NCT02718469

Brief Summary

The purpose of this study is to assess the safety profile of the Zaire Ebola vaccine and the strength of the immune response.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2015

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

Study Start

First participant enrolled

December 22, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2016

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

March 9, 2016

Last Update Submit

April 3, 2017

Conditions

Ebola Virus Disease

Keywords

EbolaVSVVesicular Stomatitis VirusVaccineZaire

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)

    To establish the maximum safe and tolerated dose of a monovalent Ebola Zaire vaccine, as determined by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse experiences.

    9 months

Study Arms (4)

Ebola Vaccine - low dose

EXPERIMENTAL

Low Dose Zaire Ebola Vaccine

Biological: Ebola Vaccine - low dose

Ebola Vaccine - mid dose

EXPERIMENTAL

Mid Dose Zaire Ebola Vaccine

Biological: Ebola Vaccine - mid dose

Ebola Vaccine - high dose

EXPERIMENTAL

High Dose Zaire Ebola Vaccine

Biological: Ebola Vaccine - high dose

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

Ebola Vaccine - low doseBIOLOGICAL

2 x 0.5ml vaccine will be given as intramuscular injections on each of day 1 and day 28

Also known as: Ebola Zaire Vaccine (2.5 x 10^4 pfu)
Ebola Vaccine - low dose
Ebola Vaccine - mid doseBIOLOGICAL

2 x 0.5ml vaccine will be given as intramuscular injections on each of day 1 and day 28

Also known as: Ebola Zaire Vaccine (2.5 x 10^5 pfu)
Ebola Vaccine - mid dose
Ebola Vaccine - high doseBIOLOGICAL

2 x 1.0ml vaccine will be given as intramuscular injections on each of day 1 and day 28

Also known as: High Dose Ebola Zaire Vaccine (2.0 x 10^6 pfu)
Ebola Vaccine - high dose
PlaceboBIOLOGICAL

2 x 0.5ml or 2 x 1.0ml placebo will be given as intramuscular injections on each of day 1 and day 28 depending on cohort

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects who have provided written informed consent and an authorization for disclosure of protected health information must meet the following criteria:
  • Healthy adult men or women, 18 to 60 (inclusive) years of age.
  • Have provided written informed consent prior to screening procedures.
  • Free of clinically significant health problems, as determined by pertinent medical history, physical examination without significant findings in the 28 days prior to enrollment, and clinical judgment of the Investigator.
  • Agrees not to have, or plan to have, non-study vaccines within 60 days after receiving the initial study vaccine, unless medically indicated (i.e., tetanus, rabies vaccine).
  • Agrees not to have contact with ruminant animals or other hoofed animals such as horses, pigs and cows 7 days after each vaccination.
  • Available, able, and willing to participate for all study visits and procedures through Day 182 (Week 26).
  • Be willing to minimize blood and body fluid exposure of others for 7 days after vaccination by:
  • using effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse;
  • avoiding the sharing of needles, razors, or toothbrushes; and
  • avoiding open mouth kissing.
  • Body mass index (BMI) less than 40 kg/m2.
  • Laboratory criteria without clinically significant findings within 28 days prior to enrollment:
  • hemoglobin ≥11.5 g/dL for women and ≥13.5 g/dL for men.
  • white blood cell count ≥3500 cells/mm3.
  • +10 more criteria

You may not qualify if:

  • Any subject who meets any of the following criteria will not qualify for entry into the study:
  • History of prior infection with a filovirus or prior participation in a filovirus vaccine trial.
  • History of prior infection with VSV or receipt of a VSV vectored vaccine.
  • Has traveled to an area where the World Health Organization (WHO) has declared as an Ebola outbreak zone.
  • Healthcare worker who has direct contact with patients (nurse, physician, dentist, emergency medical technician, dental hygienist).
  • Has a household contact (HHC) who is immunodeficient, on immunosuppressive medications, HIV positive, pregnant or breast-feeding, or has an unstable medical condition.
  • Breast-feeding, or is a childcare worker, or HHC, who has direct contact with children, 5 years of age or younger.
  • Direct hands-on job preparing food in the food industry.
  • History of employment in an industry involved in contact with ruminant animals, other hoofed animals such as pigs and horses, veterinary sciences, or other potential exposure to VSV.
  • History of employment or activity that involves potential contact with filoviruses.
  • History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions.
  • Known allergy to any rVSVN4CT1 vectored vaccine component.
  • Receipt of investigational product (IP) up to 30 days prior to randomization or ongoing participation in another clinical trial except observational studies.
  • Receipt of licensed non-live or live vaccines within 30 days prior to planned study immunization.
  • Ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the Investigator, unacceptably obscured due to a physical condition or permanent body art.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optimal Research

Melbourne, Florida, 32934, United States

Location

Related Publications (1)

  • Clarke DK, Xu R, Matassov D, Latham TE, Ota-Setlik A, Gerardi CS, Luckay A, Witko SE, Hermida L, Higgins T, Tremblay M, Sciotto-Brown S, Chen T, Egan MA, Rusnak JM, Ward LA, Eldridge JH. Safety and immunogenicity of a highly attenuated rVSVN4CT1-EBOVGP1 Ebola virus vaccine: a randomised, double-blind, placebo-controlled, phase 1 clinical trial. Lancet Infect Dis. 2020 Apr;20(4):455-466. doi: 10.1016/S1473-3099(19)30614-0. Epub 2020 Jan 14.

    PMID: 31952923DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Interventions

Ebola Vaccines

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Murray A Kimmel, DO

    Optimal Research, LLC

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 24, 2016

Study Start

December 22, 2015

Primary Completion

September 15, 2016

Study Completion

September 15, 2016

Last Updated

April 4, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)