Clinical trial NCT04794218: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Lassa Fever
Lassa Virus Infection
Lead sponsor: International AIDS Vaccine Initiative
Sponsor class: NETWORK
Collaborators: name: George Washington University
name: Brigham and Women's Hospital
name: Redemption Hospital
name: East-West Medical Research Institute
First posted: 2021-03-11
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine
timeFrame: 20 months
Secondary outcomes:
measure: Immunogenicity: To determine LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine
timeFrame: 20 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Brookline
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New Kru Town
country: Liberia
facility: Redemption Hospital
state: Greater Monrovia
Study officials:
References: