A Lassa Fever Vaccine Trial in Adults and Children Residing in West Africa

NCT05868733 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IAVI C105
• Study Type: interventional
• Target: 612
• Locations: 3 countries
• Sites: 3

Brief Summary

A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults and Children Residing in West Africa

Conditions

Lassa Fever

Outcome Measures

Primary Outcomes (5)

• To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children

  Proportion of participants with Grade 3 or higher reactogenicity, ie, solicited AEs, within 14 days after IP administration

  14 days

• To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children

  Proportion of participants with IP-related Grade 2 or higher unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration

  28 days

• To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children

  Proportion of participants with any Grade 2 or higher unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration

  28 days

• To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children

  Proportion of participants with IP-related SAEs throughout the study period

  7 months

• To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children

  Proportion of participants with AESIs throughout the study period

  7 months

Secondary Outcomes (7)

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

  6 months/2.5 years

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

  6 months/2.5 years

• To determine neutralizing LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine in a subset of participants in each group

  6 months/2.5 years

• To determine neutralizing LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine in a subset of participants in each group

  6 months/2.5 years

• To evaluate the magnitude and duration of the rVSV∆G-LASV-GPC vaccine viremia in plasma in a subset of participants

  6 months/2.5 years

Study Arms (10)

Cohort 1A

EXPERIMENTAL

Healthy Adults, 18-70yrs

Drug: Day 1 Lower Dose (2×106 pfu); Drug: Placebo

Cohort 2A

EXPERIMENTAL

HIV-infected Adults, 18-50yrs

Drug: Day 1 Lower Dose (2×106 pfu); Drug: Placebo

Cohort 3A

EXPERIMENTAL

Adolescents, 12 17yrs

Drug: Day 1 Lower Dose (2×106 pfu); Drug: Placebo

Cohort 4A

EXPERIMENTAL

Children, 6-11yrs

Drug: Day 1 Lower Dose (2×106 pfu); Drug: Placebo

Cohort 5A

EXPERIMENTAL

Children, 18mos-5yrs

Drug: Day 1 Lower Dose (2×106 pfu); Drug: Placebo

Cohort 1B

EXPERIMENTAL

Healthy Adults, 18-70yrs

Drug: Day 1 Higher Dose (1×107 pfu); Drug: Placebo

Cohort 2B

EXPERIMENTAL

HIV-infected Adults,18-50yrs

Drug: Day 1 Higher Dose (1×107 pfu); Drug: Placebo

Cohort 3B

EXPERIMENTAL

Adolescents, 12 17yrs

Drug: Day 1 Higher Dose (1×107 pfu); Drug: Placebo

Cohort 4B

EXPERIMENTAL

Children, 6-11yrs

Drug: Day 1 Higher Dose (1×107 pfu); Drug: Placebo

Cohort 5B

EXPERIMENTAL

Children, 18mos-5yrs

Drug: Day 1 Higher Dose (1×107 pfu); Drug: Placebo

Interventions

Day 1 Lower Dose (2×106 pfu) DRUG

rVSV∆G-LASV-GPC

Cohort 1A; Cohort 2A; Cohort 3A; Cohort 4A; Cohort 5A

Day 1 Higher Dose (1×107 pfu) DRUG

rVSV∆G-LASV-GPC

Cohort 1B; Cohort 2B; Cohort 3B; Cohort 4B; Cohort 5B

Placebo DRUG

Placebo

Cohort 1A; Cohort 1B; Cohort 2A; Cohort 2B; Cohort 3A; Cohort 3B; Cohort 4A; Cohort 4B; Cohort 5A; Cohort 5B

Eligibility Criteria

• Age: 18 Months - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, adolescents, and children in good general health as assessed by medical history and physical examination (group-specific criteria apply).
• At least 18 months old on the day of screening and not more than 70 years old on the day of vaccination (group-specific criteria apply).
• Participant or parent/guardian willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
• In the opinion of the Principal Investigator (PI) or designee and based on Assessment of Informed Consent Understanding (AOU), participant or parent/guardian has understood the information provided and potential impact and/or risks linked to administration and participation in the trial; written informed consent will be obtained before any study-related procedures are performed. Children old enough to understand the procedures will be asked to assent, in addition to parent/guardian consent, in accordance with local requirements.
• Willing to undergo HIV testing, risk reduction counselling, and receive HIV test results (group-specific timepoints apply).
• All participants of child-bearing potential engaging in sexual activity that could lead to pregnancy must commit to use an effective hormonal contraception or intrauterine device beginning 2 weeks prior and extending for 4 months following receipt of vaccine/placebo. Study sites will choose which methods are most appropriate for their population and this will be specified in the Informed Consent Document (ICD).
• All sexually active participants must consistently use male or female condoms with all sexual partners for 4 months following IP administration.
• All participants who are not engaging in sexual activity that could lead to pregnancy at screening must agree to utilize an effective method of contraception if they begin engaging in sexual activity that could lead to pregnancy, as outlined above.
• All participants of childbearing potential must be willing to undergo a pregnancy test at time points indicated in the SOA.
• Willing to forgo donation of blood or any other tissues for transfusion or transplantation, from screening onward throughout the course of the study.
• Participant must be aged at least 18 years old on the day of screening and not more than 50 years old on the day of vaccination.
• Participant must have documented HIV-1 or HIV-2 infection for at least 6 months prior to screening.
• Participant must be on a stable (at least 6 months) regimen of Highly Active Antiretroviral Therapy (HAART), as defined as potent anti-HIV treatment including a combination of antiretroviral agents (pre- or post-exposure prophylaxis does not count as HAART).
• Participant entering the study should have a screening viral load \<50 copies/ml.
• Participant must be willing to continue their HAART and HIV care follow up throughout the study as directed by their regular caregiver and be willing to give access to records of their ongoing care.

You may not qualify if:

• Confirmed HIV-1 or HIV-2 infection (except as outlined for Group 2)
• Any clinically relevant abnormality on history or examination including history of immunodeficiency (except for Group 2) or autoimmune disease; use of corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the Investigator within the previous 6 months. The following exceptions are permitted and will not preclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on Investigator clinical judgment) at least 2 weeks prior to enrollment in this study.
• Any clinically significant chronic medical condition that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study (except for HIV in Group 2). Note: Participants aged \>50years with the following chronic but controlled conditions may be enrolled:
• Hypertension with systolic ≤150 mmHg and/or diastolic ≤90 mmHg; (regardless of treatment status)
• Diabetes mellitus with a HbA1C \<10% and /or with type 2 diabetes mellitus on stable medication for at least 2 months prior to enrollment.
• Pregnant or lactating.
• Bleeding disorder that was diagnosed by a physician (eg, factor deficiency, coagulopathy, or platelet disorder that requires special precautions). Note: A participant who states that he or she has easy bruising or bleeding but does not have a formal diagnosis and has intramuscular (IM) injections and blood draws without any adverse experience is eligible.
• Infectious disease: chronic active hepatitis B infection (HBsAg-positive), current hepatitis C infection, prior clinical diagnosis of Lassa Fever disease (LF) or Ebola virus disease (EVD) by medical history, active syphilis (positive screening and confirmatory tests unless adequately treated), positive viral detection test for SARS-CoV-2. Note: COVID-19 screening is not applicable for Group 5.
• History of splenectomy or functional asplenia.
• Any of the following abnormal laboratory parameters listed below:
• Hematology
• Absolute Neutrophil Count (ANC): ≤1,000 cells/mm3 or ≤ 1.0 × 109 cells/L
• Absolute Lymphocyte Count (ALC): ≤650 cells/mm3 or ≤ 0.65 × 109 cells/L
• Hemoglobin: \<9.5 g/dl in females; \<11.0 g/dl in males; \<10 g/dl in children \<11 years of age
• Platelets \<100,000 cells/mm3

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead
• Coalition for Epidemic Preparedness Innovations: collaborator

Study Sites (3)

Noguchi Memorial Institute for Medical Research (NMIMR)

Accra, Ghana

RECRUITING

PREVAIL_ John F. Kennedy Medical Center (JFK)

Monrovia, Liberia

RECRUITING

Walter Reed Program - Nigeria

Wuse, Nigeria

RECRUITING

MeSH Terms

Conditions

Lassa Fever

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Gaudensia Mutua

CONTACT

+254-719-043-000; gmutua@iavi.org

Babalwa Jongihlati

CONTACT

NAP; BJongihlati@iavi.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Study staff and participants will be blinded in terms of active product versus placebo.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 22, 2023
• Study Start: March 6, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1); GH (1); NG (1)