Clinical trial NCT01412801: Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
Official title: A Phase II Open-Label, Multi-Center Study of a Group B Streptococcus Vaccine in HIV Positive and HIV Negative Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Keywords: Group B streptococcus
GBS
Vaccine
Prevention of group B streptococcus infection
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-08-09
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the study investigated the maternal to fetal transfer of antibodies induced by the investigational vaccine.


Eligibility criteria: Inclusion Criteria:

* Pregnant women 18-40 years of age between 24-35 weeks gestation
* Women who were HIVneg or HIVpos with WHO stage I or II disease and with CD4+ counts \> 50 cells/µL

Exclusion Criteria:

* Women who had CD4+ count ≤ 50 cells/µL
* Women who were HIVpos with WHO stage III or IV disease, history of severe allergic reactions after previous vaccinations

Primary outcomes:
measure: Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth
timeFrame: Day of delivery/birth
measure: Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth.
timeFrame: Day of delivery/birth
Secondary outcomes:
measure: Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
timeFrame: Day 1, 15, 31 and at Delivery
measure: Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
timeFrame: Day of Delivery
measure: Percentages of Subjects With Solicited Local Adverse Events (AEs)
timeFrame: From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks
measure: Percentages of Subjects With Solicited Systemic AEs
timeFrame: From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks
measure: Percentages of Subjects Who Experienced Unsolicited Adverse Events
timeFrame: Day 1 to Study Termination, for up to 24 weeks
measure: Percentages of Infants Who Experienced Unsolicited Adverse Events
timeFrame: Birth to Study Termination, for up to 24 weeks
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Limbe Health Center
city: Bertsham
country: South Africa
facility: Chris Hani Baragwanath Hospital
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Heyderman RS, Madhi SA, French N, Cutland C, Ngwira B, Kayambo D, Mboizi R, Koen A, Jose L, Olugbosi M, Wittke F, Slobod K, Dull PM. Group B streptococcus vaccination in pregnant women with or without HIV in Africa: a non-randomised phase 2, open-label, multicentre trial. Lancet Infect Dis. 2016 May;16(5):546-555. doi: 10.1016/S1473-3099(15)00484-3. Epub 2016 Feb 8.