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

1. Current or history of untreated high-grade cervical lesion (either CIN2 or CIN3).

2. Current or history of cervical, vulvar, or vaginal cancer.

3. Prior exposure to HPV prophylactic vaccine, regardless of number of doses received, or participation in another HPV vaccination clinical trial.

4. Current acute or chronic disease, other than HPV 16/18 infection, which would be expected to interfere with the protocol-defined evaluations.

5. Clinically significant gynecological abnormalities that could interfere with study procedures (eg, prolapse, severe vaginal atrophy, myoma, hysterectomy) in the judgment of the investigator.

6. Malignancy, or treatment for malignancy, within the previous 2 years, with the exception of basal cell or squamous cell carcinoma of the skin.

7. 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).

8. Administration of any live viral vaccine within 3 months or any inactivated (nonlive) vaccine within 2 weeks prior to screening.

9. 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).

10. History of severe allergy requiring hospital care or history of severe asthma requiring oral or parenteral drug management in the last year.

11. Known hypersensitivity to imiquimod.

12. History of a severe reaction to any drug or vaccination.

13. Medical condition with clinical and/or biological consequences judged by the investigator to be incompatible with ID vaccination.

14. History of, or positive test results at screening for, human immunodeficiency virus, hepatitis B virus surface Ag, or hepatitis C virus.

15. Current episode of symptomatic vaginal or genital infection.

16. Current episode or history of genital herpes.

17. Subject is pregnant or lactating/breastfeeding.

18. Use of any investigational drug within 30 days before screening or current participation in another clinical trial.

19. History of recent (within 1 year) alcohol/drug abuse.

20. Employee or family member of the investigator or study site personnel.

21. Enrollment goals have been reached in the subject's age cohort

What this study is about