CClinicalTrials.gg
Sign In
Active, not recruitingNCT02568566Updated Jul 10, 2026Results posted

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

A Phase 2 interventional study of Laboratory Biomarker Analysis and Recombinant Human Papillomavirus Nonavalent Vaccine in Human Papillomavirus-Related Carcinoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 2 sites in United States. Open to participants aged 9 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
201
Allocation
Not applicable
Ages
9 Years to 11 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Human Papillomavirus-Related Carcinoma
03

In context

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
201 participants (actual)

Study arms

  • 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 · Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

Interventions

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • BiologicalRecombinant Human Papillomavirus Nonavalent Vaccine

    Given IM

    Also known as: Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine

06

What researchers measure

Primary outcomes

  1. Change in Human Papilloma Virus (HPV)16/18 Antibody Titer

    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.

    Time frame: Between 6 and 24 months after prime dose and prior to the administration of the second dose

Secondary outcomes

  1. Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11

    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.

    Time frame: Data are not available. The study team is working on analyzing the antibody titers of other HPV types.

  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

07

Results

Posted Apr 5, 2022

Participant flow

Participant flow — Overall Study
MilestonePrevention (Gardasil 9)
Started201
Completed187
Not completed14

Outcome measures

PrimaryChange in Human Papilloma Virus (HPV)16/18 Antibody Titer

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.

Time frame:
Between 6 and 24 months after prime dose and prior to the administration of the second dose
Reported as:
Mean · Log10 IU/ml
Change in Human Papilloma Virus (HPV)16/18 Antibody Titer
Log10 IU/mlPrevention (Gardasil 9)
Difference in HPV16 titers between 6 and 12 months-0.55 ± 0.54
Difference in HPV16 titers between 12 and 18 months0.03 ± 0.62
Difference in HPV16 titers between 18 and 24 months-0.002 ± 0.64
Difference in HPV18 titers between 6 and 12 months-0.38 ± 0.46
Difference in HPV18 titers between 12 and 18 months-0.005 ± 0.53
Difference in HPV18 titers between 18 and 24 months-0.02 ± 0.63
SecondaryChange in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11

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.

Time frame:
Data are not available. The study team is working on analyzing the antibody titers of other HPV types.

Results for this outcome have not been posted.

SecondaryIncidence 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

Results for this outcome have not been posted.

SecondaryVaccine Reactogenicity
Time frame:
Up to 30 months

Results for this outcome have not been posted.

Adverse events

Collected over 30 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Prevention (Gardasil 9)0/201 (0%)2/201 (1%)151/201 (75.1%)
Most frequent serious events
Most frequent serious events
EventPrevention (Gardasil 9)
AppendicitisInfections and infestations1/201
WheezingRespiratory, thoracic and mediastinal disorders1/201
Most frequent other events
Showing 10 of 12
Most frequent other events
EventPrevention (Gardasil 9)
Injection site reactionGeneral disorders69/201
HeadacheNervous system disorders34/201
Upper respiratory infectionInfections and infestations29/201
Stomach painGastrointestinal disorders16/201
Flu like symptomsGeneral disorders15/201
Pain in extremityMusculoskeletal and connective tissue disorders14/201
Nasal congestionRespiratory, thoracic and mediastinal disorders14/201
NauseaGastrointestinal disorders13/201
FeverGeneral disorders11/201
PainGeneral disorders11/201

Baseline characteristics

Age, Continuous
Age, Continuous(years)Prevention (Gardasil 9)
Mean10 ± 0.82
Sex: Female, Male
Sex: Female, Male(Participants)Prevention (Gardasil 9)
Female143
Male58
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Prevention (Gardasil 9)
Hispanic or Latino100
Not Hispanic or Latino100
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Prevention (Gardasil 9)
American Indian or Alaska Native4
Asian23
Native Hawaiian or Other Pacific Islander1
Black or African American7
White131
More than one race27
Unknown or Not Reported8
Region of Enrollment
Region of Enrollment(participants)Prevention (Gardasil 9)
United States201
08

Study locations

2 sites
  • Banner University Medical Center - Tucson
    Tucson, Arizona 85719, United States
  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles, California 90095, United States
09

References and documents

Publications

  • 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. PubMed 30935375 ↗

Study documents

  • Protocol, analysis plan and consent form · Apr 23, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02568566
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 6, 2015
Start date
May 19, 2016
Primary completion
Feb 6, 2020
Completion
Jan 10, 2027 (estimated)
Results posted
Apr 5, 2022
Last update
Jul 10, 2026

Study contacts

Hsiao-Hui (Sherry) Chow
principal investigator · The University of Arizona Medical Center-University Campus

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

National Cancer Institute (NCI)

Start the discussion