CompletedPhase 1

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

Brazil60 participantsStarted 2018-05-20

Plain-language summary

The study will be conducted as a randomized, controlled, double blind Phase 1b dose-escalating clinical trial in up to 60 healthy adult males and non-pregnant females living in the S. mansoni-endemic area of Americaninhas, Brazil. The primary objective of this trial is to assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel(R) (10mcg, 30mcg, or 100mcg) vaccine with or without AP 10-701 given as three doses administered on Days 1, 57, and 113.

Who can participate

Age range

18 Years – 50 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 50, 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.

Exclusion criteria

. Vital signs (oral temperature, pulse, and blood pressure) are all within normal protocol-defined ranges.
The normal protocol-defined ranges for vital signs include (a) oral temperature less than 38.0 degrees celsius, (b) pulse 50 to 100 bpm, inclusive, (c) systolic blood pressure 85 to 150 mmHg, inclusive, and (d) diastolic blood pressure 55 to 90 mmHg, inclusive. Pulse rate \<50 is acceptable for 2nd and 3rd vaccinations if the subject is otherwise healthy with documented sinus bradycardia at baseline.

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

The occurrence of new-onset chronic medical conditions (including AESI)

Timeframe: From Day 1 to Day 478

The occurrence of solicited injection site reactogenicity

Timeframe: From Day 1 to Day 7

The occurrence of solicited injection site reactogenicity

Timeframe: From Day 113 to Day 120

The occurrence of solicited injection site reactogenicity

Timeframe: From Day 57 to Day 64

The occurrence of solicited systemic reactogenicity

Timeframe: From Day 1 to Day 7

The occurrence of solicited systemic reactogenicity

Timeframe: From Day 113 to Day 120

The occurrence of solicited systemic reactogenicity

Timeframe: From Day 57 to Day 64

Trial details

NCT IDNCT03110757

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2019-11-14

View on ClinicalTrials.gov More Schistosomiasis trials

Plain-language summary

Who can participate

Age range

18 Years – 50 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 50, 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.

Exclusion criteria

. Vital signs (oral temperature, pulse, and blood pressure) are all within normal protocol-defined ranges.
The normal protocol-defined ranges for vital signs include (a) oral temperature less than 38.0 degrees celsius, (b) pulse 50 to 100 bpm, inclusive, (c) systolic blood pressure 85 to 150 mmHg, inclusive, and (d) diastolic blood pressure 55 to 90 mmHg, inclusive. Pulse rate \<50 is acceptable for 2nd and 3rd vaccinations if the subject is otherwise healthy with documented sinus bradycardia at baseline.

What they're measuring

The occurrence of new-onset chronic medical conditions (including AESI)

Timeframe: From Day 1 to Day 478

The occurrence of solicited injection site reactogenicity

Timeframe: From Day 1 to Day 7

The occurrence of solicited injection site reactogenicity

Timeframe: From Day 113 to Day 120

The occurrence of solicited injection site reactogenicity

Timeframe: From Day 57 to Day 64

The occurrence of solicited systemic reactogenicity

Timeframe: From Day 1 to Day 7

The occurrence of solicited systemic reactogenicity

Timeframe: From Day 113 to Day 120

The occurrence of solicited systemic reactogenicity

Timeframe: From Day 57 to Day 64