Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women
Status and phase
Completed
Phase 1
Conditions
Group B Streptococcus
Treatments
Biological: Group B streptococcus (GBS) vaccine- low dose
Biological: Group B streptococcus (GBS) vaccine- High dose
Biological: Placebo- Saline
Details and patient eligibility
About
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.
Enrollment
678 patients
Sex
Female
Ages
18 to 40 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
678 participants in 9 patient groups, including a placebo group
5 µg_No Adj
Experimental group
Description:
Subjects received either 1 or 2 doses of active vaccine (5 µg) without any adjuvant
Treatment:
Biological: Group B streptococcus (GBS) vaccine- low dose
20 µg_No Adj
Experimental group
Description:
Subjects received either 1 or 2 doses of active vaccine (20 µg) without any adjuvant.
Treatment:
Biological: Group B streptococcus (GBS) vaccine- High dose
5 µg_Alum
Experimental group
Description:
Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.
Treatment:
Biological: Group B streptococcus (GBS) vaccine- low dose
20 µg_Alum
Experimental group
Description:
Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.
Treatment:
Biological: Group B streptococcus (GBS) vaccine- High dose
5 µg_MF59-H
Experimental group
Description:
Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 4.87 mg of MF59
Treatment:
Biological: Group B streptococcus (GBS) vaccine- low dose
20 µg_MF59-H
Experimental group
Description:
Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 4.87 mg of MF59
Treatment:
Biological: Group B streptococcus (GBS) vaccine- High dose
5 µg_MF59-F
Experimental group
Description:
Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 9.75 mg of MF59
Treatment:
Biological: Group B streptococcus (GBS) vaccine- low dose
20 µg_MF59-F
Experimental group
Description:
Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 9.75 mg of MF59
Treatment:
Biological: Group B streptococcus (GBS) vaccine- High dose
Placebo
Placebo Comparator group
Description:
Subjects received 2 injections of placebo administered 1 month apart
Treatment:
Biological: Placebo- Saline
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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