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.

International Vaccine Institute0 sites120 target enrollmentFebruary 10, 2023

Overview

No summary available.

Registry

who.int

Start Date

February 10, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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).

•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