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HealthyPhase 1NCT02325050

A Safety and Immunogenicity Study of Heterologous and Homologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants

A Phase 1 study testing 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.ZEBOV as heterologous and homologous 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?
MVA-BN-Filo and Ad26. ZEBOV
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
164 participants
Where
1 siteUnited States
Study dates
8 Jan 2015to 8 May 2017
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

  • Must be healthy on the basis of physical examination, medical history, and the investigator's clinical judgment
  • Have a body mass index (BMI) ≥18.5 and <35.0 kg/m2
  • Women of childbearing potential must have a negative serum β-human chorionic gonadotropin pregnancy test at screening, a negative urine pregnancy test immediately prior to each study vaccine administration, and practice adequate birth control measures from 28 days before the prime vaccination until at least 3 months after the boost vaccination as specified in the study protocol. If not heterosexually active at screening, must agree to practice adequate birth control measures if they become heterosexually active during their participation in the study (from screening onwards until at least 3 months after the boost vaccination). Agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during participation in the study (from screening onwards until at least 3 months after the boost vaccination)
  • Women of non-childbearing potential, defined as postmenopausal (>45 years of age with amenorrhea for ≥2 years or any age with amenorrhea for ≥6 months and serum follicle-stimulating hormone [FSH] >40 mIU/mL) or surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), are not required to use the birth control methods as specified in the study protocol
  • A man who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use a double-barrier method of birth control, such as either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. In case the female partner is using an adequate method of birth control, a single-barrier method of birth control for the male subject is acceptable. Men must also agree not to donate sperm during their participation in the study (from screening onwards until at least 3 months after the boost vaccination)
  • Must be available and willing to participate for the duration of the study visits and follow-up, provide verifiable identification, and have a means to be contacted

Who cannot join

  • Has been vaccinated with a candidate Ebola vaccine
  • Has been diagnosed with Ebola disease or exposed to Ebola including travel to West Africa in the last 12 months. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone. Participants who anticipate traveling to epidemic Ebola areas before the start of the long-term follow-up period will also be excluded from enrollment into the study
  • Has received any Ad26- or MVA-based candidate vaccine in the past
  • Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines), including known allergy to egg or aminoglycosides
  • A woman who is pregnant or breast-feeding, or planning to become pregnant while enrolled in the study or within 3 months after the boost vaccination
  • History of diabetes mellitus type 1 or type 2, including cases controlled with diet alone; thyroidectomy, or thyroid disease requiring medication during the last 12 months; uncontrolled hypertension as defined in the study protocol; or, major psychiatric illness and/or substance abuse problems during the past 12 months that in the opinion of the investigator would preclude participation

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, Randomized, Placebo-Controlled, Observer-Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous and Homologous Prime-Boost Regimens Using MVA-BN-Filo® and Ad26.ZEBOV Administered in Different Doses, Sequences and Schedules in Healthy Adult Subjects

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous and homologous prime-boost vaccine regimens in healthy adult participants.

Read the detailed description

This study consists of 3 parts: the first and third part with standard doses and the second part with higher doses. All parts are randomized, placebo-controlled, observer-blind to evaluate the safety, tolerability and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different doses, sequences and schedules to healthy adult participants. The study consists of a screening period of up to 28 days, a vaccination period in which participants will be vaccinated at baseline (Day 1) followed by a boost on Day 15, 29, or 57, and third vaccine 1-year post-prime (3rd vaccination is optional for subjects in groups 1-8). The total duration of the study will be about 1 year for participants who wiil receive boost vaccine and about 3 months for participants who will receive placebo and 2 year for participants who will receive a 3rd dose. Safety will be monitored during the study.

Conditions
Healthy
Being tested
MVA-BN-Filo, Ad26. ZEBOV, Placebo
Keywords
Healthy, Ebola viruses, Ebola Viral Disease (EVD), Filoviruses, monovalent vaccine, Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV), Modified Vaccinia Virus Ankara - Bavarian Nordic (MVA-BN) Filo-vector, Safety, Immunogenicity

What participants receive

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

  • MVA-BN-FiloBiological

    One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).

  • Ad26. ZEBOVBiological

    One 0.5 mL IM injection of 5*10^10 viral particles (vp).

  • MVA-BN-FiloBiological

    One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).

  • Ad26. ZEBOVBiological

    One 0.5 mL IM injection of 1*10^11 viral particles (vp).

