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

NCT05724472 | Completed Phase 1 FDA Drug

• 1 other identifier: IAVI C108
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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

Conditions

Ebola Sudan Virus Disease

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  14 days

• To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine

  Proportion of participants with vaccine-related SAEs throughout the study period

  14 days

Secondary Outcomes (4)

• To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine

  6.5 months

• To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine

  6.5 months

• To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine

  6.5 months

• To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine

  6.5 months

Other Outcomes (4)

• To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine

  6.5 months

• To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine

  6.5 months

• To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine

  6.5 months

Study Arms (3)

Study Group 1

EXPERIMENTAL

rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10\^6 pfu intramuscularly Day 1

Drug: rVSV∆G-SEBOV-GP Vaccine or Placebo

Study Group 2

EXPERIMENTAL

rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10\^7 pfu intramuscularly Day 1

Drug: rVSV∆G-SEBOV-GP Vaccine or Placebo

Study Group 3

EXPERIMENTAL

rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10\^8 pfu intramuscularly Day 1

Drug: rVSV∆G-SEBOV-GP Vaccine or Placebo

Interventions

rVSV∆G-SEBOV-GP Vaccine or Placebo DRUG

rVSV∆G-SEBOV-GP Vaccine or Placebo

Study Group 1; Study Group 2; Study Group 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health
• ≥18 years of age on the day of screening and are ≤50 years of age on the day of IP administration
• Adherence to the requirements of the protocol and the follow-up for the planned duration of the study
• Undergo HIV testing, risk reduction counseling, and receive HIV test results
• As applicable use male or female condoms for 1 month following IP administration
• Use an effective method of contraception from at least 2 weeks before and continue until 3 months following receipt of vaccine
• As applicable undergo urine pregnancy tests
• Forgo donation of blood or any other tissues throughout the course of the study

You may not qualify if:

• Any clinically relevant abnormality
• Any clinically significant acute or chronical medical condition
• Women who are pregnant or breastfeeding
• Bleeding disorder
• Infectious disease
• History of splenectomy
• Receipt of any vaccine within the previous 28 days or planned receipt within 28 days after vaccination with IP.
• Receipt of blood transfusion or blood-derived products within 3 months prior to screening
• Prior exposure to SEBOV or history of any hemorrhagic fever
• Prior receipt of any VSV-vectored vaccine
• Receipt of another IP within 3 months prior to enrollment or expected participation during this study.
• Prior receipt of another Sudan Ebola vaccine or receipt of polyclonal or monoclonal antibodies directed against Sudan Ebola in the past 6 months
• History of severe reactogenicity to vaccines or severe allergy to food or medications
• A history of malignancy in the past 5 years (prior to screening) or ongoing malignancy.
• Serious infections requiring antibiotic, antiviral, or antifungal therapy within 30 days prior to enrollment

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (2)

Benchmark Research

Austin, Texas, 78705, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It is a single blind study. The participant will be unaware of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This is a 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.

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: February 13, 2023
• Study Start: June 19, 2023
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

US (2)