Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine

NCT02270944 | Completed Phase 2 Results

• 3 other identifiers: 205220V98_212013-003111-22
• Study Type: interventional
• Target: 1,053
• Locations: 3 countries
• Sites: 9

Brief Summary

The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration), and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and pregnant women in the clinical development program to date.

Conditions

Infections, Streptococcal; Streptococcal Infections

Keywords

GBS; vaccine comparability; Group B Strep

Outcome Measures

Primary Outcomes (3)

• Concentration of Serotype Ia GBS IgG Levels in Healthy Non-pregnant Women

  To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).

  At Day 31 after a single vaccination

• Concentration of Serotype III GBS IgG Levels in Healthy Non-pregnant Women

  To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).

  At Day 31 after a single vaccination

• Concentration of Serotype Ib GBS IgG Levels in Healthy Non-pregnant Women

  To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Geometric mean concentrations (GMCs) were measured and expressed in micrograms per milliliter (μg/mL). As the singleton ELISA was no longer in use at the time of serotype Ib testing, results were obtained using multiplex immunoassay.

  At Day 31 after a single vaccination

Secondary Outcomes (3)

• Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)

  From 6 hours through Day 7 post-vaccination

• Number of Subjects Reporting Any Unsolicited AEs

  From Day 1 to Day 181 (end of the study)

• Number of Subjects Reporting Any Serious Adverse Events (SAEs)

  From Day 1 to Day 181 (end of the study)

Study Arms (2)

Liquid GBS trivalent vaccine

EXPERIMENTAL

Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine

Biological: GBS Vaccine

Lyophilized GBS trivalent vaccine

ACTIVE COMPARATOR

Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine

Biological: GBS Vaccine

Interventions

GBS Vaccine BIOLOGICAL

Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus

Liquid GBS trivalent vaccine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy females 18-40 years of age, inclusive.
• Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.
• Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
• Individuals who can comply with all study procedures and are available for follow-up.

You may not qualify if:

• Individuals who are pregnant (urine pregnancy test at Study Day 1) or who anticipate becoming pregnant prior to the end of the study, Day 181 Visit.
• Individuals "of childbearing potential", heterosexually active, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry and who will not continue to use acceptable contraceptive methods through to the end of the study, Day 181 Visit.
• Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
• Acceptable birth control methods are defined as one or more of the following:
• hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring); barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse; intrauterine device (IUD); monogamous relationship with vasectomized partner who was vasectomized for at least six months prior to the subject's study entry; or abstinence/no sexual intercourse.
• Individuals who are nursing (breastfeeding).
• Individuals who have participated in any clinical trial with another investigational product 30 days prior to first study visit or who intend to participate in another trial prior to the end of the study, Day 181 Visit.
• Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens.
• Individuals who receive:
• live vaccine 30 days prior to study vaccination
• inactivated vaccines 15 days prior to study vaccination
• any vaccines within 30 days after 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 with a fever (oral temperature ≥ 38°C) within 3 days prior to Study Day 1.
• Individuals with acute or chronic infection(s) (e.g. requiring systemic antibiotic treatment or antiviral therapy) within 7 days prior to Study Day 1.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Novartis Vaccines: collaborator

Study Sites (9)

GSK Investigational Site

Redding, California, 96001, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21201, United States

Location

GSK Investigational Site

Stevensville, Michigan, 49127, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84109, United States

Location

GSK Investigational Site

Antwerp, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Hradec Králové, 50002, Czechia

Location

Related Publications (1)

• Beran J, Leroux-Roels G, Van Damme P, de Hoon J, Vandermeulen C, Al-Ibrahim M, Johnson C, Peterson J, Baker S, Seidl C, Dreisbach A, Karsten A, Corsaro B, Henry O, Lattanzi M, Bebia Z. Safety and immunogenicity of fully liquid and lyophilized formulations of an investigational trivalent group B streptococcus vaccine in healthy non-pregnant women: Results from a randomized comparative phase II trial. Vaccine. 2020 Apr 3;38(16):3227-3234. doi: 10.1016/j.vaccine.2020.02.085. Epub 2020 Mar 10.

  PMID: 32169390 DERIVED

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 22, 2014
• Study Start: November 20, 2014
• Primary Completion: April 23, 2015
• Study Completion: September 22, 2015
• Last Updated: December 5, 2019
• Results First Posted: July 28, 2017

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• 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 (3); US (5); CZ (1)