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
Overview
- Phase
- Phase 1
- Intervention
- Placebo/Diluent
- Conditions
- Lassa Fever
- Sponsor
- International AIDS Vaccine Initiative
- Enrollment
- 114
- Locations
- 4
- Primary Endpoint
- Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Study Group 4A
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^7 or Placebo
Intervention: Placebo/Diluent
Study Group 1
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^4 or Placebo
Intervention: rVSV∆G-LASV-GPC
Study Group 1
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^4 or Placebo
Intervention: Placebo/Diluent
Study Group 2
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^5 or Placebo
Intervention: rVSV∆G-LASV-GPC
Study Group 2
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^5 or Placebo
Intervention: Placebo/Diluent
Study Group 3
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^6 or Placebo
Intervention: rVSV∆G-LASV-GPC
Study Group 3
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^6 or Placebo
Intervention: Placebo/Diluent
Study Group 4A
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^7 or Placebo
Intervention: rVSV∆G-LASV-GPC
Study Group 5
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^5 or Placebo
Intervention: rVSV∆G-LASV-GPC
Study Group 5
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^5 or Placebo
Intervention: Placebo/Diluent
Study Group 6
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^6 or Placebo
Intervention: rVSV∆G-LASV-GPC
Study Group 6
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^6 or Placebo
Intervention: Placebo/Diluent
Study Group 7
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^7 or Placebo
Intervention: rVSV∆G-LASV-GPC
Study Group 7
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^7 or Placebo
Intervention: Placebo/Diluent
Study Group 4B
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 and Day 42 2 X 10\^7 or Placebo
Intervention: rVSV∆G-LASV-GPC
Study Group 4B
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 and Day 42 2 X 10\^7 or Placebo
Intervention: Placebo/Diluent
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)