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

NCT02370589 | Completed Phase 1

• 1 other identifier: EBOV-H-101
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Ebola

Keywords

Ebola

Outcome Measures

Primary Outcomes (2)

• Assessment of Adverse Events, SAEs, Medically Attended Events and Significant New Medical Conditions.

  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.

  Day 0 to Day 385

• Immunogenicity as assessed by serum IgG antibody levels specific for EBOV Gp antigen as detected by ELISA.

  * Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)

  Day 0 to Day 385

Secondary Outcomes (2)

• 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.

  Day 0 to Day 385

• Immunogenicity as assessed by serum EBOV neutralizing antibody reciprocal titers as detected by a VSV pseudotype-based method.

  Day 0 to Day 385

Study Arms (13)

Group A

EXPERIMENTAL

Day 0: Base Dose EBOV GP Vaccine; IM Day 21: Base Dose EBOV GP Vaccine; IM

Biological: Base Dose EBOV GP Vaccine

Group B

EXPERIMENTAL

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

Group C

EXPERIMENTAL

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

Group D

EXPERIMENTAL

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

Group E

EXPERIMENTAL

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

Group F

EXPERIMENTAL

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

Group G

EXPERIMENTAL

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

Group H

EXPERIMENTAL

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

Group J

EXPERIMENTAL

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

Group K

EXPERIMENTAL

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

Group L

EXPERIMENTAL

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

Group M

EXPERIMENTAL

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

Group N

PLACEBO COMPARATOR

Day 0: Placebo; IM Day 21: Placebo; IM

Biological: Placebo

Interventions

Base Dose EBOV GP Vaccine BIOLOGICAL

Group A; Group B; Group C

2x Base Dose EBOV GP Vaccine BIOLOGICAL

Group D; Group E; Group F

4x Base Dose EBOV GP Vaccine BIOLOGICAL

Group G; Group H; Group J

8x Base Dose EBOV GP Vaccine BIOLOGICAL

Group K; Group L; Group M

Placebo BIOLOGICAL

Group C; Group F; Group J; Group M; Group N

Matrix-M Adjuvant BIOLOGICAL

Group B; Group C; Group E; Group F; Group H; Group J; Group L; Group M

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male or females, ≥18 years of age, with an upper limitation of \<50 years.
• Willing and able to give informed consent prior to study enrollment,
• Able to comply with study requirements, and
• 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.

You may not qualify if:

• Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
• Participation in research involving investigational product (drug/biologic/device) within 45 days before planned date of first vaccination.
• History of a serious reaction to prior vaccination.
• Any occupational or other exposure to Ebolaviruses or recovery from past Ebolavirus disease.
• Received any vaccine in the 4 weeks preceding the study vaccination; or any Ebolavirus vaccine at any time.
• Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
• 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).

Sponsors & Collaborators

• Novavax: lead

Study Sites (3)

Q-Pharm Pty Ltd.

Brisbane, Queensland, 4006, Australia

Location

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Related Links

• Novavax, Inc.

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Officials

• Clinical Development

  Novavax, Inc.

  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: February 10, 2015
• First Posted: February 25, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 24, 2021

Record last verified: 2016-09

Locations

AU (3)