  • PlaceboOther

    One 0.5 mL IM injection of 0.9% saline.

Study groups in NCT02325050
Study groupRoleWhat they receive
Group 1ExperimentalParticipants will receive MVA-BN-Filo/ Ad26.ZEBOV (Day 1 /Day 15) or Placebo (Day 1/Day 15). Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
Receives: Biological: MVA-BN-Filo; Biological: Ad26. ZEBOV; Other: Placebo
Group 2ExperimentalParticipants will receive MVA-BN-Filo/Ad26.ZEBOV (Day 1 /Day 29) or placebo (Day 1/Day 29). Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
Receives: Biological: MVA-BN-Filo; Biological: Ad26. ZEBOV; Other: Placebo
Group 3ExperimentalParticipants will receive MVA-BN-Filo /Ad26.ZEBOV/ (Day 1/Day 57) or placebo (Day 1/Day 57). Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
Receives: Biological: MVA-BN-Filo; Biological: Ad26. ZEBOV; Other: Placebo
Group 4ExperimentalParticipants will receive Ad26.ZEBOV/ MVA-BN-Filo (Day 1/Day 29) or placebo (Day 1/Day 29). Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
Receives: Biological: MVA-BN-Filo; Biological: Ad26. ZEBOV; Other: Placebo
Group 5ExperimentalParticipants will receive MVA-BN-Filo (Day 1 and Day 15) or placebo (Day 1 and Day 15). Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
Receives: Biological: MVA-BN-Filo; Biological: Ad26. ZEBOV; Other: Placebo
Group 6ExperimentalParticipants will receive Ad26.ZEBOV (Day 1 and Day 15) or placebo (Day 1 and Day 15). Participants will receive MVA-BN-Filo (1*10^8 TCID50) on Day 360.
Receives: Biological: MVA-BN-Filo; Biological: Ad26. ZEBOV; Other: Placebo
Group 7ExperimentalParticipants will receive Ad26.ZEBOV/ MVA-BN-Filo (Day 1/Day 15) or Placebo (Day 1/Day 15). Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
Receives: Biological: Ad26. ZEBOV; Biological: MVA-BN-Filo; Other: Placebo
Group 8ExperimentalParticipants will receive Ad26.ZEBOV/ MVA-BN-Filo (Day 1 /Day 29) or Placebo (Day 1/Day 29). Participants will receive Ad26.ZEBOV (1x10^11 vp) on Day 360.
Receives: Biological: MVA-BN-Filo; Biological: Ad26. ZEBOV; Other: Placebo
Group 9ExperimentalParticipants will receive MVA-BN-Filo/ Ad26.ZEBOV (Day 1 /Day 8) or Placebo (Day 1/Day 8).
Receives: Biological: MVA-BN-Filo; Biological: Ad26. ZEBOV; Other: Placebo
Group 10ExperimentalParticipants will receive MVA-BN-Filo/ Ad26.ZEBOV (Day 1 /Day 15) or Placebo (Day 1/Day 15).
Receives: Biological: MVA-BN-Filo; Biological: Ad26. ZEBOV; Other: Placebo

What is being measured

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

  1. Number of participants with adverse events

    Measured: Up to 21 days after the last vaccination (up to Day 381)

  2. Number of participants with serious adverse events

    Measured: Up to the end of long term follow-up (up to Day 720)

  3. Number of participants with reactogenicity (ie, solicited local and systemic adverse events)

    Measured: 1 week after each study vaccine administration

Secondary outcomes (3)

  1. Immune responses to the study vaccine regimens as measured by a virus neutralization assay

    Measured: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)

  2. Immune responses to the study vaccine regimens as measured by an enzyme-linked immunosorbent assay (ELISA)

    Measured: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)

  3. Immune responses to the study vaccine regimens as measured by an enzyme-linked immunospot (ELISpot) assay

    Measured: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)

Timeline

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

  1. First posted24 Dec 2014 (estimated)
  2. Study start8 Jan 2015
  3. Primary completion2 Jul 2015
  4. Study completion8 May 2017

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
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02325050
Sponsor's protocol ID
CR106479
Other IDs
VAC52150EBL1002
Status last verified
Jun 2017
First submitted
19 Dec 2014
Last updated
14 Jun 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 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 6 inclusion and 6 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 14 Jun 2017. 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 (time frame: Up to 21 days after the last vaccination (up to Day 381)). 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 NCT02325050.

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 14 Jun 2017.

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