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

International AIDS Vaccine Initiative

Status and phase: Active, not recruiting; Phase 1

Conditions: Lassa Virus Infection; Lassa Fever

Treatments: Drug: rVSV∆G-LASV-GPC; Other: Placebo/Diluent

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04794218

IAVI C102

Details and patient eligibility

About

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

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 51 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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114 participants in 8 patient groups

Study Group 1

Experimental group

Description:

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^4 or Placebo

Treatment:

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Other: Placebo/Diluent

Study Group 2

Experimental group

Description:

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^5 or Placebo

Treatment:

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Other: Placebo/Diluent

Study Group 3

Experimental group

Description:

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^6 or Placebo

Treatment:

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Other: Placebo/Diluent

Study Group 4A

Experimental group

Description:

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^7 or Placebo

Treatment:

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Other: Placebo/Diluent

Study Group 5

Experimental group

Description:

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^5 or Placebo

Treatment:

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Other: Placebo/Diluent

Study Group 6

Experimental group

Description:

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^6 or Placebo

Treatment:

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Other: Placebo/Diluent

Study Group 7

Experimental group

Description:

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10\^7 or Placebo

Treatment:

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Other: Placebo/Diluent

Study Group 4B

Experimental group

Description:

rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 and Day 42 2 X 10\^7 or Placebo

Treatment:

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Drug: rVSV∆G-LASV-GPC

Other: Placebo/Diluent