Human papillomavirus (HPV) is a common sexually-transmitted virus which causes infections that usually last only a few months, but sometimes can last a long time and cause cancers of the cervix, vagina, vulva, anus or oropharynx over many years among adults. This phase IIA trial studies how well does the nonavalent HPV vaccine (which can prevent nine different types of HPV) work when given in an alternative dosing schedule to heathy young research participants.
PRIMARY OBJECTIVES: I. To determine the persistence and stability of serologic geometric mean titer (GMT) of HPV 16/18 between 6, 12, 18, and 24 months after the prime dose and prior to the administration of the second dose. SECONDARY OBJECTIVES: I. To determine the persistence and stability of serologic GMT of HPV types 6/11/31/33/45/52/58 between 6, 12, 18, and 24 months after prime dose and prior to the administration of the second dose. II. To assess safety and reactogenicity to each vaccine dose. OUTLINE: Participants receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline (priming injection) and at 24 and 30 months (booster injections). After completion of study, participants are followed up for 2 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
201
Correlative studies
Given IM
Banner University Medical Center - Tucson
Tucson, Arizona, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Change in Human Papilloma Virus (HPV)16/18 Antibody Titer
Difference in the log-transformed HPV 16/18 antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.
Time frame: Between 6 and 24 months after prime dose and prior to the administration of the second dose
Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11
Difference in the log-transformed HPV type-specific antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.
Time frame: Data are not available. The study team is working on analyzing the antibody titers of other HPV types.
Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Time frame: Up to 2 weeks post-treatment
Vaccine Reactogenicity
Time frame: Up to 30 months
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