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
NCT ID: NCT02860650
Last Updated: 2018-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2016-08-31
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
Ad26.Filo
Ad26.Filo intramuscular (IM) injection at a dose of 9\*10\^10 viral particles (vp).
MVA-BN-Filo
MVA-BN-Filo intramuscular (IM) injection at a dose of 5\*10\^8 infectious units (Inf U).
Placebo
IM injection of 0.9 percent saline.
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.
Ad26.Filo
Ad26.Filo intramuscular (IM) injection at a dose of 9\*10\^10 viral particles (vp).
MVA-BN-Filo
MVA-BN-Filo intramuscular (IM) injection at a dose of 5\*10\^8 infectious units (Inf U).
Placebo
IM injection of 0.9 percent saline.
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.
Ad26.Filo
Ad26.Filo intramuscular (IM) injection at a dose of 9\*10\^10 viral particles (vp).
MVA-BN-Filo
MVA-BN-Filo intramuscular (IM) injection at a dose of 5\*10\^8 infectious units (Inf U).
Placebo
IM injection of 0.9 percent saline.
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.
Ad26.Filo
Ad26.Filo intramuscular (IM) injection at a dose of 9\*10\^10 viral particles (vp).
Placebo
IM injection of 0.9 percent saline.
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.
Ad26.ZEBOV
Ad26.ZEBOV intramuscular (IM) injection at a dose of 5\*10\^10 vp.
Placebo
IM injection of 0.9 percent saline.
MVA-BN-Filo
MVA-BN-Filo intramuscular (IM) injection at a dose of 1\*10\^8 Inf U.
Interventions
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Ad26.Filo
Ad26.Filo intramuscular (IM) injection at a dose of 9\*10\^10 viral particles (vp).
MVA-BN-Filo
MVA-BN-Filo intramuscular (IM) injection at a dose of 5\*10\^8 infectious units (Inf U).
Ad26.ZEBOV
Ad26.ZEBOV intramuscular (IM) injection at a dose of 5\*10\^10 vp.
Placebo
IM injection of 0.9 percent saline.
MVA-BN-Filo
MVA-BN-Filo intramuscular (IM) injection at a dose of 1\*10\^8 Inf U.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
50 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Janssen Vaccines & Prevention B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Vaccines & Prevention B.V. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Vaccines & Prevention B.V.
Locations
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Rockville, Maryland, United States
Countries
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References
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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.
Other Identifiers
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VAC69120FLV1001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108144
Identifier Type: -
Identifier Source: org_study_id
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