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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: MVA-BN-Filo

Biological: Ad26.Filo

Biological: Ad26.ZEBOV

Biological: Placebo

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT02860650

CR108144

VAC69120FLV1001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

72 participants in 5 patient groups

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

Experimental group

Description:

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

Treatment:

Biological: Ad26.Filo

Biological: Placebo

Biological: MVA-BN-Filo

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

Experimental group

Description:

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

Treatment:

Biological: Ad26.Filo

Biological: Placebo

Biological: MVA-BN-Filo

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

Experimental group

Description:

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

Treatment:

Biological: Ad26.Filo

Biological: Placebo

Biological: MVA-BN-Filo

Subset of Group 3: AD26.Filo or Placebo

Experimental group

Description:

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.

Treatment:

Biological: Ad26.Filo

Biological: Placebo

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

Experimental group

Description:

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

Treatment:

Biological: Placebo

Biological: Ad26.ZEBOV

Biological: MVA-BN-Filo