Actively Recruiting
A Lassa Fever Vaccine Trial in Adults and Children Residing in West Africa
Led by International AIDS Vaccine Initiative · Updated on 2025-05-11
612
Participants Needed
3
Research Sites
160 weeks
Total Duration
On this page
Sponsors
I
International AIDS Vaccine Initiative
Lead Sponsor
C
Coalition for Epidemic Preparedness Innovations
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults and Children Residing in West Africa
CONDITIONS
Official Title
A Lassa Fever Vaccine Trial in Adults and Children Residing in West Africa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults, adolescents, and children in good general health as assessed by medical history and physical examination (group-specific criteria apply)
- Aged at least 18 months and no more than 70 years old on vaccination day (group-specific criteria apply)
- Participant or parent/guardian willing to comply with protocol requirements and available for follow-up
- Participant or parent/guardian has understood study information and risks; written informed consent obtained; assent from children old enough
- Willing to undergo HIV testing, counseling, and receive results (group-specific timepoints apply)
- Sexually active participants of childbearing potential must use effective contraception and condoms as specified
- Participants not sexually active must agree to contraception if they begin sexual activity that could lead to pregnancy
- Willing to forgo donation of blood or tissues for transfusion or transplantation during study
- Adults with HIV must be 18-50 years old with documented infection for at least 6 months, on stable HAART regimen for at least 6 months, viral load <50 copies/ml, and in good medical condition
- Pediatric participants must have parent/guardian consent and assent as appropriate, be within defined age strata (12-17, 6-11, or 18 months-5 years), healthy by clinical judgment, and up to date on routine immunizations
You will not qualify if you...
- Confirmed HIV infection except for designated HIV group
- Clinically relevant abnormalities including immunodeficiency, autoimmune disease, or significant medication use in past 6 months (with some corticosteroid exceptions)
- Significant chronic medical conditions deemed unsuitable by investigator except controlled hypertension or diabetes in older adults
- Pregnant or lactating individuals
- Diagnosed bleeding disorders requiring special precautions
- Chronic active hepatitis B, hepatitis C, prior Lassa or Ebola virus disease, active syphilis, or positive SARS-CoV-2 test (except certain groups)
- History of splenectomy or functional asplenia
- Abnormal lab values including low blood counts, abnormal liver or kidney function, or abnormal urinalysis
- Recent receipt of any vaccine within 28 days before or planned within 28 days after study vaccine
- Prior investigational Lassa vaccine (placebo in previous trial allowed with approval)
- Blood transfusion within past 3 months
- Participation in other clinical trials recently or planned, unless approved
- History of severe vaccine reaction
- Psychiatric conditions or substance abuse affecting safety or compliance
- Recent seizures or seizure disorder
- Recent malignancy or ongoing active malignancy
- Active serious infections requiring treatment
- Specific weight for height restrictions by group
- Hearing impairments or ear conditions that interfere with hearing assessment
- Neurologic conditions affecting safety or protocol compliance
- Investigator judgment deeming participation not in participant's best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Noguchi Memorial Institute for Medical Research (NMIMR)
Accra, Ghana
Actively Recruiting
2
PREVAIL_ John F. Kennedy Medical Center (JFK)
Monrovia, Liberia
Actively Recruiting
3
Walter Reed Program - Nigeria
Wuse, Nigeria
Actively Recruiting
Research Team
G
Gaudensia Mutua
CONTACT
B
Babalwa Jongihlati
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
10
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