Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01446289
First received: September 27, 2011
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.


Condition Intervention Phase
Streptococcal Infection
Gram-positive Bacterial Infection
Bacterial Infection
Biological: Group B Streptococcus Trivalent Vaccine
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: A Phase II Randomized, Observer-Blind, Multi-Center, Controlled Study of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth [ Time Frame: Day of delivery/birth ] [ Designated as safety issue: No ]
    GMCs of anti-Group B Streptococcus (GBS) capsular polysaccharide (CPS) antibodies against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.

  • Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery [ Time Frame: Day of delivery/birth ] [ Designated as safety issue: No ]
    The Geometric mean transfer ratio of anti-GBS CPS antibodies against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.


Secondary Outcome Measures:
  • GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects [ Time Frame: Day 1, day 31 and day 91 post-delivery ] [ Designated as safety issue: No ]
    GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in maternal subjects at study day 1, study day 31 and at day 91 post-partum after one administration of GBS vaccine or placebo are reported.

  • Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects [ Time Frame: Day 31, day of delivery, day 91 post-delivery ] [ Designated as safety issue: No ]
    GMRs of GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III, in maternal subjects at study day 31, at delivery and at day 91 post-partum versus day 1 (baseline) after one administration of GBS vaccine or placebo are reported.

  • GMC (ELISA) of Anti-GBS CPS Antibodies in Infants [ Time Frame: Day of birth and day 91 after birth ] [ Designated as safety issue: No ]
    GMC (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in infants at birth and at 3 months of age are reported.

  • GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth [ Time Frame: Day 91 after birth ] [ Designated as safety issue: No ]
    GMRs of anti-GBS CPS antibody GMCs (ELISA) against serotypes Ia, Ib and III in infants at 3 months of age (day 91 after birth) versus GMCs at birth are reported.

  • Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization [ Time Frame: 1 month after the last routine infant immunization ] [ Designated as safety issue: No ]
    Percentages of infant subjects showing anti-diphtheria antibodies GMCs (ELISA) over 0.1 IU/mL in sera collected at 1 month after the last routine infant immunization (ie, either 5 months or 7 months after birth, depending on the vaccination schedule) are reported.

  • Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: From day 1 to 7 after vaccination ] [ Designated as safety issue: Yes ]
    Percentage of maternal subjects reporting solicited local and systemic AEs and other indicators of reactogenicity from day 1 to 7 after vaccination are reported.

  • Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) [ Time Frame: All AEs were recorded until delivery, after delivery all AEs requiring a non-routine physician's visit and AEs leading to withdrawal from the study. SAEs were collected for the duration of the trial. ] [ Designated as safety issue: Yes ]
    Percentage of maternal subjects reporting unsolicited AEs, SAEs, AEs requiring a non-routine physician's visit, AEs leading to withdrawal are reported.

  • Percentages of Infants Reporting SAEs [ Time Frame: From birth until study termination ] [ Designated as safety issue: Yes ]
    Percentages of infants born from women who received either one injection of the study vaccine or placebo, reporting SAEs from birth until study termination are reported.


Enrollment: 86
Study Start Date: September 2011
Study Completion Date: October 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group B Streptococcus Trivalent Vaccine
Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine.
Biological: Group B Streptococcus Trivalent Vaccine
Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine administered intramuscularly.
Placebo Comparator: Placebo
Pregnant women who received one injection of saline solution.
Biological: Placebo
Pregnant women who received one injection of saline solution administered intramuscularly.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy pregnant women 18-40 years of age at 24-35 weeks of gestation at screening.
  2. Individuals who have given a written consent after the nature of the study has been explained according to local regulatory requirements.
  3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
  4. Individuals who will be available for all scheduled visits (ie, not planning to leave the area before the end of the study period).

Exclusion Criteria:

  1. Individuals who were unwilling and/or unable to give written informed consent to participate in the study.
  2. Individuals with a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.
  3. Individuals with any known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from:

    • receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose > 15 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy).
    • receipt of immunostimulants.
    • receipt of parenteral immunoglobulin preparation, blood products, and /or plasma derivatives within 12 weeks prior to enrollment and for the full length of the study.

    Note: Anti-D (Rho) Immunoglobulins (anti-RhD) given for Anti-D prophylaxis were to be allowed.

  4. Individuals characterized as "high risk" pregnancies at investigator discretion, such as those who have:

    • gestational diabetes
    • preeclampsia/eclampsia
    • women at risk of preterm labor (except positivity for vaginal GBS)
    • History of previous pregnancy complications including delivery of preterm infant.
    • History of still-birth, late abortions and children with congenital anomalies.
  5. Individuals who had received any other investigational agent or investigational intervention during the course of the study.
  6. Individuals with acute infection including oral temperature ≥ 38°C were to be temporarily excluded. They could be enrolled once the infection had resolved (as judged by investigator).
  7. HIV positive by history.
  8. Individuals reporting any known or suspected serious acute, chronic or progressive disease (eg, any history of neoplasm, malignancy, including lymphoproliferative disorder, diabetes, cardiac disease, malnutrition, renal failure, autoimmune disease, HBV or HCV, blood disorders).

    Note: Malignancies, highly likely to having been cured at the investigators discretion are allowed. (eg, no relapse since 5 years post last malignancy specific treatment).

  9. Individuals with bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time.
  10. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, might have interfered with the subject's ability to participate in the study (eg, who were not able to comprehend or to follow all required study procedures for the whole period of the study).
  11. Individuals with any progressive or severe neurologic disorder, seizure disorder, epilepsy or Guillain-Barré syndrome.
  12. Individuals with history or any illness that, in the opinion of the investigator, might have posed additional risk to subjects due to participation in the study.
  13. Individuals who were part of study personnel or close family members conducting this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446289

Locations
Belgium
UZ Leuven
Herestraat, Leuven, Belgium, 49-B-3000
Regionaal Ziekenhuis Heilig Hart,
Gasthuismolenstraat 31, Tienen, Belgium, 3300
Canada, British Columbia
University of British Columbia, Rm B3 25 B, 4500 Oak Street,
Vancouver, British Columbia, Canada, V6H3N1
Canada, Nova Scotia
Dalhousie University, IWK Health Centre, 5850/5980 University Avenue,
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Quebec
Centre hospitalier universitaire de Quebec (CHUQ)- hospital CHUL, Centre de recherche en infectiologie, 2705,
Boulevard laurier, S-745, Quebec, Canada, G1V 4G2
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
Principal Investigator: Gilbert Donders, Prof. Regional Hospital Heilig Hart, Tienen, Belgium
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01446289     History of Changes
Other Study ID Numbers: V98_04, 2010-020840-36
Study First Received: September 27, 2011
Results First Received: June 20, 2014
Last Updated: September 5, 2014
Health Authority: Canada: Public Health Agency of Canada - Health Canada
Belgium: FAMHP, Federal Agency for Medicinal and Health Products

Keywords provided by Novartis:
Group B streptococcus
GBS
Vaccine
Prevention of group B streptococcus infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Streptococcal Infections
Gram-Positive Bacterial Infections

ClinicalTrials.gov processed this record on October 01, 2014