Clinical Trials Logo

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:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 1, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 59 Years
Eligibility Inclusion Criteria: 1. Healthy male or female participants aged 20 to 59 years at the time of consent. 2. 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. 3. 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. 4. Participant who can comply with the study procedures and available for the entire duration of the study (32 weeks). 5. 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. 6. 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. 7. 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: 1. Participant with major congenital abnormalities which in the opinion of investigator may affect the subject's participation in the study. 2. Participant concomitantly enrolled or scheduled to be enrolled in another trial. 3. Positive rapid test for HIV 1-2 confirmed by a positive blood test for human immunodeficiency virus (positive antibodies to HIV 1/2). 4. Participant seropositive for hepatitis B virus surface antigen (HBsAg). 5. Participant seropositive for hepatitis C virus (Antibodies to HCV). 6. 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. 7. Participant with soiled transmitted helminths infections (STH) as diagnosed by microscopy (KK) and/or real-time PCR. 8. Participant with malaria infection/malaria as diagnosed by the blood smear. 9. Any other confirmed or suspected immunosuppressive or immunodeficient state such as asplenia, recurrent severe infections. 10. Body mass index (BMI) = 35 kg/m2 11. 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. 12. Receipt of blood or blood-derived products in the past 3 months. 13. 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. 14. 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. 15. 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. 16. 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. 17. Any female participant who is lactating*, pregnant or planning for pregnancy** during the course of study period. 18. 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. 19. 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). 20. Individuals who were research staff involved with the clinical study or family/household members of research staff. 21. As per Investigator's medical judgement individual could be excluded from the study despite meeting all inclusion/exclusion criteria mentioned above.

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
See also
  Status Clinical Trial Phase
Completed NCT04115072 - Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study Phase 2/Phase 3
Not yet recruiting NCT05999825 - Sm-p80 Schistosomiasis Challenge Study Phase 2
Completed NCT00463931 - Using Community-Based Volunteers to Reach Non-Enrolled School Aged Children Through Community-Directed Treatment of Schistosomiasis in School-Aged Children in Rural Northern Ghana N/A
Completed NCT00215267 - The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda N/A
Completed NCT00276224 - Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia N/A
Completed NCT03845140 - L-PZQ ODT in Schistosoma Infected Children Phase 3
Completed NCT01512277 - Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis Phase 1
Active, not recruiting NCT03910972 - Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults Phase 1/Phase 2
Completed NCT05085470 - Repeated Controlled Human Schistosoma Mansoni Infection N/A
Completed NCT02755324 - Single-sex Controlled Human Schistosomiasis Infection: Safety and Dose Finding N/A
Recruiting NCT05868005 - Delivering a Multi-disease Screening Tool to Migrant Populations N/A
Active, not recruiting NCT01869465 - Evaluation of Strategies for Improved Uptake of Preventive Treatment for Intestinal Schistosomiasis N/A
Completed NCT01553552 - Schistosomiasis Effect on Response to Vaccines, Anaemia and Nutritional Status of Children of Northern Senegal N/A
Recruiting NCT04589390 - Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension Phase 2
Completed NCT02868385 - Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST) Phase 3
Not yet recruiting NCT06182176 - Effectiveness and Cost-effectiveness of Integrated Model for Malaria and Helminth Control N/A
Completed NCT05292391 - Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults Phase 1
Completed NCT03110757 - A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults Phase 1
Completed NCT01154049 - Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis Phase 1
Active, not recruiting NCT05354258 - Feasibility and Safety of Combining Anti-malarial With Deworming Drugs in African Children N/A