Clinical Trial: A Study to Evaluate Safety and Immunogenicity of 1 Booster Dose of 1790GAHB Vaccine in Healthy Adults Primed With 3 Doses of 1790GAHB Vaccine in Study H03_01TP Compared to 1 Vaccination of 1790GAHB in Either Subjects Who Received Placebo in the Same Study or naïve Subjects Not Part of H03_01TP Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1, Open Label, Non-randomized, Single Center Study to Evaluate the Safety and Immunogenicity of 1 Booster Vaccination With (GVGH Shigella Sonnei 1790GAHB) Vaccine Administered Intramuscularly

Brief Summary:

GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella sonnei.

A post-hoc analysis of subjects who participated in the parent study showed significantly different responses in subjects with detectable versus undetectable antibody titres at baseline, suggesting the possibility that the vaccine might not be sufficiently immunogenic in completely naïve adults.

This study was then designed to further characterize the immunogenicity profile of the vaccine and to evaluate whether it was able to induce an immunological memory response.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Immunoglobulin (IgG) concentrations against Shigella sonnei (S. sonnei) O antigen [ Time Frame: At Day 8 post-vaccination ]

Original Primary Outcome: Immunoglobulin (IgG) concentrations against Shigella sonnei (S. sonnei) O antigen [ Time Frame: At Day 8 post-vaccination ]

Current Secondary Outcome:

• Number of subjects with abnormal haematological test values [ Time Frame: At Screening, and from vaccination at Day 1 up to Day 85 post-vaccination ]
  Assessed haematological parameters are: white blood cells (WBC), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct), platelets (PLT), eosinophils (EOS), basophils (BAS), neutrophils (NEU), monocytes (MCT), lymphocytes (LYM) and prothrombin time (PTT). The latter is performed at the screening visit only for all subjects.
• Number of subjects with solicited local reactions [ Time Frame: During 7 days post-vaccination ]
  Assessed solicited local reactions include injection site erythema, injection site induration and injection site pain. Solicited local reactions are assessed using a scoring system as follows: grade 0 (absent) measuring 1-24 millimeters (mm) for injection site erythema/induration and presenting no pain at injection site. Grade 1 (mild) = measuring 25-50 mm for injection site erythema/induration and presenting pain that does not interfere with activity. Grade 2 (moderate) = measuring 51-100 mm for injection site erythema/induration and presenting pain that interferes with activities. Grade 3 (Severe) = measuring over > 100 mm for injection site erythema/induration and presenting pain that prevents daily activity.
• Number of subjects with solicited systemic reactions [ Time Frame: During 7 days post-vaccination ]
  Assessed solicited systemic reactions include headache, arthralgia, chills, fatigue, malaise, myalgia and oral fever. Solicited systemic reactions are assessed using a scoring system as follows: Grade 0 headache/arthralgia/chills/fatigue = symptoms absent. Grade 1 (mild) headache/arthralgia/chills = symptoms present but do not interfere with activity. Grade 1 (mild) fatigue = does not interfere with activity. Grade 2 (moderate) headache/arthralgia/chills = symptoms interfere with activity. Grade 2 (moderate) Fatigue = symptom has some interference with activity. Grade 3 (severe) headache/arthralgia/chills/fatigue = symptoms prevent daily activity.
• Number of subjects with unsolicited adverse events (AEs) [ Time Frame: From Screening up to study end at Day 85 ]
  An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject.
• Number of subjects with serious adverse events (SAEs) [ Time Frame: From screening up to study end at Day 85 ]
  A serious adverse event is defined as an untoward medical occurrence that any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, is a congenital anomaly/birth defect, or results in disability/incapacity.
• Concentrations of IgG against S. sonnei O-antigen [ Time Frame: At Day 8, 15, 29 and 85 post-vaccination ]
  Antibody concentrations expressed as Geometric Mean Concentrations (GMCs) as assessed by ELISA.
• Number of subjects with seroresponse for anti- S. sonnei LPS [ Time Frame: At Day 8, 15, 29 and 85 post-vaccination ]
  Seroresponse is defined as an increase of at least 50% in the post-vaccination sample as compared to baseline, if baseline value is greater than (>) 50 ELISA Units (EU) [(post-vac minus baseline/baseline)100% greater than or equal to (≥) 50%], or an increase of at least 25 EU in the post-vaccination sample as comparted to baseline, if baseline value is less or equal to (≤) 50 EU [(post-vac minus baseline)≥25 EU].
• Number of subjects with anti- S. sonnei LPS antibody concentrations ≥ assay cut-off value [ Time Frame: At Day 8, 15, 29 and 85 post-vaccination ]
  Antibody concentrations are assessed by ELISA, assay cut-off values are ≥ 121 EU/ millilitre (ml).

Original Secondary Outcome:

• Number of subjects with abnormal haematological test values [ Time Frame: At Screening, and from vaccination at Day 1 up to Day 85 post-vaccination ]
• Number of subjects with solicited local reactions [ Time Frame: During 7 days post-vaccination ]
• Number of subjects with solicited systemic reactions [ Time Frame: During 7 days post-vaccination ]
• Number of subjects with unsolicited adverse events (AEs) [ Time Frame: From Screening up to study end at Day 85 ]
• Number of subjects with serious adverse events (SAEs) [ Time Frame: From screening up to study end at Day 85 ]
• Concentrations of IgG against S. sonnei O-antigen [ Time Frame: At Day 8, 15, 29 and 85 post-vaccination ]
• Number of subjects with seroresponse for anti- S. sonnei LPS [ Time Frame: At Day 8, 15, 29 and 85 post-vaccination ]
• Number of subjects with anti- S. sonnei LPS antibody concentrations ≥ assay cut-off value [ Time Frame: At Day 8, 15, 29 and 85 post-vaccination ]

Dates:
Date Received: March 21, 2017
Date Started: March 16, 2017
Date Completion: August 11, 2017
Last Updated: April 24, 2017
Last Verified: April 2017