Phase 2
N=667
Prevention of GBS Colonization Via Immunity
Beta Haemolytic Streptococcal Infection
Bottom Line
View on ClinicalTrials.gov: NCT00128219 ↗Enrolled (actual)
667
Serious AEs
5.4%
Results posted
Jul 2010
Primary outcome: Primary: The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. — 325; 325; 20; 15 Participants — p=0.044
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GBS III-TT (Biological); Tetanus and diptheria toxoids vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture. |
325; 325; 20; 15; 18; 15 | 0.044 sig |
| SECONDARY Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. |
0.29; 0.31; 12.35; 0.29; 12.55; 0.30 | — |
| SECONDARY Number of Participants With Any Solicited Local and Systemic Symptoms. |
175; 223; 27; 40; 23; 52 | — |
| SECONDARY Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination |
1.00; 1.00; 41.29; 0.99; 41.06; 0.98 | — |
| SECONDARY Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 1 Post-Vaccination |
277; 1 | — |
| SECONDARY Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 2 Post-Vaccination |
286; 1 | — |
| SECONDARY Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 4 Post-Vaccination |
272; 2 | — |
| SECONDARY Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 6 Post-Vaccination |
264; 1 | — |
| SECONDARY Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 8 Post-Vaccination |
256; 1 | — |
| SECONDARY Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 10 Post-Vaccination |
250; 1 | — |
| SECONDARY Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 12 Post-Vaccination |
245; 2 | — |
| SECONDARY Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 14 Post-Vaccination |
231; 3 | — |
| SECONDARY Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 16 Post-Vaccination |
228; 2 | — |
| SECONDARY Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 18 Post-Vaccination |
229; 1 | — |
| SECONDARY Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 0 |
25; 18 | — |
| SECONDARY Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 1 Post Vaccination |
192; 12 | — |
| SECONDARY Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 2 Post Vaccination |
186; 13 | — |
| SECONDARY Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 4 Post Vaccination |
174; 12 | — |
| SECONDARY Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 6 Post Vaccination |
155; 11 | — |
| SECONDARY Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 8 Post Vaccination |
151; 9 | — |
| SECONDARY Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 10 Post Vaccination |
137; 10 | — |
| SECONDARY Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 12 Post Vaccination |
136; 10 | — |
| SECONDARY Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 14 Post Vaccination |
126; 9 | — |
| SECONDARY Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 16 Post Vaccination |
122; 8 | — |
| SECONDARY Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 18 Post Vaccination |
117; 9 | — |
| SECONDARY Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study. |
39; 54; 286; 271 | 0.120 |
| SECONDARY Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. |
5; 2; 313; 314; 7; 9 | 0.089 |
| SECONDARY Number of Participants Whose Vaginal Cultures Were Persistently Type III GBS Culture Positive for Three or More Consecutive Visits |
318; 312; 7; 13 | 0.256 |
| SECONDARY The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 |
321; 320; 0; 1; 0; 0 | — |
| SECONDARY The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 |
314; 313; 1; 1; 0; 1 | — |
| SECONDARY The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 |
310; 303; 0; 1; 0; 1 | — |
| SECONDARY The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 |
301; 292; 2; 0; 1; 2 | — |
| SECONDARY The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 |
291; 293; 1; 2; 0; 0 | — |
| SECONDARY The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 |
279; 282; 3; 1; 0; 0 | — |
| SECONDARY The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 |
273; 279; 2; 1; 0; 0 | — |
| SECONDARY The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 |
266; 272; 2; 0; 0; 0 | — |
| SECONDARY The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 |
259; 268; 3; 0; 2; 1 | — |
| SECONDARY The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 |
257; 260; 2; 2; 1; 1 | — |
| SECONDARY The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 |
255; 256; 0; 2; 1; 0 | — |
Summary
The group B streptococcus (GBS) vaccine study is being done to see if a single vaccination with a GBS type III vaccine can stop women from getting GBS type III bacteria in the vagina. Approximately 600 women, ages 18-40, will be enrolled from the clinical sites participating in this study. Participants will be non-pregnant, sexually active (sex with a male at least once in the last 4 months), and GBS negative in the vagina or rectum at the screening visit. Participants will be randomly assigned to receive the experimental GBS type III vaccine or a licensed vaccine containing Tetanus and Diphtheria Toxoids (Td). Participants will be followed at one month, 2 months and every other month thereafter following vaccination (for vaginal and rectal swab collection and a blood draw) for 1½ years or a total of 10 post vaccination visits.
Eligibility Criteria
Inclusion Criteria
- Participated in and completed the group B Streptococcus (GBS) Screening Protocol
- Non-pregnant women
- Aged 18-40 years at time of the screening protocol
- Currently sexually active at time of enrollment (sex with a male at least once in the last 4 months)
- Current use of effective birth control methods and stated intention to use the method for at least the next 30 days
- Provision of written informed consent
- Intention to stay in the geographical area for the next 18 months
- Access to telephone
Exclusion Criteria
- Group B Streptococcus (GBS) positive by culture (vaginal and/or rectal), or culture positive for streptococcal strains that cross-react with GBS typing sera (vaginal and/or rectal).
- Pregnancy (all women will receive a urine pregnancy prior to vaccination).
- Any condition which in the opinion of the investigator would pose a health risk to the subject or interfere with the evaluation of the vaccine.
- Serious underlying disease, which is known at the time of vaccination (including: immunodeficiency, active or chronic hepatitis, immunosuppressive conditions which require systemic steroid therapy, or treatment for a malignancy during the past year).
- Receipt of any vaccine, blood product, or experimental medicine within the past 30 days with the exception of a licensed inactivated influenza vaccine.
- Plans to receive any vaccine, blood product, or experimental medicine in the next 30 days with the exception of a licensed inactivated influenza vaccine.
- Use of any antimicrobial agent(s) (vaginal or systemic) for treatment of any condition within 7 days prior to study enrollment (including: Monistat, Gyne-Lotrimin, et cetera )
- History of hypersensitivity to tetanus toxoid vaccine.
- Tetanus toxoid immunization within the previous 12 months.
- Previous participation in a study in which participants received tetanus toxoid vaccine or vaccine against Group B Streptococcus.
- Spontaneous or surgical menopause.
- Nursing mother.
- Hypersensitivity to thimerosal.
Data sourced from ClinicalTrials.gov (NCT00128219). 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.