Marburg Virus Disease Clinical Trial
— PHV01Official title:
A Phase 1 Randomized, Single-Blind, Placebo-Controlled, Ascending Dose Study to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP [Angola] (PHV01, MARV GP Vaccine) in Healthy Adults
This is a Phase 1 randomized, single-blind, placebo-controlled, ascending dose study to evaluate the safety and immunogenicity of rVSV∆G-MARV-GP [Angola] (PHV01, Marburg Virus glycoprotein [MARV GP] Vaccine) in healthy adults. PHV01 is a live, attenuated rVSV vaccine expressing the MARV GP. The main questions it aims to answer are: - Which dose of PHV01 is safe to administer to, and well-tolerated by healthy adult subjects? - What is the immunologic response (Marburg-specific Immunoglobulin G (IgG) ELISA antibody and neutralizing antibodies) to each dose level? Participants will receive 1 intramuscular injection of PHV01 or placebo on Day 1 and will be followed for 181 days.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | September 16, 2024 |
Est. primary completion date | April 17, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Healthy, adult, male or non-pregnant, non-lactating females, age 18-60 years - Given written informed consent - No clinically significant health problems - Negative test for SARS-CoV-2 - Agree to avoid conception through Day 29 - Agree to minimize blood and body fluid exposures to others after vaccination through Day 29 - Agree to avoid exposure to immunocompromised persons after vaccination through Day 29 Exclusion Criteria: - Prior infection with Marburg virus, related filovirus, or Ebola virus - Prior infection with vesicular stomatitis virus (VSV) - Received any VSV-vectored vaccine - BMI of = 35 - Household contact who is immunodeficient, or on immunosuppressive medication - Hepatitis B, hepatitis C, HIV-1, HIV-2, history of long COVID, diabetes, atopic dermatitis (eczema), chronic inflammatory disease, autoimmune or autoinflammatory disorder, malignancy, chronic or active neurologic disorder - History of severe reactions to any vaccine or history of severe allergies - Receipt of investigational product up to 30 days prior to randomization - Receipt of licensed or authorized non-live vaccines within 14 days of planned study immunization (30 days for live vaccines). - Known allergy to components of PHV01 - Injection sites obscured by tattoos or physical condition - Significant psychiatric or medical condition or laboratory abnormality on screening - History of Guillain Barre Syndrome or any chronic or acute neurological disorder - Alcohol or illicit drug abuse within past 5 years - Pregnant or lactating female - Administration of blood or IgG within 60 days preceding study - Administration of systemic chronic immunosuppressants (defined as more than 14 days) or other immune modifying drugs within 6 months of study entry - History of blood donation within 60 days of study - Unwilling to undergo diagnostic evaluation of rash (skin biopsy, if indicated) or joint symptoms (arthrocentesis if indicated by joint effusion), in both cases if acceptable to subject - Elective surgery planned during the study period |
Country | Name | City | State |
---|---|---|---|
United States | CenExel RCA | Hollywood | Florida |
Lead Sponsor | Collaborator |
---|---|
Public Health Vaccines LLC | Biomedical Advanced Research and Development Authority |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Solicited Adverse Events (AEs) | Incidence and severity of solicited injection site [(arm pain, local tenderness, erythema (redness), and induration (swelling/firmness)] and systemic AEs | Study Days 1-15 | |
Primary | Unsolicited AEs | Incidence and severity of unsolicited AEs | Study Days 1-29 | |
Primary | Other AEs | Incidence and severity of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | Study Days 1-181 | |
Primary | Immunogenicity, Antibodies (Ab) | Geometric mean titers (GMT) of Marburg GP protein-specific IgG antibody as measured by enzyme-linked immunosorbent assay (ELISA) on days 1 and 29 | Injection through 28 days | |
Primary | Immunogenicity, Neutralizing antibodies (NEUT) | PsVNT50 and PsVNT80 MARV GP-specific neutralizing antibodies titers | Injection through 28 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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