Sudan Virus DiseasePhase 1NCT07565090
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
A Phase 1 study testing rVSVΔG-SUDV-GP in people with Sudan Virus Disease, run by International AIDS Vaccine Initiative at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sudan Virus Disease
- What is being tested?
- rVSVΔG-SUDV-GP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 May 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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)
- All participants must be willing to forgo donation of blood or any other tissues from screening onward throughout the course of the study
Who cannot join
- Any clinically relevant abnormality on history or examination including:
- history of immunodeficiency or autoimmune disease history of splenectomy history of malignancy in the past 5 years use of corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the Investigator within the previous 6 months body mass index (BMI) ≥ 35.0 kg/m2
- Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the participant unsuitable for participation in the study
- Individuals who are pregnant or breastfeeding
- Bleeding disorder that was diagnosed by a physician
- Infectious disease: Confirmed HIV-1 or HIV-2 infection, chronic active hepatitis B infection, current hepatitis C infection, active syphilis, or medically diagnosed long COVID 19 Syndrome. Also excluded are participants with active, serious infections requiring parenteral antibiotic, antiviral, or antifungal therapy within 30 days prior to enrollment.
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- Any abnormal laboratory parameters at screening per protocol.
- Receipt of live attenuated influenza vaccine within the previous 14 days, any other live attenuated vaccine within the previous 30 days or planned receipt within 30 days after vaccination with IP; or receipt of non-live attenuated vaccine within the previous 14 days or planned receipt within 14 days after vaccination with IP, including COVID-19 vaccines
- Receipt of blood transfusion or blood-derived products within the previous 3 months
- Prior potential exposure to Marburg Virus, or a medical history of hemorrhagic fever
- Prior receipt of any VSV-vectored vaccine, any Marburg vaccine, or any vaccine containing a filovirus component. Prior receipt of monoclonal or polyclonal antibodies directed against Marburg or other filovirus in the past 12 months
- Current participation in another clinical trial, within 3 months prior to enrollment.
- History of severe local or systemic reactogenicity to vaccines, or severe allergy to food or medications, and/or allergy to any component of this vaccine.
- Neuropsychiatric condition or substance abuse that compromises safety of the participant and precludes compliance with the protocol
- Current or planned occupational (medical care, childcare) or household contact (residing in the same household) from screening through 3 months after IP administration with any individual at increased risk from exposure to a live viral vaccine including infants ≤ 1 year of age, adults
- ≥75 years of age, or immunocompromised individuals.
- In the opinion of the PI, it is not in the best interest of the participant to participate in the trial
- A history of long-term treatment (≥ 4 weeks) for arthritis
- Participants currently experiencing a rash or who have a history of severe, chronic, or frequent rash will be excluded.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Natalie Izaguirre, 617-732-6801, nataliee_izaguirre@dfci.harvard.edu
Lindsey Baden, MD
- Recruiting
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Thomas Kreamer, MD, 913-825-4400, tkreamer@jcct.com
- Recruiting
George Washington University
Washington D.C., District of Columbia, 20037
Christina Gibbs Tewary, 202-994-2909, christinag1@email.gwu.edu
Aimee Desrosiers, adesrosiers@mfa.gwu.edu
About this study
Official title: A Phase 1, Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-SUDV-GP Vaccine in Adults in Good General Health
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.
Read the detailed description
This is a Phase 1, Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSVΔG-SUDV-GP Vaccine in Adults in Good General Health. Participants will be screened up to 28 days before Investigational Product (IP) administration and will be followed for 6 months after IP administration. The study will evaluate 4 different dose levels (2 X106 1X107, 2 X 107, 5 X 107) in 4 different participant groups for which enrollment will initiate sequentially. Starting with the lowest dose group, four sentinel participants will be enrolled in a sequential manner with no more than one participant enrolled across all sites per day. A safety review will be performed by the Sponsor after enrollment of the fourth sentinel participant, after which point the remainder of participants will be enrolled in group 1. In addition, a safety assessment will be performed by the Sponsor before opening enrollment in group 2. This assessment will be performed after enrollment of the 9th participant in group 1. The same sentinel dosing followed by safety reviews approach will be repeated for each group at each dose level.[
- Conditions
- Sudan Virus Disease
- Being tested
- rVSVΔG-SUDV-GP, Placebo
- Keywords
- Sudan virus, Infections, Virus diseases, Hemorrhagic fever, Ebola
- Medical subject headings
- Infections, Virus Diseases, Hemorrhagic Fevers, Viral, Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rVSVΔG-SUDV-GPBiological
rVSVΔG-SUDV-GP
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| rVSVΔG-SUDV-GP | Experimental | rVSVΔG-SUDV-GP Receives: Biological: rVSVΔG-SUDV-GP |
| Placebo | Placebo comparator | Placebo/Diluent Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: solicited reactogenicity
Occurrence, onset, duration, and severity of local and systemic solicited adverse events within 14 days following vaccination
Measured: 14 Days
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: unsolicited reactogenicity
Occurrence, onset, duration, severity, and relationship to IP of unsolicited adverse events, including safety laboratory parameters, within 28 days following vaccination
Measured: 28 Days
