Health Trials

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

ConditionLassa Fever
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInternational AIDS Vaccine Initiative

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Day 1 Lower Dose (2×106 pfu)

    Drug

    rVSV∆G-LASV-GPC

  • Day 1 Higher Dose (1×107 pfu)

    Drug

    rVSV∆G-LASV-GPC

  • Placebo

    Drug

    Placebo

Treatment groups

612 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Cohort 1AExperimental treatment 2 interventions
Group B: Cohort 2AExperimental treatment 2 interventions
Group C: Cohort 3AExperimental treatment 2 interventions
Group D: Cohort 4AExperimental treatment 2 interventions
Group E: Cohort 5AExperimental treatment 2 interventions
Group F: Cohort 1BExperimental treatment 2 interventions
Group G: Cohort 2BExperimental treatment 2 interventions
Group H: Cohort 3BExperimental treatment 2 interventions
Group I: Cohort 4BExperimental treatment 2 interventions
Group J: Cohort 5BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
14 days
2

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

Time frame
28 days
3

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

Time frame
28 days
4

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

Time frame
7 months

Secondary outcomes

1

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

Proportion of participants with binding antibody responses to LASV-GPC

Time frame
6 months/2.5 years
2

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

Magnitude of binding antibody responses to LASV-GPC

Time frame
6 months/2.5 years
3

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

Proportion of participants with neutralizing antibody responses against LASV

Time frame
6 months/2.5 years
4

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

Magnitude of neutralizing antibody responses against LASV

Time frame
6 months/2.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

International AIDS Vaccine Initiative

Lead sponsor

Coalition for Epidemic Preparedness Innovations

Collaborator

Source ClinicalTrials.gov
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