A Phase 1, Single-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine at 3 Dose Levels in Adults in Good General Health
The purpose of this study is to provide the needed safety and immunogenicity data to support rapid deployment of the SEBOV vaccine against an ongoing or future outbreak. The intervention will be a single dose and will either be study vaccine named rVSVΔG-SEBOV-GP Vaccine, or placebo (a placebo is an inactive substance or other intervention that looks the same as and is given the same way as study vaccine or treatment being tested) There are 3 group in this study, each group has different vaccine doses. Group 1 starts with the lowest dose of the study vaccine and each subsequent group Groups 2 and Group 3 gets a higher dose of the study vaccine. Approximately 36 participants will be included in the study. The participant will be unaware of the treatment given between placebo and study vaccine. Participants will be screened up to 14 days before IP administration and will be followed for 6 months after IP administration. The anticipated study duration for each participant in Groups 1 through 3 is approximately 6.5 months from screening through last study visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
36
rVSV∆G-SEBOV-GP Vaccine or Placebo
Benchmark Research
Austin, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
Proportion of participants with Grade 3 or higher reactogenicity (ie, solicited AEs) during the 14 days after vaccine administration
Time frame: 14 days
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
Proportion of participants with Grade 2 or higher vaccine-related unsolicited AEs, including safety laboratory parameters, within 14 days of vaccine administration
Time frame: 14 days
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
Proportion of participants with Grade 2 or higher unsolicited AEs, including safety laboratory parameters, within 14 days of vaccine administration
Time frame: 14 days
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
Proportion of participants with vaccine-related SAEs throughout the study period
Time frame: 14 days
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Proportion of participants with binding antibody responses to SEBOV-GP
Time frame: 6.5 months
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Magnitude of binding antibody responses to SEBOV-GP
Time frame: 6.5 months
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Proportion of participants with neutralizing antibody responses against SEBOV
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6.5 months
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Magnitude of neutralizing antibody responses against SEBOV
Time frame: 6.5 months