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

NCT03610581 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: CR1084582018-000200-41VAC81623HPV1002
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 12

Brief Summary

The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.

Conditions

Human Papillomavirus Infections

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Solicited Local Adverse Events (AEs)

  Number of participants with solicited local AEs were reported. Solicited local AE's included pain/tenderness, erythema, and induration/swelling.

  Up to 7 days after each vaccination (Up to Day 64)

• Number of Participants With Solicited Systemic AEs

  Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, chills, and fever.

  Up to 7 days after each vaccination (Up to Day 64)

• Number of Participants With Unsolicited AEs

  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.

  28 days after each vaccination (Up to Day 85)

• Number of Participants With Serious Adverse Events (SAEs)

  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.

  Up to 12 months after the first vaccination (target visit Day 366)

Secondary Outcomes (6)

• Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+

  Day 57, Day 78, Day 239, and Day 366

• Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+

  Day 57, Day 78, Day 239, and Day 366

• Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+

  Day 57, Day 78, Day 239, and Day 366

• Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+

  Day 57, Day 78, Day 239, and Day 366

• Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+

  Day 57, Day 78, Day 239, and Day 366

Study Arms (4)

Regimen 1: Single Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18

EXPERIMENTAL

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; Biological: Ad26.HPV18; Biological: MVA.HPV16/18

Regimen 2: Double Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18

EXPERIMENTAL

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; Biological: Ad26.HPV18; Biological: MVA.HPV16/18

Regimen 3: Ad26.HPV16/Ad26.HPV18 mix and MVA.HPV16/18

EXPERIMENTAL

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; Biological: Ad26.HPV18; Biological: MVA.HPV16/18

Control: Placebo

PLACEBO COMPARATOR

Participants will receive matched placebo as prime and boost immunizations.

Biological: Placebo

Interventions

Ad26.HPV16 BIOLOGICAL

Participants will receive Ad26.HPV16 as a solution for intramuscular injection.

Also known as: JNJ-63682918

Regimen 1: Single Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18; Regimen 2: Double Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18; Regimen 3: Ad26.HPV16/Ad26.HPV18 mix and MVA.HPV16/18

Ad26.HPV18 BIOLOGICAL

Participants will receive Ad26.HPV18 as a solution for intramuscular injection.

Also known as: JNJ-63682931

Regimen 1: Single Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18; Regimen 2: Double Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18; Regimen 3: Ad26.HPV16/Ad26.HPV18 mix and MVA.HPV16/18

MVA.HPV16/18 BIOLOGICAL

Participants will receive MVA.HPV16/18 as a solution for intramuscular injection.

Also known as: JNJ-65195208

Regimen 1: Single Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18; Regimen 2: Double Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18; Regimen 3: Ad26.HPV16/Ad26.HPV18 mix and MVA.HPV16/18

Placebo BIOLOGICAL

Participants will receive matched placebo as a solution for intramuscular injection.

Control: Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead
• Bavarian Nordic: collaborator

Study Sites (12)

Doral Medical Research

Doral, Florida, 33166, United States

Location

Clinical Physiology Associates

Fort Myers, Florida, 33912, United States

Location

Florida Research Center Inc.

Miami, Florida, 33174, United States

Location

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014, United States

Location

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

Medpharmics, LLC

Metairie, Louisiana, 70006, United States

Location

Meridian Clinical Research, LLC

Norfolk, Nebraska, 68701, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

VGR & NOCCR - Knoxville

Knoxville, Tennessee, 37920, United States

Location

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

As the study was terminated prematurely, the Sponsor performed a limited analysis on the available data to meet the requirement for reporting the study.

Results Point of Contact

• Title: Clinical Franchise Leader
• Organization: Janssen Vaccines & Prevention B.V

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 1, 2018
• Study Start: September 27, 2018
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: February 4, 2025
• Results First Posted: November 9, 2021

Record last verified: 2025-01

Locations

US (11); BE (1)