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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 HPV16 or HPV18 Infection of the Cervix

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ClinicalTrials.gov Identifier: NCT03610581
Recruitment Status : Terminated (Low enrolment and increasing COVID restrictions, following an earlier enrolment pause in April made it clear that completion of the study would not be feasible)
First Posted : August 1, 2018
Results First Posted : November 9, 2021
Last Update Posted : November 24, 2021
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 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)
Actual Enrollment : 9 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 HPV16 or 18 Infection of the Cervix
Actual Study Start Date : September 27, 2018
Actual Primary Completion Date : October 15, 2020
Actual Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

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. Number of Participants With Solicited Local Adverse Events (AEs) [ Time Frame: Up to 7 days after each vaccination (Up to Day 64) ]
    Number of participants with solicited local AEs were reported. Solicited local AE's included pain/tenderness, erythema, and induration/swelling.

  2. Number of Participants With Solicited Systemic AEs [ Time Frame: Up to 7 days after each vaccination (Up to Day 64) ]
    Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, chills, and fever.

  3. Number of Participants With Unsolicited AEs [ Time Frame: 28 days after each vaccination (Up to Day 85) ]
    Number of participants with unsolicited AEs were reported. Unsolicited AEs included all AEs for which the participant was not specifically questioned in the participant diary.

  4. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 12 months after the first vaccination (target visit Day 366) ]
    Number of participants with SAEs were reported. 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+ T-cell Responses: Interferon (IFN)g+ [ Time Frame: Day 57, Day 78, Day 239, and Day 366 ]
    Percentage of participants with HPV-Specific CD4+ T-cell responses for IFNg+ to peptide pools were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

  2. Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ [ Time Frame: Day 57, Day 78, Day 239, and Day 366 ]
    Percentage of participants with HPV-Specific CD4+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

  3. Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ [ Time Frame: Day 57, Day 78, Day 239, and Day 366 ]
    Percentage of participants with HPV-Specific CD4+ T-cell responses for TNF a+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

  4. Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ [ Time Frame: Day 57, Day 78, Day 239, and Day 366 ]
    Percentage of participants with HPV-Specific CD8+ T-cell responses for IFNg+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

  5. Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ [ Time Frame: Day 57, Day 78, Day 239, and Day 366 ]
    Percentage of participants with HPV-Specific CD8+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

  6. Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ [ Time Frame: Day 57, Day 78, Day 239, and Day 366 ]
    Percentage of participants with HPV-Specific CD8+ T-cell responses for TNFa+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).


Eligibility Criteria
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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 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:

  • 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 (including genital herpes) as confirmed by physician or investigator
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


Locations
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United States, Florida
Doral Medical Research
Doral, Florida, United States, 33166
Clinical Physiology Associates
Fort Myers, Florida, United States, 33912
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States, 33014
Florida Research Center Inc.
Miami, Florida, United States, 33174
United States, Iowa
University of Iowa Hospital
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Heartland Research Associates, LLC
Newton, Kansas, United States, 67114
United States, Louisiana
Medpharmics, LLC
Metairie, Louisiana, United States, 70006
United States, Nebraska
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States, 68701
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Tennessee
VGR & NOCCR - Knoxville
Knoxville, Tennessee, United States, 37920
Belgium
UZ Leuven
Leuven, Belgium, 3000
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.
  Study Documents (Full-Text)

Documents provided by Janssen Vaccines & Prevention B.V.:
Study Protocol  [PDF] August 20, 2019
Statistical Analysis Plan  [PDF] October 14, 2020

More Information
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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT03610581    
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
Results First Posted: November 9, 2021
Last Update Posted: November 24, 2021
Last Verified: November 2021

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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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Infections
Communicable Diseases
Papillomavirus Infections
Disease Attributes
 Pathologic Processes
DNA Virus Infections
Virus Diseases
Tumor Virus Infections