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Virus Therapy

rVSV-Nipah Virus Vaccine for Nipah Virus

Phase 1
Waitlist Available
Led By Carlos Fierro, MD
Research Sponsored by Public Health Vaccines LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Booster cohort only: received PHV02 (or placebo)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 29 days after vaccination
Awards & highlights

Study Summary

This trial is testing a new vaccine for the Nipah virus, to see if it is safe and effective in healthy adults.

Who is the study for?
Healthy adults who agree to avoid certain activities like working with livestock, exposing immunocompromised people, and conception until Day 29 post-vaccination. Excluded are healthcare workers in direct contact with patients, those with severe allergies or reactions to vaccines, drug abusers, pregnant women, and individuals with various chronic diseases.Check my eligibility
What is being tested?
The trial is testing PHV02—a vaccine candidate for Nipah virus—against a placebo. Participants will receive either the vaccine or placebo to assess safety and immune response. The study includes initial vaccination and a booster cohort for previous recipients of PHV02 or placebo.See study design
What are the potential side effects?
Potential side effects may include typical vaccine-related reactions such as soreness at injection site, mild fever, fatigue or allergic responses. Since it's an early-phase trial assessing safety, close monitoring for any unexpected adverse events is part of the protocol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~29 days after vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and 29 days after vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Nipah-specific antibody and neutralizing antibody responses as assessed by ELISA
Number of participants with treatment-related adverse events as assessed by the Toxicity Grading Scale

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: PHV02 5x10^8 pfu (Prime)Experimental Treatment1 Intervention
Group II: PHV02 5x10^8 pfu (Boost)Experimental Treatment1 Intervention
Group III: PHV02 2x10^7 pfuExperimental Treatment1 Intervention
Group IV: PHV02 2x10^6 pfuExperimental Treatment1 Intervention
Group V: PHV02 2x10^5 pfuExperimental Treatment1 Intervention
Group VI: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PHV02
2022
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Public Health Vaccines LLCLead Sponsor
2 Previous Clinical Trials
156 Total Patients Enrolled
Coalition for Epidemic Preparedness InnovationsOTHER
35 Previous Clinical Trials
75,288 Total Patients Enrolled
Thomas Monath, MD, FASTMHStudy DirectorCrozet BioPharma

Media Library

PHV02 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05178901 — Phase 1
Nipah Virus Research Study Groups: PHV02 2x10^5 pfu, PHV02 2x10^6 pfu, PHV02 2x10^7 pfu, Placebo, PHV02 5x10^8 pfu (Boost), PHV02 5x10^8 pfu (Prime)
Nipah Virus Clinical Trial 2023: PHV02 Highlights & Side Effects. Trial Name: NCT05178901 — Phase 1
PHV02 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05178901 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the patient pool for this research open to those aged 35 and above?

"This clinical trial only accepts participants aged 18 to 60, as detailed in the eligibility criteria."

Answered by AI

How many participants are being recruited for this investigation?

"Affirmative. The information on clinicaltrials.gov reveals that this medical study is currently searching for eligible participants, with the initial listing made on October 1st 2022 and last edited April 19th of the same year. Sixty patients need to be registered from a single centre."

Answered by AI

May I participate in this clinical exploration?

"This trial is looking for 60 participants infected with nipah virus, aged 18 to 60. Applicants must fit the following profile: Healthy adults (male or non-pregnant and non-lactating female), lack of clinically significant health issues, agree not to conceive through day 29 post vaccination, minimize exposure of body fluids/blood after receiving vaccination until day 29 has passed, and abstain from employment in livestock industry during this period."

Answered by AI

Are there any opportunities for enrollment in this experiment at present?

"The test subjects for this clinical trial are actively being recruited, as evidenced by the details on clinicaltrials.gov which were first published on January 10th 2022 and most recently revised April 19th 2022."

Answered by AI

How secure is PHV02 in terms of its potential to cause harm?

"Since PHV02 is still in its first stage of clinical trials, the safety rating for this medication is low at 1. As a result, there is limited evidence to demonstrate this drug's performance and efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 1 Study to Evaluate Safety & Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
2022. "A Phase 1 Study to Evaluate Safety & Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05178901.
~18 spots leftby Apr 2025
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