A Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adults

• ClinicalTrials.gov Identifier: NCT02860650
• Recruitment Status: Completed
• First Posted: August 9, 2016
• Last Update Posted: February 5, 2018
• Sponsor: Janssen Vaccines & Prevention B.V.
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): Janssen Vaccines & Prevention B.V.

Tracking Information

• First Submitted Date: August 4, 2016
• First Posted Date: August 9, 2016
• Last Update Posted Date: February 5, 2018
• Actual Study Start Date: August 2016
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 24, 2017)

• Number of Participants With Adverse events (AEs) [ Time Frame: Up to 28 days after the last vaccination ]
• Number of Participants With Reactogenicity (ie, Solicited Local and Systemic Adverse Events) [ Time Frame: One Week after each study vaccine administration ]
• Number of Participants With Serious Adverse Events [ Time Frame: Up to the end of long-term follow-up (Day 360) ]

Original Primary Outcome Measures (submitted: August 4, 2016)

• Number of Participants With Adverse events (AEs) [ Time Frame: Up to 21 days after the second vaccination: Group 1, 2 and 4: up to Day 78; Group 3: up to Day 36 ]
• Number of Participants With Reactogenicity (ie, Solicited Local and Systemic Adverse Events) [ Time Frame: One Week after each study vaccine administration ]
• Number of Participants With Serious Adverse Events [ Time Frame: Up to the end of long-term follow-up (Day 360) ]

• Current Secondary Outcome Measures (submitted: August 4, 2016): Binding Antibody Responses Against Ebola Virus (EBOV), Marburg Virus (MARV), and Sudan Virus (SUDV) Glycoproteins (GPs) [ Time Frame: Up to Day 360 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adults
• Official Title: A Phase 1, First-in-human Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adult
• Brief Summary: The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Healthy

Intervention

• Biological: Ad26.Filo
  Ad26.Filo intramuscular (IM) injection at a dose of 9*10^10 viral particles (vp).
• Biological: MVA-BN-Filo
  MVA-BN-Filo intramuscular (IM) injection at a dose of 5*10^8 infectious units (Inf U).
• Biological: Ad26.ZEBOV
  Ad26.ZEBOV intramuscular (IM) injection at a dose of 5*10^10 vp.
• Biological: Placebo
  IM injection of 0.9 percent saline.
• Biological: MVA-BN-Filo
  MVA-BN-Filo intramuscular (IM) injection at a dose of 1*10^8 Inf U.

Study Arms

• Experimental: Group 1: AD26.Filo/MVA-BN-Filo or Placebo
  Participants will receive Ad26.Filo or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.
  Interventions:

  • Biological: Ad26.Filo
  • Biological: MVA-BN-Filo
  • Biological: Placebo
• Experimental: Group 2: MVA-BN-Filo/AD26.Filo or Placebo
  Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 57.
  Interventions:

  • Biological: Ad26.Filo
  • Biological: MVA-BN-Filo
  • Biological: Placebo
• Experimental: Group 3: MVA-BN-Filo/AD26.Filo or Placebo
  Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 15.
  Interventions:

  • Biological: Ad26.Filo
  • Biological: MVA-BN-Filo
  • Biological: Placebo
• Experimental: Subset of Group 3: AD26.Filo or Placebo
  The first 8 participants in Group 3 who are willing to enroll in the subset for third vaccination, will receive a third vaccination at Day 92. Participants who previously received placebo will receive placebo a third time and participants who previously received MVA-BN-Filo/Ad26.Filo vaccination will receive Ad26.Filo as third vaccination. After enrollment of the 8 participants, the unblinded monitor and unblinded pharmacist will assess whether 7 participants who previously received MVA-BN-Filo/Ad26.Filo vaccination have been enrolled. If less than 7 participants of the active vaccine regimen have been enrolled, 2 additional participants will be enrolled. If at least 7 participants of the active vaccine regimen have been enrolled, no further will be enrolled. The aim is to enroll 7 or 8 participants who will receive Ad26.Filo as third vaccination.
  Interventions:

  • Biological: Ad26.Filo
  • Biological: Placebo
• Experimental: Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo
  Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.
  Interventions:

  • Biological: Ad26.ZEBOV
  • Biological: Placebo
  • Biological: MVA-BN-Filo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 4, 2016): 72
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2018
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Body mass index (BMI) of greater than or equal to (>=) 18.5 and less than (<) 35.0 kilogram per square meter (kg/m^2)
• Healthy on the basis of physical examination, medical history, and the investigator's clinical judgment
• All women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at screening, have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction from the start of screening onwards until at least 3 months after the last vaccination
• Participant must be available and willing to participate for the duration of the study visits and follow-up

Exclusion Criteria:

• Has been vaccinated with a candidate filovirus vaccine
• Has received any Ad26- or MVA-based candidate vaccines in the past
• Has been diagnosed with disease caused by Ebola virus (EBOV), Marburg virus (MARV), Sudan virus (SUDV), or Taï Forest virus (TAFV) or exposed to EBOV, MARV, SUDV, or TAFV, including participants who traveled to epidemic filovirus areas in West Africa during the last 2 years (that is, since the start of the last Ebolavirus outbreak) should be excluded from the study
• Chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
• Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or body temperature greater than or equal to (>=) 38.0 degree Celsius on Day 1

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02860650
• Other Study ID Numbers: CR108144; VAC69120FLV1001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Responsible Party: Janssen Vaccines & Prevention B.V.
• Study Sponsor: Janssen Vaccines & Prevention B.V.
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial; Janssen Vaccines & Prevention B.V.

• PRS Account: Janssen Vaccines & Prevention B.V.
• Verification Date: February 2018