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

Phase 2

Completed

• Conditions: Group B Streptococcus Infections
• Interventions: Biological: Multivalent Group B streptococcus vaccine; Biological: Tetanus, diphtheria, and acellular pertussis vaccine; Biological: Placebo

• Registration Number: NCT04766086
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-23
• Study Start: 2022-08-12
• Primary Completion: 2023-04-27
• Study Completion: 2023-04-27
• Status Verified: 2024-04
• Results First Submitted: 2024-04-25
• Results First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Results First Posted: 2024-05-24
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 306

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GBS6 and Placebo	Placebo	Multivalent group B streptococcus vaccine and Placebo
GBS6 and Tdap	Multivalent Group B streptococcus vaccine	Multivalent group B streptococcus vaccine and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)
Placebo and Tdap	Tetanus, diphtheria, and acellular pertussis vaccine	Placebo and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)
GBS6 and Placebo	Multivalent Group B streptococcus vaccine	Multivalent group B streptococcus vaccine and Placebo
Placebo and Tdap	Placebo	Placebo and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)
GBS6 and Tdap	Tetanus, diphtheria, and acellular pertussis vaccine	Multivalent group B streptococcus vaccine and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 6 Months After Vaccination	Day 1 (day of vaccination) through 6 Months post-vaccination	A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Geometric Mean Concentration (GMC) of Anti-Pertussis Toxin (PT), Anti-Filamentous Hemagglutinin (FHA), and Anti-Pertactin (PRN) Antibodies; GMR of Anti-PT, Anti-FHA, and Anti-PRN for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination	1 Month after Vaccination (Day 1, day of vaccination)	GMCs of anti-PT, anti-FHA, and anti-PRN was reported as descriptive data for the GBS6 +Tdap and placebo + Tdap groups, along with associated 2-sided 95% confidence interval. GMR for anti-PT, anti-FHA and anti-PRN antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data.
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination	Day 1 (day of vaccination) to Day 7	Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter \[cm\]). Grading: Grade 1/mild (greater than \[\>\] 2.0 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination	Day 1 (day of vaccination) to Day 7	Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours \[h\]), Grade 2/moderate: (\>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, chills, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Vaccination	Day 1 (day of vaccination) through 1 Month post-vaccination	An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. In this outcome measure results excluded data for local reactions and systemic events.
GMC of GBS Capsular Polysaccharide (CPS) Serotype-Specific Immunoglobulin G (IgG) Antibodies; GMR of GBS CPS Serotype-specific IgG Antibodies for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination	1 Month after Vaccination (Day 1, day of vaccination)	GBS CPS serotype-specific IgG GMCs (Ia, Ib, II, III, IV, V) were reported as descriptive data for the GBS6+Tdap and GBS6+placebo groups, along with associated 2-sided 95% confidence interval. GMR of GBS CPS serotype-specific IgG antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data.
Percentage of Participants Achieving Anti-tetanus Toxoid (Anti-TTd) and Anti-diphtheria Toxoid (Anti-DTd) Antibody Concentration >=0.1 IU/mL at 1 Month After Vaccination: GBS6 + Tdap and Placebo + Tdap Groups	1 Month after Vaccination (Day 1, day of vaccination)	IU/mL stands for international units per milliliter.

Trial Locations

Locations (10)

DM Clinical Research - Brookline; 🇺🇸 Houston, Texas, United States

Accellacare - Raleigh; 🇺🇸 Raleigh, North Carolina, United States

Accellacare - Wilmington; 🇺🇸 Wilmington, North Carolina, United States

PriMED Clinical Research; 🇺🇸 Dayton, Ohio, United States

PriMed Clinical Research; 🇺🇸 Dayton, Ohio, United States

Lynn Health Science Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

Benchmark Research; 🇺🇸 Fort Worth, Texas, United States

J. Lewis Research, Inc. / Foothill Family Clinic South; 🇺🇸 Salt Lake City, Utah, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Knoxville, Tennessee, United States

Quality Clinical Research, Inc; 🇺🇸 Omaha, Nebraska, United States