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

Sponsor

International AIDS Vaccine Initiative (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05724472

Collaborator

Biomedical Advanced Research and Development Authority (U.S. Fed)

Enrollment

Arms

8.3

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Ebola Sudan Virus Disease	Drug: rVSV∆G-SEBOV-GP Vaccine or Placebo	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (Participant)

Masking Description:

It is a single blind study. The participant will be unaware of the intervention.

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Feb 20, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine [14 days]
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 [14 days]
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 [14 days]
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 [14 days]
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 [6.5 months]
Proportion of participants with binding antibody responses to SEBOV-GP
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine [6.5 months]
Magnitude of binding antibody responses to SEBOV-GP
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine [6.5 months]
Proportion of participants with neutralizing antibody responses against SEBOV
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine [6.5 months]
Magnitude of neutralizing antibody responses against SEBOV

Other Outcome Measures

To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine [6.5 months]
Anti-GP IgG antibodies as measured in 'effector assays' such as ADCC
To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine [6.5 months]
Anti-GP antibody epitope specificity
To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine [6.5 months]
Anti-VSV-N antibodies
To explore the characteristics of the immune responses induced by rVSV∆G-SEBOV-GP vaccine [6.5 months]
Additional exploratory immunological assessments may be conducted as warranted

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

International AIDS Vaccine Initiative
Biomedical Advanced Research and Development Authority

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

International AIDS Vaccine Initiative

ClinicalTrials.gov Identifier:

NCT05724472

Other Study ID Numbers:

IAVI C108

First Posted:

Feb 13, 2023

Last Update Posted:

Feb 13, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Virus Diseases

Study Results

No Results Posted as of Feb 13, 2023