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

NCT01446289 | Completed Phase 2 Results

• 2 other identifiers: V98_042010-020840-36
• Study Type: interventional
• Target: 86
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Streptococcal Infection; Gram-positive Bacterial Infection; Bacterial Infection

Keywords

Group B streptococcus; GBS; Vaccine; Prevention of group B streptococcus infection

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth

  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.

  Day of delivery/birth

• Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery

  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.

  Day of delivery/birth

Secondary Outcomes (8)

• GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects

  Day 1, day 31 and day 91 post-delivery

• Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects

  Day 31, day of delivery, day 91 post-delivery

• GMC (ELISA) of Anti-GBS CPS Antibodies in Infants

  Day of birth and day 91 after birth

• GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth

  Day 91 after birth

• Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization

  1 month after the last routine infant immunization

Study Arms (2)

Group B Streptococcus Trivalent Vaccine

EXPERIMENTAL

Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine.

Biological: Group B Streptococcus Trivalent Vaccine

Placebo

PLACEBO COMPARATOR

Pregnant women who received one injection of saline solution.

Biological: Placebo

Interventions

Group B Streptococcus Trivalent Vaccine BIOLOGICAL

Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine administered intramuscularly.

Group B Streptococcus Trivalent Vaccine

Placebo BIOLOGICAL

Pregnant women who received one injection of saline solution administered intramuscularly.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant women 18-40 years of age at 24-35 weeks of gestation at screening.
• Individuals who have given a 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 (ie, not planning to leave the area before the end of the study period).

You may not qualify if:

• Individuals who were unwilling and/or unable to give written informed consent to participate in the study.
• 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.
• 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.
• 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.
• Individuals who had received any other investigational agent or investigational intervention during the course of the study.
• 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).

Sponsors & Collaborators

• Novartis: lead
• Novartis Vaccines: collaborator

Study Sites (5)

UZ Leuven

Herestraat, Leuven, 49-B-3000, Belgium

Location

Regionaal Ziekenhuis Heilig Hart,

Gasthuismolenstraat 31, Tienen, 3300, Belgium

Location

University of British Columbia, Rm B3 25 B, 4500 Oak Street,

Vancouver, British Columbia, V6H3N1, Canada

Location

Dalhousie University, IWK Health Centre, 5850/5980 University Avenue,

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Centre hospitalier universitaire de Quebec (CHUQ)- hospital CHUL, Centre de recherche en infectiologie, 2705,

Boulevard Laurier, S-745, Quebec, G1V 4G2, Canada

Location

Related Publications (2)

• Fabbrini M, Rigat F, Tuscano G, Chiarot E, Donders G, Devlieger R, Filippini S, Frigimelica E, Forte P, Wittke F, Halperin SA, Slobod K, Grandi G, Margarit I. Functional activity of maternal and cord antibodies elicited by an investigational group B Streptococcus trivalent glycoconjugate vaccine in pregnant women. J Infect. 2018 May;76(5):449-456. doi: 10.1016/j.jinf.2018.01.006. Epub 2018 Jan 31.

  PMID: 29374589 DERIVED

• Donders GG, Halperin SA, Devlieger R, Baker S, Forte P, Wittke F, Slobod KS, Dull PM. Maternal Immunization With an Investigational Trivalent Group B Streptococcal Vaccine: A Randomized Controlled Trial. Obstet Gynecol. 2016 Feb;127(2):213-21. doi: 10.1097/AOG.0000000000001190.

  PMID: 26942345 DERIVED

MeSH Terms

Conditions

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Posting Director
• Organization: Novartis vaccines

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

• Gilbert Donders, Prof.

  Regional Hospital Heilig Hart, Tienen, Belgium

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: October 5, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 8, 2014
• Results First Posted: September 8, 2014

Record last verified: 2014-09

Locations

BE (2); CA (3)