Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women

Group B Streptococcus Infections Clinical Trial

Official title:

A PHASE 2B, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE WHEN ADMINISTERED CONCOMITANTLY WITH TETANUS, DIPHTHERIA, AND ACELLULAR PERTUSSIS VACCINE (TDAP) IN HEALTHY NONPREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04766086
• Other study ID #: C1091005
• Status: Completed
• Phase: Phase 2
• Start date: August 12, 2022
• Est. completion date: April 27, 2023

Study information

• Verified date: June 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine administered concomitantly with Tdap in healthy nonpregnant women 18 through 49 years of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: April 27, 2023
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Healthy women =18 and =49 years of age.
• Participants who are willing and able to comply with scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures, including completion of the e-diary from Day 1 to Day 7 following administration of investigational product.
• Healthy females at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
• Expected to be available for the duration of the study and who can be contacted by telephone during study participation.
• Capable of giving personal signed informed consent.

Exclusion Criteria:

• Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (prior to vaccination)
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197-containing vaccine.
• History of microbiologically proven invasive disease caused by group B streptococcus.
• Immunocompromised participants with known or suspected immunodeficiency.
• Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection.
• Other acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Previous vaccination with any licensed or investigational GBS vaccine, or planned receipt during the participant's participation in the study (through the 1-month follow-up visit [Visit 2]).
• Vaccination within 5 years with tetanus and diphtheria toxoids and acellular pertussis-containing vaccines (Tdap) before investigational product administration.
• Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids
• Vaccination with diphtheria- or CRM197-containing vaccine(s) from 6 months before investigational product administration, or planned receipt through the 1-month follow-up visit.
• Receipt or planned receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration through the 1-month follow-up visit
• Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation

Related Conditions & MeSH terms

• Group B Streptococcus Infections
• Streptococcal Infections

Intervention

Biological:
• Multivalent Group B streptococcus vaccine
Multivalent Group B streptococcus vaccine
• Tetanus, diphtheria, and acellular pertussis vaccine
Tetanus, diphtheria, and acellular pertussis vaccine
• Placebo
Saline control

Locations

Country	Name	City	State
United States	PriMED Clinical Research	Dayton	Ohio
United States	PriMed Clinical Research	Dayton	Ohio
United States	Benchmark Research	Fort Worth	Texas
United States	DM Clinical Research - Brookline	Houston	Texas
United States	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee
United States	Alliance for Multispecialty Research, LLC	Las Vegas	Nevada
United States	Alliance for Multispecialty Research, LLC	Newton	Kansas
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Quality Clinical Research, Inc	Omaha	Nebraska
United States	Accellacare - Raleigh	Raleigh	North Carolina
United States	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah
United States	Accellacare - Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants reporting prompted local reactions within 7 days following investigational product administration	Describe prompted local reactions following investigational product administration	Day 7
Primary	Proportion of participants reporting prompted systemic events within 7 days following investigational product administration	Describe prompted systemic events following investigational product administration	Day 7
Primary	Proportion of participants reporting adverse events (AEs) through 1 month following investigational product administration	Describe AEs occurring through 1 month following administration of investigational product	1 month following administration of investigational product
Primary	Proportion of participants reporting medically attended adverse events (MAEs) and serious adverse events (SAEs) through 1 month following investigational product administration	Describe MAEs and SAEs through 1 month following administration of investigational product	1 month following administration of investigational product
Primary	Difference in proportions of participants with anti-tetanus toxoid antibody concentrations greater than or equal to 0.1 IU/mL measured 1 month after vaccination between the GBS6 and Tdap group and the placebo and Tdap group	Describe that the immune responses induced by Tdap when administered concomitantly with GBS6 compared to the immune responses induced by Tdap alone.	1 month after investigational product administration
Primary	Difference in proportions of participants with anti-diphtheria toxoid antibody concentrations greater than or equal to 0.1 IU/mL measured 1 month after vaccination between GBS6 and Tdap group and placebo and Tdap group	Describe that the immune responses induced by Tdap when administered concomitantly with GBS6 compared to the immune responses induced by Tdap alone.	1 month after investigational product administration
Primary	Geometric mean ratio (GMR), estimated by GMR of anti-pertussis toxin antibodies from the GBS6 and Tdap group to the placebo and Tdap group measured 1 month after vaccination.	Describe that the immune responses induced by Tdap when administered concomitantly with GBS6 compared to the immune responses induced by Tdap alone.	1 month after investigational product administration
Primary	GMR, estimated by the GMR of anti-filamentous hemagglutinin (anti-FHA) antibodies from the GBS6 and Tdap group to the placebo and Tdap group measured 1 month after vaccination.	Describe that the immune responses induced by Tdap when administered concomitantly with GBS6 compared to the immune responses induced by Tdap alone.	1 month after investigational product administration
Primary	GMR, estimated by the GMR of antipertactin (anti-PRN) antibodies from the GBS6 and Tdap group to the placebo and Tdap group measured 1 month after vaccination.	Describe that the immune responses induced by Tdap when administered concomitantly with GBS6 compared to the immune responses induced by Tdap alone.	1 month after investigational product administration
Primary	GBS capsular polysaccharide (CPS) serotype-specific IgG GMR, estimated by the GMR of GBS CPS serotype-specific IgG antibodies from the GBS6 and Tdap group to the GBS6 and placebo group measured 1 month after vaccination.	Describe that the immune responses induced by GBS6 when administered concomitantly with Tdap (GBS6 and Tdap) compared to the immune responses induced by GBS6 (GBS6 and placebo) alone	1 month after investigational product administration

External Links

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