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

NCT ID: NCT02568566

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-19
• Study Completion Date: 2026-01-10

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.

Conditions

Human Papillomavirus-Related Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prevention (Gardasil 9)

Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Recombinant Human Papillomavirus Nonavalent Vaccine

Intervention Type: BIOLOGICAL

Given IM

Interventions

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Recombinant Human Papillomavirus Nonavalent Vaccine

Given IM

Intervention Type: BIOLOGICAL

Other Intervention Names

Gardasil 9; Nonavalent HPV VLP Vaccine; Recombinant HPV Nonavalent Vaccine; Recombinant Human Papillomavirus 9-valent Vaccine

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsiao-Hui (Sherry) Chow

Role: PRINCIPAL_INVESTIGATOR

The University of Arizona Medical Center-University Campus

Locations

Banner University Medical Center - Tucson

Tucson, Arizona, United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

References

Zeng Y, Moscicki AB, Sahasrabuddhe VV, Garcia F, Woo H, Hsu CH, Szabo E, Dimond E, Vanzzini S, Mondragon A, Butler V, DeRose H, Chow HS. 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 - clinical protocol. BMC Cancer. 2019 Apr 1;19(1):290. doi: 10.1186/s12885-019-5444-4.

Reference Type: DERIVED

PMID: 30935375 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

NCI-2015-01645

Identifier Type: REGISTRY

Identifier Source: secondary_id

N01CN00031

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01-CN-2012-00031

Identifier Type: -

Identifier Source: secondary_id

1512261519

Identifier Type: OTHER

Identifier Source: secondary_id

UAZ2015-05-01

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA023074

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2015-01645

Identifier Type: -

Identifier Source: org_study_id