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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05762393
Other study ID # IVI VASA 001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 17, 2023
Est. completion date December 1, 2024

Study information

Verified date April 2024
Source International Vaccine Institute
Contact Florian Marks
Phone +447402515431
Email fmarks@ivi.int
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this phase 1b, multicenter, randomized, placebo-controlled, observer-blinded, dose-escalation study is to assess the safety, tolerability, and immunogenicity of a three-dose regimen, spaced four weeks apart, given intramuscularly in healthy adults (20-59 years old). Three different dose formulations of the study product with varying antigen contents will be investigated. A total of 120 eligible participants will be recruited in 3 sequential cohorts (A, B, and C) in Burkina Faso (N=60) and in Madagascar (N=60). Cohort A will receive the low-dose antigen formulation (10 µg) or placebo, Cohort B will receive the medium-dose antigen formulation (30 µg) or placebo, and Cohort C will receive the high-dose antigen formulation (100 µg) or placebo; all antigens with 5 μg adjuvant (GLA-SE). In each cohort, volunteers will be randomized in a blinded manner into one of two arms, candidate vaccine or placebo, by a 3:1 ratio. A subset of five out of 20 subjects in each cohort will be sampled by convenience to enable us to further characterize the immune response using the peripheral blood mononuclear cells (PBMC). The Primary Objective of the study is to evaluate the safety and tolerability of 3 different dose formulations (low dose, medium dose, and high dose) of SchistoShield® vaccine given intramuscularly on D0, D28 and D56 to healthy participants 2018 to 59 years of age in Burkina Faso and Madagascar.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Sm-p80 + GLA-SE
Combination vaccine containing Sm-p80 antigen and GLA-SE adjuvant.

Locations

Country Name City State
Burkina Faso Groupe de Recherche Action en Santé (GRAS) Ouagadougou
Madagascar Madagascar Institute for Vaccine Research (University of Antananarivo) Antananarivo

Sponsors (1)

Lead Sponsor Collaborator
International Vaccine Institute

Countries where clinical trial is conducted

Burkina Faso,  Madagascar, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants with of any Serious Adverse Events (SAEs)/ adverse events of special interest (AESI) from the time of the first study vaccination through the final study visit. Day 1 through Day 224
Primary Proportion of participants with immediate adverse events (reactogenicity events) within 60 min from the time of each study vaccination Day 1 through Day 56
Primary Proportion of participants with solicited local and solicited systemic AEs as measured for 7 days (inclusive) following immunization with the three different dose formulations. Day 1 through Day 63
Primary Proportion of participants with unsolicited AEs from the time of vaccination until 28 days post immunization with the three different dose formulations. Day 1 through Day 84
Primary Proportion of participants with clinical safety laboratory adverse events measured at 7 days and 28 days after each study vaccination. Day 1 through Day 84
Secondary For Sm-p80 IgG antibodies, seroconversion rate at approximately 4 weeks (28 days) after each dose of study vaccination as compared to baseline Day 1 through Day 84
Secondary For Sm-p80 IgG antibodies, seroconversion rate at approximately 24 weeks after third dose of study vaccination as compared to baseline Day 1 through Day 224
Secondary Geometric Mean Titers (GMTs) of serum Sm-p80 IgG antibodies at approximately 4 weeks after each dose of study vaccination. Day 1 through Day 84
Secondary Geometric Mean Titers (GMTs) of serum Sm-p80 IgG antibodies at approximately 24 weeks after third dose of study vaccination. Day 1 through Day 224
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