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Vaccines

Development and Use of a Serum Bactericidal Assay Using Pooled Human Complement To Assess Responses to a Meningococcal Group A Conjugate Vaccine in African Toddlers

Margaret C. Bash, Freyja Lynn, Brian Mocca, Ray Borrow, Helen Findlow, Musa Hassan-King, Marie-Pierre Preziosi, Olubukola Idoko, Samba Sow, Prasad Kulkarni, F. Marc LaForce
C. J. Papasian, Editor
Margaret C. Bash
aCenter for Biologics Evaluation and Research, FDA, Bethesda, Maryland, USA
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Freyja Lynn
aCenter for Biologics Evaluation and Research, FDA, Bethesda, Maryland, USA
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Brian Mocca
aCenter for Biologics Evaluation and Research, FDA, Bethesda, Maryland, USA
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Ray Borrow
bVaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, United Kingdom
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Helen Findlow
bVaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, United Kingdom
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Musa Hassan-King
cMeningitis Vaccine Project, PATH, Ferney-Voltaire, France
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Marie-Pierre Preziosi
cMeningitis Vaccine Project, PATH, Ferney-Voltaire, France
dMeningitis Vaccine Project, Initiative for Vaccine Research, World Health Organization, Geneva, Switzerland
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Olubukola Idoko
eMedical Research Council, Basse, The Gambia
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Samba Sow
fCentre pour le Développement des Vaccins, Bamako, Mali
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Prasad Kulkarni
gSerum Institute of India, Pune, India
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F. Marc LaForce
cMeningitis Vaccine Project, PATH, Ferney-Voltaire, France
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C. J. Papasian
Roles: Editor
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DOI: 10.1128/CVI.00812-13
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  • FIG 1
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    FIG 1

    hSBA titers of serum samples determined using independent pooled human complement (hC′) lots. Two-fold serum dilutions from 1:4 to 1:1,024 were tested. Titers of <4 are shown as values of 2. (A) Comparison of hSBA titers for 15 samples using hC′ lots C12, C13, and C14 analyzed in the CBER laboratory; data for 3 samples tested with lot C11 are included. Indeterminate titers (n = 2) and titers of ≥64 with insufficient sample to test at higher dilutions (n = 2) are not shown. (B) Comparison of reported titers for 18 samples tested using hC′ lots C11, C12, and C13 in the PHE laboratory. Two samples with data available for only one hC′ lot are not shown. (C) Comparison of the median values of 14 samples between the CBER and PHE laboratories. Sample 33005 is not shown, as a valid median titer (panel B) was not determined.

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    FIG 2

    The hSBA geometric mean titers (GMTs) are shown by vaccination group at 28 days and 10 months after primary immunization (H, Hib; M, PsACWY; P, PsA-TT). For groups that received a second meningococcal immunization, GMTs are shown at 28 days after the second immunization and at 2 years postenrollment. The first letter designates the first immunization, and the second letter designates the second immunization. Error bars show ±1 standard deviation.

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    FIG 3

    Reverse cumulative distribution curves for hSBA responses to PsA-TT vaccination. Shown is the proportion of subjects with hSBA titers at or above the x axis value for the PsA-TT primary immunization group at 28 days (P 1 mo) and 10 months (P 10 mo) after primary immunization, PsA-TT-primed subjects who received a second PsA-TT dose (PP) or a one-fifth dose of PsACWY challenge (PM) at 28 days (PP 11 mo or PM 11 mo, respectively) and 14 months (PP 24 mo or PM 24 mo, respectively) after the second immunization. The distribution of hSBA titers among the reference PsACWY vaccine group is shown at 28 days after primary immunization (M 1 mo).

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  • TABLE 1

    Proportion of subjects with hSBA titers of ≥8 in the intention-to-treat population

    Primary vaccineSecondary vaccineNo. of subjects with titers of ≥8/total no. of subjects; % (95% CI)
    28 days after primary10 mo after primary28 days after 2nd vaccined14 mo after 2nd vaccined
    PsA-TT42/57; 73.7a (60.3, 84.5)11/55; 20.0b (10.4, 33.0)
    PsA-TT11/13; 84.6 (54.6, 98.1)12/15; 80.0 (51.9, 95.7)
    PsACWY22/22; 100.0 (84.6, 100.0)16/22; 72.7 (49.8, 89.3)
    Hib3/18; 16.7 (3.6, 41.4)4/19; 21.1 (6.1, 45.6)
    PsACWY20/61; 32.8c (21.3, 46.0)1/61; 1.6 (0.0, 8.8)
    PsA-TT13/19; 68.4 (43.4, 87.4)7/20; 35.0 (15.4, 59.2)
    PsACWY9/17; 52.9 (27.8, 77.0)5/18; 27.8 (9.7, 53.5)
    Hib2/21; 9.5 (1.2, 30.4)8/22; 36.4 (17.2, 59.3)
    Hib8/62; 13.1 (5.8, 24.2)3/59; 5.1 (1.1, 14.1)
    PsA-TT6/16; 37.5 (15.2, 64.6)5/16; 31.3 (11.0, 58.7)
    PsACWY4/22; 18.2 (5.2, 40.3)3/20; 15.0 (3.2, 37.9)
    Hib1/18; 5.6 (0.1, 27.3)4/19; 26.3 (9.1, 51.2)
    • ↵a Fisher's exact test of percentage of subjects with titers of ≥8, P < 0.0001 for PsA-TT compared to PsACWY and compared to Hib at 28 days after primary immunization.

    • ↵b Fisher's exact test of percentage of subjects with titers of ≥8, P = 0.0014 for PsA-TT compared to PsACWY, and P = 0.0212 for PsA-TT compared to Hib at 10 months after primary immunization.

    • ↵c Fisher's exact test of percentage of subjects with titers of ≥8, P = 0.0169 for PsACWY compared to Hib at 28 days after primary immunization.

    • ↵d No significance testing performed.

Additional Files

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    Files in this Data Supplement:

    • Supplemental file 1 -

      Table S1. Demographic and serologic characteristics of 100 adult blood donor sera and selected subsets used for pooled human complement. Fig. S1. Serologic characteristics of adult blood donor sera screened as complement sources. Fig. S2. PsA-TT study in African toddlers 12 to 23 months of age.

      PDF, 215K

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Development and Use of a Serum Bactericidal Assay Using Pooled Human Complement To Assess Responses to a Meningococcal Group A Conjugate Vaccine in African Toddlers
Margaret C. Bash, Freyja Lynn, Brian Mocca, Ray Borrow, Helen Findlow, Musa Hassan-King, Marie-Pierre Preziosi, Olubukola Idoko, Samba Sow, Prasad Kulkarni, F. Marc LaForce
Clinical and Vaccine Immunology May 2014, 21 (5) 755-761; DOI: 10.1128/CVI.00812-13

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Development and Use of a Serum Bactericidal Assay Using Pooled Human Complement To Assess Responses to a Meningococcal Group A Conjugate Vaccine in African Toddlers
Margaret C. Bash, Freyja Lynn, Brian Mocca, Ray Borrow, Helen Findlow, Musa Hassan-King, Marie-Pierre Preziosi, Olubukola Idoko, Samba Sow, Prasad Kulkarni, F. Marc LaForce
Clinical and Vaccine Immunology May 2014, 21 (5) 755-761; DOI: 10.1128/CVI.00812-13
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