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

Purpose

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

Condition	Intervention	Phase
Streptococcal Infection Gram-positive Bacterial Infection Bacterial Infection	Biological: Group B streptococcus vaccine Biological: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study 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:

MedlinePlus related topics: Bacterial Infections Streptococcal Infections

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Transfer rate (%) of maternal anti-Group B strep. [ Time Frame: At delivery / birth (from inclusion up to 4 months) ] [ Designated as safety issue: No ]
CPS antibody that is transferred to the newborn, calculated as the ratio between cord blood antibody level (µg/mL) and maternal antibody level (µg/mL) at time of delivery, per each serotype
Concentration (µg/mL) of maternal anti-Group B strep. [ Time Frame: At delivery / birth (from inclusion up to 4 months) ] [ Designated as safety issue: No ]
CPS antibody that is transferred to the newborn, calculated as the ratio between cord blood antibody level (µg/mL) and maternal antibody level (µg/mL) at time of delivery, per each serotype
Measurement of safety and tolerability in pregnant women and infants by analysis of local reactogenicity, AEs and SAEs, and infant development. [ Time Frame: Responses will be analyzed up to 5-7 months post delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Concentration of anti-Group B strep specific antibodies in sera collected from vaccine and placebo injected subjects and from their infants at different time points [ Time Frame: At vaccination, 30 days after vaccination, at delivey and 3 months post delivery ] [ Designated as safety issue: No ]
Concentration of anti-diphtheria antibodies in sera of infants collected 1 month after the last routine infant anti-diphtheria vaccination. [ Time Frame: esponses will be analyzed at 5-7 months post delivery ] [ Designated as safety issue: Yes ]

Enrollment:	86
Study Start Date:	September 2011
Estimated Study Completion Date:	November 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vaccine	Biological: Group B streptococcus vaccine There are two arms: Vaccine and Placebo treatment arms
Placebo Comparator: Placebo	Biological: Placebo There are two arms: Vaccine and Placebo treatment arms

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Individuals characterized as "high risk" pregnancies at investigator discretion
Individuals with any known or suspected impairment/alteration of immune function, either congenital or resulting from: (a) 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/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy, topical corticosteroids are allowed), (b) receipt of immunostimulants, (c) 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 Immunoglobulins given for Anti-D prophylaxis are allowed
Individuals with a history of severe allergic reactions after previous vaccinations.

Contacts and Locations

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,
Halifix, 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

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
Last Updated:	April 16, 2013
Health Authority:	Canada: Public Health Agency of Canada Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Novartis:

Group B streptococcus
GBS
Vaccine
Prevention of group B streptococcus infection

Additional relevant MeSH terms:

Bacterial Infections
Streptococcal Infections
Gram-Positive Bacterial Infections

ClinicalTrials.gov processed this record on June 13, 2013