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.
- Conditions
- Schistosomiasis
- Registration Number
- PACTR202307901658960
- Lead Sponsor
- International Vaccine Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. 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.<br>[Time Frame: Day 1 through Day 224]<br>2. Proportion of participants with immediate adverse events (reactogenicity events) within 60 min from the time of each study vaccination<br>[Time Frame: Day 1 through Day 56]<br>3. Proportion of participants with solicited local and solicited systemic AEs as measured for 7 days (inclusive) following immunization with the three different dose formulations.<br>[Time Frame: Day 1 through Day 63]<br>4. Proportion of participants with unsolicited AEs from the time of vaccination until 28 days post immunization with the three different dose formulations.<br>[Time Frame: Day 1 through Day 84]<br>5. Proportion of participants with clinical safety laboratory adverse events measured at 7 days and 28 days after each study vaccination.<br>[Time Frame: Day 1 through Day 84]
- Secondary Outcome Measures
Name Time Method 6. For Sm-p80 IgG antibodies, seroconversion rate at approximately 4 weeks (28 days) after each dose of study vaccination as compared to baseline<br>[Time Frame: Day 1 through Day 84]<br>7. For Sm-p80 IgG antibodies, seroconversion rate at approximately 24 weeks after third dose of study vaccination as compared to baseline<br>[Time Frame: Day 1 through Day 224]<br>8. Geometric Mean Titers (GMTs) of serum Sm-p80 IgG antibodies at approximately 4 weeks after each dose of study vaccination.<br>[Time Frame: Day 1 through Day 84]<br>9. Geometric Mean Titers (GMTs) of serum Sm-p80 IgG antibodies at approximately 24 weeks after third dose of study vaccination.<br>[Time Frame: Day 1 through Day 224]