NCT02313077

Brief Summary

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV 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
87

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2014

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

December 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

December 17, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2016

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

4 months

First QC Date

December 5, 2014

Last Update Submit

April 13, 2017

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 after the 2nd vaccination (Day 36 for Group 5 or 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)

    Up to 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:Day 1(pre-vaccination), 8, 29(pre-vaccination), 36, 50, 180, 240, 360; Groups 2 and 4:Day 1(pre-vaccination), 8, 29, 57(pre-vaccination), 64, 78, 180, 240, 360; Group 5:Day 1(pre-vaccination), 8, 15(pre-vaccination), 22, 36, 180, 240, 360

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

    Groups 1 and 3:Day 1(pre-vaccination), 8, 29(pre-vaccination), 36, 50, 180, 240, 360; Groups 2 and 4:Day 1(pre-vaccination), 8, 29, 57(pre-vaccination), 64, 78, 180, 240, 360; Group 5:Day 1(pre-vaccination), 8, 15(pre-vaccination), 22, 36, 180, 240, 360

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

    Groups 1 and 3:Day 1(pre-vaccination), 8, 29(pre-vaccination), 36, 50, 180, 240, 360; Groups 2 and 4:Day 1(pre-vaccination), 8, 29, 57(pre-vaccination), 64, 78, 180, 240, 360; Group 5:Day 1(pre-vaccination), 8, 15(pre-vaccination), 22, 36, 180, 240, 360

Study Arms (5)

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. ZEBOVOther: 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. ZEBOVOther: 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. ZEBOVOther: 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. ZEBOVOther: Placebo

Group 5

EXPERIMENTAL

Participants will receive Ad26.ZEBOV/ MVA-BN-filo (Day 1/Day 15).

Biological: MVA-BN-filoBiological: Ad26. ZEBOV

Interventions

MVA-BN-filoBIOLOGICAL

One 0.5 mL intramuscular (IM) injection of 1E8 (50%Tissue Culture Infectious Dose \[TCID50\]) on Day 1 (Groups 1 and 2), or on Day 29 (Group 3), or on Day 57 (Group 4), or on Day 15 (Group 5).

Group 1Group 2Group 3Group 4Group 5
Ad26. ZEBOVBIOLOGICAL

One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1 (Groups 3, 4 and 5), or on Day 29 (Group 1), or on Day 57 (Group 2).

Group 1Group 2Group 3Group 4Group 5
PlaceboOTHER

One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 (Groups 1 and 3), or on Day 1 and 57 (Groups 2 and 4).

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 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 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 is sexually active with a woman of childbearing potential and who has not had a vasectomy 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 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
  • 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

Oxford, United Kingdom

Location

Related Publications (2)

  • Wagstaffe HR, Clutterbuck EA, Bockstal V, Stoop JN, Luhn K, Douoguih M, Shukarev G, Snape MD, Pollard AJ, Riley EM, Goodier MR. Ebola virus glycoprotein stimulates IL-18-dependent natural killer cell responses. J Clin Invest. 2020 Jul 1;130(7):3936-3946. doi: 10.1172/JCI132438.

    PMID: 32315287DERIVED

  • Milligan ID, Gibani MM, Sewell R, Clutterbuck EA, Campbell D, Plested E, Nuthall E, Voysey M, Silva-Reyes L, McElrath MJ, De Rosa SC, Frahm N, Cohen KW, Shukarev G, Orzabal N, van Duijnhoven W, Truyers C, Bachmayer N, Splinter D, Samy N, Pau MG, Schuitemaker H, Luhn K, Callendret B, Van Hoof J, Douoguih M, Ewer K, Angus B, Pollard AJ, Snape MD. Safety and Immunogenicity of Novel Adenovirus Type 26- and Modified Vaccinia Ankara-Vectored Ebola Vaccines: A Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1610-23. doi: 10.1001/jama.2016.4218.

    PMID: 27092831DERIVED

Study Officials

  • Crucell Holland BV Clinical Trial

    Crucell Holland BV

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 5, 2014

First Posted

December 9, 2014

Study Start

December 17, 2014

Primary Completion

April 17, 2015

Study Completion

March 15, 2016

Last Updated

April 14, 2017

Record last verified: 2017-04

Locations

GB(1)