Clinical Trial: Study to Evaluate the Immunogenicity and Safety of an Ebola Virus (EBOV) Glycoprotein (GP) Vaccine in Healthy Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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.
Detailed Summary:
Sponsor: Novavax
Current 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)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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)
Original Secondary Outcome: Same as current
Information By: Novavax
Dates:
Date Received: February 10, 2015
Date Started: February 2015
Date Completion:
Last Updated: September 20, 2016
Last Verified: September 2016