Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.

NCT02690181 | Completed Phase 2 Results

• 3 other identifiers: 2054212015-003094-15V98_06E1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this extension study is the initial assessment of safety and immunogenicity of the second dose of GBS Trivalent Vaccine following the time interval that is close to the inter-pregnancy interval observed in the general population.

Conditions

Bacterial Infection Due to Streptococcus, Group B; Streptococcus Agalactiae

Outcome Measures

Primary Outcomes (6)

• Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61

  Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 61 post-vaccination, as measured by Enzyme-linked immunosorbent Assay (ELISA).

  At Day 61

• Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61

  Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

  At Day 61

• Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61

  Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

  At Day 61

• Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs)

  Threshold for Erythema, Swelling and Induration: None (0 mm), Any (\>= 1 mm).

  Day 1 to Day 7

• Number of Subjects With Any Unsolicited Adverse Events (AEs)

  The number of subjects with any unsolicited AEs from the day of vaccination in study V98\_06E1 to Day 31. 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. Possibly Related AE definition: the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes. Probably Related AE definition: exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified.

  Day 1 to Day 31

• Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal

  An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: Death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. "Medically attended adverse event" is defined as an adverse event that leads to a visit to a healthcare provider and "AEs leading to withdrawal" are defined as adverse events leading to study or vaccine withdrawal.

  Day 1 to Day 181

Secondary Outcomes (13)

• Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31

  At Day 31

• Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31

  At Day 31

• Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31

  At Day 31

• Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia

  At Day 1, Day 31 and Day 61.

• Geometric Mean Antibody Concentrations of GBS Serotype Ib

  At Day 1, Day 31 and Day 61

Study Arms (6)

GBS NoAdj/GBS NoAdj

EXPERIMENTAL

Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).

Biological: GBS Trivalent Vaccine

GBS Alum/GBS NoAdj

EXPERIMENTAL

Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).

Biological: GBS Trivalent Vaccine

GBS MF59 Full/GBS NoAdj

EXPERIMENTAL

Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).

Biological: GBS Trivalent Vaccine

GBS MF59 Half/GBS NoAdj

EXPERIMENTAL

Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).

Biological: GBS Trivalent Vaccine

Placebo/GBS NoAdj

EXPERIMENTAL

Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).

Biological: GBS Trivalent Vaccine

Naive/GBS NoAdj

EXPERIMENTAL

Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).

Biological: GBS Trivalent Vaccine

Interventions

GBS Trivalent Vaccine BIOLOGICAL

Administration of lyophilized formulation of a GBS trivalent vaccine containing 5 µg of each polysaccharide capsules from serotypes Ia, Ib, and III of Group B Streptococcus conjugated to CRM-197 .

GBS Alum/GBS NoAdj; GBS MF59 Full/GBS NoAdj; GBS MF59 Half/GBS NoAdj; GBS NoAdj/GBS NoAdj; Naive/GBS NoAdj; Placebo/GBS NoAdj

Eligibility Criteria

• Age: 22 Years - 46 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, non-pregnant subjects who have received a single 5 µg dose of GBS Trivalent Vaccine or placebo in the V98\_06 study and healthy non-pregnant female subjects aged 22-46 years inclusive on the day of informed consent who have not received any GBS vaccine in the past
• Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator
• Females of childbearing potential who are using an effective birth control method which they intend to use until the end of the study (day 181 visit) or females of non-childbearing potential

You may not qualify if:

• Progressive, unstable or uncontrolled clinical conditions, or clinical conditions representing a contraindication to intramuscular vaccination and blood draws
• Abnormal function of the immune system
• Received immunoglobulins or any blood products within 180 days prior to informed consent
• Received an investigational or non-registered medicinal product within 30 days prior to informed consent
• 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 received any other vaccines within 14 days for inactivated vaccines or 28 days for live vaccines prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccination. Exception - an inactivated influenza vaccine may be administered up to 7 days prior to study vaccination or 7 days after study vaccination
• Individuals who anticipate becoming pregnant prior to the end of the study, or individuals who are breastfeeding
• Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens that was not part of V98\_06 study
• Individuals with a fever (oral temperature ≥ 38°C) within 3 days prior to day 1 or use of antipyretics and/or analgesic medications within 24 hours prior to day 1
• Individuals with acute or chronic infection(s) that require systemic antibiotic treatment or antiviral therapy, within 7 days prior to day 1

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

Location

Related Publications (1)

• Leroux-Roels G, Bebia Z, Maes C, Aerssens A, De Boever F, Grassano L, Buffi G, Margarit I, Karsten A, Cho S, Slobod K, Corsaro B, Henry O. Safety and Immunogenicity of a Second Dose of an Investigational Maternal Trivalent Group B Streptococcus Vaccine in Nonpregnant Women 4-6 Years After a First Dose: Results From a Phase 2 Trial. Clin Infect Dis. 2020 Jun 10;70(12):2570-2579. doi: 10.1093/cid/ciz737.

  PMID: 31394574 BACKGROUND

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 24, 2016
• Study Start: March 29, 2016
• Primary Completion: November 2, 2016
• Study Completion: November 2, 2016
• Last Updated: April 4, 2024
• Results First Posted: July 16, 2018

Record last verified: 2024-03

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

BE (1)