Status:
COMPLETED
Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
Lead Sponsor:
Public Health Vaccines LLC
Collaborating Sponsors:
Coalition for Epidemic Preparedness Innovations
Conditions:
Nipah Virus Infection
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
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 adu...
Eligibility Criteria
Inclusion
- 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
- 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
- History of severe reactions to any vaccine or history of severe allergies
- Receipt of investigational product up to 30 days prior to, or planned receipt within 196 days after randomization, or ongoing participation in another interventional clinical trial.
- Receipt of licensed non-live vaccines within 14 days of planned study immunization (30 days for live vaccines) or planned receipt of non-live or live vaccine within 60 days after first study immunization (30 days after the 2nd vaccination).
- Known allergy to components of PHV02
- 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 120 days preceding study
- 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
Key Trial Info
Start Date :
January 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06221813
Start Date
January 26 2024
End Date
October 2 2024
Last Update
June 8 2025
Active Locations (3)
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1
Cenexel ACT (Anaheim Clinical Trials)
Anaheim, California, United States, 92801
2
Cenexel RCA (Research Centers of America)
Hollywood, Florida, United States, 33024
3
Cenexel JBR (JBR Clinical Research)
Salt Lake City, Utah, United States, 84107