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

Primary Purpose

Ebola Sudan Virus Disease

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rVSV∆G-SEBOV-GP Vaccine or Placebo
Sponsored by
International AIDS Vaccine Initiative
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ebola Sudan Virus Disease

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Benchmark Research
  • Clinical Trials of Texas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Study Group 1

Study Group 2

Study Group 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Proportion of participants with binding antibody responses to SEBOV-GP
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Magnitude of binding antibody responses to SEBOV-GP
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Proportion of participants with neutralizing antibody responses against SEBOV
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Magnitude of neutralizing antibody responses against SEBOV

Full Information

First Posted
January 5, 2023
Last Updated
August 18, 2023
Sponsor
International AIDS Vaccine Initiative
Collaborators
Biomedical Advanced Research and Development Authority
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1. Study Identification

Unique Protocol Identification Number
NCT05724472
Brief Title
Evaluation of Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine in Adults With Good General Health
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International AIDS Vaccine Initiative
Collaborators
Biomedical Advanced Research and Development Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ebola Sudan Virus Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
It is a single blind study. The participant will be unaware of the intervention.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group 1
Arm Type
Experimental
Arm Description
rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^6 pfu intramuscularly Day 1
Arm Title
Study Group 2
Arm Type
Experimental
Arm Description
rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^7 pfu intramuscularly Day 1
Arm Title
Study Group 3
Arm Type
Experimental
Arm Description
rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^8 pfu intramuscularly Day 1
Intervention Type
Drug
Intervention Name(s)
rVSV∆G-SEBOV-GP Vaccine or Placebo
Intervention Description
rVSV∆G-SEBOV-GP Vaccine or Placebo
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
Description
Proportion of participants with Grade 3 or higher reactogenicity (ie, solicited AEs) during the 14 days after vaccine administration
Time Frame
14 days
Title
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
Description
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
Title
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
Description
Proportion of participants with Grade 2 or higher unsolicited AEs, including safety laboratory parameters, within 14 days of vaccine administration
Time Frame
14 days
Title
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
Description
Proportion of participants with vaccine-related SAEs throughout the study period
Time Frame
14 days
Secondary Outcome Measure Information:
Title
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Description
Proportion of participants with binding antibody responses to SEBOV-GP
Time Frame
6.5 months
Title
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Description
Magnitude of binding antibody responses to SEBOV-GP
Time Frame
6.5 months
Title
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Description
Proportion of participants with neutralizing antibody responses against SEBOV
Time Frame
6.5 months
Title
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Description
Magnitude of neutralizing antibody responses against SEBOV
Time Frame
6.5 months
Other Pre-specified Outcome Measures:
Title
To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine
Description
Anti-GP IgG antibodies as measured in 'effector assays' such as ADCC
Time Frame
6.5 months
Title
To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine
Description
Anti-GP antibody epitope specificity
Time Frame
6.5 months
Title
To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine
Description
Anti-VSV-N antibodies
Time Frame
6.5 months
Title
To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine
Description
Additional exploratory immunological assessments may be conducted as warranted
Time Frame
6.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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