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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lassa Fever, Lassa Virus Infection

Intervention / Treatment
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* Drug: rVSV∆G-LASV-GPC
* Drug: rVSV∆G-LASV-GPC
* Drug: rVSV∆G-LASV-GPC
* Drug: rVSV∆G-LASV-GPC
* Other: Placebo/Diluent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 51 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |