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

Phase 1

Completed

• Conditions: Streptococcal Infections
• Interventions: Biological: Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg; Biological: Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg; Other: saline solution; Biological: Group B Streptococcus Trivalent Vaccine - 5/5/5 μg; Biological: Group B Streptococcus Trivalent Vaccine - 20/20/20 μg

• Registration Number: NCT01193920
• Lead Sponsor: Novartis Vaccines

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Study Start: 2010-10
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Results First Submitted: 2013-12-17
• Results First Submitted QC: 2014-04-03
• Results First Posted: 2014-05-05
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 380

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg	Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg	Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg	Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg	Pregnant Women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
6: Placebo - Sterile saline	saline solution	Pregnant Women who received one injection of saline solution.
2: Placebo - Sterile saline	saline solution	Non-Pregnant Women who received two injection of saline solution.
5: GBS Trivalent Vaccine - 5/5/5 µg	Group B Streptococcus Trivalent Vaccine - 5/5/5 μg	Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg	Group B Streptococcus Trivalent Vaccine - 20/20/20 μg	Non-pregnant women who received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.

Primary Outcome Measures

Name	Time	Method
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.	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.
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.	Day 61, 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.	Day 61, 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 .
Antibody GMC in Maternal Subjects at Day of Delivery	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

Name	Time	Method
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.	Day 361, 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	Day 361, 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.
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.	Day 31, 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.
Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events	Day 61	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	From day 1 to one year after delivery	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 in Maternal Subjects at One Month After Vaccination	day 31	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.
Antibody GMC Per Serotype at Different Time Points in Infants	Day 4, day 43 and day 91 after birth	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	one year after birth	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

Trial Locations

Locations (1)

Chris Hani Baragwanath Hospital; 🇿🇦 Chris Hani Rd, Soweto, Johannesburg, South Africa