A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults i… (NCT04794218) | Clinical Trial Compass
UnknownPhase 1
A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath
United States, Liberia114 participantsStarted 2021-06-23
Plain-language 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
Who can participate
Age range18 Years – 51 Years
SexALL
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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
✕
What they're measuring
1
Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine