Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis

NCT01512277 | Completed Phase 1

• 3 other identifiers: CP97/10498002980056
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schistosomiasis; Bilharziasis; Urinary Schistosomiasis

Keywords

vaccines; safety; drug tolerance; immunogenic protein; antibody response; cytokine

Outcome Measures

Primary Outcomes (8)

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

  Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection. Complete physical examination including an examination of general appearance, body weight and rectal temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances

  D1 : administration, clinical observation, clinical analysis

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

  Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection. Complete physical examination including an examination of general appearance, body weight and rectal temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances

  D21 : clinical observation, clinical analysis

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

  Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection. Complete physical examination including an examination of general appearance, body weight and rectal temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances

  D28 : administration, clinical observation, clinical analysis

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

  Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection. Complete physical examination including an examination of general appearance, body weight and rectal temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances

  D29 : clinical observation, clinical analysis

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

  Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection. Complete physical examination including an examination of general appearance, body weight and rectal temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances

  D120 : clinical observation, clinical analysis

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

  Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection. Complete physical examination including an examination of general appearance, body weight and rectal temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances

  D150 : administration, clinical observation, clinical analysis

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

  Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection. Complete physical examination including an examination of general appearance, body weight and rectal temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances

  D165 : clinical observation, clinical analysis

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

  Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection. Complete physical examination including an examination of general appearance, body weight and rectal temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances

  D180 : clinical observation, clinical analysis

Secondary Outcomes (1)

• Immunogenicity

  Day of first administration and D21, D28, D29, D49, D120, D150, D165 and D180

Study Arms (3)

3 administrations of 100 µg of rSh28GST

EXPERIMENTAL

Adult volunteers (n=8) receive 100μg of rSh28GST together with aluminium hydroxide (Alum) as adjuvant at D0, D28, and D150.

Biological: rSh28GST

2 administrations of 300 µg of rSh28GST

EXPERIMENTAL

Adult volunteers (n=8) receive 300μg of rSh28GST together with aluminium hydroxide (Alum) as adjuvant at D0 and D28.

Biological: rSh28GST

Placebo

PLACEBO COMPARATOR

Adult volunteers (n=8) receive aluminium hydroxide (Alum) alone at D0 and D28.

Biological: rSh28GST

Interventions

rSh28GST BIOLOGICAL

subcutaneous route at Day 0, Day 28, and Day 150 for the third administration of 100µg for Arm 1

Also known as: Bilhvax

2 administrations of 300 µg of rSh28GST; 3 administrations of 100 µg of rSh28GST; Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian volunteers
• No smoker
• biological parameters (haematological, biochemical, renal and hepatic) in normal range
• Health Insurance
• sign inform consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Centre d'Investigation Clinique - CHRU de Lille

Lille, 59000, France

Location

Related Publications (4)

• Capron A, Riveau G, Capron M, Trottein F. Schistosomes: the road from host-parasite interactions to vaccines in clinical trials. Trends Parasitol. 2005 Mar;21(3):143-9. doi: 10.1016/j.pt.2005.01.003.

  PMID: 15734662 BACKGROUND

• Capron A, Riveau GJ, Bartley PB, McManus DP. Prospects for a schistosome vaccine. Curr Drug Targets Immune Endocr Metabol Disord. 2002 Oct;2(3):281-90. doi: 10.2174/1568008023340587.

  PMID: 12476492 BACKGROUND

• Capron A, Capron M, Riveau G. Vaccine development against schistosomiasis from concepts to clinical trials. Br Med Bull. 2002;62:139-48. doi: 10.1093/bmb/62.1.139.

  PMID: 12176856 BACKGROUND

• Riveau G, Deplanque D, Remoue F, Schacht AM, Vodougnon H, Capron M, Thiry M, Martial J, Libersa C, Capron A. Safety and immunogenicity of rSh28GST antigen in humans: phase 1 randomized clinical study of a vaccine candidate against urinary schistosomiasis. PLoS Negl Trop Dis. 2012;6(7):e1704. doi: 10.1371/journal.pntd.0001704. Epub 2012 Jul 3.

  PMID: 22802974 RESULT

MeSH Terms

Conditions

Schistosomiasis; Schistosomiasis haematobia

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases; Urinary Tract Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• André CAPRON, MD

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

• Gilles RIVEAU, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

• Christian LIBERSA, MD

  CIC, University Hospital, Lille

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 19, 2012
• Study Start: September 1, 1998
• Primary Completion: March 1, 1999
• Study Completion: September 1, 1999
• Last Updated: August 27, 2013

Record last verified: 2013-08

Locations

FR (1)