Lassa Fever, Lassa Virus Infection
Conditions
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.
Interventions
DRUGrVSV∆G-LASV-GPC
2 × 10\^4 pfu delivered intramuscularly
OTHERPlacebo/Diluent
N/A delivered intramuscularly
Sponsors
George Washington University
Brigham and Women's Hospital
Redemption Hospital
East-West Medical Research Institute
International AIDS Vaccine Initiative
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 51 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine | 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
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity: To determine LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine | 20 months | * 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 |
Countries
Liberia, United States
Outcome results
None listed