Ebola Sudan Virus DiseasePhase 1NCT05724472
Evaluation of Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine in Adults With Good General Health
A Phase 1 study of Ebola Sudan Virus Disease, run by International AIDS Vaccine Initiative at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola Sudan Virus Disease
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jun 2023to 9 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Benchmark Research
Austin, Texas, 78705
Clinical Trials of Texas
San Antonio, Texas, 78229
About this study
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
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
Read the 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.
- Conditions
- Ebola Sudan Virus Disease
- Being tested
- rVSV∆G-SEBOV-GP Vaccine or Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rVSV∆G-SEBOV-GP Vaccine or PlaceboDrug
rVSV∆G-SEBOV-GP Vaccine or Placebo
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^6 pfu intramuscularly Day 1 Receives: Drug: rVSV∆G-SEBOV-GP Vaccine or Placebo |
| Study Group 2 | Experimental | rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^7 pfu intramuscularly Day 1 Receives: Drug: rVSV∆G-SEBOV-GP Vaccine or Placebo |
| Study Group 3 | Experimental | rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^8 pfu intramuscularly Day 1 Receives: Drug: rVSV∆G-SEBOV-GP Vaccine or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
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
Measured: 14 days
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
Measured: 14 days
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
Proportion of participants with vaccine-related SAEs throughout the study period
Measured: 14 days
Secondary outcomes (4)
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Proportion of participants with binding antibody responses to SEBOV-GP
Measured: 6.5 months
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Magnitude of binding antibody responses to SEBOV-GP
Measured: 6.5 months
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Proportion of participants with neutralizing antibody responses against SEBOV
Measured: 6.5 months
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Magnitude of neutralizing antibody responses against SEBOV
Measured: 6.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start19 Jun 2023
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ebola 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
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
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
- NCT05724472
- Sponsor's protocol ID
- IAVI C108
- Status last verified
- Nov 2024
- First submitted
- 5 Jan 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Laufer DS, Marini A, Philiponis V, Fast PE, Zaric M, Sigei F, Bromell RV, Fernandez N, Hayes PJ, Yun H, Varma R, Pindolia H, Amini F, Hunt D, Boutwell A, Morrow G, Cooper CL, Parks CL, Meller M, Talasila S, Sayeed E, Halpern J, Kennedy A, Mugo C, Chandel S, Mabushi AF, Park H, Chu L, Denham DS, Kilianski A, Malkevich N, Feinberg MB, Gupta SB. Safety and immunogenicity of a recombinant vesicular stomatitis virus-based Sudan virus vaccine in adults in the USA: a single-blind, first-in-human, dose-escalation phase 1 clinical trial. Lancet Microbe. 2026 Sep 23:101492. doi: 10.1016/j.lanmic.2026.101492. Online ahead of print.
PubMed 42777745
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05724472
- Acronym / sponsor ID
- IAVI C108
- Conditions
- Ebola Sudan Virus Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- International AIDS Vaccine InitiativeResearch network
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 13 Feb 2023 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Drug: rVSV∆G-SEBOV-GP Vaccine or PlaceborVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^6 pfu intramuscularly Day 1 |
| Study Group 2 | Experimental | Drug: rVSV∆G-SEBOV-GP Vaccine or PlaceborVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^7 pfu intramuscularly Day 1 |
| Study Group 3 | Experimental | Drug: rVSV∆G-SEBOV-GP Vaccine or PlaceborVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^8 pfu intramuscularly Day 1 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- Any clinically relevant abnormality
- Any clinically significant acute or chronical medical condition
- Women who are pregnant or breastfeeding
- Bleeding disorder
- Infectious disease
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 |
|---|---|---|
| rVSV∆G-SEBOV-GP Vaccine or PlaceborVSV∆G-SEBOV-GP Vaccine or Placebo | Drug | Study Group 1, Study Group 2, Study Group 3 |
Primary outcome
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 14 days
Proportion of participants with vaccine-related SAEs throughout the study period
4 secondary outcomes
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Time frame: 6.5 months
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Time frame: 6.5 months
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Time frame: 6.5 months
To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine
Time frame: 6.5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Derived from this study: PubMed 42777745Laufer DS, Marini A, Philiponis V, Fast PE, Zaric M, Sigei F, Bromell RV, Fernandez N, Hayes PJ, Yun H, Varma R, Pindolia H, Amini F, Hunt D, Boutwell A, Morrow G, Cooper CL, Parks CL, Meller M, Talasila S, Sayeed E, Halpern J, Kennedy A, Mugo C, Chandel S, Mabushi AF, Park H, Chu L, Denham DS, Kilianski A, Malkevich N, Feinberg MB, Gupta SB. Safety and immunogenicity of a recombinant vesicular stomatitis virus-based Sudan virus vaccine in adults in the USA: a single-blind, first-in-human, dose-escalation phase 1 clinical trial. Lancet Microbe. 2026 Sep 23:101492. doi: 10.1016/j.lanmic.2026.101492. Online ahead of print.
Related trials for Ebola Sudan Virus Disease
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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
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Ebola Sudan Virus Disease, run by International AIDS Vaccine Initiative at 2 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 8 inclusion and 17 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: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine (time frame: 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05724472, which also lists 1 linked publication.
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 6 Nov 2024.