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

NCT02689726 | Terminated Phase 1

• 2 other identifiers: PC10VAC05016462
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

HPV 16- and/or HPV 18-Infected Women With Normal Cytology, ASCUS, or LSIL

Outcome Measures

Primary Outcomes (1)

• 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.

  14-day period following an injection

Secondary Outcomes (4)

• Level of anti-CyaA serum as a measure of cellular and humoral Immunogenicity

  12 weeks

• Percentage of subjects with anti-CyaA serum antibody response as a measure of cellular and humoral immunogenicity

  12 weeks

• Specific responses to HPV 16 and HPV 18 E7 Ag stimulation as a measure of cellular and humoral Immunogenicity

  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

  12 weeks

Study Arms (1)

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

Drug: GTL001+; Drug: Aldara

Interventions

GTL001+ DRUG

GTL001 + Aldara, 5% imiquimod cream

Aldara DRUG

5% imiquimod cream

GTL001 + Aldara, 5% imiquimod cream

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Genticel: lead
• PPD Development, LP: collaborator

Study Sites (4)

University of Louisville

Louisville, Kentucky, 40208, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Clinical Research Advantage, Inc./ Columbus Obstetricians and Gynecology, Inc.

Columbus, Ohio, 43213, United States

Location

Planned Parenthood Southeastern Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Atypical Squamous Cells of the Cervix

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Uterine Cervical Dysplasia; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: February 24, 2016
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 2, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)