Bilhvax1a
Phase 1 Study Evaluating Safety and Immunological Criteria of Efficacy of the Recombinant Vaccine Candidate Bilhvax Against Schistosomiasis
Sponsor study identifier
Secondary identifiers
OTHER · Sponsor
OTHER · DGS
interventional
24
1 country
1
Study Start
September 1998
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 1999
Actual (reported)Study Completion
September 1999
Actual (reported)The purpose of this clinical study is to evaluate safety and immunogenicity in adult healthy volunteers of the vaccine candidate against schistosomiasis named Bilhvax.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1999
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1998
Date type not reportedThis date has not been verified as actual or estimated.
March 1999
Actual (reported)September 1999
Actual (reported)January 9, 2012
Actual (reported)January 19, 2012
Actual (reported)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
Adult volunteers (n=8) receive 100μg of rSh28GST together with aluminium hydroxide (Alum) as adjuvant at D0, D28, and D150.
Adult volunteers (n=8) receive 300μg of rSh28GST together with aluminium hydroxide (Alum) as adjuvant at D0 and D28.
Adult volunteers (n=8) receive aluminium hydroxide (Alum) alone at D0 and D28.
subcutaneous route at Day 0, Day 28, and Day 150 for the third administration of 100µg for Arm 1
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centre d'Investigation Clinique - CHRU de Lille
Lille, 59000, France
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.
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.
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.
André CAPRON, MD
Institut National de la Santé Et de la Recherche Médicale, France
Gilles RIVEAU, PhD
Institut National de la Santé Et de la Recherche Médicale, France
Christian LIBERSA, MD
CIC, University Hospital, Lille
24 participants (actual enrollment reported by the registry).
First Submitted
January 9, 2012
First Posted
January 19, 2012
Study Start
September 1998
Date type not reportedThis date has not been verified as actual or estimated.
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
Immunogenicity
Day of first administration and D21, D28, D29, D49, D120, D150, D165 and D180
Contact the study team to confirm eligibility.
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.
Primary Completion
March 1999
Actual (reported)Study Completion
September 1999
Actual (reported)Last Updated
August 27, 2013
Record last verified: 2013-08
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Source: ClinicalTrials.gov.
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