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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Group B Streptococcal Infections

Treatments: Biological: Multivalent group B streptococcus vaccine; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03170609

C1091001

Details and patient eligibility

About

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).

Enrollment: 365 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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365 participants in 7 patient groups, including a placebo group

Lowest dose formulation a

Experimental group

Description:

Multivalent group B streptococcus vaccine

Treatment:

Biological: Multivalent group B streptococcus vaccine

Middle dose formulation a

Experimental group

Description:

Multivalent group B streptococcus vaccine

Treatment:

Biological: Multivalent group B streptococcus vaccine

Highest dose formulation a

Experimental group

Description:

Multivalent group B streptococcus vaccine

Treatment:

Biological: Multivalent group B streptococcus vaccine

Lowest dose formulation b

Experimental group

Description:

Multivalent group B streptococcus vaccine

Treatment:

Biological: Multivalent group B streptococcus vaccine

Middle dose formulation b

Experimental group

Description:

Multivalent group B streptococcus vaccine

Treatment:

Biological: Multivalent group B streptococcus vaccine

Highest dose formulation b

Experimental group

Description:

Multivalent group B streptococcus vaccine

Treatment:

Biological: Multivalent group B streptococcus vaccine

Placebo

Placebo Comparator group

Description:

Saline control

Treatment:

Biological: Placebo