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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Lassa Fever; Lassa Virus Infection
• Intervention / Treatment: Drug: rVSV∆G-LASV-GPC; Drug: rVSV∆G-LASV-GPC; Drug: rVSV∆G-LASV-GPC; Drug: rVSV∆G-LASV-GPC; Other: Placebo/Diluent

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 Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dagna Laufer; Phone Number: +1-212-328-7459; Email: dlaufer@iavi.org

Study Locations

• Liberia
  • Greater Monrovia
    • New Kru Town, Greater Monrovia, Liberia
      • Redemption Hospital
• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Massachusetts
    • Brookline, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 51 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

1. Adults in good general health as assessed by medical history, physical examination, and laboratory tests
2. At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of vaccination
3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
4. Willing to undergo HIV testing, risk reduction counselling, and receive HIV test results
5. Use effective method of contraception
6. Understand the study and provide written informed consent

Exclusion Criteria

1. Confirmed HIV-1 or HIV-2 infection
2. Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease
3. Any clinically significant chronic medical condition that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study
4. Pregnant or lactating
5. Bleeding disorder that was diagnosed by a physician
6. Prior receipt of another investigational Lassa vaccine candidate
7. Receipt of blood transfusion or blood-derived products within the previous 3 months
8. Prior exposure to LASV as documented by history
9. History of severe local or systemic reactogenicity to any vaccine
10. Body mass index (BMI) ≥35
11. Mild or greater hearing impairment defined as ≥26dB loss in either ear

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group 1; rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^4 or Placebo	Drug: rVSV∆G-LASV-GPC; 2 × 10^4 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^5 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^6 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^7 pfu delivered intramuscularly; Other: Placebo/Diluent; N/A delivered intramuscularly
Experimental: Study Group 2; rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo	Drug: rVSV∆G-LASV-GPC; 2 × 10^4 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^5 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^6 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^7 pfu delivered intramuscularly; Other: Placebo/Diluent; N/A delivered intramuscularly
Experimental: Study Group 3; rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo	Drug: rVSV∆G-LASV-GPC; 2 × 10^4 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^5 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^6 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^7 pfu delivered intramuscularly; Other: Placebo/Diluent; N/A delivered intramuscularly
Experimental: Study Group 4A; rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo	Drug: rVSV∆G-LASV-GPC; 2 × 10^4 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^5 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^6 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^7 pfu delivered intramuscularly; Other: Placebo/Diluent; N/A delivered intramuscularly
Experimental: Study Group 5; rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo	Drug: rVSV∆G-LASV-GPC; 2 × 10^4 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^5 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^6 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^7 pfu delivered intramuscularly; Other: Placebo/Diluent; N/A delivered intramuscularly
Experimental: Study Group 6; rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo	Drug: rVSV∆G-LASV-GPC; 2 × 10^4 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^5 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^6 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^7 pfu delivered intramuscularly; Other: Placebo/Diluent; N/A delivered intramuscularly
Experimental: Study Group 7; rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo	Drug: rVSV∆G-LASV-GPC; 2 × 10^4 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^5 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^6 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^7 pfu delivered intramuscularly; Other: Placebo/Diluent; N/A delivered intramuscularly
Experimental: Study Group 4B; rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 and Day 42 2 X 10^7 or Placebo	Drug: rVSV∆G-LASV-GPC; 2 × 10^4 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^5 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^6 pfu delivered intramuscularly; Drug: rVSV∆G-LASV-GPC; 2 × 10^7 pfu delivered intramuscularly; Other: Placebo/Diluent; N/A delivered intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine	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	20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity: To determine LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine	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	20 months

Collaborators and Investigators

• Sponsor: International AIDS Vaccine Initiative
• Collaborators: Brigham and Women's Hospital; George Washington University; Redemption Hospital; East-West Medical Research Institute

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): December 19, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral; Arenaviridae Infections; Lassa Fever
• Other Study ID Numbers: IAVI C102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No