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Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With Persistent Human Papillomavirus HPV16 or HPV18 Infection of the Cervix

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ClinicalTrials.gov Identifier: NCT03610581
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Bavarian Nordic
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Study Description
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Brief Summary:
The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Infections Biological: Ad26.HPV16 Biological: Ad26.HPV18 Biological: MVA.HPV16/18 Biological: Placebo Phase 1 Phase 2

Detailed Description:
This study is part of a vaccine program which aims to generate a therapeutic vaccine for women with persistent HPV types 16 or 18 infection, with a focus on early disease interception. The study consists of 3 periods: Screening period of up to 42 days (6 weeks), followed by prime and boost immunizations and follow-up visits up to 12 months after the first vaccination. Evaluation of the safety/reactogenicity of the vaccine regimens will include physical assessment by study-site personnel, participant reports on signs and symptoms and laboratory assessments following vaccinations. Immunogenicity and Virology/Histology assessments will also be performed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, First-in-Human, Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Otherwise Healthy Women With Persistent HPV16 or 18 Infection of the Cervix
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : August 9, 2020
Estimated Study Completion Date : April 8, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Biological: Ad26.HPV16
Participants will receive Ad26.HPV16 as a solution for intramuscular injection.
Other Name: JNJ-63682918

Biological: Ad26.HPV18
Participants will receive Ad26.HPV18 as a solution for intramuscular injection.
Other Name: JNJ-63682931

Biological: MVA.HPV16/18
Participants will receive MVA.HPV16/18 as a solution for intramuscular injection.
Other Name: JNJ-65195208
Experimental: 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.
 Biological: Ad26.HPV16
Participants will receive Ad26.HPV16 as a solution for intramuscular injection.
Other Name: JNJ-63682918

Biological: Ad26.HPV18
Participants will receive Ad26.HPV18 as a solution for intramuscular injection.
Other Name: JNJ-63682931

Biological: MVA.HPV16/18
Participants will receive MVA.HPV16/18 as a solution for intramuscular injection.
Other Name: JNJ-65195208
Experimental: 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.
 Biological: Ad26.HPV16
Participants will receive Ad26.HPV16 as a solution for intramuscular injection.
Other Name: JNJ-63682918

Biological: Ad26.HPV18
Participants will receive Ad26.HPV18 as a solution for intramuscular injection.
Other Name: JNJ-63682931

Biological: MVA.HPV16/18
Participants will receive MVA.HPV16/18 as a solution for intramuscular injection.
Other Name: JNJ-65195208
Placebo Comparator: Control: Placebo
Participants will receive matched placebo as prime and boost immunizations.
 Biological: Placebo
Participants will receive matched placebo as a solution for intramuscular injection.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: 7 Days after each vaccination (approximately up to Day 64) ]
    Solicited local AEs: pain/tenderness, erythema, and induration/swelling. Solicited systemic AEs: headache, fatigue, myalgia, arthralgia, chills and fever.

  2. Percentage of Participants with Unsolicited AEs [ Time Frame: 28 Days after each vaccination (approximately up to Day 85) ]
    Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.

  3. Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Approximately up to Month 12 ]
    SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.


Secondary Outcome Measures :
  1. Percentage of Participants with Human Papillomavirus (HPV)-Specific CD4+ and CD8+ T-Cell Responses [ Time Frame: 21 Days after last vaccination (approximately Day 78) ]
    Expression of cytokines (for example [e.g.] interferon gamma [IFNγ], tumor necrosis factor alpha [TNFα], interleukin [IL]-2) by CD4+ and CD8+ T cell subsets will be determined by flow cytometry.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • Must have a 12-month persistent human papillomavirus (HPV) types 16 or 18 infection of the cervix, defined as at least 2 positive cervical HPV polymerase chain reaction (PCR) tests with an interval of at least 11 months as follows: 2 positive HPV16 (or 2 positive HPV18) tests or, if the genotype of the first test is unknown and after consultation with the sponsor, high-risk (HR)-HPV positivity followed by HPV16 (or HPV18) positivity
  • Must have a recent colposcopy result (less than 6 months old at screening)
  • 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:

  • In case cytology results are available, participant has current or history of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma in situ (AIS) or any high-grade vulvar, vaginal or anal intraepithelial neoplasia
  • 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
  • History of or currently active genital herpes disease
Contacts and Locations
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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): NCT03610581


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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United States, Florida
Doral Medical Research Recruiting
Doral, Florida, United States, 33166
Clinical Physiology Associates Completed
Fort Myers, Florida, United States, 33912
San Marcus Research Clinic, Inc. Recruiting
Miami Lakes, Florida, United States, 33014
Florida Research Center Inc. Recruiting
Miami, Florida, United States, 33174
United States, Iowa
University of Iowa Hospital Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66160
Heartland Research Associates, LLC Completed
Newton, Kansas, United States, 67114
United States, Louisiana
Medpharmics, LLC Completed
Metairie, Louisiana, United States, 70006
United States, Nebraska
Meridian Clinical Research, LLC Recruiting
Norfolk, Nebraska, United States, 68701
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
United States, North Carolina
Wake Research Associates Withdrawn
Raleigh, North Carolina, United States, 27612
PMG Research of Rocky Mount, LLC Withdrawn
Rocky Mount, North Carolina, United States, 27804
United States, Ohio
Optimed Research LTD Withdrawn
Columbus, Ohio, United States, 43235
United States, Tennessee
VGR & NOCCR - Knoxville Recruiting
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Bavarian Nordic
Investigators
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Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
More Information
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Additional Information:
To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site

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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT03610581     History of Changes
Other Study ID Numbers: CR108458
2018-000200-41 ( EudraCT Number )
VAC81623HPV1002 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
 Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs