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Study to Evaluate the Immunogenicity and Safety of an Ebola Virus (EBOV) Glycoprotein (GP) Vaccine in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02370589
First Posted: February 25, 2015
Last Update Posted: September 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novavax
  Purpose

This is a randomized, observer-blind, placebo-controlled trial in male and female subjects ≥18 to <50 years of age. Subjects will be healthy adults based on history, physical examination, and baseline clinical laboratory testing.

Approximately 230 eligible subjects will be enrolled into 1 of 13 treatment groups.

Treatments will comprise two IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids with the test article assigned (i.e., saline placebo, dose of EBOV GP vaccine with or without Matrix-M adjuvant), in a 0.5mL injection volume.


Condition Intervention Phase
Ebola Biological: Base Dose EBOV GP Vaccine Biological: 2x Base Dose EBOV GP Vaccine Biological: 4x Base Dose EBOV GP Vaccine Biological: 8x Base Dose EBOV GP Vaccine Biological: Placebo Biological: Matrix-M Adjuvant Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 1, Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an Ebola Virus (EBOV) Glycoprotein (GP) Nanoparticle Vaccine, With or Without Matrix-M™ Adjuvant, in Healthy Subjects ≥18 to <50 Years of Age

Resource links provided by NLM:


Further study details as provided by Novavax:

Primary Outcome Measures:
  • Assessment of Adverse Events, SAEs, Medically Attended Events and Significant New Medical Conditions. [ Time Frame: Day 0 to Day 385 ]
    Numbers and percentages (with 95% confidence intervals [CIs]) of subjects with solicited local and systemic AEs over the 7 days post-injection; and all AEs, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 84 days post-first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year after the second dose.

  • Immunogenicity as assessed by serum IgG antibody levels specific for EBOV Gp antigen as detected by ELISA. [ Time Frame: Day 0 to Day 385 ]
    • Geometric mean titer (GMT)
    • Geometric mean ratio (GMR)
    • Seroconversion rate (SCR)
    • Seroresponse rate (SRR)


Secondary Outcome Measures:
  • Immunogenicity as assessed by epitope-specific immune responses to the EBOV GP antigen measured by serum titers in a competition ELISA assay using known-neutralizing monoclonal antibodies. [ Time Frame: Day 0 to Day 385 ]
    • Geometric mean titer (GMT)
    • Geometric mean ratio (GMR)
    • Seroconversion rate (SCR)
    • Seroresponse rate (SRR)

  • Immunogenicity as assessed by serum EBOV neutralizing antibody reciprocal titers as detected by a VSV pseudotype-based method. [ Time Frame: Day 0 to Day 385 ]
    • Geometric mean titer (GMT)
    • Geometric mean ratio (GMR)
    • Seroconversion rate (SCR)
    • Seroresponse rate (SRR)


Enrollment: 230
Study Start Date: February 2015
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Day 0: Base Dose EBOV GP Vaccine; IM Day 21: Base Dose EBOV GP Vaccine; IM
Biological: Base Dose EBOV GP Vaccine
Experimental: Group B
Day 0: Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM
Biological: Base Dose EBOV GP Vaccine Biological: Matrix-M Adjuvant
Experimental: Group C
Day 0: Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM
Biological: Base Dose EBOV GP Vaccine Biological: Placebo Biological: Matrix-M Adjuvant
Experimental: Group D
Day 0: 2x Base Dose EBOV GP Vaccine; IM Day 21: 2x Base Dose EBOV GP Vaccine; IM
Biological: 2x Base Dose EBOV GP Vaccine
Experimental: Group E
Day 0: 2x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: 2x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM
Biological: 2x Base Dose EBOV GP Vaccine Biological: Matrix-M Adjuvant
Experimental: Group F
Day 0: 2x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM
Biological: 2x Base Dose EBOV GP Vaccine Biological: Placebo Biological: Matrix-M Adjuvant
Experimental: Group G
Day 0: 4x Base Dose EBOV GP Vaccine; IM Day 21: 4x Base Dose EBOV GP Vaccine; IM
Biological: 4x Base Dose EBOV GP Vaccine
Experimental: Group H
Day 0: 4x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: 4x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM
Biological: 4x Base Dose EBOV GP Vaccine Biological: Matrix-M Adjuvant
Experimental: Group J
Day 0: 4x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM
Biological: 4x Base Dose EBOV GP Vaccine Biological: Placebo Biological: Matrix-M Adjuvant
Experimental: Group K
Day 0: 8x Base Dose EBOV GP Vaccine; IM Day 21: 8x Base Dose EBOV GP Vaccine; IM
Biological: 8x Base Dose EBOV GP Vaccine
Experimental: Group L
Day 0: 8x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: 8x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM
Biological: 8x Base Dose EBOV GP Vaccine Biological: Matrix-M Adjuvant
Experimental: Group M
Day 0: 8x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM
Biological: 8x Base Dose EBOV GP Vaccine Biological: Placebo Biological: Matrix-M Adjuvant
Placebo Comparator: Group N
Day 0: Placebo; IM Day 21: Placebo; IM
Biological: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult male or females, ≥18 years of age, with an upper limitation of <50 years.
  2. Willing and able to give informed consent prior to study enrollment,
  3. Able to comply with study requirements, and
  4. Women of childbearing potential must have a negative urine pregnancy test prior to each vaccination, and will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity or prior surgical sterilization, hormonal contraceptives (oral, injectable, implant, patch, ring), barrier contraceptives (condom or diaphragm), and intrauterine device (IUD). Women with an adequately documented history of surgical sterility are exempt from urine pregnancy testing.

Exclusion Criteria:

  1. Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.

    • Asymptomatic conditions or findings (e.g. mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (i.e., unlikely to result in symptomatic illness within the time-course of this study) in the opinion of the investigator.
    • Note that illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies used to treat them (see exclusion criteria 2, 5, 7, 8, 9).
  2. Participation in research involving investigational product (drug/biologic/device) within 45 days before planned date of first vaccination.
  3. History of a serious reaction to prior vaccination.
  4. Any occupational or other exposure to Ebolaviruses or recovery from past Ebolavirus disease.
  5. Received any vaccine in the 4 weeks preceding the study vaccination; or any Ebolavirus vaccine at any time.
  6. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
  7. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressive dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical and nasal glucocorticoids will be permitted. Inhaled glucocorticoids ≥500µg per day of beclamethasone or fluticasone, or 800μg per day of budesonide are exclusionary.
  8. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  9. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration).
  10. Known disturbance of coagulation. The use of ≤325mg of aspirin per day as prophylaxis is permitted, but use of other platelet aggregation inhibitors, thrombin inhibitors, factor Xa inhibitors, or warfarin derivatives is exclusionary, regardless of bleeding history, because these imply treatment or prophylaxis of known cardiac or vascular disease.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370589


Locations
Australia, Queensland
Q-Pharm Pty Ltd.
Brisbane, Queensland, Australia, 4006
Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Novavax
Investigators
Study Director: D. Nigel Thomas, PhD Novavax, Inc.
  More Information

Additional Information:
Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT02370589     History of Changes
Other Study ID Numbers: EBOV-H-101
First Submitted: February 10, 2015
First Posted: February 25, 2015
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Novavax:
Ebola

Additional relevant MeSH terms:
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Virus Diseases
Filoviridae Infections
Mononegavirales Infections
Vaccines
Krestin
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents


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