A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS

A PHASE 2, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS

This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a primary GBS6 dose, to healthy adult males and nonpregnant women. The study will determine whether individuals who received a primary dose of GBS6 have additional benefit following a booster dose.

Study Overview

• Status: Completed
• Conditions: Group B Streptococcal Infections
• Intervention / Treatment: Biological: Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric & Adult Research Inc.
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Inc. / Foothill Family Clinic South
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research, Inc./ Foothill Family Clinic South

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adults (male and female) 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. Participants who were enrolled in the C1091001 study, received GBS6, and completed the 1-month blood draw.

Exclusion Criteria:

1. Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (prior to vaccination); and WOCBP who are, in the opinion of the investigator, sexually active and at risk for pregnancy and fertile men and WOCBP who are unwilling or unable to use effective methods of contraception as outlined in this protocol from the signing of the informed consent until 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 participant 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 (other than GBS6), or planned receipt during the participant's participation in the study (through 6-month telephone call).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GBS6 no aluminum phosphate (GBS6 no AlPO4)	Biological: Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6); 2 formulations at 1 dose level; Other Names: GBS6
Experimental: GBS6 with aluminum phosphate (GBS6 with AlPO4)	Biological: Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6); 2 formulations at 1 dose level; Other Names: GBS6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site)	Local reactions were collected by using an e-diary and included pain at injection site, redness, and swelling graded below: pain at injection site: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever >24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity), grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.0-5.0 centimeter [cm]), moderate (greater than [>] 5.0-10.0 cm),severe (>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis).Maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived.	Within 14 days after booster dose
Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain)	Nausea/Vomiting:Mild:No interference with activity or 1-2 times in 24 hours;Moderate:Some interference with activity or>2 times in 24 hours;Severe:Prevented daily activity, required IV hydration.Diarrhea:Mild:2-3 loose stools in 24 hours;Moderate: 4-5 loose stools in 24 hours;Severe:>=6 loose stools in 24 hours.Headache:Mild:No interference with activity;Moderate:Repeated use of nonnarcotic pain reliever >24 hours or some interference with activity;Severe:Significant; any use of narcotic pain reliever or prevents daily activity.Fatigue:Mild:No interference with activity;Moderate: Some interference with activity;Severe: Significant; prevented daily activity.Muscle pain:Mild: No interference with activity;Moderate:Some interference with activity;Severe:Significant;prevented daily activity.Muscle/joint pain:Mild: No interference with activity;Moderate:Some interference with activity;Severe:Significant; prevented daily activity.Grade 4 for all AEs:Emergency visit or hospitalization.	Within 14 days after booster dose
Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month Following Booster Dose	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. AEs included both non-serious AEs and SAEs.	Within 1 month after booster dose
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Within 6 Months Following Booster Dose	An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.	Within 6 months after booster dose
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Booster Dose	An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.	Within 6 months after booster dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose	Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.	Before and 1 month after booster dose
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose	OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose.	Within 6 months after primary dose and within 1 month after booster dose
GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose	IgG for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose.	1 month after booster dose
GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose	OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose.	1 month after booster dose
GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose)	Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. The pre-vaccination immunogenicity blood draw and booster vaccination were both performed on Day 1.	1 month after booster dose

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2020
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections
• Other Study ID Numbers: C1091007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No