RecruitingPhase 1

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

United States112 participantsStarted 2026-05-08

Plain-language summary

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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adults in good general health
. Participants who are 18 to 50 years of age
. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
. In the opinion of the PI, participant understands risks and written informed consent will be obtained before any study-related procedures are performed
. Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results
. All sexually active participants must consistently use male or female condoms with all sexual partners for 3 months following IP administration
. All individuals of childbearing potential engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception from at least 2 weeks before and continue until 3 months following receipt of vaccine/placebo
. All individuals of childbearing potential must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Activities (SOA)

Exclusion criteria

. Any clinically relevant abnormality on history or examination including:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability of rVSVΔG-SUDV-GP vaccination: solicited reactogenicity

Timeframe: 14 Days

Safety and tolerability of rVSVΔG-SUDV-GP vaccination: unsolicited reactogenicity

Timeframe: 28 Days

Safety and tolerability of rVSVΔG-SUDV-GP vaccination: SAEs and AESIs

Timeframe: 7 Months

Trial details

NCT IDNCT07565090

SponsorInternational AIDS Vaccine Initiative

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Johannes Beeslaar, MD

212-328-7459 JBeeslaar@iavi.org

View on ClinicalTrials.gov More Sudan Virus Disease trials