Sudan Virus Disease
Conditions
Keywords
Sudan virus, Infections, Virus diseases, Hemorrhagic fever, Ebola
Brief 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.
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.\[
Interventions
BIOLOGICALrVSVΔG-SUDV-GP
rVSVΔG-SUDV-GP
OTHERPlacebo
Placebo
Sponsors
International AIDS Vaccine Initiative
Biomedical Advanced Research and Development Authority
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
This will be an observer-blind study. Investigators and participants will remain blinded to treatment assignment throughout the duration of the study. Unblinded site pharmacists will be responsible for investigational product preparation. The active product and placebo will be identical in appearance to maintain the blind. The Sponsor and study statistician will be unblinded. Strict data firewalls will be maintained to ensure that no unblinded information is shared with blinded clinical site staff until the database is locked.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adults in good general health 2. Participants who are 18 to 50 years of age 3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study 4. In the opinion of the PI, participant understands risks and written informed consent will be obtained before any study-related procedures are performed 5. Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results 6. All sexually active participants must consistently use male or female condoms with all sexual partners for 3 months following IP administration 7. 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 8. All individuals of childbearing potential must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Activities (SOA) 9. All participants must be willing to forgo donation of blood or any other tissues from screening onward throughout the course of the study
Exclusion criteria
1. 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 2. 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 3. Individuals who are pregnant or breastfeeding 4. Bleeding disorder that was diagnosed by a physician 5. 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. 6. Any abnormal laboratory parameters at screening per protocol. 7. 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 8. Receipt of blood transfusion or blood-derived products within the previous 3 months 9. Prior potential exposure to Marburg Virus, or a medical history of hemorrhagic fever 10. 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 11. Current participation in another clinical trial, within 3 months prior to enrollment. 12. 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. 13. Neuropsychiatric condition or substance abuse that compromises safety of the participant and precludes compliance with the protocol 14. 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. 15. In the opinion of the PI, it is not in the best interest of the participant to participate in the trial 16. A history of long-term treatment (≥ 4 weeks) for arthritis 17. Participants currently experiencing a rash or who have a history of severe, chronic, or frequent rash will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of rVSVΔG-SUDV-GP vaccination: solicited reactogenicity | 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 | 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 | 7 Months | Occurrence, onset, duration, severity, and relationship to IP of SAEs and AESIs throughout the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SUDV-GP-specific serum antibody responses | Throughout the study, up to 6 months after immunization | Proportion of participants with binding antibody responses to SUDV-GP |
| SUDV-GP-specific serum antibody responses magnitude and duration | Throughout the study, up to 6 months after immunization | 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) |
| SUDV-GP-specific serum antibody neutralization | Throughout the study, up to 6 months after immunization | Proportion of participants with neutralizing antibody against Sudan virus as measured by PRNT assay |
| SUDV-GP-specific serum antibody magnitude and duration of neutralization | Throughout the study, up to 6 months after immunization | 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) |
Countries
United States
Contacts
CONTACTJohannes Beeslaar, MD
Outcome results
None listed