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

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

Overview

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

• Biological rVSVΔG-SUDV-GP
  rVSVΔG-SUDV-GP
• Other Placebo
  Placebo

Primary outcome measures

• Safety and tolerability of rVSVΔG-SUDV-GP vaccination: solicited reactogenicity [Time frame: 14 Days]
• Safety and tolerability of rVSVΔG-SUDV-GP vaccination: unsolicited reactogenicity [Time frame: 28 Days]
• Safety and tolerability of rVSVΔG-SUDV-GP vaccination: SAEs and AESIs [Time frame: 7 Months]

Secondary outcome measures (4)

• 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]

Eligibility criteria

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)
• 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

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Single group

Masking

Triple blind

Primary purpose

Prevention

Study locations

United States · 3 centers

• George Washington University — Washington D.C.
• Johnson County Clin-Trials — Lenexa
• Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT07565090 · IAVI C109

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