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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

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

August 4, 2016
August 9, 2016
February 5, 2018
August 2016
May 2017   (Final data collection date for primary outcome measure)
  • 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) ]
  • 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) ]
Complete list of historical versions of study NCT02860650 on ClinicalTrials.gov Archive Site
Binding Antibody Responses Against Ebola Virus (EBOV), Marburg Virus (MARV), and Sudan Virus (SUDV) Glycoproteins (GPs) [ Time Frame: Up to Day 360 ]
Same as current
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Healthy
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
Same as current
January 2018
May 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02860650
CR108144
VAC69120FLV1001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Janssen Vaccines & Prevention B.V.
Janssen Vaccines & Prevention B.V.
National Institute of Allergy and Infectious Diseases (NIAID)
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
Janssen Vaccines & Prevention B.V.
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP