Sudan Virus Vaccine for Ebola Virus Disease Prevention

Not yet recruiting at 2 trial locations

Overseen By Johannes Beeslaar, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: International AIDS Vaccine Initiative

Must not be taking: Corticosteroids, Immunosuppressive, Anticancer, others

Disqualifiers: Immunodeficiency, Autoimmune disease, Obesity, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am willing and able to follow all study requirements and attend follow-up visits.

I understand the study risks and can give written consent.

1. Adults in good general health

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive the rVSVΔG-SUDV-GP vaccine or placebo in a dose-escalation manner

1 day

1 visit (in-person)

Safety Monitoring

Participants are monitored for solicited and unsolicited adverse events following vaccination

4 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and immunogenicity, including antibody responses, up to 6 months after immunization

6 months

Regular visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• rVSVΔG-SUDV-GP

How Is the Trial Designed?

Group I: rVSVΔG-SUDV-GP Experimental Treatment 1 Intervention

rVSVΔG-SUDV-GP

Group II: Placebo Placebo Group 1 Intervention

Placebo/Diluent

Who Is Running the Clinical Trial?

International AIDS Vaccine Initiative

Lead Sponsor

Trials

52

Recruited

13,300+

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+