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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar

Primary Purpose

Schistosomiasis

Status
Not yet recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Sm-p80 + GLA-SE
Sponsored by
International Vaccine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schistosomiasis focused on measuring Vaccine, Schistosomiasis

Eligibility Criteria

20 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy male or female participants aged 20 to 59 years at the time of consent. Participant who has completed the deworming using praziquantel (PZQ) and albendazole (ABZ) according to local guidelines, with the last dose of PZQ/ABZ administered at least 5 weeks prior to first dose of study product. Participant who, after the nature of the study has been explained, has voluntarily given informed consent, according to the local regulatory requirements, prior to study entry. Participant who can comply with the study procedures and available for the entire duration of the study (32 weeks). Individuals in good health as determined by the outcome of medical history, physical examination, hematology and biochemistry tests at the time of screening and the clinical judgment of the investigator. Women of childbearing potential* with negative urinary test result on a human chorionic gonadotropin pregnancy test on the day of randomization, before receiving any study product. Males or females of childbearing potential who are using an effective birth control method recommended by the national health system for at least four (4) weeks before the first vaccination (for female participants only) and up to four (4) weeks after the third vaccination (i.e., for at least 4 months). Exclusion Criteria: Participant with major congenital abnormalities which in the opinion of investigator may affect the subject's participation in the study. Participant concomitantly enrolled or scheduled to be enrolled in another trial. Positive rapid test for HIV 1-2 confirmed by a positive blood test for human immunodeficiency virus (positive antibodies to HIV 1/2). Participant seropositive for hepatitis B virus surface antigen (HBsAg). Participant seropositive for hepatitis C virus (Antibodies to HCV). Participant with active or chronic Schistosomiasis infection defined by a positive result for microscopy (Urine filtration, Kato-Katz (KK)) and point-of-care - circulating cathodic antigen (POC -CCA) and/or real-time PCR. Participant with soiled transmitted helminths infections (STH) as diagnosed by microscopy (KK) and/or real-time PCR. Participant with malaria infection/malaria as diagnosed by the blood smear. Any other confirmed or suspected immunosuppressive or immunodeficient state such as asplenia, recurrent severe infections. Body mass index (BMI) ≥ 35 kg/m2 Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisolone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs. Receipt of blood or blood-derived products in the past 3 months. Participant who has received other vaccines 4 weeks prior to test vaccination or plans to receive any vaccine within 4 weeks of last dose of study vaccine, exception made for COVID-19 vaccines. Known history of allergy to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for IM injections/blood extractions. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives and compromise the health of the volunteers. Any female participant who is lactating*, pregnant or planning for pregnancy** during the course of study period. Individuals with behavioral or cognitive impairment or psychiatric disease or neural disorders that, in the opinion of the investigator, could interfere with the individual's ability to participate in the trial. Any clinically significant abnormal finding on serum chemistry or hematology or urinalysis at the screening visit as per US FDA toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (any biological finding grade 4 constitutes an exclusion criteria). Individuals who were research staff involved with the clinical study or family/household members of research staff. As per Investigator's medical judgement individual could be excluded from the study despite meeting all inclusion/exclusion criteria mentioned above.

Sites / Locations

  • Groupe de Recherche Action en Santé (GRAS)
  • Madagascar Institute for Vaccine Research (University of Antananarivo)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort A

Cohort B

Cohort C

Arm Description

Cohort A will receive the low-dose antigen formulation(10 μg Sm-p80 + 5 μg GLA-SE) or placebo. Cohort will include 20 participants randomized to receive either Sm-p80 product or placebo in a 3:1 ratio. All participants will receive three intramuscular injections of 0.5 mL of the designated study product / placebo, on Days 0, 28, and 56 (28 days apart).

Cohort B will receive the low-dose antigen formulation(30 μg Sm-p80 + 5 μg GLA-SE) or placebo. Cohort will include 20 participants randomized to receive either Sm-p80 product or placebo in a 3:1 ratio. All participants will receive three intramuscular injections of 0.5 mL of the designated study product / placebo, on Days 0, 28, and 56 (28 days apart).

Cohort C will receive the low-dose antigen formulation(100 μg Sm-p80 + 5 μg GLA-SE) or placebo. Cohort will include 20 participants randomized to receive either Sm-p80 product or placebo in a 3:1 ratio. All participants will receive three intramuscular injections of 0.5 mL of the designated study product / placebo, on Days 0, 28, and 56 (28 days apart).

