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

International AIDS Vaccine Initiative3 sites in 3 countries612 target enrollmentMarch 6, 2024

ConditionsLassa Fever

InterventionsPlacebo Day 1 Lower Dose (2×106 pfu)Day 1 Higher Dose (1×107 pfu)

DrugsDay 1 Lower Dose (2×106 pfu)Day 1 Higher Dose (1×107 pfu)Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Lassa Fever
Sponsor: International AIDS Vaccine Initiative
Enrollment: 612
Locations: 3
Primary Endpoint: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Detailed Description

rVSVΔG-LASV-GPC is a candidate vaccine that has been shown to be safe and protects against LF disease in animals. The vaccine was studied studied in a Phase 1 trial and has been well tolerated and immunogenic. This Phase 2 trial will add to data from the Phase 1 trial to establish a broader profile of safety and immunogenicity in adults and expand the population to include a subset of adults with HIV infection as well as older adults and healthy children, in preparation for an efficacy trial in West Africa. Primary Objective: • To evaluate the safety and tolerability of rVSVΔG-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children Secondary Objectives: • To determine binding LASV-GPC-specific antibody responses induced by rVSVΔG-LASV-GPC vaccine • To determine neutralizing LASV-GPC-specific antibody responses induced by rVSVΔG-LASV-GPC vaccine in a subset of participants in each group • To evaluate the magnitude and duration of the rVSVΔG-LASV-GPC vaccine viremia in plasma in a subset of participants. • To evaluate the magnitude and duration of the rVSVΔG-LASV-GPC vaccine shedding in saliva and urine, and possibly semen and cervicovaginal fluid, in a subset of participants Exploratory Objective • To explore the characteristics of the immune responses induced by rVSVΔG-LASV-GPC vaccine in a subset of participants

Registry

clinicaltrials.gov

Start Date

March 6, 2024

End Date

April 2027

Last Updated

11 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

International AIDS Vaccine Initiative

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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-
•Note: COVID-19 screening is not applicable for Group
•History of splenectomy or functional asplenia.

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: 7 months

Proportion of participants with AESIs throughout the study period

Secondary Outcomes

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 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)
To evaluate the magnitude and duration of the rVSV∆G-LASV-GPC vaccine shedding in saliva and urine, and possibly semen and cervicovaginal fluid, in a subset of participants(6 months/2.5 years)