Evaluation of Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine in Adults With Good General Health

Phase 1

Completed

• Conditions: Ebola Sudan Virus Disease
• Interventions: Drug: rVSV∆G-SEBOV-GP Vaccine or Placebo

• Registration Number: NCT05724472
• Lead Sponsor: International AIDS Vaccine Initiative

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-13
• Study Start: 2023-06-19
• Primary Completion: 2024-01-09
• Study Completion: 2024-01-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group 2	rVSV∆G-SEBOV-GP Vaccine or Placebo	rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10\^7 pfu intramuscularly Day 1
Study Group 1	rVSV∆G-SEBOV-GP Vaccine or Placebo	rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10\^6 pfu intramuscularly Day 1
Study Group 3	rVSV∆G-SEBOV-GP Vaccine or Placebo	rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10\^8 pfu intramuscularly Day 1

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine	14 days	Proportion of participants with vaccine-related SAEs throughout the study period

Secondary Outcome Measures

Name	Time	Method
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine	6.5 months	Magnitude of neutralizing antibody responses against SEBOV

Trial Locations

Locations (2)

Benchmark Research; 🇺🇸 Austin, Texas, United States

Clinical Trials of Texas; 🇺🇸 San Antonio, Texas, United States