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Cancer Vaccine
SchistoShield® Vaccine for Schistosomiasis
Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight >/= 50 kg and body mass index (BMI) < 35.0 kg/m2
Male or non-pregnant female 18 through 55 years of age, inclusive, at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28 through day 208
Awards & highlights
Study Summary
This trial is testing a new vaccine for safety, reactogenicity (side effects), and immunogenicity (how well it works) in adults. 45 people will get 3 shots of the vaccine 28 days apart. The primary objective is to assess the safety and reactogenicity of the vaccine.
Who is the study for?
Healthy adults aged 18-55 who are not pregnant, breastfeeding, or planning to become pregnant. They must be willing to use contraception and have normal vital signs and lab values. Excluded are those with past schistosomiasis infection, severe asthma, cardiovascular disease, psychiatric conditions that affect compliance, autoimmune diseases, immunodeficiencies, substance abuse issues affecting protocol adherence or health risks during the study.Check my eligibility
What is being tested?
The trial is testing a vaccine called Sm-p80+GLA-SE for schistosomiasis in healthy adults. Participants will receive three intramuscular injections of varying doses at different schedules over approximately 20 months to assess safety and immune response.See study design
What are the potential side effects?
Potential side effects may include typical reactions at the injection site such as pain or swelling, general symptoms like fever or fatigue following vaccination (reactogenicity), and any unexpected adverse events related to immune system activation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 50 kg and my BMI is under 35.
Select...
I am between 18 and 55 years old and not pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 28 through day 208
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28 through day 208
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of all unsolicited adverse events (AEs), regardless of the assessment of seriousness or relatedness.
Occurrence of clinical safety laboratory Adverse Events (AEs)
Occurrence of serious adverse events (SAEs), adverse events of special interests (AESIs), medically attended adverse events (MAAEs), and new onset chronic medical conditions (NOCMCs).
+2 moreSecondary outcome measures
Geometric mean titers of serum Sm-p80 IgG antibodies
Sm-p80 IgG antibodies, number of subjects achieving seroconversion.
Trial Design
5Treatment groups
Experimental Treatment
Group I: EExperimental Treatment1 Intervention
0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57. N=9.
Group II: DExperimental Treatment1 Intervention
0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57. N=9.
Group III: CExperimental Treatment1 Intervention
0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180. N=9.
Group IV: BExperimental Treatment1 Intervention
0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57. N=9
Group V: AExperimental Treatment1 Intervention
0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57. N=9
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,423 Total Patients Enrolled
6 Trials studying Schistosomiasis
4,949 Patients Enrolled for Schistosomiasis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a fever or been sick in the last three days.I weigh at least 50 kg and my BMI is under 35.I have diabetes.I have asthma that is not mild or is not well-controlled.I have a long-term or active brain condition.I haven't received blood products or donated blood recently.I have a history of heart disease, heart attack, or heart inflammation.I agree not to donate blood during the study.I plan to have surgery within six months after joining the study.I have had schistosomiasis or traveled to areas where it's common and may have been exposed.I have been treated for schistosomiasis.I haven't had, nor plan to have, any vaccines or allergy shots 14 days around my study injection.I am between 18 and 55 years old and not pregnant.I regularly use corticosteroid creams or pills.I haven't had and don't plan to get a live vaccine around the time of the study injection.I am willing and able to follow the study's procedures for its duration.I am not breastfeeding nor planning to breastfeed from the start of the study until 30 days after the last injection.I currently have active cancer.I have a weakened immune system due to a condition or treatment.
Research Study Groups:
This trial has the following groups:- Group 1: E
- Group 2: C
- Group 3: D
- Group 4: A
- Group 5: B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there availabilities for patients to enroll in this trial?
"Affirmative. Clinicaltrials.gov hosts data that confirms this research trial is actively seeking patients from one centre, with 45 individuals being sought out in total - the experiment was launched on May 23rd 2022 and last edited on September 21st 2022."
Answered by AI
Has the combination of Sm-p80 and GLA-SE been officially sanctioned by the FDA?
"The safety of Sm-p80 + GLA-SE has been assigned a score of 1 in our team's assessment due to its Phase 1 status, which indicates that there is limited data available suggesting the drug is efficacious and safe."
Answered by AI
Is the upper age limit for this trial fixed at 45 years?
"According to the criteria of this medical trial, potential participants must be 18 years or older and no more than 55."
Answered by AI
What is the current capacity for individuals to participate in this experimental research?
"Correct. The information on clinicaltrials.gov affirms that the trial is actively enrolling, having initially been posted on May 23rd 2022 and last updated on September 21st 2022; 45 participants are sought from one medical site."
Answered by AI
Do I have the credentials necessary to partake in this research?
"To be considered for this study, applicants must suffer from schistosomiasis and fit within the ages of 18-55. Around 45 people are needed to complete this trial."
Answered by AI
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