Clinical trial NCT01193920: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Streptococcal Infections
Keywords: Group B streptococcus
GBS
Vaccine
Prevention of group B streptococcus infection
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-09-02
Enrollment: 380
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
timeFrame: Day 61, one month after the second vaccination
measure: Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.
timeFrame: Day 61, one month after the second vaccination
measure: The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
timeFrame: Day of delivery
measure: Antibody GMC in Maternal Subjects at Day of Delivery
timeFrame: Day of delivery
Secondary outcomes:
measure: The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
timeFrame: Day 31, one month after vaccination
measure: Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination
timeFrame: day 31
measure: The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
timeFrame: Day 361, one year after the first vaccination
measure: Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination
timeFrame: Day 361, one year after the first vaccination
measure: Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events
timeFrame: Day 61
measure: Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events
timeFrame: From day 1 to one year after delivery
measure: Antibody GMC Per Serotype at Different Time Points in Infants
timeFrame: Day 4, day 43 and day 91 after birth
measure: Number of Infants Reporting Serious Adverse Events
timeFrame: one year after birth
Other outcomes:
Locations:
city: Chris Hani Rd, Soweto
country: South Africa
facility: Chris Hani Baragwanath Hospital
state: Johannesburg
Study officials:
affiliation: Novartis
name: Novartis Vaccines and Diagnostics
role: STUDY_CHAIR
References:
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.
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.
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.