Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix
NCT ID: NCT03610581
Last Updated: 2025-02-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
9 participants
INTERVENTIONAL
2018-09-27
2020-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Regimen 1: Single Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18
Participants will receive a dose of adenovirus serotype 26 (Ad26)-human papillomavirus (HPV)16 or HPV18 (Ad26.HPV16 or Ad26.HPV18) as prime immunization and a dose of Modified Vaccinia Ankara (MVA)-HPV16/18 (MVA.HPV16/18) as boost immunization.
Ad26.HPV16
Participants will receive Ad26.HPV16 as a solution for intramuscular injection.
Ad26.HPV18
Participants will receive Ad26.HPV18 as a solution for intramuscular injection.
MVA.HPV16/18
Participants will receive MVA.HPV16/18 as a solution for intramuscular injection.
Regimen 2: Double Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18
Participants will receive a double dose of Ad26.HPV16 or Ad26.HPV18 as prime immunization and a dose of MVA.HPV16/18 as boost immunization.
Ad26.HPV16
Participants will receive Ad26.HPV16 as a solution for intramuscular injection.
Ad26.HPV18
Participants will receive Ad26.HPV18 as a solution for intramuscular injection.
MVA.HPV16/18
Participants will receive MVA.HPV16/18 as a solution for intramuscular injection.
Regimen 3: Ad26.HPV16/Ad26.HPV18 mix and MVA.HPV16/18
Participants will receive a mix of Ad26.HPV16/Ad26.HPV18 as prime immunization and a dose of MVA.HPV16/18 as boost immunization.
Ad26.HPV16
Participants will receive Ad26.HPV16 as a solution for intramuscular injection.
Ad26.HPV18
Participants will receive Ad26.HPV18 as a solution for intramuscular injection.
MVA.HPV16/18
Participants will receive MVA.HPV16/18 as a solution for intramuscular injection.
Control: Placebo
Participants will receive matched placebo as prime and boost immunizations.
Placebo
Participants will receive matched placebo as a solution for intramuscular injection.
Interventions
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Ad26.HPV16
Participants will receive Ad26.HPV16 as a solution for intramuscular injection.
Ad26.HPV18
Participants will receive Ad26.HPV18 as a solution for intramuscular injection.
MVA.HPV16/18
Participants will receive MVA.HPV16/18 as a solution for intramuscular injection.
Placebo
Participants will receive matched placebo as a solution for intramuscular injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have an human papillomavirus (HPV) type 16 or 18 infection of the cervix as determined by a qualitative PCR test within 8 weeks prior to screening or at the time of screening. Available history of high-risk (HR)-HPV positivity and HPV16 or HPV18 positivity positivity will be recorded
* Must have a recent colposcopy result (with a maximum of 12 months old at screening); in case a colposcopy has not been performed before, it will be done as screening procedure
* Contraceptive (birth control) use by participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
* Agrees not to donate blood until 3 months after receiving the last dose of study vaccine
Exclusion Criteria
* Current or history of cervical intraepithelial neoplasia (CIN)2+ or cervical cancer
* Confirmed co-infection with both HPV16 and HPV18
* History of an underlying clinically significant acute or chronic medical condition, other than infection with HPV, or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Tests positive for human immunodeficiency virus (HIV) at screening
* Chronic active hepatitis B or hepatitis C infection, verified at screening by hepatitis B surface antigen or anti-hepatitis C virus antibody, respectively
* Vaginal atrophy with or without topical hormonal therapies or systemic selective estrogen receptor modulators
* Exposed to at least 1 dose of an HPV prophylactic vaccine or participant has participated in the past in another preventive or therapeutic HPV vaccine study
* Clinically significant gynecological abnormalities that could, in the judgment of the investigator, interfere with study evaluation (for example \[e.g.\], prolapse, myoma, fibroid, hysterectomy)
* Symptomatic vaginal or genital infection (including genital herpes) as confirmed by physician or investigator
18 Years
60 Years
FEMALE
No
Sponsors
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Bavarian Nordic
INDUSTRY
Janssen Vaccines & Prevention B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Vaccines & Prevention B.V. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Vaccines & Prevention B.V.
Locations
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Doral Medical Research
Doral, Florida, United States
Clinical Physiology Associates
Fort Myers, Florida, United States
Florida Research Center Inc.
Miami, Florida, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States
University of Iowa Hospital
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
Medpharmics, LLC
Metairie, Louisiana, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Columbia University Medical Center
New York, New York, United States
VGR & NOCCR - Knoxville
Knoxville, Tennessee, United States
UZ Leuven
Leuven, , Belgium
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-000200-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VAC81623HPV1002
Identifier Type: OTHER
Identifier Source: secondary_id
CR108458
Identifier Type: -
Identifier Source: org_study_id
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