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AzTrials

HealthyPhase 1NCT02860650

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 study testing Ad26.Filo, MVA-BN-Filo and Ad26.ZEBOV in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Ad26.Filo, MVA-BN-Filo and Ad26.ZEBOV
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteUnited States
Study dates
Aug 2016to Jan 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    Rockville, Maryland

Other trials in United States

About this study

Official title: 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.

Conditions
Healthy
Being tested
Ad26.Filo, MVA-BN-Filo, Ad26.ZEBOV, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ad26.FiloBiological

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

  • MVA-BN-FiloBiological

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

  • Ad26.ZEBOVBiological

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

  • PlaceboBiological

    IM injection of 0.9 percent saline.

  • MVA-BN-FiloBiological

    MVA-BN-Filo intramuscular (IM) injection at a dose of 1*10^8 Inf U.

Study groups in NCT02860650
Study groupRoleWhat they receive
Group 1: AD26.Filo/MVA-BN-Filo or PlaceboExperimentalParticipants will receive Ad26.Filo or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.
Receives: Biological: Ad26.Filo; Biological: MVA-BN-Filo; Biological: Placebo
Group 2: MVA-BN-Filo/AD26.Filo or PlaceboExperimentalParticipants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 57.
Receives: Biological: Ad26.Filo; Biological: MVA-BN-Filo; Biological: Placebo
Group 3: MVA-BN-Filo/AD26.Filo or PlaceboExperimentalParticipants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 15.
Receives: Biological: Ad26.Filo; Biological: MVA-BN-Filo; Biological: Placebo
Subset of Group 3: AD26.Filo or PlaceboExperimentalThe 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.
Receives: Biological: Ad26.Filo; Biological: Placebo
Group 4: Ad26.ZEBOV/MVA-BN-Filo or placeboExperimentalParticipants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.
Receives: Biological: Ad26.ZEBOV; Biological: Placebo; Biological: MVA-BN-Filo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse events (AEs)

    Measured: Up to 28 days after the last vaccination

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

    Measured: One Week after each study vaccine administration

  3. Number of Participants With Serious Adverse Events

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

Secondary outcomes (1)

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

    Measured: Up to Day 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionMay 2017
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02860650
Sponsor's protocol ID
CR108144
Other IDs
VAC69120FLV1001
Status last verified
Feb 2018
First submitted
4 Aug 2016
Last updated
5 Feb 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 36197845

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ad26.Filo, MVA-BN-Filo and Ad26.ZEBOV in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse events (AEs) (time frame: Up to 28 days after the last vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02860650, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.

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