A Phase 1 interventional study of rVSV∆G-SEBOV-GP Vaccine or Placebo in Ebola Sudan Virus Disease, sponsored by International AIDS Vaccine Initiative. Completed at 2 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by International AIDS Vaccine Initiative · Phase 1, Interventional, and Prevention
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.
914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.
This study's enrollment of 36 is below the median of 102 across 604 interventional studies indexed under Virus Diseases.
Browse Virus Diseases studies →International AIDS Vaccine Initiative is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion:
rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10\^6 pfu intramuscularly Day 1
Drug: rVSV∆G-SEBOV-GP Vaccine or Placebo
rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10\^7 pfu intramuscularly Day 1
Drug: rVSV∆G-SEBOV-GP Vaccine or Placebo
rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10\^8 pfu intramuscularly Day 1
Drug: rVSV∆G-SEBOV-GP Vaccine or Placebo
rVSV∆G-SEBOV-GP Vaccine or Placebo
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
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
To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine
Anti-GP IgG antibodies as measured in 'effector assays' such as ADCC
Time frame: 6.5 months
To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine
Anti-GP antibody epitope specificity
Time frame: 6.5 months
To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine
Anti-VSV-N antibodies
Time frame: 6.5 months
To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine
Additional exploratory immunological assessments may be conducted as warranted
Time frame: 6.5 months
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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International AIDS Vaccine Initiative