EbolaPhase 1NCT02370589
Study to Evaluate the Immunogenicity and Safety of an Ebola Virus (EBOV) Glycoprotein (GP) Vaccine in Healthy Subjects
A Phase 1 study testing Base Dose EBOV GP Vaccine, 2x Base Dose EBOV GP Vaccine and 4x Base Dose EBOV GP Vaccine in people with Ebola, run by Novavax at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola
- What is being tested?
- Base Dose EBOV GP Vaccine, 2x Base Dose EBOV GP Vaccine and 4x Base Dose EBOV GP Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 3 sitesAustralia
- Study dates
- Feb 2015to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
- 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.
Show all 12Show fewer
- 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.
- 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.
- 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).
- 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.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Q-Pharm Pty Ltd.
Brisbane, Queensland, 4006
Nucleus Network
Melbourne, Victoria, 3004
Linear Clinical Research
Nedlands, Western Australia, 6009
About this study
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
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
- Being tested
- Base Dose EBOV GP Vaccine, 2x Base Dose EBOV GP Vaccine, 4x Base Dose EBOV GP Vaccine, 8x Base Dose EBOV GP Vaccine, Placebo
- Keywords
- Ebola
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Base Dose EBOV GP VaccineBiological
2x Base Dose EBOV GP VaccineBiological
4x Base Dose EBOV GP VaccineBiological
8x Base Dose EBOV GP VaccineBiological
PlaceboBiological
Matrix-M AdjuvantBiological
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Day 0: Base Dose EBOV GP Vaccine; IM Day 21: Base Dose EBOV GP Vaccine; IM Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
- Geometric mean titer (GMT)
- Geometric mean ratio (GMR)
- Seroconversion rate (SCR)
- Seroresponse rate (SRR)
Measured: Day 0 to Day 385
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)
Measured: Day 0 to Day 385
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EbolaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development, Study director, Novavax, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370589
- Sponsor's protocol ID
- EBOV-H-101
- Status last verified
- Sep 2016
- First submitted
- 10 Feb 2015
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02370589
- Acronym / sponsor ID
- EBOV-H-101
- Conditions
- Ebola
- Keywords
- Ebola
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Base Dose EBOV GP VaccineDay 0: Base Dose EBOV GP Vaccine; IM Day 21: Base Dose EBOV GP Vaccine; IM |
| Group B | Experimental | Biological: Base Dose EBOV GP Vaccine, Biological: Matrix-M AdjuvantDay 0: Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM |
| Group C | Experimental | Biological: Base Dose EBOV GP Vaccine, Biological: Placebo, Biological: Matrix-M AdjuvantDay 0: Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM |
| Group D | Experimental | Biological: 2x Base Dose EBOV GP VaccineDay 0: 2x Base Dose EBOV GP Vaccine; IM Day 21: 2x Base Dose EBOV GP Vaccine; IM |
| Group E | Experimental | Biological: 2x Base Dose EBOV GP Vaccine, Biological: Matrix-M AdjuvantDay 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 |
| Group F | Experimental | Biological: 2x Base Dose EBOV GP Vaccine, Biological: Placebo, Biological: Matrix-M AdjuvantDay 0: 2x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM |
| Group G | Experimental | Biological: 4x Base Dose EBOV GP VaccineDay 0: 4x Base Dose EBOV GP Vaccine; IM Day 21: 4x Base Dose EBOV GP Vaccine; IM |
| Group H | Experimental | Biological: 4x Base Dose EBOV GP Vaccine, Biological: Matrix-M AdjuvantDay 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 |
| Group J | Experimental | Biological: 4x Base Dose EBOV GP Vaccine, Biological: Placebo, Biological: Matrix-M AdjuvantDay 0: 4x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM |
| Group K | Experimental | Biological: 8x Base Dose EBOV GP VaccineDay 0: 8x Base Dose EBOV GP Vaccine; IM Day 21: 8x Base Dose EBOV GP Vaccine; IM |
| Group L | Experimental | Biological: 8x Base Dose EBOV GP Vaccine, Biological: Matrix-M AdjuvantDay 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 |
| Group M | Experimental | Biological: 8x Base Dose EBOV GP Vaccine, Biological: Placebo, Biological: Matrix-M AdjuvantDay 0: 8x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM |
| Group N | Placebo comparator | Biological: PlaceboDay 0: Placebo; IM Day 21: Placebo; IM |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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)
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Novavax, Inc.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development study director
Novavax, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Base Dose EBOV GP Vaccine, 2x Base Dose EBOV GP Vaccine and 4x Base Dose EBOV GP Vaccine in people with Ebola, run by Novavax at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Adverse Events, SAEs, Medically Attended Events and Significant New Medical Conditions. (time frame: Day 0 to Day 385). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.