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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 months
Awards & highlights

Study Summary

This trial is testing a new vaccine for Lassa fever in adults to see if it is safe and effective.

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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 50 years old.

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

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

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
1,609 Previous Clinical Trials
11,470,213 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

Frequently Asked Questions

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

Does this experiment encompass participants aged 35 and over?

"This clinical trial is available to those above the age of majority, but no older than 51 years old."

Answered by AI

How many people are eligible for inclusion in this trial?

"Affirmative, clinicaltrials.gov confirms the active recruitment of participants for this trial which was originally posted on June 23rd 2021 and had its latest update November 21st 2022. A total of 110 volunteers are required at 2 sites across the nation."

Answered by AI

To whom is this trial open for enrollment?

"Researchers are searching for 110 individuals between 18 and 51 years old with lassa fever. Candidates must be of-age on the day of screening, willing to comply with study requirements, and use an appropriate form contraception."

Answered by AI

Is enrollment available for this experiment?

"Clinicaltrials.gov confirms that this clinical trial is looking for new candidates; the original post date was June 23rd 2021 with a most recent update on November 21st 2022."

Answered by AI

What potential risks exist with the administration of rVSV∆G-LASV-GPC?

"Based on available clinical data, the safety of rVSV∆G-LASV-GPC was rated a 1 since it is currently in its first phase. This implies that there are only rudimentary findings concerning both efficacy and security."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath
2021. "A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04794218.
~30 spots leftby Apr 2025
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