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Virus Therapy

Group A, Low Dose PHV01 for Marburg Virus Disease (PHV01 Trial)

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, age 18-60 years

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study days 1-181

Awards & highlights

PHV01 Trial Summary

"This trial is testing a new vaccine called PHV01 for safety and immune response in healthy adults. The vaccine is given as a single injection and the study aims to find out the safe dose to administer

Who is the study for?

This clinical trial is for healthy adults who can participate in a study testing the safety and immune response to a Marburg virus vaccine called PHV01. Participants will receive one shot and be monitored for about 6 months.Check my eligibility

What is being tested?

The trial is testing different doses of the PHV01 vaccine, which is designed to protect against Marburg virus disease. It's comparing how safe it is and what kind of immune response it creates compared to a placebo (a shot with no active ingredients).See study design

What are the potential side effects?

Possible side effects may include typical reactions at the injection site like pain or swelling, flu-like symptoms such as fever or fatigue, and potentially other mild to moderate symptoms commonly associated with vaccines.

PHV01 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am a healthy adult between 18 and 60 years old, not pregnant or breastfeeding.

PHV01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study days 1-181

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study days 1-181

This trial's timeline: 3 weeks for screening, Varies for treatment, and study days 1-181 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Immunogenicity, Antibodies (Ab)

Immunogenicity, Neutralizing antibodies (NEUT)

Other AEs

+2 more

PHV01 Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Group C, Hjigh Dose PHV01Experimental Treatment1 Intervention

Group C (10 subjects) PHV01 @ 10^7 pfu/dose

Group II: Group B, Medium Dose PHV01Experimental Treatment1 Intervention

Group B (10 subjects) PHV01 @ 10^6 pfu/dose

Group III: Group A, Low Dose PHV01Experimental Treatment1 Intervention

Group A (10 subjects) PHV01 @ 10^5 pfu/dose

Group IV: Group D, PlaceboPlacebo Group1 Intervention

Group D (6 subjects) Placebo

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityFED

82 Previous Clinical Trials

909,721 Total Patients Enrolled

1 Trials studying Marburg Virus Disease

125 Patients Enrolled for Marburg Virus Disease

Public Health Vaccines LLCLead Sponsor

2 Previous Clinical Trials

180 Total Patients Enrolled

Richard Kenney, MDStudy DirectorPublic Health Vaccines

5 Previous Clinical Trials

277 Total Patients Enrolled

Frequently Asked Questions

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

Do I meet the necessary criteria to participate in this research study?

"Individuals aged between 18 and 60 with a confirmed diagnosis of Marburg virus disease are eligible to participate in this study, which aims to enroll approximately 36 participants."

Answered by AI

Does this medical study have an age restriction that excludes individuals below the age of 45?

"Individuals aged between 18 and 60 are eligible for participation in this trial. It is important to note that there are a total of 34 trials focused on individuals below the age of 18, while there are 73 studies dedicated to patients over the age of 65."

Answered by AI

Has Group A received official authorization from the FDA?

"Given the limited data supporting safety and efficacy in this Phase 1 trial, Group A has been assigned a safety rating of 1 by our team at Power."

Answered by AI

What is the collective count of individuals actively involved in this research trial?

"Indeed, information retrieved from clinicaltrials.gov highlights the ongoing patient recruitment for this trial. It was initially posted on February 5th, 2024 and last modified on February 9th, 2024. The study aims to enroll a total of 36 participants across one designated site."

Answered by AI

Is the process of enrolling participants currently underway for this clinical trial?

"Affirmative. According to information on clinicaltrials.gov, this ongoing research study is actively seeking volunteers for participation. Initially shared on February 5th, 2024, the trial was most recently revised on February 9th, 2024. The target recruitment goal is set at enrolling a total of 36 individuals from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Recombinant Vesicular Stomatitis Virus (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects

2024. "Study to Evaluate the Recombinant Vesicular Stomatitis Virus (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06265012.

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