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

Phase 1

Active, not recruiting

• Conditions: Lassa Fever; Lassa Virus Infection
• Interventions: Drug: rVSV∆G-LASV-GPC; Other: Placebo/Diluent

• Registration Number: NCT04794218
• Lead Sponsor: International AIDS Vaccine Initiative

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.

Approximately 110 participants (88 active product and 22 placebo recipients) will be included in the study Participants will be screened up to 42 days before IP administration and will be followed for 12 months after IP administration.

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-11
• Study Start: 2021-06-23
• Primary Completion: 2023-12-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group 1	Placebo/Diluent	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^4 or Placebo
Study Group 1	rVSV∆G-LASV-GPC	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^4 or Placebo
Study Group 2	rVSV∆G-LASV-GPC	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^5 or Placebo
Study Group 2	Placebo/Diluent	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^5 or Placebo
Study Group 5	rVSV∆G-LASV-GPC	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^5 or Placebo
Study Group 5	Placebo/Diluent	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^5 or Placebo
Study Group 3	rVSV∆G-LASV-GPC	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^6 or Placebo
Study Group 3	Placebo/Diluent	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^6 or Placebo
Study Group 4A	rVSV∆G-LASV-GPC	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^7 or Placebo
Study Group 4A	Placebo/Diluent	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^7 or Placebo
Study Group 6	rVSV∆G-LASV-GPC	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^6 or Placebo
Study Group 6	Placebo/Diluent	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^6 or Placebo
Study Group 7	rVSV∆G-LASV-GPC	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^7 or Placebo
Study Group 4B	rVSV∆G-LASV-GPC	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 and Day 42 2 X 10\^7 or Placebo
Study Group 7	Placebo/Diluent	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^7 or Placebo
Study Group 4B	Placebo/Diluent	rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 and Day 42 2 X 10\^7 or Placebo

Primary Outcome Measures

Name	Time	Method
Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine	20 months	* Proportion of participants with Grade 3 or higher reactogenicity (ie, solicited AEs) during a 14-day follow-up period after IP administration; * Proportion of participants with Grade 2 or higher IP-related unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration; * Proportion of participants with Grade 2 or higher unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration; * Proportion of participants with IP-related SAEs throughout the study period Proportion of participants with AEs of Special Interest (AESI) post-vaccination throughout the study period

Secondary Outcome Measures

Name	Time	Method
Immunogenicity: To determine LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine	20 months	* Magnitude and duration of viral RNA in plasma by PCR; * Magnitude and duration of rVSV∆G-LASV-GPC vaccine viremia by culture; * Magnitude and duration of viral RNA in urine and saliva by PCR; * Magnitude and duration of rVSV∆G-LASV-GPC vaccine shedding in urine and saliva by culture

Trial Locations

Locations (4)

George Washington University; 🇺🇸 Washington, District of Columbia, United States

Brigham and Women's Hospital; 🇺🇸 Brookline, Massachusetts, United States

Redemption Hospital; 🇱🇷 New Kru Town, Greater Monrovia, Liberia

East-West Medical Research Institute; 🇺🇸 Honolulu, Hawaii, United States