A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-05

Study Completion Date

2018-06-25

Brief Summary

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This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study evaluating the investigational multivalent group B streptococcus vaccine. Healthy adults aged 18 to 49 years of age with no history of group B streptococcal vaccination will be randomized to receive either a single intramuscular dose of multivalent group B streptococcus vaccine (various formulations at 3 dose levels) or a placebo (saline control).

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Detailed Description

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Conditions

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Group B Streptococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lowest dose formulation a

Multivalent group B streptococcus vaccine

Group Type EXPERIMENTAL

Multivalent group B streptococcus vaccine

Intervention Type BIOLOGICAL

Various formulations at three dose levels

Middle dose formulation a

Multivalent group B streptococcus vaccine

Group Type EXPERIMENTAL

Multivalent group B streptococcus vaccine

Intervention Type BIOLOGICAL

Various formulations at three dose levels

Highest dose formulation a

Multivalent group B streptococcus vaccine

Group Type EXPERIMENTAL

Multivalent group B streptococcus vaccine

Intervention Type BIOLOGICAL

Various formulations at three dose levels

Lowest dose formulation b

Multivalent group B streptococcus vaccine

Group Type EXPERIMENTAL

Multivalent group B streptococcus vaccine

Intervention Type BIOLOGICAL

Various formulations at three dose levels

Middle dose formulation b

Multivalent group B streptococcus vaccine

Group Type EXPERIMENTAL

Multivalent group B streptococcus vaccine

Intervention Type BIOLOGICAL

Various formulations at three dose levels

Highest dose formulation b

Multivalent group B streptococcus vaccine

Group Type EXPERIMENTAL

Multivalent group B streptococcus vaccine

Intervention Type BIOLOGICAL

Various formulations at three dose levels

Placebo

Saline control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Saline Control

Interventions

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Multivalent group B streptococcus vaccine

Various formulations at three dose levels

Intervention Type BIOLOGICAL

Placebo

Saline Control

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Healthy adults (male and female) 18 to 49 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
2. Negative urine pregnancy test at Visit 1 for all female subjects who are of childbearing potential.

Exclusion Criteria

1. Male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for at least 3 months after the last dose of investigational product.
2. Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. Chronic medical conditions include human immunodeficiency virus, chronic hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C virus infection.
3. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine.
4. History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus agalactiae).
5. Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the subject's participation in the study (through the last blood draw).

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes