Phase 2
N=151
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
Group B Streptococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT04258995 ↗Enrolled (actual)
151
Serious AEs
0.7%
Results posted
Oct 2021
Primary outcome: Primary: Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) — 68.4; 42.7; 53.9; 38.7 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6) (Biological)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) |
68.4; 42.7; 53.9; 38.7; 11.8; 4.0 | — |
| PRIMARY Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) |
3.9; 1.3; 1.3; 0; 2.6; 1.3 | — |
| PRIMARY Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month Following Booster Dose |
6.6; 12.0 | — |
| PRIMARY Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Within 6 Months Following Booster Dose |
11.8; 9.3 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Booster Dose |
1.3; 0 | — |
| SECONDARY GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose |
3.070; 3.252; 47.600; 52.038; 0.537; 0.588 | — |
| SECONDARY GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose |
1368; 1361; 9374; 8809; 3307; 2734 | — |
| SECONDARY GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose |
15.504; 16.003; 45.282; 34.191; 9.853; 10.130 | — |
| SECONDARY GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose |
6.9; 6.5; 9.1; 6.4; 4.8; 4.2 | — |
| SECONDARY GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) |
55.766; 148.088; 47.396; 45.843; 40.327; 112.434 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- Participants who were enrolled in the C1091001 study, received GBS6, and completed the 1-month blood draw.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT04258995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.