Phase 1
N=35
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
Dysentery, Bacillary
Bottom Line
View on ClinicalTrials.gov: NCT03089879 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Concentrations of Immunoglobulin (IgG) Against Lipopolysaccharide (LPS) S. Sonnei O-antigen — 168; 5.17; 38 EU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- GVGH Shigella sonnei 1790GAHB vaccine (Biological)
- Age
- Adult · 22+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentrations of Immunoglobulin (IgG) Against Lipopolysaccharide (LPS) S. Sonnei O-antigen |
168; 5.17; 38 | — |
| SECONDARY Number of Subjects With Abnormal Haematological Test Values |
0; 0; 7; 28; 0; 0 | — |
| SECONDARY Number of Subjects With Solicited Local Adverse Events |
1; 0; 0; 1; 6; 24 | — |
| SECONDARY Number of Subjects With Solicited Systemic Adverse Events |
1; 3; 1; 1; 3; 11 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events |
4; 7; 0; 0; 0; 1 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
0; 0 | — |
| SECONDARY Concentrations of IgG Against LPS S. Sonnei O-antigen |
883; 36; 106; 623; 35; 110 | — |
| SECONDARY Anti-LPS S. Sonnei IgG Geometric Mean Ratios |
6.87; 1.49; 2.32; 36; 10; 6.88 | — |
| SECONDARY Percentage of Subjects With Seroresponse for Anti-LPS S. Sonnei |
86; 0; 26; 100; 50; 72 | — |
| SECONDARY Percentage of Subjects With Anti-LPS S. Sonnei Concentrations Equal to or Above (≥) 121 EU/mL |
71; 0; 30; 86; 0; 40 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Males and females, aged 22 to 50 years, who were previously vaccinated, with either vaccine (3 doses) or placebo, in H03\_01TP and who had undetectable antibody titers at baseline, or Males and females, aged 22 to 50 years, who were not part of H03\_01TP.
- Individuals who, after the nature of the study has been explained to them, and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements.
- Individuals in good health as determined by the outcome of medical history, physical examination, hematological blood tests and clinical judgment of the investigator.
- If women of child-bearing potential, have a negative urinary pregnancy test prior study vaccination and willingness to use acceptable birth control measures for the entire study duration.
- Individuals affiliated to a social security regimen.
Exclusion Criteria
- Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
- Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
- Individuals who are not able to understand and to follow all required study procedures for the whole period of the study.
- Individuals with known hepatitis B or C or suspected HIV infection or HIV related disease with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system.
- Progressive, unstable or uncontrolled clinical conditions.
- Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
- Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- Abnormal function of the immune system resulting from:
- Clinical conditions;
- Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to informed consent;
- Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
- Received immunoglobulins or any blood products within 180 days prior to informed consent.
- Study personnel as an immediate family or household member.
- Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
- Individuals who have received an investigational product in another clinical trial 28 days prior to first study visit or intent to receive another investigational product at any time during the conduct of this study.
- Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within the entire study duration. Inactivated influenza vaccine can be given, but only 4 weeks earlier or 4 weeks later than the date of immunization.
- Individuals who have received blood, blood products, and/or plasma derivatives including parenteral immunoglobulin preparations in the past 180 days.
- Individuals with body temperature > 38.0 degrees Celsius within 3 days of intended study vaccination.
- Individuals with Body Mass Index > 30 kg/m2.
- Individuals with history of substance or alcohol abuse within the past 2 years.
- Women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study.
- Females with history of stillbirth, neonatal loss, or previous infant with anomaly.
- Individuals who have a previously laboratory confirmed or suspected disease caused by S. sonnei.
- Individuals who have had household contact with/and or intimate exposure to an indi
Data sourced from ClinicalTrials.gov (NCT03089879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.