NCT02568566

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

A Prospective, Single-arm, Open-label, Non-randomized, Phase IIA Trial of a Nonavalent Prophylactic HPV Vaccine to Assess Immunogenicity of a Prime and Deferred-booster Dosing Schedule Among 9-11 Year-old Girls and Boys

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 9 Years – 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Papillomavirus-Related Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Recombinant Human Papillomavirus Nonavalent Vaccine	Given IM

Timeline

• Start date: 2016-05-19
• Primary completion: 2020-02-06
• Completion: 2027-01-10
• First posted: 2015-10-06
• Last updated: 2026-04-13
• Results posted: 2022-04-05

Locations

2 sites across 1 country: United States