What side effects are associated with this type of intervention?

The rVSV-Nipah Virus Vaccine Candidate PHV02, like other recombinant vesicular stomatitis virus (rVSV) vector-based vaccines, may cause side effects such as fever, headache, muscle pain, and fatigue. These side effects are generally mild to moderate in severity. In some cases, more serious adverse events like allergic reactions or inflammation at the injection site may occur. It is important to monitor for these side effects and consult healthcare providers for appropriate management.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Nipah Virus. The rVSV-Nipah Virus Vaccine Candidate PHV02, which uses a recombinant vesicular stomatitis virus vector to deliver Nipah virus antigens, is currently being studied for its safety and immunogenicity. This approach is similar to other rVSV-based vaccines that have been developed for viruses like Ebola, which have shown promise in preclinical and clinical trials.

What other types of research exist?

Promising alternatives to the rVSV-Nipah Virus Vaccine Candidate PHV02 for Nipah Virus patients include subunit vaccines that target specific viral proteins, mRNA vaccines that encode Nipah virus antigens, and other viral vector-based vaccines. Additionally, antiviral treatments and monoclonal antibodies that have shown efficacy in preclinical or clinical studies could be considered as novel therapeutic options.

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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

Must not have

Prior infection with Nipah virus or suspected Henipavirus

History of Guillain Barre Syndrome or any chronic or acute neurological disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 29 days after vaccination

Summary

This trial tests a new vaccine for Nipah virus in healthy adults. The vaccine uses a modified virus to help the immune system recognize and fight the Nipah virus.

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 29 days after vaccination

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The rVSV-Nipah Virus Vaccine Candidate PHV02 employs a recombinant vesicular stomatitis virus (VSV) vector to deliver Nipah virus antigens, thereby stimulating the immune system to recognize and fight the virus. This mechanism is crucial for Nipah Virus patients as it aims to provide immunity against the virus, potentially preventing infection or mitigating disease severity. This approach is similar to other VSV-based vaccines, which have shown promise in eliciting strong immune responses and providing protection in preclinical studies.

The possible of immunotherapy for COVID-19: A systematic review.The Practical Consideration of Poliovirus as an Oncolytic Virotherapy.Dynamics of melanoma tumor therapy with vesicular stomatitis virus: explaining the variability in outcomes using mathematical modeling.