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Virus Therapy

Lassa Fever Vaccine for Lassa Fever

Phase 1
Waitlist Available
Research Sponsored by International AIDS Vaccine Initiative
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of vaccination
Be between 18 and 65 years old
Must not have
Bleeding disorder that was diagnosed by a physician
Confirmed HIV-1 or HIV-2 infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 months
Awards & highlights

Summary

This trial is testing a new vaccine called rVSV∆G-LASV-GPC in healthy adults. The vaccine uses a modified virus to help the immune system learn how to fight the real virus. The study aims to ensure the vaccine is safe and effective. The vaccine has shown promise in providing rapid and long-term protection against Lassa virus infection.

Who is the study for?
This trial is for adults aged 18 to 50 in good health, willing to use contraception and undergo HIV testing. It's not for those with chronic conditions, pregnant or breastfeeding women, people with bleeding disorders, prior Lassa vaccine recipients, recent blood product receivers, those exposed to Lassa virus, individuals allergic to vaccines, obese persons (BMI ≥35), or anyone with significant hearing loss or confirmed HIV.
What is being tested?
The study tests the safety and immune response of a new Lassa fever vaccine called rVSV∆G-LASV-GPC against a placebo. Participants are randomly assigned to receive either the vaccine or placebo without knowing which one they get. The dosage may increase as the trial progresses.
What are the potential side effects?
Potential side effects include typical reactions at the injection site like pain and swelling, general symptoms such as fever and fatigue that usually follow vaccination. Since it's an investigational vaccine other unforeseen side effects might occur.

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 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a bleeding disorder by a doctor.
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I am HIV positive.
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I have a history of immune system problems.
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I have been exposed to Lassa virus in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine
Secondary study objectives
Immunogenicity: To determine LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine
Other study objectives
Immunogenicity: To explore the characteristics of the immune responses induced by rVSV∆G-LASV-GPC vaccine

Trial Design

8Treatment groups
Experimental Treatment
Group I: Study Group 7Experimental Treatment2 Interventions
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^7 or Placebo
Group II: Study Group 6Experimental Treatment2 Interventions
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^6 or Placebo
Group III: Study Group 5Experimental Treatment2 Interventions
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^5 or Placebo
Group IV: Study Group 4BExperimental Treatment2 Interventions
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 and Day 42 2 X 10\^7 or Placebo
Group V: Study Group 4AExperimental Treatment2 Interventions
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^7 or Placebo
Group VI: Study Group 3Experimental Treatment2 Interventions
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^6 or Placebo
Group VII: Study Group 2Experimental Treatment2 Interventions
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^5 or Placebo
Group VIII: Study Group 1Experimental Treatment2 Interventions
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^4 or Placebo

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∆G-LASV-GPC vaccine for Lassa Fever uses a recombinant vesicular stomatitis virus (VSV) vector to express the Lassa virus glycoprotein complex, which elicits an immune response in the host. This mechanism is crucial as it trains the immune system to recognize and combat the Lassa virus effectively, potentially preventing the disease or reducing its severity. Similar treatments, such as the ChAdOx1-Lassa-GPC vaccine, also use viral vectors to induce robust cellular and humoral immune responses, providing protection against lethal Lassa virus challenges. These approaches are significant for Lassa Fever patients as they offer a proactive means to build immunity, thereby reducing morbidity and mortality associated with the virus.
ChAdOx1-vectored Lassa fever vaccine elicits a robust cellular and humoral immune response and protects guinea pigs against lethal Lassa virus challenge.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Redemption HospitalUNKNOWN
East-West Medical Research InstituteUNKNOWN
Brigham and Women's HospitalOTHER
1,655 Previous Clinical Trials
11,499,496 Total Patients Enrolled

Media Library

rVSV∆G-LASV-GPC Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04794218 — Phase 1
Lassa Fever Research Study Groups: Study Group 4B, Study Group 4A, Study Group 2, Study Group 1, Study Group 5, Study Group 3, Study Group 7, Study Group 6
Lassa Fever Clinical Trial 2023: rVSV∆G-LASV-GPC Vaccine Highlights & Side Effects. Trial Name: NCT04794218 — Phase 1
rVSV∆G-LASV-GPC Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04794218 — Phase 1
~27 spots leftby Oct 2025