Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01412801
First received: August 8, 2011
Last updated: September 5, 2014
Last verified: September 2014
Results First Received: June 20, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Intervention: Biological: Group B streptococcus vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at Malawi and South Africa

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All the enrolled subjects are included in the trial. Also,only the mothers who received the glycoconjugates were considered enrolled.

Reporting Groups
  Description
HIVposCD4LOW_Maternal HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
HIVposCD4HIGH_Maternal HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
HIVneg_Maternal HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
HIVposCD4LOW(Infants) Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL .
HIVposCD4HIGH(Infants) Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
HIVneg(Infants) Infants born to HIV-antibody negative maternal subjects

Participant Flow:   Overall Study
    HIVposCD4LOW_Maternal     HIVposCD4HIGH_Maternal     HIVneg_Maternal     HIVposCD4LOW(Infants)     HIVposCD4HIGH(Infants)     HIVneg(Infants)  
STARTED     91     89     90     91     88     87  
COMPLETED     87     84     83     87     85     84  
NOT COMPLETED     4     5     7     4     3     3  
Death                 0                 1                 0                 4                 2                 2  
Lost to Follow-up                 1                 2                 4                 0                 1                 1  
Withdrawal by Subject                 3                 2                 1                 0                 0                 0  
Relocated to another area                 0                 0                 2                 0                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HIVposCD4LOW_Maternal HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
HIVposCD4HIGH_Maternal HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
HIVneg_Maternal HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
HIVposCD4LOW (Infants) Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
HIVposCD4HIGH (Infants) Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
HIVneg (Infants) Infants born to HIV-antibody negative maternal subjects
Total Total of all reporting groups

Baseline Measures
    HIVposCD4LOW_Maternal     HIVposCD4HIGH_Maternal     HIVneg_Maternal     HIVposCD4LOW (Infants)     HIVposCD4HIGH (Infants)     HIVneg (Infants)     Total  
Number of Participants  
[units: participants]
  91     89     90     91     88     87     536  
Age, Customized  
[units: years]
Mean ± Standard Deviation
             
Maternal Subjects     28.3  ± 4.8     28.1  ± 5.2     24.7  ± 4.4     NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   27.1  ± 5.0  
Age, Customized  
[units: days]
Mean ± Standard Deviation
             
Infants     NA  ± NA [2]   NA  ± NA [2]   NA  ± NA [2]   4.1  ± 1.6     6.7  ± 2.5     1.3  ± 1.1     1.6  ± 1.0  
Gender  
[units: participants]
             
Female     91     89     90     42     40     41     393  
Male     0     0     0     49     48     46     143  
[1] "Mothers' ages only provided Here"
[2] "Infants' ages only provided here"



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth   [ Time Frame: Day of delivery/birth ]

2.  Primary:   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.   [ Time Frame: Day of delivery/birth ]

3.  Secondary:   Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery   [ Time Frame: Day 1, 15, 31 and at Delivery ]

4.  Secondary:   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   [ Time Frame: Day of Delivery ]

5.  Secondary:   Percentages of Subjects With Solicited Local Adverse Events (AEs)   [ Time Frame: From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks ]

6.  Secondary:   Percentages of Subjects With Solicited Systemic AEs   [ Time Frame: From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks ]

7.  Secondary:   Percentages of Subjects Who Experienced Unsolicited Adverse Events   [ Time Frame: Day 1 to Study Termination, for up to 24 weeks ]

8.  Secondary:   Percentages of Infants Who Experienced Unsolicited Adverse Events   [ Time Frame: Birth to Study Termination, for up to 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com


No publications provided


Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01412801     History of Changes
Other Study ID Numbers: V98_05
Study First Received: August 8, 2011
Results First Received: June 20, 2014
Last Updated: September 5, 2014
Health Authority: South Africa: Medicines Control Council
Malawi: PMPB (Pharmacy, Medicine and Poisons Board)