Status:
ACTIVE_NOT_RECRUITING
A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath
Lead Sponsor:
International AIDS Vaccine Initiative
Collaborating Sponsors:
George Washington University
Brigham and Women's Hospital
Conditions:
Lassa Fever
Lassa Virus Infection
Eligibility:
All Genders
18-51 years
Phase:
PHASE1
Brief Summary
A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health
Detailed Description
This is a Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health. ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Adults in good general health as assessed by medical history, physical examination, and laboratory tests
- At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of vaccination
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
- Willing to undergo HIV testing, risk reduction counselling, and receive HIV test results
- Use effective method of contraception
- Understand the study and provide written informed consent
- Exclusion Criteria
- Confirmed HIV-1 or HIV-2 infection
- Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease
- Any clinically significant chronic medical condition that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study
- Pregnant or lactating
- Bleeding disorder that was diagnosed by a physician
- Prior receipt of another investigational Lassa vaccine candidate
- Receipt of blood transfusion or blood-derived products within the previous 3 months
- Prior exposure to LASV as documented by history
- History of severe local or systemic reactogenicity to any vaccine
- Body mass index (BMI) ≥35
- Mild or greater hearing impairment defined as ≥26dB loss in either ear
Exclusion
Key Trial Info
Start Date :
June 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04794218
Start Date
June 23 2021
End Date
March 1 2024
Last Update
January 18 2024
Active Locations (4)
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1
George Washington University
Washington D.C., District of Columbia, United States, 20037
2
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
3
Brigham and Women's Hospital
Brookline, Massachusetts, United States, 02115
4
Redemption Hospital
New Kru Town, Greater Monrovia, Liberia