Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants

Phase 2

Active, not recruiting

Interventions: Other: Laboratory Biomarker Analysis
Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Healthy, medically well girls and boys
Ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant
Ability to understand and the willingness to sign a written assent document by the participant

Exclusion Criteria

Previous vaccination against HPV
The use of any investigational agent within 30 days preceding the first dose of the study vaccine or subsequent participation in another clinical trial at any time during the study period, in which the subject will be exposed to an investigational product
Chronic administration of immunosuppressive agents or other immune-modifying drugs or chemotherapeutic agents within six months prior to the first vaccine dose; use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed
Receiving active treatment for cancer or an autoimmune condition
Confirmed or suspected immunosuppressive or immunodeficient condition
Known bleeding disorders that preclude intramuscular injection (e.g., on anticoagulants or thrombocytopenia)
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal dysfunction, which in the opinion of the investigator precludes administration of the study vaccine
History of allergic reactions attributed to compounds of similar chemical or biologic composition of GARDASIL 9 (recombinant human papillomavirus nonavalent vaccine), including yeast allergy
Are pregnant

Arm && Interventions

Group	Intervention	Description
Prevention (Gardasil 9)	Laboratory Biomarker Analysis	Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).
Prevention (Gardasil 9)	Recombinant Human Papillomavirus Nonavalent Vaccine	Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).

Primary Outcome Measures

Name	Time	Method
Change in Human Papilloma Virus (HPV)16/18 Antibody Titer	Between 6 and 24 months after prime dose and prior to the administration of the second dose	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.

Secondary Outcome Measures

Name	Time	Method
Vaccine Reactogenicity	Up to 30 months
Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11	Data are not available. The study team is working on analyzing the antibody titers of other HPV types.	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.
Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0	Up to 2 weeks post-treatment

Locations (2): UCLA / Jonsson Comprehensive Cancer Center
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Los Angeles, California, United States
Banner University Medical Center - Tucson
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Tucson, Arizona, United States