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

NCT04794218 | Unknown Phase 1 FDA Drug

• 1 other identifier: IAVI C102
• Study Type: interventional
• Target: 114
• Locations: 2 countries
• Sites: 4

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

Conditions

Lassa Fever; Lassa Virus Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immunogenicity: To determine LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine

  20 months

Study Arms (8)

Study Group 1

EXPERIMENTAL

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

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

Study Group 2

EXPERIMENTAL

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

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

Study Group 3

EXPERIMENTAL

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

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

Study Group 4A

EXPERIMENTAL

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

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

Study Group 5

EXPERIMENTAL

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

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

Study Group 6

EXPERIMENTAL

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

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

Study Group 7

EXPERIMENTAL

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

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

Study Group 4B

EXPERIMENTAL

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

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

Interventions

rVSV∆G-LASV-GPC DRUG

2 × 10\^4 pfu delivered intramuscularly

Study Group 1

Placebo/Diluent OTHER

N/A delivered intramuscularly

Study Group 1; Study Group 2; Study Group 3; Study Group 4A; Study Group 4B; Study Group 5; Study Group 6; Study Group 7

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead
• George Washington University: collaborator
• Brigham and Women's Hospital: collaborator
• Redemption Hospital: collaborator
• East-West Medical Research Institute: collaborator

Study Sites (4)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Brigham and Women's Hospital

Brookline, Massachusetts, 02115, United States

Location

Redemption Hospital

New Kru Town, Greater Monrovia, Liberia

Location

Related Publications (1)

• Malkin E, Zaric M, Kieh M, Baden LR, Fitz-Patrick D, Marini A, Yun H, Hayes P, Bromell R, Ayorinde M, Fernandez N, Varma R, Sigei F, Ward M, Pindolia H, Sewell S, Amini F, Blie J, Wilson B, Faley P, McCullough J, Tokpah F, Wisseh C, Towalid E, Hadawale S, Sayeed E, Hunt D, Keshavarzi N, Barin B, Maljkovic Berry I, Parks CL, Truter SG, Walker K, Vekemans J, Lehrman J, Engelbrecht M, Malherbe M, Laufer D, Philiponis V, Higgs E, Mutua G, Fast PE, Gupta SB; rVSVDeltaG-LASV-GPC Study Group. Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate. N Engl J Med. 2025 Nov 6;393(18):1807-1818. doi: 10.1056/NEJMoa2501073.

  PMID: 41191941 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Lassa Fever

Condition Hierarchy (Ancestors)

Arenaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 11, 2021
• Study Start: June 23, 2021
• Primary Completion: December 19, 2023
• Study Completion: March 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

US (3); LI (1)