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

NCT04258995 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: C1091007
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Group B Streptococcal Infections

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose

  Before and 1 month after booster dose

• GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 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

  1 month after booster dose

• GBS Serotype-Specific OPA GMFR Measured Before and 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)

  1 month after booster dose

Study Arms (2)

GBS6 no aluminum phosphate (GBS6 no AlPO4)

EXPERIMENTAL

Biological: Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)

GBS6 with aluminum phosphate (GBS6 with AlPO4)

EXPERIMENTAL

Biological: Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)

Interventions

Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6) BIOLOGICAL

2 formulations at 1 dose level

Also known as: GBS6

GBS6 no aluminum phosphate (GBS6 no AlPO4); GBS6 with aluminum phosphate (GBS6 with AlPO4)

Eligibility Criteria

• Age: 20 Years - 51 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who were enrolled in the C1091001 study, received GBS6, and completed the 1-month blood draw.

You may not qualify if:

• 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.
• 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.
• History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine.
• History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus agalactiae).
• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Kentucky Pediatric & Adult Research Inc.

Bardstown, Kentucky, 40004, United States

Location

J. Lewis Research, Inc./ Foothill Family Clinic South

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Related Publications (1)

• Jongihlati B, Segall N, Block SL, Absalon J, Perez J, Munson S, Sanchez-Pearson Y, Simon R, Silmon de Monerri NC, Radley D, McLaughlin LC, Gaylord M, Gruber WC, Jansen KU, Scott DA, Anderson AS. Safety and immunogenicity of a booster dose of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 2, open-label extension of a phase 1/2 randomised controlled trial. Lancet Infect Dis. 2025 Oct;25(10):1138-1148. doi: 10.1016/S1473-3099(25)00216-6. Epub 2025 Jun 13.

  PMID: 40523378 DERIVED

Related Links

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

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There are two arms in the study however based on the prior formulation received participants can only be enrolled into one predetermined arm in the study. Participants are assigned by an interactive response technology (IRT) based on prior formulation received.

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: February 11, 2020
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: October 13, 2021
• Results First Posted: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

US (4)