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

NCT01193920 | Completed Phase 1 Results

• 2 other identifiers: V98_08MCC Reference n° 20100601
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Streptococcal Infections

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (8)

• 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

• Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination

  day 31

• 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

• Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination

  Day 361, one year after the first vaccination

• Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events

  Day 61

Study Arms (6)

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

EXPERIMENTAL

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

Biological: Group B Streptococcus Trivalent Vaccine - 20/20/20 μg

2: Placebo - Sterile saline

PLACEBO COMPARATOR

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

Other: Saline solution

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

EXPERIMENTAL

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

Biological: Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg

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

EXPERIMENTAL

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

Biological: Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg

5: GBS Trivalent Vaccine - 5/5/5 µg

EXPERIMENTAL

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

Biological: Group B Streptococcus Trivalent Vaccine - 5/5/5 μg

6: Placebo - Sterile saline

PLACEBO COMPARATOR

Pregnant Women who received one injection of saline solution.

Other: saline solution

Interventions

Group B Streptococcus Trivalent Vaccine - 20/20/20 μg BIOLOGICAL

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

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

saline solution OTHER

Subjects received two injection of saline solution.

2: Placebo - Sterile saline

Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg BIOLOGICAL

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

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

Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg BIOLOGICAL

Subjects received one injection of 2.5/2.5/2.5 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 - 5/5/5 μg BIOLOGICAL

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

5: GBS Trivalent Vaccine - 5/5/5 µg

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

Chris Hani Baragwanath Hospital

Chris Hani Rd, Soweto, Johannesburg, South Africa

Location

Related Publications (3)

• 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.

  PMID: 29029127 DERIVED

• 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.

  PMID: 27139805 DERIVED

• 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.

  PMID: 26409812 DERIVED

MeSH Terms

Conditions

Streptococcal Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines and Diagnostics

  Novartis

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 2, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: August 22, 2014
• Results First Posted: May 5, 2014

Record last verified: 2014-08

Locations

ZA (1)