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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2017-31-08
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
Completed
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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