A Phase 1b Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Prime-Boost Regimen of Three Dose Levels of PHV02, a Nipah Virus Vaccine Candidate (rVSV-ΔG-EBOV GP-NiVG) in Healthy Adults
Overview
- Phase
- Phase 1
- Intervention
- PHV02
- Conditions
- Nipah Virus Infection
- Sponsor
- Public Health Vaccines LLC
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- Percentage of participants with local injection site and systemic adverse events (AEs)
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
The goal of this clinical trial is to test the safety and immunogenicity of PHV02 live, attenuated recombinant vesicular stomatitis virus vaccine expressing the Nipah Virus glycoprotein in healthy adult subjects. The main questions it aims to answer are:
- which doses of PHV02 are safe to administer to and well-tolerated by healthy adult subjects as a 2 dose regimen given 1 month apart?
- what is the immunologic response (Nipah-specific IgG ELISA antibody and neutralizing antibodies) to each dose level after a 2-dose regimen given 1 month apart? Participants will receive 2 intramuscular injections of PHV02 (2x105, 2x106, and 2x107 plaque-forming units [pfu]) or placebo on Day 1 and Day 29 and will be followed for 197 days.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy, adult, male or non-pregnant, non-lactating females
- •Given written informed consent
- •No clinically significant health problems
- •Negative test for SARS-CoV-2
- •Agree to avoid conception through Day 57
- •Agree to minimize blood and body fluid exposures to others after vaccination through Day 57
- •Agree to avoid exposure to immunocompromised persons after vaccination through Day 57
- •Agree to avoid employment in industry involved with livestock after vaccination through Day 57
Exclusion Criteria
- •Prior infection with Nipah virus, related Henipaviruses or Ebola virus
- •Prior infection with vesicular stomatitis virus (VSV)
- •Received VSV-vectored vaccine or Ebola vaccine
- •BMI \< 18.5 or ≥ 35
- •Healthcare worker with direct physical contact with patients
- •Childcare worker in direct contact with children 5 years old or younger
- •Household contact who is immunodeficient, or on immunosuppressive medication
- •Hands-on food preparation job
- •Primary care or treatment of cattle, horses, or swine
- •Hepatitis B, hepatitis C, HIV-1, HIV-2, diabetes, atopic dermatitis (eczema), chronic inflammatory disease, autoimmune or autoinflammatory disorder, malignancy, chronic or active neurologic disorder
Arms & Interventions
Cohort 1 (first 60 subjects) PHV02 high dose
Intervention: PHV02
Cohort 1 (first 60 subjects) PHV02 medium dose
Intervention: PHV02
Cohort 1 (first 60 subjects) PHV02 low dose
Intervention: PHV02
Cohort 1 (first 60 subjects) Placebo
Intervention: Lactated Ringer's
Cohort 2 (next 60 subjects) PHV02 high dose
Intervention: PHV02
Cohort 2 (next 60 subjects) PHV02 medium dose
Intervention: PHV02
Cohort 2 (next 60 subjects) PHV02 low dose
Intervention: PHV02
Cohort 2 (next 60 subjects) Placebo
Intervention: Lactated Ringer's
Outcomes
Primary Outcomes
Percentage of participants with local injection site and systemic adverse events (AEs)
Time Frame: 14 days after each dose
Percentage of participants with joint related symptoms, rash and unsolicited AEs
Time Frame: 28 days after each dose
Percentage of participants with neurologic AEs
Time Frame: Study Days 1-57
Percentage of participants with medically-attended AEs (MAAEs) and serious AEs (SAEs)
Time Frame: From time of injection through final study visit (Day 197)
Proportion of participants with recombinant vesicular stomatitis virus (rVSV) RNA (Cohort 1 only) in plasma, urine and saliva
Time Frame: From time of injection through Day 43
Proportion of participants who seroconvert compared to Day 1
Time Frame: Day 29 and Day 57
Geometric mean titers of IgG and ELISA neutralizing antibodies
Time Frame: Day 1, 29, 57