A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath

Status unconfirmed · Phase 1 · Has a placebo group

Conditions studied: Lassa Fever, Lassa Virus Infection

In brief

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

Key facts

Study ID

NCT04794218

Run by

International AIDS Vaccine Initiative

People needed

114

Starts

2021-06-23

Expected to finish

2024-03-01

Last updated by the study team

2024-01-18

Who can join

Age: 18 and older, up to 51. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• George Washington University — Washington D.C., District of Columbia, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Brigham and Women's Hospital — Brookline, Massachusetts, United States
• Redemption Hospital — New Kru Town, Greater Monrovia, Liberia

Full record on ClinicalTrials.gov

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