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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Ebola Sudan Virus Disease
• Intervention / Treatment: Drug: rVSV∆G-SEBOV-GP Vaccine or Placebo

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dagna Laufer; Phone Number: 1.212.328.7459; Email: dlaufer@iavi.org
• Study Contact Backup: Name: Shailja Chandel; Email: schandel@iavi.org

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Benchmark Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion:

• 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

Exclusion:

• 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
• Body mass index (BMI) ≥35
• Current or planned occupational or household contact from screening through 3 months after vaccine administration with any immunocompromised individual

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group 1; 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
Experimental: Study Group 2; 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
Experimental: Study Group 3; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine	Proportion of participants with binding antibody responses to SEBOV-GP	6.5 months
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine	Magnitude of binding antibody responses to SEBOV-GP	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	6.5 months
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine	Magnitude of neutralizing antibody responses against SEBOV	6.5 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6.5 months
To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine	Anti-GP antibody epitope specificity	6.5 months
To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine	Anti-VSV-N antibodies	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	6.5 months

Collaborators and Investigators

• Sponsor: International AIDS Vaccine Initiative
• Collaborators: Biomedical Advanced Research and Development Authority

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Virus Diseases
• Other Study ID Numbers: IAVI C108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No