Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants
Condition: Cervical Cancer; Precancerous Condition
MeSH terms: Uterine Cervical Neoplasms; Neoplasms; Uterine Cervical Dysplasia; Precancerous Conditions
Intervention: human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine; hepatitis A inactivated virus vaccine
Intervention description: Three doses of Cervarix vaccine administered on a 0, 1, 6-month schedule; Three doses of Havrix vaccine administered on a 0, 1, 6-month schedule
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 7466.0
Sex: Female
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cervical intraepithelial neoplasia grade 2; cervical cancer; cervical intraepithelial neoplasia grade 3

Summary:

      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer form forming, growing,
      or coming back. Vaccines may help the body build an effective immune response against human
      papillomavirus and may be effective in preventing cervical intraepithelial neoplasia or
      cervical cancer. It is not yet known whether human papillomavirus vaccine is more effective
      than hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer.

      PURPOSE: This randomized phase III trial is studying human papillomavirus vaccine to see how
      well it works compared to hepatitis A vaccine in preventing cervical intraepithelial
      neoplasia or cervical cancer in younger healthy participants.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

        •Healthy participants

          -  Deemed to be in good general health by history and physical examination

             •Resident of Guanacaste Province of Costa Rica and surrounding areas

          -  Must remain a resident for ≥ 6 months after the first study vaccination

        PATIENT CHARACTERISTICS:

        Age

          -  18 to 25

        Performance status

        •Not specified

        Life expectancy

        •Not specified

        Hematopoietic

        •Not specified

        Hepatic

          -  No history of chronic hepatitis requiring treatment

          -  No acute or chronic clinically significant hepatic function abnormality by physical
             examination or laboratory findings

          -  No known history of hepatitis A infection

        Renal

          -  No history of kidney disease requiring treatment

          -  No acute or chronic clinically significant kidney function abnormality by physical
             examination or laboratory findings

        Cardiovascular

          -  No acute or chronic clinically significant cardiovascular function abnormality by
             physical examination or laboratory findings Pulmonary

          -  No acute or chronic clinically significant pulmonary function abnormality by physical
             examination or laboratory findings Immunology

          -  No history of allergic disease

          -  No history of autoimmune disorder requiring treatment

          -  No history of allergic reaction (e.g., difficulty breathing) to any vaccine

          -  No suspected allergy or reaction likely to be exacerbated by a component of the study
             vaccines (e.g., 2-phenoxyethanol or neomycin)

          -  No hypersensitivity to latex

          -  No diagnosis or suspicion of any immunodeficient condition by medical history or
             physical examination Other

          -  Not pregnant or nursing

             ◦No delivery within the past 3 months

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception for 30 days before, during, and for
             60 days after completion of study treatment

          -  Able to speak or understand Spanish

          -  Mentally competent

          -  Able to undergo pelvic exam (i.e., no heavy bleeding [menstruation or otherwise] or
             heavy vaginal discharge)

          -  No history of cancer requiring treatment

          -  No history of diabetes requiring treatment

          -  No history of other chronic conditions requiring treatment

          -  No acute or chronic clinically significant neurologic function abnormality by physical
             examination or laboratory findings

          -  No other acute disease

          -  No fever ≥ 37.5º C

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  More than 6 months since prior chronic administration (i.e., > 14 days) of
             immune-modulating drugs

          -  More than 90 days since prior immunoglobulins

          -  More than 30 days since prior and no other concurrent investigational or
             non-registered vaccines

          -  More than 30 days since prior registered vaccines

          -  More than 8 days since prior routine meningococcal, hepatitis B, influenza, or
             diphtheria/tetanus vaccine

          -  No prior vaccination against hepatitis A

          -  No prior vaccination against human papillomavirus

          -  No prior monophosphoryl lipid A or AS04 adjuvant

        Chemotherapy

        •Not specified

        Endocrine therapy

          -  More than 6 months since prior chronic administration (i.e., > 14 days) of
             corticosteroids (e.g., ≥ 0.5 mg/kg/day of prednisone or equivalent)

          -  Concurrent inhaled or topical steroids allowed

        Radiotherapy

        •Not specified

        Surgery

        •No prior hysterectomy

        Other

          -  More than 6 months since prior chronic administration (i.e., > 14 days) of
             immunosuppressants

          -  More than 30 days since prior and no other concurrent investigational or
             non-registered drugs