NCT02376426

Brief Summary

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered 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 Mar 2015

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

First Submitted

Initial submission to the registry

January 26, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

6 months

First QC Date

January 26, 2015

Last Update Submit

December 7, 2016

Conditions

Healthy

Keywords

HealthyEbola virusesEbola Viral Disease (EVD)FilovirusesMonovalent vaccineHuman adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV)Modified Vaccinia Virus Ankara - Bavarian Nordic (MVA-BN) Filo-vectorSafetyImmunogenicity

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With Adverse Events

    Up to 21 days post-boost (Day 50 for Groups 1 and 3 or Day 78 for Groups 2 and 4)

  • Number of Participants With Serious Adverse Events

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

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

    1 week after each study vaccine administration

Secondary Outcomes (3)

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

    Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)

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

    Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)

  • Immune responses to the study vaccine regimens as measured by an Enzyme-linked Immunospot Assay (ELISpot)

    Groups 1 and 3: Days 1 (pre-vaccination), 8, 29 (pre-vaccination), 36, 50, 113, 180, 240, and 360; Groups 2 and 4: Days 1 (pre-vaccination), 8, 29, 57 (pre-vaccination), 64, 78, 141, 180, 240, and 360)

Study Arms (4)

Group 1

EXPERIMENTAL

Participants will receive MVA-BN-filo/ Ad26.ZEBOV (Day 1 /Day 29) or Placebo (Day 1/Day 29).

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

Group 2

EXPERIMENTAL

Participants will receive MVA-BN-filo/Ad26.ZEBOV (Day 1 /Day 57) or placebo ( Day 1/Day 57).

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

Group 3

EXPERIMENTAL

Participants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 29) or placebo (Day 1/Day 29).

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

Group 4

EXPERIMENTAL

Participants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 57) or placebo (Day 1/Day 57).

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

Interventions

MVA-BN-FiloBIOLOGICAL

One 0.5 milliliter (ml) intramuscular (IM) injection of 1\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]) on Day 1, 29, 57.

Group 1Group 2Group 3Group 4
Ad26.ZEBOVBIOLOGICAL

One 0.5 mL IM injection of 5\*10\^10 viral particles (vp) on Day 1, 29, 57.

Group 1Group 2Group 3Group 4
PlaceboBIOLOGICAL

One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.

Group 1Group 2Group 3Group 4

Eligibility Criteria

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

You may qualify if:

  • Must be healthy on the basis of physical examination, medical history, and the investigator's clinical judgment
  • Women of childbearing potential must have a negative serum beta-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).
  • 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

You may not qualify if:

  • 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. During the long-term follow-up period, travel to epidemic Ebola areas is allowed but during this period sampling can only take place if participant has returned at least 1 month from the epidemic Ebola area to ensure the samples are not carrying the Ebola-virus
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Nairobi, Kenya

Location

Related Publications (1)

  • Mutua G, Anzala O, Luhn K, Robinson C, Bockstal V, Anumendem D, Douoguih M. Safety and Immunogenicity of a 2-Dose Heterologous Vaccine Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical Trial in Nairobi, Kenya. J Infect Dis. 2019 Jun 5;220(1):57-67. doi: 10.1093/infdis/jiz071.

    PMID: 30796816DERIVED

Study Officials

  • Crucell Holland BV Clinical Trial

    Crucell Holland BV

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 26, 2015

First Posted

March 3, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2015

Study Completion

June 1, 2016

Last Updated

December 8, 2016

Record last verified: 2016-12

Locations

KE(1)