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

February 2, 2018 updated by: Janssen Vaccines & Prevention B.V.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse events (AEs)
Time Frame: Up to 28 days after the last vaccination
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
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)
Up to the end of long-term follow-up (Day 360)

Secondary Outcome Measures

Outcome Measure
Time Frame
Binding Antibody Responses Against Ebola Virus (EBOV), Marburg Virus (MARV), and Sudan Virus (SUDV) Glycoproteins (GPs)
Time Frame: Up to Day 360
Up to Day 360

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Vaccines & Prevention B.V.

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CR108144
  • VAC69120FLV1001 (Other Identifier: Janssen Vaccines & Prevention B.V.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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