CompletedPhase 1

Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis

France24 participantsStarted 1998-09

Plain-language summary

The purpose of this clinical study is to evaluate safety and immunogenicity in adult healthy volunteers of the vaccine candidate against schistosomiasis named Bilhvax.

Who can participate

Age range

18 Years – 30 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

All subjects had to meet the study inclusion criteria within 21 days prior to treatment, Inclusion Criteria: * Caucasian volunteers * No smoker * biological parameters (haematological, biochemical, renal and hepatic) in normal range * Health Insurance * sign inform consent Exclusion Criteria: * inflammatory or immunological pathology such as atopic diseases, evidence of inflammation or acute infection (including positive serology to viral hepatitis B and C or HIV) * any immunological deficiency * any clinically relevant alcohol or drug use (cannabis, opiates, cocaine, amphetamines, benzodiazepines, nicotine, barbiturates, meprobamate or antidepressant drugs according to urine drug and metabolites screen) * current immunosuppressor treatment * any other medication use within 2 weeks before the study * any vaccination within the last 6 months * no antibodies against Sh28GST protein.

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

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: D1 : administration, clinical observation, clinical analysis

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: D21 : clinical observation, clinical analysis

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: D28 : administration, clinical observation, clinical analysis

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: D29 : clinical observation, clinical analysis

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: D120 : clinical observation, clinical analysis

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: D150 : administration, clinical observation, clinical analysis

Trial details

NCT IDNCT01512277

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion1999-03

View on ClinicalTrials.gov More Schistosomiasis trials

Who can participate

Age range

18 Years – 30 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: D1 : administration, clinical observation, clinical analysis

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: D21 : clinical observation, clinical analysis

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: D28 : administration, clinical observation, clinical analysis

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: D29 : clinical observation, clinical analysis

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: D120 : clinical observation, clinical analysis

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: D150 : administration, clinical observation, clinical analysis