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

Streptococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193920
• Other study ID #: V98_08
• Secondary ID: MCC Reference n°
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 1, 2010
• Last updated: August 18, 2014
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council (MCC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Streptococcal Infections

Intervention

Biological:
• Group B Streptococcus Trivalent Vaccine - 20/20/20 µg
Subjects received two injections of 20/20/20 µg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.

Other:
• Saline solution
Subjects received two injection of saline solution.

Biological:
• Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 µg
Subjects received one injection of 0.5/0.5/0.5 µg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
• Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 µg
Subjects received one injection of 2.5/2.5/2.5 µg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
• Group B Streptococcus Trivalent Vaccine - 5/5/5 µg
Subjects received one injection of 5/5/5 µg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.

Other:
• saline solution
Subjects received one injection of saline solution.

Locations

Country	Name	City	State
South Africa	Chris Hani Baragwanath Hospital	Chris Hani Rd, Soweto	Johannesburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 61, one month after the second vaccination	No
Primary	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 .	Day 61, one month after the second vaccination	No
Primary	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.	Day of delivery	No
Primary	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.	Day of delivery	No
Secondary	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.	Day 31, one month after vaccination	No
Secondary	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.	day 31	No
Secondary	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.	Day 361, one year after the first vaccination	No
Secondary	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.	Day 361, one year after the first vaccination	No
Secondary	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.	Day 61	Yes
Secondary	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.	From day 1 to one year after delivery	Yes
Secondary	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.	Day 4, day 43 and day 91 after birth	No
Secondary	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	one year after birth	Yes