Ebola
Conditions
Keywords
Ebola
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.
Interventions
BIOLOGICALBase Dose EBOV GP Vaccine
BIOLOGICAL2x Base Dose EBOV GP Vaccine
BIOLOGICAL4x Base Dose EBOV GP Vaccine
BIOLOGICAL8x Base Dose EBOV GP Vaccine
BIOLOGICALPlacebo
BIOLOGICALMatrix-M Adjuvant
Sponsors
Novavax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity as assessed by serum IgG antibody levels specific for EBOV Gp antigen as detected by ELISA. | Day 0 to Day 385 | * Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR) |
| Assessment of Adverse Events, SAEs, Medically Attended Events and Significant New Medical Conditions. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | * 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. | Day 0 to Day 385 | * Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR) |
Countries
Australia
Outcome results
None listed