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Virus Therapy

Cohort 1 (first 60 subjects) PHV02 high dose for Nipah Virus

Phase 1
Recruiting
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
Healthy, adult, male or non-pregnant, non-lactating females
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 29, 57
Awards & highlights

Study Summary

This trial is testing a new vaccine called PHV02 in healthy adults. The trial wants to find out what doses of PHV02 are safe and well-tolerated, and what the immune response

Who is the study for?
This trial is for healthy adults who can participate in a study testing the safety of a Nipah virus vaccine called PHV02. Participants will receive two doses one month apart and be monitored over several months. Specific eligibility criteria are not provided, but typically include being within a certain age range and having no underlying health conditions.Check my eligibility
What is being tested?
The trial is examining the safety and immune response to different doses of the PHV02 vaccine against Nipah virus in healthy adults. It involves two intramuscular injections given one month apart, with follow-up for about half a year to measure antibody levels.See study design
What are the potential side effects?
While specific side effects are not listed, common reactions to vaccines like this may include pain at injection site, fever, fatigue, headache, muscle pain, chills, joint pain or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a healthy adult, not pregnant, and not breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 29, 57
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 29, 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Geometric mean titers of IgG and ELISA neutralizing antibodies
Percentage of participants with joint related symptoms, rash and unsolicited AEs
Percentage of participants with local injection site and systemic adverse events (AEs)
+4 more

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 2 (next 60 subjects) PHV02 medium doseExperimental Treatment1 Intervention
Group II: Cohort 2 (next 60 subjects) PHV02 low doseExperimental Treatment1 Intervention
Group III: Cohort 2 (next 60 subjects) PHV02 high doseExperimental Treatment1 Intervention
Group IV: Cohort 1 (first 60 subjects) PHV02 medium doseExperimental Treatment1 Intervention
Group V: Cohort 1 (first 60 subjects) PHV02 low doseExperimental Treatment1 Intervention
Group VI: Cohort 1 (first 60 subjects) PHV02 high doseExperimental Treatment1 Intervention
Group VII: Cohort 2 (next 60 subjects) PlaceboPlacebo Group1 Intervention
Group VIII: Cohort 1 (first 60 subjects) 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
96 Total Patients Enrolled
Coalition for Epidemic Preparedness InnovationsOTHER
35 Previous Clinical Trials
75,228 Total Patients Enrolled
Joan Fusco, PhDStudy ChairPublic Health Vaccines
1 Previous Clinical Trials
36 Total Patients Enrolled

Frequently Asked Questions

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

Am I eligible to enroll in this medical research study?

"To be considered for enrollment in this clinical trial, prospective participants must have a confirmed diagnosis of Nipah virus and fall within the age range of 18 to 59. A total of 120 individuals will be accepted into the study."

Answered by AI

Are researchers currently accepting participants for this study?

"Indeed, the information provided on clinicaltrials.gov indicates that this trial is currently in the recruitment phase. It was initially posted on February 1st, 2024 and last updated on January 15th, 2024. The study aims to enroll a total of 120 participants across three different sites."

Answered by AI

How large is the participant pool in this research endeavor?

"To successfully execute this clinical trial, a total of 120 eligible participants who meet the inclusion criteria are required. Public Health Vaccines LLC, the sponsor of the study, will administer and oversee the trial across multiple sites. These include Cenexel ACT (Anaheim Clinical Trials) located in Anaheim, California, as well as Cenexel JBR (JBR Clinical Research) situated in Salt Lake City, Utah."

Answered by AI

Are individuals above the age of 40 eligible to participate in this medical study?

"This trial is actively seeking individuals who are above 18 years old but below 59 years old to participate."

Answered by AI

Has the PHV02 medium dose been granted approval by the FDA for Cohort 2, comprising the next 60 participants?

"Based on the nature of this Phase 1 trial, our team at Power assesses the safety of PHV02 medium dose in Cohort 2 (consisting of the next 60 participants) to be a score of 1. This is due to limited available data supporting both safety and efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Cenexel RCA (Research Centers of America)
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
2024. "Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06221813.
All > Miami
~48 spots leftby Jul 2024
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