Clinical trial NCT02690181: Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.
Official title: A Phase 2, Non-Randomized, Controlled, Open-Label, Parallel-Group, Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-pregnant Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bacterial Infection Due to Streptococcus, Group B
Streptococcus Agalactiae
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-02-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator
3. 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

Exclusion Criteria:

1. Progressive, unstable or uncontrolled clinical conditions, or clinical conditions representing a contraindication to intramuscular vaccination and blood draws
2. Abnormal function of the immune system
3. Received immunoglobulins or any blood products within 180 days prior to informed consent
4. Received an investigational or non-registered medicinal product within 30 days prior to informed consent
5. 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
6. 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
7. Individuals who anticipate becoming pregnant prior to the end of the study, or individuals who are breastfeeding
8. Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens that was not part of V98_06 study
9. 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
10. Individuals with acute or chronic infection(s) that require systemic antibiotic treatment or antiviral therapy, within 7 days prior to day 1

Primary outcomes:
measure: Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61
timeFrame: At Day 61
measure: Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61
timeFrame: At Day 61
measure: Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61
timeFrame: At Day 61
measure: Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs)
timeFrame: Day 1 to Day 7
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: Day 1 to Day 31
measure: Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal
timeFrame: Day 1 to Day 181
Secondary outcomes:
measure: Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31
timeFrame: At Day 31
measure: Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31
timeFrame: At Day 31
measure: Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31
timeFrame: At Day 31
measure: Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia
timeFrame: At Day 1, Day 31 and Day 61.
measure: Geometric Mean Antibody Concentrations of GBS Serotype Ib
timeFrame: At Day 1, Day 31 and Day 61
measure: Geometric Mean Antibody Concentrations of GBS Serotype III
timeFrame: At Day 1, Day 31 and Day 61
measure: Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ)
timeFrame: At Day 1, Day 31 and Day 61
measure: Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ
timeFrame: At Day 1, Day 31 and Day 61
measure: Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ
timeFrame: At Day 1, Day 31 and Day 61
measure: Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ
timeFrame: At Day 1, Day 31 and Day 61
measure: Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ
timeFrame: At Day 1, Day 31 and Day 61
measure: Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ
timeFrame: At Day 1, Day 31 and Day 61
measure: Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations in All Subjects
timeFrame: At Day 1 (V98_06 or V98_06E1) and Day 61
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.