What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

The most common side effects of treatments for Lassa Fever, particularly those similar to the rVSV∆G-LASV-GPC vaccine, include fever, headache, muscle pain, and injection site reactions. Severe side effects are rare but can include allergic reactions and, in very rare cases, vaccine-induced immune thrombotic thrombocytopenia (VITT).

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Lassa Fever. The rVSV∆G-LASV-GPC vaccine, which is a recombinant vesicular stomatitis virus vector expressing the Lassa virus glycoprotein complex, is currently being studied for its safety and immunogenicity. This approach is similar to the development of vaccines for other viral hemorrhagic fevers, such as the rVSV-ZEBOV vaccine for Ebola, which has shown promise in clinical trials but is not yet approved for Lassa Fever.

What other types of research exist?

Promising, novel alternatives to the rVSV∆G-LASV-GPC vaccine for Lassa Fever include the quadrivalent vaccine containing recombinant VSV encoding the surface glycoproteins of Marburg Angola, Zaire and Sudan species of Ebola virus, and Lassa virus. Additionally, the adenovirus/MVA vaccine platform, which has been used to develop multivalent vaccines for Ebola and Marburg viruses, could be a potential alternative. These vaccines have shown protective efficacy in nonhuman primates and have undergone phase I studies in humans, indicating their potential as alternatives for Lassa Fever treatment.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 months

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

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∆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.