any investigational drug within 30 days before screening or current participation in another clinical trial.
- History of recent (within 1 year) alcohol/drug abuse.
- Employee or family member of the investigator or study site personnel.
- Enrollment goals have been reached in the subject's age cohort
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Clinical Research Advantage, Inc./ Columbus Obstetricians and Gynecology, Inc.
Columbus, Ohio, 43213
University of Louisville
Louisville, Kentucky, 40208
Planned Parenthood Southeastern Pennsylvania
Philadelphia, Pennsylvania, 19107
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
About this study
Official title: 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
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.
Read the detailed description
This is an outpatient, open-label study. After a screening period of up to 4 weeks, all eligible subjects will receive 2 doses, 6 weeks apart, of GTL001 Powder reconstituted with water for injection. GTL001 will be adjuvanted with Aldara, 5% imiquimod cream, applied to the injection site 15 minutes and 24 hours after each vaccination. The follow-up period is 12 weeks from the first injection. The duration of the study is defined for each subject as the date that signed, written informed consent is provided through the last follow-up visit. Total duration of subject participation is approximately 16 weeks.
- Being tested
- GTL001+, Aldara
- Medical subject headings
- Atypical Squamous Cells of the Cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTL001+Drug
AldaraDrug
5% imiquimod cream
| Study group | Role | What they receive |
|---|---|---|
| GTL001 + Aldara, 5% imiquimod cream | Experimental | 2 doses, 6 weeks apart, GTL001 will be adjuvanted with Aldara, 5% imiquimod cream, applied to the injection site 15 minutes and 24 hours after each vaccination Receives: Drug: GTL001+; Drug: Aldara |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of local and systemic reactions recorded on diary cards as a measure of safety and tolerability
To assess the tolerability, with respect to vaccine-specific local and systemic reactions, of GTL001 adjuvanted with imiquimod in women in 2 age cohorts: 25 to 50 years, inclusive, and 51 to 65 years, inclusive. The diary cards will include local abd systemic reactions to the adjuvant, medications taken with start and stop dates, and other unsolicited symptoms/complaints, including start and stop dates.
Measured: 14-day period following an injection
Secondary outcomes (4)
Level of anti-CyaA serum as a measure of cellular and humoral Immunogenicity
Measured by enzyme-linked immunoabsorbent assay (ELISA) at weeks 0,2,6,8, and 12 (Visits 1,2,3,4, and 5, respectively) To assess the cellular and humoral immunogenicity of GTL001 adjuvanted with imiquimod in the 2 age cohorts.
Measured: 12 weeks
Percentage of subjects with anti-CyaA serum antibody response as a measure of cellular and humoral immunogenicity
Measured at weeks 2,6,8, and 12 (Visits 2,3,4, and 5, respectively) To assess the cellular and humoral immunogenicity of GTL001 adjuvanted with imiquimod in the 2 age cohorts.
Measured: 12 weeks
Specific responses to HPV 16 and HPV 18 E7 Ag stimulation as a measure of cellular and humoral Immunogenicity
Measured at weeks 0,2,6,8, and 12 (Visits 1,2,3,4, and 5, respectively) To assess the cellular and humoral immunogenicity of GTL001 adjuvanted with imiquimod in the 2 age cohorts.
Measured: 12 weeks
Percentage of subjects with positive specific response to HPV 16 and/or HPV 18 E7 stimulation as a measure of cellular and humoral Immunogenicity
To assess the cellular and humoral immunogenicity of GTL001 adjuvanted with imiquimod in the 2 age cohorts.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Lack of efficacy in European Phase 2 study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV 16- and/or HPV 18-Infected Women With Normal Cytology, ASCUS, or LSILStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genticel
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689726
- Sponsor's protocol ID
- PC10VAC05
- Other IDs
- 016462
- Status last verified
- Oct 2016
- First submitted
- 29 Jun 2015
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02689726
- Acronym / sponsor ID
- PC10VAC05
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy in European Phase 2 study
- Enrolment
- 13 participants (actual)
- Lead sponsor
- GenticelIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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.
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.
Detailed description
This is an outpatient, open-label study. After a screening period of up to 4 weeks, all eligible subjects will receive 2 doses, 6 weeks apart, of GTL001 Powder reconstituted with water for injection. GTL001 will be adjuvanted with Aldara, 5% imiquimod cream, applied to the injection site 15 minutes and 24 hours after each vaccination. The follow-up period is 12 weeks from the first injection. The duration of the study is defined for each subject as the date that signed, written informed consent is provided through the last follow-up visit. Total duration of subject participation is approximately 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GTL001 + Aldara, 5% imiquimod cream | Experimental | Drug: GTL001+, Drug: Aldara2 doses, 6 weeks apart, GTL001 will be adjuvanted with Aldara, 5% imiquimod cream, applied to the injection site 15 minutes and 24 hours after each vaccination |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (21 listed)
- 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.
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 |
|---|---|---|
| GTL001+ | Drug | GTL001 + Aldara, 5% imiquimod cream |
| Aldara5% imiquimod cream | Drug | GTL001 + Aldara, 5% imiquimod cream |
Primary outcome
Incidence of local and systemic reactions recorded on diary cards as a measure of safety and tolerability
Time frame: 14-day period following an injection
To assess the tolerability, with respect to vaccine-specific local and systemic reactions, of GTL001 adjuvanted with imiquimod in women in 2 age cohorts: 25 to 50 years, inclusive, and 51 to 65 years, inclusive. The diary cards will include local abd systemic reactions to the adjuvant, medications taken with start and stop dates, and other unsolicited symptoms/complaints, including start and stop dates.
4 secondary outcomes
Level of anti-CyaA serum as a measure of cellular and humoral Immunogenicity
Time frame: 12 weeks
Percentage of subjects with anti-CyaA serum antibody response as a measure of cellular and humoral immunogenicity
Time frame: 12 weeks
Specific responses to HPV 16 and HPV 18 E7 Ag stimulation as a measure of cellular and humoral Immunogenicity
Time frame: 12 weeks
Percentage of subjects with positive specific response to HPV 16 and/or HPV 18 E7 stimulation as a measure of cellular and humoral Immunogenicity
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Lack of efficacy in European Phase 2 study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GTL001+ and Aldara in people with HPV 16- and/or HPV 18-Infected Women With Normal Cytology, ASCUS, or LSIL, run by Genticel at 4 sites 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 7 inclusion and 21 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: stopped early, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of efficacy in European Phase 2 study). Results are not available in the source record.
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?
Incidence of local and systemic reactions recorded on diary cards as a measure of safety and tolerability (time frame: 14-day period following an injection). 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 2 Dec 2016.