NCT02860650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2016

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

August 4, 2016

Last Update Submit

February 2, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With Adverse events (AEs)

    Up to 28 days after the last vaccination

  • Number of Participants With Reactogenicity (ie, Solicited Local and Systemic Adverse Events)

    One Week after each study vaccine administration

  • Number of Participants With Serious Adverse Events

    Up to the end of long-term follow-up (Day 360)

Secondary Outcomes (1)

  • Binding Antibody Responses Against Ebola Virus (EBOV), Marburg Virus (MARV), and Sudan Virus (SUDV) Glycoproteins (GPs)

    Up to Day 360

Study Arms (5)

Group 1: AD26.Filo/MVA-BN-Filo or Placebo

EXPERIMENTAL

Participants will receive Ad26.Filo or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.

Biological: Ad26.FiloBiological: MVA-BN-FiloBiological: Placebo

Group 2: MVA-BN-Filo/AD26.Filo or Placebo

EXPERIMENTAL

Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 57.

Biological: Ad26.FiloBiological: MVA-BN-FiloBiological: Placebo

Group 3: MVA-BN-Filo/AD26.Filo or Placebo

EXPERIMENTAL

Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 15.

Biological: Ad26.FiloBiological: MVA-BN-FiloBiological: Placebo

Subset of Group 3: AD26.Filo or Placebo

EXPERIMENTAL

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.FiloBiological: Placebo

Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo

EXPERIMENTAL

Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.

Biological: Ad26.ZEBOVBiological: PlaceboBiological: MVA-BN-Filo

Interventions

Ad26.FiloBIOLOGICAL

Ad26.Filo intramuscular (IM) injection at a dose of 9\*10\^10 viral particles (vp).

Group 1: AD26.Filo/MVA-BN-Filo or PlaceboGroup 2: MVA-BN-Filo/AD26.Filo or PlaceboGroup 3: MVA-BN-Filo/AD26.Filo or PlaceboSubset of Group 3: AD26.Filo or Placebo
MVA-BN-FiloBIOLOGICAL

MVA-BN-Filo intramuscular (IM) injection at a dose of 5\*10\^8 infectious units (Inf U).

Group 1: AD26.Filo/MVA-BN-Filo or PlaceboGroup 2: MVA-BN-Filo/AD26.Filo or PlaceboGroup 3: MVA-BN-Filo/AD26.Filo or Placebo
Ad26.ZEBOVBIOLOGICAL

Ad26.ZEBOV intramuscular (IM) injection at a dose of 5\*10\^10 vp.

Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo
PlaceboBIOLOGICAL

IM injection of 0.9 percent saline.

Group 1: AD26.Filo/MVA-BN-Filo or PlaceboGroup 2: MVA-BN-Filo/AD26.Filo or PlaceboGroup 3: MVA-BN-Filo/AD26.Filo or PlaceboGroup 4: Ad26.ZEBOV/MVA-BN-Filo or placeboSubset of Group 3: AD26.Filo or Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Rockville, Maryland, United States

Location

Related Publications (1)

  • Bockstal V, Shukarev G, McLean C, Goldstein N, Bart S, Gaddah A, Anumenden D, Stoop JN, Marit de Groot A, Pau MG, Hendriks J, De Rosa SC, Cohen KW, McElrath MJ, Callendret B, Luhn K, Douoguih M, Robinson C. First-in-human study to evaluate safety, tolerability, and immunogenicity of heterologous regimens using the multivalent filovirus vaccines Ad26.Filo and MVA-BN-Filo administered in different sequences and schedules: A randomized, controlled study. PLoS One. 2022 Oct 5;17(10):e0274906. doi: 10.1371/journal.pone.0274906. eCollection 2022.

    PMID: 36197845DERIVED

Study Officials

  • Janssen Vaccines & Prevention B.V. Clinical Trial

    Janssen Vaccines & Prevention B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 9, 2016

Study Start

August 1, 2016

Primary Completion

May 1, 2017

Study Completion

January 1, 2018

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

US(1)