Outcomes

Primary Outcome Measures

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.
Proportion of participants with immediate adverse events (reactogenicity events) within 60 min from the time of each study vaccination
Proportion of participants with solicited local and solicited systemic AEs as measured for 7 days (inclusive) following immunization with the three different dose formulations.
Proportion of participants with unsolicited AEs from the time of vaccination until 28 days post immunization with the three different dose formulations.
Proportion of participants with clinical safety laboratory adverse events measured at 7 days and 28 days after each study vaccination.

Secondary Outcome Measures

For Sm-p80 IgG antibodies, seroconversion rate at approximately 4 weeks (28 days) after each dose of study vaccination as compared to baseline
For Sm-p80 IgG antibodies, seroconversion rate at approximately 24 weeks after third dose of study vaccination as compared to baseline
Geometric Mean Titers (GMTs) of serum Sm-p80 IgG antibodies at approximately 4 weeks after each dose of study vaccination.
Geometric Mean Titers (GMTs) of serum Sm-p80 IgG antibodies at approximately 24 weeks after third dose of study vaccination.

Full Information

First Posted
February 28, 2023
Last Updated
March 17, 2023
Sponsor
International Vaccine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05762393
Brief Title
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar
Official Title
A Phase 1b, Multicenter, Randomized, Placebo-controlled, Observer-blinded, Dose-escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Vaccine Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This is a phase 1b, multicenter, randomized, placebo-controlled, observer-blinded, dose-escalation study, assessing 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), as shown in the Table 1, below. 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). To ensure that the study participants at enrollment do not have any active schistosomiasis or helminth infection and are schistosomiasis egg-negative, pre-screening activities including schistosomiasis treatment will be carried out in potential study participants prior to enrollment. Potential study participants will be identified in the catchment population and will be offered anti-helminth treatment using praziquantel (PZQ) and Albendazole (ABZ) as per local guidelines at study site. The pre-screening visit will be conducted 6-8 weeks before the screening visit. The last dose of PZQ/ABZ will be administered at least 5 weeks prior to the first dose of study product. The Primary objective 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 20 to 59 years of age in Burkina Faso and Madagascar. The Secondary objective is to evaluate the immunogenicity of 3 different dose formulations (low dose, medium dose, and high dose) of SchistoShield® vaccine 28 days post-vaccination on D28, D56, and D84 as compared with the baseline and with those who received placebo. The Exploratory objective is to describe the antigen-specific B- and T-cell responses, memory responses, and innate and adaptive immune signatures from samples collected at specified timepoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schistosomiasis
Keywords
Vaccine, Schistosomiasis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The PI, study staff, and participants will be blinded as to receipt of study vaccine or placebo. The unblinded pharmacy staff preparing the study product syringes and the unblinded study nurse who is administering the product will not be involved in the safety assessment of participants and will be instructed not to comment on the experimental agent to study staff.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Experimental
Arm Description
Cohort A will receive the low-dose antigen formulation(10 μg Sm-p80 + 5 μg GLA-SE) or placebo. Cohort will include 20 participants randomized to receive either Sm-p80 product or placebo in a 3:1 ratio. All participants will receive three intramuscular injections of 0.5 mL of the designated study product / placebo, on Days 0, 28, and 56 (28 days apart).
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
Cohort B will receive the low-dose antigen formulation(30 μg Sm-p80 + 5 μg GLA-SE) or placebo. Cohort will include 20 participants randomized to receive either Sm-p80 product or placebo in a 3:1 ratio. All participants will receive three intramuscular injections of 0.5 mL of the designated study product / placebo, on Days 0, 28, and 56 (28 days apart).
Arm Title
Cohort C
Arm Type
Experimental
Arm Description
Cohort C will receive the low-dose antigen formulation(100 μg Sm-p80 + 5 μg GLA-SE) or placebo. Cohort will include 20 participants randomized to receive either Sm-p80 product or placebo in a 3:1 ratio. All participants will receive three intramuscular injections of 0.5 mL of the designated study product / placebo, on Days 0, 28, and 56 (28 days apart).
Intervention Type
Biological
Intervention Name(s)
Sm-p80 + GLA-SE
Intervention Description
Combination vaccine containing Sm-p80 antigen and GLA-SE adjuvant.
Primary Outcome Measure Information:
Title
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.
Time Frame
Day 1 through Day 224
Title
Proportion of participants with immediate adverse events (reactogenicity events) within 60 min from the time of each study vaccination
Time Frame
Day 1 through Day 56
Title
Proportion of participants with solicited local and solicited systemic AEs as measured for 7 days (inclusive) following immunization with the three different dose formulations.
Time Frame
Day 1 through Day 63
Title
Proportion of participants with unsolicited AEs from the time of vaccination until 28 days post immunization with the three different dose formulations.
Time Frame
Day 1 through Day 84
Title
Proportion of participants with clinical safety laboratory adverse events measured at 7 days and 28 days after each study vaccination.
Time Frame
Day 1 through Day 84
Secondary Outcome Measure Information:
Title
For Sm-p80 IgG antibodies, seroconversion rate at approximately 4 weeks (28 days) after each dose of study vaccination as compared to baseline
Time Frame
Day 1 through Day 84
Title
For Sm-p80 IgG antibodies, seroconversion rate at approximately 24 weeks after third dose of study vaccination as compared to baseline
Time Frame
Day 1 through Day 224
Title
Geometric Mean Titers (GMTs) of serum Sm-p80 IgG antibodies at approximately 4 weeks after each dose of study vaccination.
Time Frame
Day 1 through Day 84
Title
Geometric Mean Titers (GMTs) of serum Sm-p80 IgG antibodies at approximately 24 weeks after third dose of study vaccination.
Time Frame
Day 1 through Day 224

