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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02370589




Registration number
NCT02370589
Ethics application status
Date submitted
10/02/2015
Date registered
25/02/2015
Date last updated
22/09/2016

Titles & IDs
Public title
Study to Evaluate the Immunogenicity and Safety of an Ebola Virus (EBOV) Glycoprotein (GP) Vaccine in Healthy Subjects
Scientific 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
Secondary ID [1] 0 0
EBOV-H-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ebola 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Base Dose EBOV GP Vaccine
Other interventions - 2x Base Dose EBOV GP Vaccine
Other interventions - 4x Base Dose EBOV GP Vaccine
Other interventions - 8x Base Dose EBOV GP Vaccine
Other interventions - Placebo
Other interventions - Matrix-M Adjuvant

Experimental: Group A - Day 0: Base Dose EBOV GP Vaccine; IM Day 21: Base Dose EBOV GP Vaccine; IM

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

Experimental: Group C - Day 0: Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM

Experimental: Group D - Day 0: 2x Base Dose EBOV GP Vaccine; IM Day 21: 2x Base Dose EBOV GP Vaccine; IM

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

Experimental: Group F - Day 0: 2x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM

Experimental: Group G - Day 0: 4x Base Dose EBOV GP Vaccine; IM Day 21: 4x Base Dose EBOV GP Vaccine; IM

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

Experimental: Group J - Day 0: 4x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM

Experimental: Group K - Day 0: 8x Base Dose EBOV GP Vaccine; IM Day 21: 8x Base Dose EBOV GP Vaccine; IM

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

Experimental: Group M - Day 0: 8x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM

Placebo Comparator: Group N - Day 0: Placebo; IM Day 21: Placebo; IM


Other interventions: Base Dose EBOV GP Vaccine


Other interventions: 2x Base Dose EBOV GP Vaccine


Other interventions: 4x Base Dose EBOV GP Vaccine


Other interventions: 8x Base Dose EBOV GP Vaccine


Other interventions: Placebo


Other interventions: Matrix-M Adjuvant


Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 0 to Day 385
Primary outcome [2] 0 0
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)
Timepoint [2] 0 0
Day 0 to Day 385
Secondary outcome [1] 0 0
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. - Geometric mean titer (GMT)
Geometric mean ratio (GMR)
Seroconversion rate (SCR)
Seroresponse rate (SRR)
Timepoint [1] 0 0
Day 0 to Day 385
Secondary outcome [2] 0 0
Immunogenicity as assessed by serum EBOV neutralizing antibody reciprocal titers as detected by a VSV pseudotype-based method. - Geometric mean titer (GMT)
Geometric mean ratio (GMR)
Seroconversion rate (SCR)
Seroresponse rate (SRR)
Timepoint [2] 0 0
Day 0 to Day 385

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd. - Brisbane
Recruitment hospital [2] 0 0
Nucleus Network - Melbourne
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novavax
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02370589
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
D. Nigel Thomas, PhD
Address 0 0
Novavax, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications