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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568566
Recruitment Status : Active, not recruiting
First Posted : October 6, 2015
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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.

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Persistence and stability of serologic geometric mean titer (GMT) of human papilloma virus (HPV)16/18 [ Time Frame: Between 6 and 24 months after prime dose and prior to the administration of the second dose ]
    A one-sided paired t test will be performed to compare the difference in the mean of the log-transformed antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months, respectively, to evaluate whether the GMT at 12/18/24 months, respectively, is not inferior to the GMT at 6/12/18 months. Percentage of participants whose type-specific antibody levels decrease, increase, or remain stable between the 6 and 12 month study visits, between the 12 and 18 month study visits, and between the18 month and 24 month study visits will be reported along with the associated 95% confidence interval.


Secondary Outcome Measures :
  1. Persistence and stability of serologic GMT of other carcinogenic HPV types 31/33/45/52/58 and non-carcinogenic HPV 6/11 [ Time Frame: Between 6 and 24 months after prime dose and prior to the administration of the second dose ]
    A one-sided paired t test will be performed to compare the difference in the mean of the log-transformed antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months, respectively, to evaluate whether the GMT at 12/18/24 months, respectively, is not inferior to the GMT at 6/12/18 months. Percentage of participants whose type-specific antibody levels decrease, increase, or remain stable between the 6 and 12 month study visits, between the 12 and 18 month study visits, and between the18 month and 24 month study visits will be reported along with the associated 95% confidence interval.

  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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568566


Locations
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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
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Principal Investigator: Yi Zeng The University of Arizona Medical Center-University Campus
  Study Documents (Full-Text)

Documents provided by National Cancer Institute (NCI):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs