Search / Trial NCT06221813

Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of RVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects

Launched by PUBLIC HEALTH VACCINES LLC · Jan 15, 2024

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Trial Information

Current as of December 31, 2024

Active, not recruiting

Keywords

Live, Attenuated Vaccine Nipah Virus Phv02 Recombinant Vesicular Stomatitis Virus

ClinConnect Summary

This clinical trial is studying a vaccine called PHV02, which is designed to protect against Nipah Virus, a serious infection. The main goals are to determine how safe the vaccine is and how well it helps the body create an immune response after giving two doses one month apart. Participants will receive either the vaccine at different dose levels or a placebo (an inactive substance) in two injections, with follow-up for about six and a half months to monitor their health and immune response.

To participate, individuals must be healthy adults between the ages of 18 and 65 and not currently pregnant or breastfeeding. They should not have any significant health issues, must pass a COVID-19 test, and agree to avoid pregnancy and close contact with certain vulnerable groups for a short period after vaccination. Participants can expect to have their health monitored closely throughout the study, and they will receive detailed information about what to expect during the trial. It's important to note that there are specific conditions that would exclude someone from participating, such as having had certain infections or serious allergies.

Gender

ALL

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
  • • 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

Trial Officials

Joan Fusco, PhD

Study Chair

Public Health Vaccines

Thomas P Monath, MD

Study Director

Quigley Biopharma

Gray P Heppner, MD

Study Director

Quigley Biopharma

About Public Health Vaccines Llc

Public Health Vaccines LLC is a dedicated clinical trial sponsor focused on the development and advancement of innovative vaccines to enhance global public health. With a strong emphasis on research-driven solutions, the organization collaborates with leading scientific institutions and healthcare professionals to ensure the efficacy and safety of its vaccine candidates. Through rigorous clinical trials and a commitment to transparency, Public Health Vaccines LLC aims to address critical health challenges and improve vaccination access worldwide, ultimately contributing to the prevention of infectious diseases and the promotion of community well-being.

Locations

Hollywood, Florida, United States

Anaheim, California, United States

Salt Lake City, Utah, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0