Last updated: 02/18/2020 07:40:12

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

GSK study ID
205905
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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 in healthy adults previously primed with three doses of the same vaccine in study H03_01TP compared to 1 vaccination with (1790GAHB) administered intramuscularly either to subjects who received placebo in the H03_01TP study or naïve subjects who were not part of H03_01TP study
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Concentrations of immunoglobulin (IgG) against Lipopolysaccharide (LPS) S. sonnei O-antigen

Timeframe: At Day 8 (7 days after vaccination)

Secondary outcomes:

Number of subjects with abnormal haematological test values

Timeframe: At Day 8 (7 days after vaccination) and Day 85 (84 days after vaccination)

Number of subjects with solicited local adverse events

Timeframe: From 30 minutes through Day 7 post-vaccination

Number of subjects with solicited systemic adverse events

Timeframe: From 30 minutes through Day 7 post-vaccination

Number of subjects with unsolicited adverse events

Timeframe: Throughout the study period (From Day 1 up to Day 85)

Number of subjects with serious adverse events (SAEs)

Timeframe: Throughout the study period (from Day 1 up to Day 85)

Concentrations of IgG against LPS S. sonnei O-antigen

Timeframe: At Days 15, 29 and 85 (14, 28 and 84 days after vaccination)

Anti-LPS S. Sonnei IgG geometric mean ratios

Timeframe: At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination)

Percentage of subjects with seroresponse for anti-LPS S. sonnei

Timeframe: At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination)

Percentage of subjects with anti-LPS S. sonnei concentrations equal to or above (≥) 121 EU/mL

Timeframe: At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination)

Interventions:
  • Biological/vaccine: GVGH Shigella sonnei 1790GAHB vaccine
  • Enrollment:
    35
    Primary completion date:
    2017-31-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Launay O et al. (2019) Booster Vaccination With GVGH Shigella sonnei 1790GAHB GMMA Vaccine Compared to Single Vaccination in Unvaccinated Healthy European Adults: Results From a Phase 1 Clinical Trial. Front Immunol. 10:335.
    Medical condition
    Dysentery, Bacillary
    Product
    GSK3536852A
    Collaborators
    Not applicable
    Study date(s)
    March 2017 to August 2017
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    22 - 50 years
    Accepts healthy volunteers
    Yes
    • 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 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Paris, France, 75679
    Status
    Study Complete

    Study documents

    Statistical analysis plan
    Available language(s): English
    Protocol
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2017-31-08
    Actual study completion date
    2017-31-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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