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male or female participants aged 20 to 59 years at the time of consent. Participant who has completed the deworming using praziquantel (PZQ) and albendazole (ABZ) according to local guidelines, with the last dose of PZQ/ABZ administered at least 5 weeks prior to first dose of study product. Participant who, after the nature of the study has been explained, has voluntarily given informed consent, according to the local regulatory requirements, prior to study entry. Participant who can comply with the study procedures and available for the entire duration of the study (32 weeks). Individuals in good health as determined by the outcome of medical history, physical examination, hematology and biochemistry tests at the time of screening and the clinical judgment of the investigator. Women of childbearing potential* with negative urinary test result on a human chorionic gonadotropin pregnancy test on the day of randomization, before receiving any study product. Males or females of childbearing potential who are using an effective birth control method recommended by the national health system for at least four (4) weeks before the first vaccination (for female participants only) and up to four (4) weeks after the third vaccination (i.e., for at least 4 months). Exclusion Criteria: Participant with major congenital abnormalities which in the opinion of investigator may affect the subject's participation in the study. Participant concomitantly enrolled or scheduled to be enrolled in another trial. Positive rapid test for HIV 1-2 confirmed by a positive blood test for human immunodeficiency virus (positive antibodies to HIV 1/2). Participant seropositive for hepatitis B virus surface antigen (HBsAg). Participant seropositive for hepatitis C virus (Antibodies to HCV). Participant with active or chronic Schistosomiasis infection defined by a positive result for microscopy (Urine filtration, Kato-Katz (KK)) and point-of-care - circulating cathodic antigen (POC -CCA) and/or real-time PCR. Participant with soiled transmitted helminths infections (STH) as diagnosed by microscopy (KK) and/or real-time PCR. Participant with malaria infection/malaria as diagnosed by the blood smear. Any other confirmed or suspected immunosuppressive or immunodeficient state such as asplenia, recurrent severe infections. Body mass index (BMI) ≥ 35 kg/m2 Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisolone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs. Receipt of blood or blood-derived products in the past 3 months. Participant who has received other vaccines 4 weeks prior to test vaccination or plans to receive any vaccine within 4 weeks of last dose of study vaccine, exception made for COVID-19 vaccines. Known history of allergy to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for IM injections/blood extractions. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives and compromise the health of the volunteers. Any female participant who is lactating*, pregnant or planning for pregnancy** during the course of study period. Individuals with behavioral or cognitive impairment or psychiatric disease or neural disorders that, in the opinion of the investigator, could interfere with the individual's ability to participate in the trial. Any clinically significant abnormal finding on serum chemistry or hematology or urinalysis at the screening visit as per US FDA toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (any biological finding grade 4 constitutes an exclusion criteria). Individuals who were research staff involved with the clinical study or family/household members of research staff. As per Investigator's medical judgement individual could be excluded from the study despite meeting all inclusion/exclusion criteria mentioned above.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florian Marks
Phone
+447402515431
Email
fmarks@ivi.int
First Name & Middle Initial & Last Name or Official Title & Degree
Birkneh Tadesse
Phone
+8228811231
Email
Birkneh.Tadesse@ivi.int
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Marks
Organizational Affiliation
International Vaccine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe de Recherche Action en Santé (GRAS)
City
Ouagadougou
Country
Burkina Faso
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sodiomon Bienvenu Sirima
Phone
+22625355690
Email
gras@fasonet.bf
Facility Name
Madagascar Institute for Vaccine Research (University of Antananarivo)
City
Antananarivo
Country
Madagascar
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphaël Rakotozandrindrainy
Phone
+261320210812
Email
Rakrapha13@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar

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