Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women

Study Overview
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Brief Summary
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This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.

Official Title
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A Phase Ib Randomized, Observer-Blind, Controlled, Single Center, Dose-Ranging Study of a Group B Streptococcus Vaccine in Healthy Women 18-40 Years of Age

Conditions
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Group B Streptococcus

Intervention / Treatment
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* Biological: Group B streptococcus (GBS) vaccine- low dose
* Biological: Group B streptococcus (GBS) vaccine- High dose
* Biological: Placebo- Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy females 18-40 years of age inclusive. Exclusion Criteria: Individuals who are pregnant or nursing. Individuals who have had a previous immunization with a vaccine containing streptococcus antigens or any vaccine within 30 days of enrollment through 30 days of study completion. Individuals with a history of severe allergic reactions after previous vaccination Individuals with designated blood tests that are not within normal range

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5 µg_No Adj<br>Subjects received either 1 or 2 doses of active vaccine (5 µg) without any adjuvant | Biological: Group B streptococcus (GBS) vaccine- low dose<br> <br> |
| Experimental: 20 µg_No Adj<br>Subjects received either 1 or 2 doses of active vaccine (20 µg) without any adjuvant. | Biological: Group B streptococcus (GBS) vaccine- High dose<br> <br> |
| Experimental: 5 µg_Alum<br>Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant. | Biological: Group B streptococcus (GBS) vaccine- low dose<br> <br> |
| Experimental: 20 µg_Alum<br>Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant. | Biological: Group B streptococcus (GBS) vaccine- High dose<br> <br> |
| Experimental: 5 µg_MF59-H<br>Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 4.87 mg of MF59 | Biological: Group B streptococcus (GBS) vaccine- low dose<br> <br> |
| Experimental: 20 µg_MF59-H<br>Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 4.87 mg of MF59 | Biological: Group B streptococcus (GBS) vaccine- High dose<br> <br> |
| Experimental: 5 µg_MF59-F<br>Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 9.75 mg of MF59 | Biological: Group B streptococcus (GBS) vaccine- low dose<br> <br> |
| Experimental: 20 µg_MF59-F<br>Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 9.75 mg of MF59 | Biological: Group B streptococcus (GBS) vaccine- High dose<br> <br> |
| Placebo Comparator: Placebo<br>Subjects received 2 injections of placebo administered 1 month apart | Biological: Placebo- Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 | The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women. | Day 1 and Day 61 | 
| Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 | Serotype-specific (Ia, Ib & III) group B streptococcus (GBS) IgG antibody levels in healthy subjects for potential use in pregnant woman was assessed in terms of Geometric Mean Concentrations (GMCs) at Day 61 in cohorts 1 and 2. | Day 1 and Day 61 | 
| Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype | Geometric mean ratios (GMRs) relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels measured at Day 61 for subjects across cohorts 1 and 2. | Day 61/Day 1 | 
| Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 | The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL at day 361 across all the cohorts for potential use in non-pregnant women. | Day 1 and Day 361 | 
| Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 | Serotype-specific (Ia, Ib & III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant woman was assessed in terms of GMCs at Day 361 across all cohorts. | Day 1 and Day 361 | 
| Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 | GMRs relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant women, measured at Day 361 across all cohorts. | Day 1 and day 361 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 | Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving trivalent GBS vaccine from day 1 to day 7 for subjects across cohorts 1 and 2. | Day 1 to Day 7 | 
| Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 | Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving GBS vaccine from day 1 to day 7 for subjects in cohorts 3 and 4. | Day 1 to Day 7 | 
| Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 | Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 1 and 2. | Day 1 through Day 721 | 
| Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 | Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 3 and 4. | Day 1 through Day 721 | 
| Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 | The persistence of Serotype-specific (Ia, Ib & III) GBS IgG antibody response was assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohorts 1 and 2. | Day 1 and Day 721 | 
| Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 | The persistence of Serotype-specific (Ia, Ib & III) GBS IgG antibody response assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohort 3 and 4. | Day 1 and Day 721 | 
| Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 | GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across all cohorts 1 and 2. | Day 1 and Day 721 | 
| Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 | GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across cohorts 3 and 4. | Day 1 and Day 721 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group B streptococcus, GBS, Vaccine, Group B streptococcus (GBS) disease