NCT04794218Active, not recruitingPhase 1

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 Heath

International AIDS Vaccine Initiative4 sites in 2 countries114 target enrollmentStarted: June 23, 2021Last updated: January 18, 2024

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor: International AIDS Vaccine Initiative
Enrollment: 114
Locations: 4
Primary Endpoint: Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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 Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Prevention
Masking: Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages: 18 Years to 51 Years (Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Study Group 4A

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo

Intervention: Placebo/Diluent (Other)

Study Group 1

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^4 or Placebo

Intervention: rVSV∆G-LASV-GPC (Drug)

Study Group 1

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^4 or Placebo

Intervention: Placebo/Diluent (Other)

Study Group 2

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo

Intervention: rVSV∆G-LASV-GPC (Drug)

Study Group 2

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo

Intervention: Placebo/Diluent (Other)

Study Group 3

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo

Intervention: rVSV∆G-LASV-GPC (Drug)

Study Group 3

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo

Intervention: Placebo/Diluent (Other)

Study Group 4A

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo

Intervention: rVSV∆G-LASV-GPC (Drug)

Study Group 5

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo

Intervention: rVSV∆G-LASV-GPC (Drug)

Study Group 5

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo

Intervention: Placebo/Diluent (Other)

Study Group 6

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo

Intervention: rVSV∆G-LASV-GPC (Drug)

Study Group 6

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo

Intervention: Placebo/Diluent (Other)

Study Group 7

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo

Intervention: rVSV∆G-LASV-GPC (Drug)

Study Group 7

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo

Intervention: Placebo/Diluent (Other)

Study Group 4B

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 and Day 42 2 X 10^7 or Placebo

Intervention: rVSV∆G-LASV-GPC (Drug)

Study Group 4B

Experimental

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 and Day 42 2 X 10^7 or Placebo

Intervention: Placebo/Diluent (Other)

Outcomes

Primary Outcomes

Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine

Time Frame: 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 Outcomes

Immunogenicity: To determine LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine(20 months)

Investigators

Sponsor

International AIDS Vaccine Initiative

Sponsor Class

Network

Responsible Party

Sponsor

Study Sites (4)

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