Clinical trial NCT02270944: Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Streptococcal
Streptococcal Infections
Keywords: GBS
vaccine comparability
Group B Strep
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2014-10-22
Enrollment: 1053
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Concentration of Serotype Ia GBS IgG Levels in Healthy Non-pregnant Women
timeFrame: At Day 31 after a single vaccination
measure: Concentration of Serotype III GBS IgG Levels in Healthy Non-pregnant Women
timeFrame: At Day 31 after a single vaccination
measure: Concentration of Serotype Ib GBS IgG Levels in Healthy Non-pregnant Women
timeFrame: At Day 31 after a single vaccination
Secondary outcomes:
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
timeFrame: From 6 hours through Day 7 post-vaccination
measure: Number of Subjects Reporting Any Unsolicited AEs
timeFrame: From Day 1 to Day 181 (end of the study)
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs)
timeFrame: From Day 1 to Day 181 (end of the study)
Other outcomes:
Locations:
city: Redding
country: United States
facility: GSK Investigational Site
state: California
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Stevensville
country: United States
facility: GSK Investigational Site
state: Michigan
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Antwerp
country: Belgium
facility: GSK Investigational Site
city: Ghent
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.