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

• ClinicalTrials.gov Identifier: NCT02270944
• Recruitment Status: Completed
• First Posted: October 22, 2014
• Results First Posted: July 28, 2017
• Last Update Posted: December 5, 2019
• Sponsor: GlaxoSmithKline
• Collaborator: Novartis Vaccines
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infections, Streptococcal; Streptococcal Infections	Biological: GBS Vaccine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1053 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase II, Randomized, Comparative, Observer-Blind, Multi-Center Study Evaluating the Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine in Healthy Non-Pregnant Women Aged 18 to 40 Years
• Actual Study Start Date: November 20, 2014
• Actual Primary Completion Date: April 23, 2015
• Actual Study Completion Date: September 22, 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Liquid GBS trivalent vaccine; Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine	Biological: GBS Vaccine; Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus
Active Comparator: Lyophilized GBS trivalent vaccine; Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine	Biological: GBS Vaccine; Lyophilized formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus

Outcome Measures

Primary Outcome Measures :

1. Concentration of Serotype Ia GBS IgG Levels in Healthy Non-pregnant Women [ Time Frame: At Day 31 after a single vaccination ]
   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).
2. Concentration of Serotype III GBS IgG Levels in Healthy Non-pregnant Women [ Time Frame: At Day 31 after a single vaccination ]
   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).
3. Concentration of Serotype Ib GBS IgG Levels in Healthy Non-pregnant Women [ Time Frame: At Day 31 after a single vaccination ]
   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.

Secondary Outcome Measures :

1. Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: From 6 hours through Day 7 post-vaccination ]
   Safety was assessed as the number of subjects who reported solicited local and solicited systemic AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.
2. Number of Subjects Reporting Any Unsolicited AEs [ Time Frame: From Day 1 to Day 181 (end of the study) ]
   Safety was assessed as the number of subjects who reported unsolicited AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.
3. Number of Subjects Reporting Any Serious Adverse Events (SAEs) [ Time Frame: From Day 1 to Day 181 (end of the study) ]
   Safety was assessed as the number of subjects who reported SAEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.

2. 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.

3. Individuals who are nursing (breastfeeding).
4. 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.
5. Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens.

6. 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
7. Individuals with a fever (oral temperature ≥ 38°C) within 3 days prior to Study Day 1.
8. Individuals with acute or chronic infection(s) (e.g. requiring systemic antibiotic treatment or antiviral therapy) within 7 days prior to Study Day 1.
9. Individuals with a history of severe allergic reactions after previous vaccination or medication such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.
10. Individuals with known or suspected impairment of the immune system including known or suspected HIV infection or HIV-related disease, a history of or an active autoimmune disorder and receipt of immunosuppressive therapy.
11. Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) within 30 days prior to enrollment. Use of inhaled, intranasal, intra-articular, or topical corticosteroids is allowed.
12. Individuals who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
13. Individuals with any progressive or severe neurologic disorder, seizure disorder, epilepsy or Guillain-Barré syndrome.
14. 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.
15. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.
16. Individuals with history or any illness that, in the opinion of the investigator, might interfere with results of the study or pose additional risk to subjects due to participation.

Contacts and Locations

Locations

United States, California

GSK Investigational Site

Redding, California, United States, 96001

United States, Kansas

GSK Investigational Site

Lenexa, Kansas, United States, 66219

United States, Maryland

GSK Investigational Site

Baltimore, Maryland, United States, 21201

United States, Michigan

GSK Investigational Site

Stevensville, Michigan, United States, 49127

United States, Utah

GSK Investigational Site

Salt Lake City, Utah, United States, 84109

Belgium

GSK Investigational Site

Antwerp, Belgium

GSK Investigational Site

Ghent, Belgium, 9000

GSK Investigational Site

Leuven, Belgium, 3000

Czechia

GSK Investigational Site

Hradec Kralove, Czechia, 50002

Sponsors and Collaborators

GlaxoSmithKline

Novartis Vaccines

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02270944
• Other Study ID Numbers: 205220; V98_21 ( Other Identifier: Novartis ); 2013-003111-22 ( EudraCT Number )
• First Posted: October 22, 2014
• Results First Posted: July 28, 2017
• Last Update Posted: December 5, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• 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.
• URL: http://clinicalstudydatarequest.com

Keywords provided by GlaxoSmithKline:

GBS; vaccine comparability; Group B Strep

Additional relevant MeSH terms:

Infections; Communicable Diseases; Streptococcal Infections; Disease Attributes; Pathologic Processes; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaccines; Immunologic Factors; Physiological Effects of Drugs