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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-23

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine in Adults With Good General Health

NCT05724472

Ebola Sudan Virus Disease

COMPLETED PHASE1

Safety and Efficacy Study of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV)

NCT01756482

Respiratory Syncytial Virus Infections

COMPLETED PHASE2

A Safety and Immunogenicity Study of Intranasal Sendai Virus Vectored Respiratory Syncytial Virus (SeVRSV) Vaccine in Healthy Adults

NCT03473002

Antiviral Prophylaxis Respiratory Syncytial Virus Infection

COMPLETED PHASE1

Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults

NCT04785612

Respiratory Syncytial Virus Infections

COMPLETED PHASE2

Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Healthy Flavivirus Seropositive and Seronegative Adults

NCT04064905

Zika Virus

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lassa Fever Lassa Virus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Group 1

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

Group Type EXPERIMENTAL

rVSV∆G-LASV-GPC

Intervention Type DRUG

2 × 10\^4 pfu delivered intramuscularly

Placebo/Diluent

Intervention Type OTHER

N/A delivered intramuscularly

Study Group 2

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

Group Type EXPERIMENTAL

rVSV∆G-LASV-GPC

Intervention Type DRUG

2 × 10\^5 pfu delivered intramuscularly

Placebo/Diluent

Intervention Type OTHER

N/A delivered intramuscularly

Study Group 3

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

Group Type EXPERIMENTAL

rVSV∆G-LASV-GPC

Intervention Type DRUG

2 × 10\^6 pfu delivered intramuscularly

Placebo/Diluent

Intervention Type OTHER

N/A delivered intramuscularly

Study Group 4A

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

Group Type EXPERIMENTAL

rVSV∆G-LASV-GPC

Intervention Type DRUG

2 × 10\^7 pfu delivered intramuscularly

Placebo/Diluent

Intervention Type OTHER

N/A delivered intramuscularly

Study Group 5

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

Group Type EXPERIMENTAL

rVSV∆G-LASV-GPC

Intervention Type DRUG

2 × 10\^5 pfu delivered intramuscularly

Placebo/Diluent

Intervention Type OTHER

N/A delivered intramuscularly

Study Group 6

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

Group Type EXPERIMENTAL

rVSV∆G-LASV-GPC

Intervention Type DRUG

2 × 10\^6 pfu delivered intramuscularly

Placebo/Diluent

Intervention Type OTHER

N/A delivered intramuscularly

Study Group 7

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

Group Type EXPERIMENTAL

rVSV∆G-LASV-GPC

Intervention Type DRUG

2 × 10\^7 pfu delivered intramuscularly

Placebo/Diluent

Intervention Type OTHER

N/A delivered intramuscularly

Study Group 4B

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

Group Type EXPERIMENTAL

rVSV∆G-LASV-GPC

Intervention Type DRUG

2 × 10\^7 pfu delivered intramuscularly

Placebo/Diluent

Intervention Type OTHER

N/A delivered intramuscularly

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rVSV∆G-LASV-GPC

2 × 10\^4 pfu delivered intramuscularly

Intervention Type DRUG

rVSV∆G-LASV-GPC

2 × 10\^5 pfu delivered intramuscularly

Intervention Type DRUG

rVSV∆G-LASV-GPC

2 × 10\^6 pfu delivered intramuscularly

Intervention Type DRUG

rVSV∆G-LASV-GPC

2 × 10\^7 pfu delivered intramuscularly

Intervention Type DRUG

Placebo/Diluent

N/A delivered intramuscularly

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

51 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes