View clinical trials related to Nipah Virus Infection.
Filter by: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.
Background: Nipah virus (NiV) is transmitted from animals to humans, from humans to humans, and through contaminated food. Infected people may have a cough and trouble breathing. Some people may develop serious symptoms, such as brain inflammation, that can lead to death. There are no drugs or vaccines to treat or prevent NiV infection. Objective: To test the safety of an experimental vaccine (mRNA-1215) for NiV. Researchers will also evaluate how participants bodies respond to the vaccine. Eligibility: Healthy, nonpregnant adults aged 18 to 60 years. Design: Participants will visit the NIH clinic 13 to 15 times over 14 to 16 months. Participants will get 2 doses of the experimental vaccine during this study at either 1 month or 4 months apart. The vaccine will be given as a shot into the muscle of the upper arm. Participants will stay in the clinic at least 30 minutes after each vaccination. Participants will be given a diary card and a thermometer. They will record their temperature and any other symptoms for 7 days after each vaccination. During each follow-up visit, 3 to 14 tubes of blood will be drawn for research. Participants may undergo an optional procedure called apheresis. A needle will be placed into a vein in each arm. Blood will be removed through one needle. The blood will pass through a machine that separates some of the blood cells. The rest of the blood will return to the body through the other needle. The study vaccine cannot cause NiV infection.
A Phase 1 Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
A first-in-human, phase 1 trial is to be conducted in a healthy adult population in the US to assess the safety and immunogenicity of three ascending Nipah vaccine (HeV-sG-V; Hendra virus soluble glycoprotein vaccine) dosages. Different dosing regimens and number of doses will also be explored.