Clinical trial NCT06265012: Study to Evaluate the Recombinant Vesicular Stomatitis Virus (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Marburg Virus Disease
Keywords: live, attenuated vaccine
Marburg virus
PHV01 (rVSV-MARV GP) vaccine
recombinant vesicular stomatitis virus
Lead sponsor: Public Health Vaccines LLC
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2024-02-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Participants will be randomly assigned to vaccine or placebo in four dose cohorts, starting with evaluation of safety using a sentinel group at each dose level, followed by dosing of the rest of the group in the next cohort. That next cohort will also dose the sentinel group with the next higher dose.

Eligibility criteria: 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

Primary outcomes:
measure: Solicited Adverse Events (AEs)
timeFrame: Study Days 1-15
measure: Unsolicited AEs
timeFrame: Study Days 1-29
measure: Other AEs
timeFrame: Study Days 1-181
measure: Immunogenicity, Antibodies (Ab)
timeFrame: Injection through 28 days
measure: Immunogenicity, Neutralizing antibodies (NEUT)
timeFrame: Injection through 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: CenExel RCA
state: Florida
Study officials:
affiliation: Public Health Vaccines
name: Joan Fusco, PhD
role: STUDY_CHAIR
affiliation: Public Health Vaccines
name: Richard Kenney, MD
role: STUDY_DIRECTOR
References: