Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults
Uganda290 participantsStarted 2019-10-07
Plain-language summary
The study will recruit up to 290 healthy adult males and non-pregnant females into a two-part clinical trial of a vaccine to protect against schistosomiasis caused by infection with S. mansoni. Two formulations of the Sm-TSP-2 vaccine will be tested: one using Alhydrogel® only, and one using Alhydrogel® plus AP 10-701, each at 3 different doses of antigen: 10mcg, 30mcg, and 100mcg.
The first part of the study will be a Phase I dose-escalation safety and immunogenicity study followed by a Phase IIb trial in which a larger number of adults will be enrolled to assess the impact of the vaccine on infection with S. mansoni. The impact of the vaccine on infection with S. haematobium will also be assessed although this will be exploratory given that potential cross-protection against this species is only hypothetical at this point.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide written informed consent prior to any study procedures.
. Able to understand and comply with planned study procedures and be available for all study visits.
. Male or non-pregnant female aged 18 to 45, inclusive at the time of enrollment.
. Are in good health, as determined by vital signs (oral temperature, pulse, and blood pressure), medical history, and brief physical examination at screening.
. Vital signs (oral temperature, pulse, and blood pressure) are all within normal protocol-defined ranges.
. Laboratory tests (alanine aminotransferase \[ALT\], creatinine, white blood cell count (WBC), hemoglobin, and platelets) are all within protocol-defined reference ranges.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Tolerability: frequency of local and systemic reactogenicity events
Timeframe: 7 days post-vaccination
2
Safety and Tolerability: frequency of unsolicited adverse events
Timeframe: 28 days post-vaccination
3
Safety and Tolerability: frequency of vaccine-related Serious Adverse Events
Timeframe: 23 months
4
Safety and Tolerability: frequency of clinical safety laboratory adverse events
Timeframe: 7 days post-vaccination
5
Safety and Tolerability: frequency of new-onset chronic medical conditions
Timeframe: 23 months
6
Efficacy: proportion of subjects with detectable S. mansoni eggs
. Urinalysis with no greater than trace protein and negative for glucose.
. Female subjects of childbearing potential must agree to practice highly effective contraception for a minimum of 30 days prior to first vaccination and for 30 days after last vaccination.
Exclusion criteria
. Has the intention to become pregnant within 5 months after enrollment in this study.
. Female subjects who are breastfeeding or plan to breastfeed at any given time from the first study vaccination until 30 days after their last study vaccination.
. Has an acute illness, including a documented oral temperature of 38.0°C or greater, within 72 hours prior to vaccination.
. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
. Is immunosuppressed as a result of an underlying illness or treatment.
. Using or intends to continue using oral or parenteral steroids, high-dose inhaled steroids (\>800 μg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
. Positive test for HIV infection.
. Volunteer has had a history of alcohol or illicit drug abuse during the past 23 months.
8
Efficacy: Proportion of subjects with a positive CAA test