Clinical trial NCT03170609: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Group B Streptococcal Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-05-31
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade
timeFrame: 1 week after vaccination
measure: Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination
timeFrame: Within 14 days after vaccination
measure: Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination
timeFrame: Within 14 days after vaccination
measure: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
timeFrame: Within 1 month after vaccination
measure: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Month After Vaccination
timeFrame: Within 6 months after vaccination
measure: Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 6 Months After Vaccination
timeFrame: Within 6 months after vaccination
Secondary outcomes:
measure: GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination
timeFrame: 1 month after vaccination
Other outcomes:
Locations:
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Bardstown
country: United States
facility: Kentucky Pediatric / Adult Research
state: Kentucky
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Absalon J, Segall N, Block SL, Center KJ, Scully IL, Giardina PC, Peterson J, Watson WJ, Gruber WC, Jansen KU, Peng Y, Munson S, Pavliakova D, Scott DA, Anderson AS. Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial. Lancet Infect Dis. 2021 Feb;21(2):263-274. doi: 10.1016/S1473-3099(20)30478-3. Epub 2020 Sep 3.