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

NCT03089879 | Completed Phase 1 Results

• 2 other identifiers: 2059052016-004178-16
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysentery, Bacillary

Keywords

Immunogenicity, Vaccine; Immunologic Memory; GMMA; Shigella Vaccines; Shigellosis; Dysentery, Bacillary; Healthy Volunteers; Safety; Bacteria; Clinical Trials, Phase 1; Shigella sonnei

Outcome Measures

Primary Outcomes (1)

• Concentrations of Immunoglobulin (IgG) Against Lipopolysaccharide (LPS) S. Sonnei O-antigen

  IgG concentrations are expressed as Geometric Mean Concentrations (GMCs), as determined by the Enzyme-linked immunosorbent assay (ELISA) with Shigella sonnei (S.sonnei) O-antigen containing Lipopolysaccharide (LPS) coating antigen. Concentrations are presented as GMCs expressed in ELISA units per milliliter (EU/mL).

  At Day 8 (7 days after vaccination)

Secondary Outcomes (9)

• Number of Subjects With Abnormal Haematological Test Values

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

• Number of Subjects With Solicited Local Adverse Events

  From 30 minutes through Day 7 post-vaccination

• Number of Subjects With Solicited Systemic Adverse Events

  From 30 minutes through Day 7 post-vaccination

• Number of Subjects With Unsolicited Adverse Events

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

• Number of Subjects With Serious Adverse Events (SAEs)

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

Study Arms (3)

Shigella Group

EXPERIMENTAL

Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.

Biological: GVGH Shigella sonnei 1790GAHB vaccine

Placebo Group

EXPERIMENTAL

Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.

Biological: GVGH Shigella sonnei 1790GAHB vaccine

Naïve Group

EXPERIMENTAL

Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.

Biological: GVGH Shigella sonnei 1790GAHB vaccine

Interventions

GVGH Shigella sonnei 1790GAHB vaccine BIOLOGICAL

Single dose administered at Day 1, by intramuscular injection.

Naïve Group; Placebo Group; Shigella Group

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Paris, 75679, France

Location

Related Publications (2)

• Launay O, Ndiaye AGW, Conti V, Loulergue P, Scire AS, Landre AM, Ferruzzi P, Nedjaai N, Schutte LD, Auerbach J, Marchetti E, Saul A, Martin LB, Podda A. 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. 2019 Mar 8;10:335. doi: 10.3389/fimmu.2019.00335. eCollection 2019.

  PMID: 30906291 BACKGROUND

• Micoli F, Rossi O, Conti V, Launay O, Scire AS, Aruta MG, Nakakana UN, Marchetti E, Rappuoli R, Saul A, Martin LB, Necchi F, Podda A. Antibodies Elicited by the Shigella sonnei GMMA Vaccine in Adults Trigger Complement-Mediated Serum Bactericidal Activity: Results From a Phase 1 Dose Escalation Trial Followed by a Booster Extension. Front Immunol. 2021 May 4;12:671325. doi: 10.3389/fimmu.2021.671325. eCollection 2021.

  PMID: 34017343 DERIVED

MeSH Terms

Conditions

Dysentery, Bacillary

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

ass77028@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 24, 2017
• Study Start: March 16, 2017
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: June 28, 2019
• Results First Posted: March 7, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

FR (1)