Back to resultsA Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath
Primary Purpose
Lassa Fever, Lassa Virus Infection
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
rVSV∆G-LASV-GPC
rVSV∆G-LASV-GPC
rVSV∆G-LASV-GPC
rVSV∆G-LASV-GPC
Placebo/Diluent
Sponsored by
About this trial
This is an interventional prevention trial for Lassa Fever
Eligibility Criteria
Inclusion Criteria
- Adults in good general health as assessed by medical history, physical examination, and laboratory tests
- At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of vaccination
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
- Willing to undergo HIV testing, risk reduction counselling, and receive HIV test results
- Use effective method of contraception
- Understand the study and provide written informed consent
Exclusion Criteria
- Confirmed HIV-1 or HIV-2 infection
- Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease
- Any clinically significant chronic medical condition that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study
- Pregnant or lactating
- Bleeding disorder that was diagnosed by a physician
- Prior receipt of another investigational Lassa vaccine candidate
- Receipt of blood transfusion or blood-derived products within the previous 3 months
- Prior exposure to LASV as documented by history
- History of severe local or systemic reactogenicity to any vaccine
- Body mass index (BMI) ≥35
- Mild or greater hearing impairment defined as ≥26dB loss in either ear
Sites / Locations
- George Washington University
- East-West Medical Research Institute
- Brigham and Women's Hospital
- Redemption Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Study Group 1
Study Group 2
Study Group 3
Study Group 4A
Study Group 5
Study Group 6
Study Group 7
Study Group 4B
Arm Description
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^4 or Placebo
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 and Day 42 2 X 10^7 or Placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04794218
First Posted
March 3, 2021
Last Updated
March 8, 2023
Sponsor
International AIDS Vaccine Initiative
Collaborators
George Washington University, Brigham and Women's Hospital, Redemption Hospital, East-West Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04794218
Brief Title
A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International AIDS Vaccine Initiative
Collaborators
George Washington University, Brigham and Women's Hospital, Redemption Hospital, East-West Medical Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lassa Fever, Lassa Virus Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Group 1
Arm Type
Experimental
Arm Description
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^4 or Placebo
Arm Title
Study Group 2
Arm Type
Experimental
Arm Description
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo
Arm Title
Study Group 3
Arm Type
Experimental
Arm Description
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo
Arm Title
Study Group 4A
Arm Type
Experimental
Arm Description
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo
Arm Title
Study Group 5
Arm Type
Experimental
Arm Description
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5 or Placebo
Arm Title
Study Group 6
Arm Type
Experimental
Arm Description
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6 or Placebo
Arm Title
Study Group 7
Arm Type
Experimental
Arm Description
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7 or Placebo
Arm Title
Study Group 4B
Arm Type
Experimental
Arm Description
rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 and Day 42 2 X 10^7 or Placebo
Intervention Type
Drug
Intervention Name(s)
rVSV∆G-LASV-GPC
Intervention Description
2 × 10^4 pfu delivered intramuscularly
Intervention Type
Drug
Intervention Name(s)
rVSV∆G-LASV-GPC
Intervention Description
2 × 10^5 pfu delivered intramuscularly
Intervention Type
Drug
Intervention Name(s)
rVSV∆G-LASV-GPC
Intervention Description
2 × 10^6 pfu delivered intramuscularly
Intervention Type
Drug
Intervention Name(s)
rVSV∆G-LASV-GPC
Intervention Description
2 × 10^7 pfu delivered intramuscularly
Intervention Type
Other
Intervention Name(s)
Placebo/Diluent
Intervention Description
N/A delivered intramuscularly
Primary Outcome Measure Information:
Title
Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine
Description
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
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Immunogenicity: To determine LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine
Description
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
Time Frame
20 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Adults in good general health as assessed by medical history, physical examination, and laboratory tests
At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of vaccination
Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
Willing to undergo HIV testing, risk reduction counselling, and receive HIV test results
Use effective method of contraception
Understand the study and provide written informed consent
Exclusion Criteria
Confirmed HIV-1 or HIV-2 infection
Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease
Any clinically significant chronic medical condition that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study
Pregnant or lactating
Bleeding disorder that was diagnosed by a physician
Prior receipt of another investigational Lassa vaccine candidate
Receipt of blood transfusion or blood-derived products within the previous 3 months
Prior exposure to LASV as documented by history
History of severe local or systemic reactogenicity to any vaccine
Body mass index (BMI) ≥35
Mild or greater hearing impairment defined as ≥26dB loss in either ear
Facility Information:
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Brigham and Women's Hospital
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Redemption Hospital
City
New Kru Town
State/Province
Greater Monrovia
Country
Liberia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.iavi.org/
Description
Related Info
Learn more about this trial
A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath
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