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: SAEs and AESIs
Occurrence, onset, duration, severity, and relationship to IP of SAEs and AESIs throughout the study period
Measured: 7 Months
Secondary outcomes (4)
SUDV-GP-specific serum antibody responses
Proportion of participants with binding antibody responses to SUDV-GP
Measured: Throughout the study, up to 6 months after immunization
SUDV-GP-specific serum antibody responses magnitude and duration
Magnitude and duration of binding antibody to SUDV-GP throughout the full study period (1 week, 2 weeks, 4 weeks, 2 months, 3 months, 6 months after immunization)
Measured: Throughout the study, up to 6 months after immunization
SUDV-GP-specific serum antibody neutralization
Proportion of participants with neutralizing antibody against Sudan virus as measured by PRNT assay
Measured: Throughout the study, up to 6 months after immunization
SUDV-GP-specific serum antibody magnitude and duration of neutralization
Magnitude and duration of neutralizing antibody against Marburg virus as measured by PRNT assay throughout the full study period (1 week, 2 weeks, 4 weeks, 2 months, 3 months, 6 months after immunization)
Measured: Throughout the study, up to 6 months after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start8 May 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudan Virus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International AIDS Vaccine Initiative
- Sponsor type
- Research network
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565090
- Sponsor's protocol ID
- IAVI C109
- Other IDs
- 75A50121C00077
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing plans are currently under internal discussion.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-SUDV-GP Vaccine in Adults in Good General Health
- ClinicalTrials.gov ID
- NCT07565090
- Acronym / sponsor ID
- IAVI C109
- Conditions
- Sudan Virus Disease
- Keywords
- Sudan virus, Infections, Virus diseases, Hemorrhagic fever, Ebola
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- International AIDS Vaccine InitiativeResearch network
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 8 May 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1, Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSVΔG-SUDV-GP Vaccine in Adults in Good General Health. Participants will be screened up to 28 days before Investigational Product (IP) administration and will be followed for 6 months after IP administration. The study will evaluate 4 different dose levels (2 X106 1X107, 2 X 107, 5 X 107) in 4 different participant groups for which enrollment will initiate sequentially. Starting with the lowest dose group, four sentinel participants will be enrolled in a sequential manner with no more than one participant enrolled across all sites per day. A safety review will be performed by the Sponsor after enrollment of the fourth sentinel participant, after which point the remainder of participants will be enrolled in group 1. In addition, a safety assessment will be performed by the Sponsor before opening enrollment in group 2. This assessment will be performed after enrollment of the 9th participant in group 1. The same sentinel dosing followed by safety reviews approach will be repeated for each group at each dose level.[
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rVSVΔG-SUDV-GP | Experimental | Biological: rVSVΔG-SUDV-GPrVSVΔG-SUDV-GP |
| Placebo | Placebo comparator | Other: PlaceboPlacebo/Diluent |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- Any clinically relevant abnormality on history or examination including:
- history of immunodeficiency or autoimmune disease history of splenectomy history of malignancy in the past 5 years use of corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the Investigator within the previous 6 months body mass index (BMI) ≥ 35.0 kg/m2
- Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the participant unsuitable for participation in the study
- Individuals who are pregnant or breastfeeding
- Bleeding disorder that was diagnosed by a physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rVSVΔG-SUDV-GPrVSVΔG-SUDV-GP | Biological | rVSVΔG-SUDV-GP |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: solicited reactogenicity
Time frame: 14 Days
Occurrence, onset, duration, and severity of local and systemic solicited adverse events within 14 days following vaccination
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: unsolicited reactogenicity
Time frame: 28 Days
Occurrence, onset, duration, severity, and relationship to IP of unsolicited adverse events, including safety laboratory parameters, within 28 days following vaccination
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: SAEs and AESIs
Time frame: 7 Months
Occurrence, onset, duration, severity, and relationship to IP of SAEs and AESIs throughout the study period
4 secondary outcomes
SUDV-GP-specific serum antibody responses
Time frame: Throughout the study, up to 6 months after immunization
SUDV-GP-specific serum antibody responses magnitude and duration
Time frame: Throughout the study, up to 6 months after immunization
SUDV-GP-specific serum antibody neutralization
Time frame: Throughout the study, up to 6 months after immunization
SUDV-GP-specific serum antibody magnitude and duration of neutralization
Time frame: Throughout the study, up to 6 months after immunization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided. IPD sharing plans are currently under internal discussion.
Related trials for Sudan Virus Disease
Active, not recruitingPhase 2
A Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral Vectored Sudan Ebolavirus Vaccine in Healthy Adults
Ebola Sudan Virus Disease
Not yet recruitingPhase 1/2
Solidarity/Tokomeza Ebola Trial
Sudan Ebola Virus Vaccines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rVSVΔG-SUDV-GP in people with Sudan Virus Disease, run by International AIDS Vaccine Initiative at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Beeslaar, MD (212-328-7459, JBeeslaar@iavi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: solicited reactogenicity (time frame: 14 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.