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Virus Therapy

RVF Vaccine for Rift Valley Fever (RVF Trial)

Phase 2

Recruiting

Research Sponsored by U.S. Army Medical Research and Development Command

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be 18 to 65 years old at time of consent

Have in their charts: medical history within 60 days of planned first administration of vaccine, physical examination and laboratory tests within 1 year, previous chest radiograph results and electrocardiogram

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-28 days after each dose

Awards & highlights

RVF Trial Summary

This trial is to study the safety and effectiveness of a RVF vaccine.

Who is the study for?

Adults aged 18-65 at risk of Rift Valley Fever exposure, with low immunity to the virus (as shown by specific blood tests), can join this trial. Women must not be pregnant or plan pregnancy within 3 months post-vaccination. Participants should have no HIV, unresolved vaccine reactions, significant abnormal lab results, immunodeficiencies, or recent immunosuppressive treatments.Check my eligibility

What is being tested?

The trial is testing a Rift Valley Fever (RVF) vaccine's safety and ability to provoke an immune response. It involves people who've requested access under special regulatory permissions due to their risk of RVF exposure.See study design

What are the potential side effects?

Potential side effects are not detailed in the provided information but typically include local reactions at the injection site, mild fever, fatigue, headache and muscle pain. Serious adverse events will be monitored throughout the study.

RVF Trial Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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My medical records are updated with recent exams and tests.

RVF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-28 days after each dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-28 days after each dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-28 days after each dose 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 Subjects with Local and Systemic Adverse Events and Their Relationship to the Study Vaccine

Percentage of Subjects Who Developed Titers of ≥1:40 of Per-protocol Subjects

Secondary outcome measures

Frequency and Severity of Adverse Events

Geometric Mean PRNT80 (plaque reduction neutralization 80% titer) of Per-protocol Subjects

Other outcome measures

Geometric Mean PRNT50 (plaque reduction neutralization 50% titer) of Per-protocol Subjects

RVF Trial Design

1Treatment groups

Experimental Treatment

Group I: RVF VaccineExperimental Treatment1 Intervention

1.0 mL dose given SQ in upper arm

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

U.S. Army Medical Research and Development CommandLead Sponsor

286 Previous Clinical Trials

245,259 Total Patients Enrolled

3 Trials studying Rift Valley Fever

396 Patients Enrolled for Rift Valley Fever

Media Library

RVF Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03609398 — Phase 2

Rift Valley Fever Research Study Groups: RVF Vaccine

Rift Valley Fever Clinical Trial 2023: RVF Vaccine Highlights & Side Effects. Trial Name: NCT03609398 — Phase 2

RVF Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03609398 — Phase 2

Frequently Asked Questions

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

What is the current enrollment quota for this clinical experiment?

"Affirmative. Clinicaltrials.gov displays that this medical trial, initially posted on October 4th 2018, is presently enrolling participants. Approximately 500 patients will be accepted at 1 site of the study."

Answered by AI

Has the RVF Vaccine been sanctioned by the FDA?

"There is evidence that the RVF Vaccine has a modicum of safety, prompting our team to rate it as 2. As this is early-stage research, there is no definitive data yet on its efficacy."

Answered by AI

Does this experimental treatment accept participants who are of age 20 or greater?

"This trial's inclusion criteria indicates that applicants must be in between 18 and 65 years of age. For those outside this range, there are 24 trials for minors and 71 studies for seniors to consider."

Answered by AI

Who meets the criteria for participating in this research project?

"This research requires 500 participants, aged 18 to 65, with an elevated risk of exposure to Rift Valley Fever. In order for potential patients to be accepted into the trial they must not only fulfil certain age criteria but also pass medical screening conducted by a physician, agree to receive the RVF vaccine and submit their request in writing."

Answered by AI

Is this medical research accepting new participants?

"Affirmative. The trial details published on clinicaltrials.gov demonstrate that the study, which was first made public on October 4th 2018, is currently enrolling participants. 500 patients are being sought from one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine

2018. "Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03609398.

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