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

• ClinicalTrials.gov Identifier: NCT02568566
• Recruitment Status: Active, not recruiting
• First Posted: October 6, 2015
• Results First Posted: April 5, 2022
• Last Update Posted: October 19, 2022
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Cancer Institute (NCI)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Human Papillomavirus-Related Carcinoma	Other: Laboratory Biomarker Analysis; Biological: Recombinant Human Papillomavirus Nonavalent Vaccine	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 201 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: March 30, 2016
• Actual Primary Completion Date: February 6, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Prevention (Gardasil 9); Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).	Other: Laboratory Biomarker Analysis; Correlative studies; Biological: Recombinant Human Papillomavirus Nonavalent Vaccine; Given IM; Other Names: Gardasil 9; Nonavalent HPV VLP Vaccine; Recombinant HPV Nonavalent Vaccine; Recombinant Human Papillomavirus 9-valent Vaccine

Outcome Measures

Primary Outcome Measures :

1. Change in Human Papilloma Virus (HPV)16/18 Antibody Titer [ Time Frame: 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 :

1. Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11 [ Time Frame: 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.
2. 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 ]
3. Vaccine Reactogenicity [ Time Frame: Up to 30 months ]

Eligibility Criteria

• Ages Eligible for Study: 9 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Arizona

Banner University Medical Center - Tucson

Tucson, Arizona, United States, 85719

United States, California

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Yi Zeng; The University of Arizona Medical Center-University Campus

  Study Documents (Full-Text)

Documents provided by National Cancer Institute (NCI):

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] April 23, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT02568566
• Other Study ID Numbers: NCI-2015-01645; NCI-2015-01645 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); N01CN00031 ( U.S. NIH Grant/Contract ); N01-CN-2012-00031; 1512261519 ( Other Identifier: Banner University Medical Center - Tucson ); UAZ2015-05-01 ( Other Identifier: DCP ); P30CA023074 ( U.S. NIH Grant/Contract )
• First Posted: October 6, 2015
• Results First Posted: April 5, 2022
• Last Update Posted: October 19, 2022
• Last Verified: October 2022

Additional relevant MeSH terms:

Vaccines; Immunologic Factors; Physiological Effects of Drugs