Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants

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