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Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age

Primary Purpose

Streptococcal Infections

Status
Completed
Phase
Phase 1
Locations
South Africa
Study Type
Interventional
Intervention
Group B Streptococcus Trivalent Vaccine - 20/20/20 μg
Saline solution
Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg
Group B Streptococcus Trivalent Vaccine - 5/5/5 μg
saline solution
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Streptococcal Infections focused on measuring Group B streptococcus, GBS, Vaccine, Prevention of group B streptococcus infection

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive.
  • Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)

Exclusion Criteria:

  • Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive
  • Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive

Sites / Locations

  • Chris Hani Baragwanath Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg

2: Placebo - Sterile saline

3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg

4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg

5: GBS Trivalent Vaccine - 5/5/5 µg

6: Placebo - Sterile saline

Arm Description

Non-pregnant women who received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.

Non-Pregnant Women who received two injection of saline solution.

Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.

Pregnant Women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.

Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.

Pregnant Women who received one injection of saline solution.

Outcomes

Primary Outcome Measures

The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.
Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Antibody GMC in Maternal Subjects at Day of Delivery
Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.

Secondary Outcome Measures

The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination
Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.
Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination
Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.
Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events
Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.
Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events
Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.
Antibody GMC Per Serotype at Different Time Points in Infants
Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.
Number of Infants Reporting Serious Adverse Events
Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events

Full Information

First Posted
September 1, 2010
Last Updated
August 18, 2014
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT01193920
Brief Title
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
Official Title
A Phase Ib/II Randomized, Observer-Blind, Controlled, Single Centre Study of a Trivalent Group B Streptococcus Vaccine in Healthy Non-Pregnant Women Leading Into a Dose-Ranging Study in Pregnant Women in South Africa
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Streptococcal Infections
Keywords
Group B streptococcus, GBS, Vaccine, Prevention of group B streptococcus infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg
Arm Type
Experimental
Arm Description
Non-pregnant women who received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
Arm Title
2: Placebo - Sterile saline
Arm Type
Placebo Comparator
Arm Description
Non-Pregnant Women who received two injection of saline solution.
Arm Title
3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg
Arm Type
Experimental
Arm Description
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Arm Title
4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg
Arm Type
Experimental
Arm Description
Pregnant Women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Arm Title
5: GBS Trivalent Vaccine - 5/5/5 µg
Arm Type
Experimental
Arm Description
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Arm Title
6: Placebo - Sterile saline
Arm Type
Placebo Comparator
Arm Description
Pregnant Women who received one injection of saline solution.
Intervention Type
Biological
Intervention Name(s)
Group B Streptococcus Trivalent Vaccine - 20/20/20 μg
Intervention Description
Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
Intervention Type
Other
Intervention Name(s)
Saline solution
Intervention Description
Subjects received two injection of saline solution.
Intervention Type
Biological
Intervention Name(s)
Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
Intervention Description
Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Intervention Type
Biological
Intervention Name(s)
Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg
Intervention Description
Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Intervention Type
Biological
Intervention Name(s)
Group B Streptococcus Trivalent Vaccine - 5/5/5 μg
Intervention Description
Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Intervention Type
Other
Intervention Name(s)
saline solution
Intervention Description
Subjects received one injection of saline solution.
Primary Outcome Measure Information:
Title
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Description
The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Time Frame
Day 61, one month after the second vaccination
Title
Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.
Description
Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
Time Frame
Day 61, one month after the second vaccination
Title
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Description
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Time Frame
Day of delivery
Title
Antibody GMC in Maternal Subjects at Day of Delivery
Description
Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.
Time Frame
Day of delivery
Secondary Outcome Measure Information:
Title
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
Description
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Time Frame
Day 31, one month after vaccination
Title
Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination
Description
Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.
Time Frame
day 31
Title
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Description
The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.
Time Frame
Day 361, one year after the first vaccination
Title
Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination
Description
Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.
Time Frame
Day 361, one year after the first vaccination
Title
Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events
Description
Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.
Time Frame
Day 61
Title
Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events
Description
Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.
Time Frame
From day 1 to one year after delivery
Title
Antibody GMC Per Serotype at Different Time Points in Infants
Description
Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.
Time Frame
Day 4, day 43 and day 91 after birth
Title
Number of Infants Reporting Serious Adverse Events
Description
Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events
Time Frame
one year after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive. Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation) Exclusion Criteria: Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines and Diagnostics
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Chris Hani Baragwanath Hospital
City
Chris Hani Rd, Soweto
State/Province
Johannesburg
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
29029127
Citation
Madhi SA, Koen A, Cutland CL, Jose L, Govender N, Wittke F, Olugbosi M, Sobanjo-Ter Meulen A, Baker S, Dull PM, Narasimhan V, Slobod K. Antibody Kinetics and Response to Routine Vaccinations in Infants Born to Women Who Received an Investigational Trivalent Group B Streptococcus Polysaccharide CRM197-Conjugate Vaccine During Pregnancy. Clin Infect Dis. 2017 Nov 13;65(11):1897-1904. doi: 10.1093/cid/cix666.
Results Reference
derived
PubMed Identifier
27139805
Citation
Madhi SA, Cutland CL, Jose L, Koen A, Govender N, Wittke F, Olugbosi M, Meulen AS, Baker S, Dull PM, Narasimhan V, Slobod K. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in healthy women and their infants: a randomised phase 1b/2 trial. Lancet Infect Dis. 2016 Aug;16(8):923-34. doi: 10.1016/S1473-3099(16)00152-3. Epub 2016 Apr 29.
Results Reference
derived
PubMed Identifier
26409812
Citation
Cutland CL, Cunnington M, Olugbosi M, Jones SA, Hugo A, Maharaj K, Slobod K, Madhi SA. Lessons learnt from enrolment and follow up of pregnant women and their infants in clinical trials in South Africa, a low-middle income country. Vaccine. 2015 Nov 25;33(47):6406-12. doi: 10.1016/j.vaccine.2015.08.040. Epub 2015 Sep 26.
Results Reference
derived

Learn more about this trial

Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age

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