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Immunogenicity of seven-valent pneumococcal conjugate vaccine administered at 6, 14 and 40 weeks of age in South African infants.

Jones SA, Groome M, Koen A, Van Niekerk N, Sewraj P, Kuwanda L, Izu A, Adrian PV, Madhi SA - PLoS ONE (2013)

Bottom Line: The proportion of children with OPA ≥ 8 for serotypes 9V, 19F and 23F increased significantly following the 3(rd) PCV7-dose to 93.6%; 86.0% and 89.7% respectively.Geometric mean concentrations (GMCs) following the 3(rd) PCV7-dose were higher for all serotypes in this study compared to the historical cohort.The studied PCV7 dosing schedule induced good immune responses, including higher GMCs following the 3(rd-)dose at 9-months compared to when given at 14-weeks of age.

View Article: PubMed Central - PubMed

Affiliation: Department of Science/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa ; Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa.

ABSTRACT

Background: The high cost of pneumococcal conjugate vaccine (PCV) and local epidemiological factors contributed to evaluating different PCV dosing-schedules. This study evaluated the immunogenicity of seven-valent PCV (PCV7) administered at 6-weeks; 14-weeks and 9-months of age.

Methods: 250 healthy, HIV-unexposed infants were immunized with PCV7 concurrently with other childhood vaccines. Serotype-specific anti-capsular IgG concentrations were measured one-month following the 1(st) and 2(nd) PCV-doses, prior to and two-weeks following the 3(rd) dose. Opsonophagocytic killing assay (OPA) was measured for three serotypes following the 2(nd) and 3(rd) PCV7-doses. Immunogenicity of the current schedule was compared to a historical cohort of infants who received PCV7 at 6, 10 and 14 weeks of age.

Results: The proportion of infants with serotype-specific antibody ≥ 0.35 µg/ml following the 2(nd) PCV7-dose ranged from 84% for 6B to ≥ 89% for other serotypes. Robust antibody responses were observed following the 3(rd) dose. The proportion of children with OPA ≥ 8 for serotypes 9V, 19F and 23F increased significantly following the 3(rd) PCV7-dose to 93.6%; 86.0% and 89.7% respectively. The quantitative antibody concentrations following the 2(nd) PCV7-dose were comparable to that after the 3(rd) -dose in the 6-10-14 week schedule. Geometric mean concentrations (GMCs) following the 3(rd) PCV7-dose were higher for all serotypes in this study compared to the historical cohort.

Conclusions: The studied PCV7 dosing schedule induced good immune responses, including higher GMCs following the 3(rd-)dose at 9-months compared to when given at 14-weeks of age. This may confer longer persistence of antibodies and duration of protection against pneumococcal disease.

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Flow Diagram of study participation.Diagram indicating number of children enrolled into the study and number excluded or lost to follow-up during the course of the study.Withdrew consent = participant no longer wished to be part of study cohort and preferred to be vaccinated at local clinic. Relocated=participant moved out of study area and therefore unable to attend study visits. Lost to follow up = study site unable to contact study participant. Outside window period = vaccination occurred outside protocol defined period of 6-12 weeks; 12-24 weeks and 38-42 weeks for the first, second and third doses respectively. PCV= 7-valent Pneumococcal Conjugate Vaccine.
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pone-0072794-g001: Flow Diagram of study participation.Diagram indicating number of children enrolled into the study and number excluded or lost to follow-up during the course of the study.Withdrew consent = participant no longer wished to be part of study cohort and preferred to be vaccinated at local clinic. Relocated=participant moved out of study area and therefore unable to attend study visits. Lost to follow up = study site unable to contact study participant. Outside window period = vaccination occurred outside protocol defined period of 6-12 weeks; 12-24 weeks and 38-42 weeks for the first, second and third doses respectively. PCV= 7-valent Pneumococcal Conjugate Vaccine.

Mentions: 250 Black-African children, 57% of whom were male, were enrolled and received PCV7 at mean of 6.3 (range 5.7-7.7; standard deviation [S.D.] 0.04), 15.8 (range 11.5-23.4; S.D. 0.1) and 39.9 (range 38.7-46.1; S.D. 0.05) weeks of age. The mean time interval between the first and second dose of PCV was 9.4 weeks (range 5.4-16.8 weeks; S.D. 1.4weeks), with only one child receiving the vaccines less than 8 weeks apart. Overall, 250 (100%), 235 (94.0%) and 226 (90.4%) received their first, second and third doses of PCV7 within the protocol defined periods. Analysis at any specific time-point was limited to those children who had complied with earlier protocol-defined time-points, including up to the analyzed time-point. Overall, 228 (91.2%) participants were active on study by the time of the last analyzed time-point (Figure 1).


Immunogenicity of seven-valent pneumococcal conjugate vaccine administered at 6, 14 and 40 weeks of age in South African infants.

Jones SA, Groome M, Koen A, Van Niekerk N, Sewraj P, Kuwanda L, Izu A, Adrian PV, Madhi SA - PLoS ONE (2013)

Flow Diagram of study participation.Diagram indicating number of children enrolled into the study and number excluded or lost to follow-up during the course of the study.Withdrew consent = participant no longer wished to be part of study cohort and preferred to be vaccinated at local clinic. Relocated=participant moved out of study area and therefore unable to attend study visits. Lost to follow up = study site unable to contact study participant. Outside window period = vaccination occurred outside protocol defined period of 6-12 weeks; 12-24 weeks and 38-42 weeks for the first, second and third doses respectively. PCV= 7-valent Pneumococcal Conjugate Vaccine.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3755982&req=5

pone-0072794-g001: Flow Diagram of study participation.Diagram indicating number of children enrolled into the study and number excluded or lost to follow-up during the course of the study.Withdrew consent = participant no longer wished to be part of study cohort and preferred to be vaccinated at local clinic. Relocated=participant moved out of study area and therefore unable to attend study visits. Lost to follow up = study site unable to contact study participant. Outside window period = vaccination occurred outside protocol defined period of 6-12 weeks; 12-24 weeks and 38-42 weeks for the first, second and third doses respectively. PCV= 7-valent Pneumococcal Conjugate Vaccine.
Mentions: 250 Black-African children, 57% of whom were male, were enrolled and received PCV7 at mean of 6.3 (range 5.7-7.7; standard deviation [S.D.] 0.04), 15.8 (range 11.5-23.4; S.D. 0.1) and 39.9 (range 38.7-46.1; S.D. 0.05) weeks of age. The mean time interval between the first and second dose of PCV was 9.4 weeks (range 5.4-16.8 weeks; S.D. 1.4weeks), with only one child receiving the vaccines less than 8 weeks apart. Overall, 250 (100%), 235 (94.0%) and 226 (90.4%) received their first, second and third doses of PCV7 within the protocol defined periods. Analysis at any specific time-point was limited to those children who had complied with earlier protocol-defined time-points, including up to the analyzed time-point. Overall, 228 (91.2%) participants were active on study by the time of the last analyzed time-point (Figure 1).

Bottom Line: The proportion of children with OPA ≥ 8 for serotypes 9V, 19F and 23F increased significantly following the 3(rd) PCV7-dose to 93.6%; 86.0% and 89.7% respectively.Geometric mean concentrations (GMCs) following the 3(rd) PCV7-dose were higher for all serotypes in this study compared to the historical cohort.The studied PCV7 dosing schedule induced good immune responses, including higher GMCs following the 3(rd-)dose at 9-months compared to when given at 14-weeks of age.

View Article: PubMed Central - PubMed

Affiliation: Department of Science/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa ; Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa.

ABSTRACT

Background: The high cost of pneumococcal conjugate vaccine (PCV) and local epidemiological factors contributed to evaluating different PCV dosing-schedules. This study evaluated the immunogenicity of seven-valent PCV (PCV7) administered at 6-weeks; 14-weeks and 9-months of age.

Methods: 250 healthy, HIV-unexposed infants were immunized with PCV7 concurrently with other childhood vaccines. Serotype-specific anti-capsular IgG concentrations were measured one-month following the 1(st) and 2(nd) PCV-doses, prior to and two-weeks following the 3(rd) dose. Opsonophagocytic killing assay (OPA) was measured for three serotypes following the 2(nd) and 3(rd) PCV7-doses. Immunogenicity of the current schedule was compared to a historical cohort of infants who received PCV7 at 6, 10 and 14 weeks of age.

Results: The proportion of infants with serotype-specific antibody ≥ 0.35 µg/ml following the 2(nd) PCV7-dose ranged from 84% for 6B to ≥ 89% for other serotypes. Robust antibody responses were observed following the 3(rd) dose. The proportion of children with OPA ≥ 8 for serotypes 9V, 19F and 23F increased significantly following the 3(rd) PCV7-dose to 93.6%; 86.0% and 89.7% respectively. The quantitative antibody concentrations following the 2(nd) PCV7-dose were comparable to that after the 3(rd) -dose in the 6-10-14 week schedule. Geometric mean concentrations (GMCs) following the 3(rd) PCV7-dose were higher for all serotypes in this study compared to the historical cohort.

Conclusions: The studied PCV7 dosing schedule induced good immune responses, including higher GMCs following the 3(rd-)dose at 9-months compared to when given at 14-weeks of age. This may confer longer persistence of antibodies and duration of protection against pneumococcal disease.

Show MeSH