Alternate Dosing Schedules Study for HPV Vaccine (ADS)

This is an interventional prevention trial for Cervical Cancer focused on measuring Human papillomavirus, Cervical cancer, Genital warts, Vaccine, Immunogenicity Read More

Inclusion Criteria:

1. A healthy, medically well female between the ages of 9 - 18 years. (Must be between 9 years and younger than 19 years of age) at time of enrollment

2. Must be receiving either a 3rd dose of HPV vaccine (All Groups) or a 2nd dose of HPV vaccine (Group 2 only)

   • For Group 1 - EITHER 1) The second dose of HPV vaccine must not have been administered and it must be within the specified dosing interval for the second dose of HPV vaccine (> 90 days since the first dose of HPV vaccine) OR 2) The second dose of HPV vaccine must have been administered > 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose of HPV vaccine (> 60 days - < 180 days since the second dose of HPV)
   • For Group 2 - The second dose of HPV vaccine must have been administered > 30 days and < 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose (> 180 days since the second dose of HPV)
   • For Group 3 - The second dose of HPV vaccine must have been administered > 30 days and < 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose (> 60 days - < 180 days since the second dose of HPV)
   • For Group 4- The second dose of HPV vaccine must have been administered > 90 days after the first dose of HPV of HPV vaccine and it must be within the specified dosing interval for the third dose (> 180 days since the second dose of HPV)
3. Ability and willingness to participate in the study by providing written informed assent. Verbal assent is acceptable for subjects less than 12 years of age.
4. Parent/guardian provides informed consent
5. Anticipated ability and willingness to complete all study visits and evaluations

Exclusion Criteria:

1. Unable to comply with the study protocol
2. Receipt of three or more doses of HPV vaccine or receipt of doses of HPV vaccine outside the pre-specified time windows
3. Receipt of blood and or blood products (including immunoglobulin) in the past 3 months or anticipated receipt during the study period
4. Receipt of a live virus vaccine (varicella virus containing vaccine, any measles, mumps, or rubella virus containing vaccine such as MMR, or yellow fever vaccine but not including live attenuated influenza virus vaccine) within 4 weeks of receipt of the 3rd dose of HPV vaccine or anticipated receipt of a live virus vaccine within 4 weeks after the 3rd dose of HPV vaccine
5. History of any physical, mental, or developmental disorder that study personnel believe may hinder a participant's ability to comply with the study requirements
6. History of malignancy or confirmed or suspected immunodeficient condition such as HIV infection
7. Receipt of or history of receipt of any medications or treatments that affect the immune system, such as immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity since six months prior to the first HPV vaccine dose. Receipt of long-term (greater than or equal to 2 weeks) potentially immunosuppressive corticosteroid use within six months prior to HPV vaccine dose 1 and enrollment or anticipated receipt during the study period. Specifically, potentially immunosuppressive corticosteroids are any parenteral corticosteroid, high dose (>800 mcg/day) beclomethasone dipropionate or equivalent medication. Nasal and topical steroids are allowed.
8. Current or former participation in HPV vaccine related research.
9. Receipt of an investigational or alternate HPV vaccine