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

Phase 1

Recruiting

• Conditions: Lassa fever

• Registration Number: PACTR202106625781067
• Lead Sponsor: IAVI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Adults in good general health as assessed by medical history, physical examination, and laboratory tests who are =18 and <51 years of age, who are willing to comply with the requirements of the protocol, and understand the information provided and potential impact and/or risks associated with the trial, are eligible to participate. All women of childbearing potential (WOCBP) must commit to use an effective method of contraception. All sexually active participants must be willing to use male or female condoms for 4 months after receipt of IP. All potential participants must be willing to forgo donation of blood or any other tissues from screening onward throughout the course of the study.

Exclusion Criteria

Participants will not be eligible to participate in this study if they have confirmed HIV-1 or HIV-2 infection. They will also be excluded if they have any clinically relevant abnormality on history or examination or have any clinically significant acute or chronic medical condition that is considered progressive. All WOCBP must not be pregnant or lactating. If participants have a bleeding disorder, any infectious diseases, or history of splenectomy, as well as abnormal laboratory parameters, they are also excluded. They are excluded if they have recently participated in another clinical trial of an investigational product (IP) or have a history of severe local or systemic reactogenicity to vaccines. They should have no psychiatric condition or substance abuse in the last 3 years that compromises their safety, nor seizure disorder in the last 3 years.

Study & Design

• Study Type: Interventional
• Study Design: Not specified