Safety and immunogenicity of pneumococcal conjugate vaccines in a high-risk population: A randomized controlled trial of 10-valent and 13-valent pneumococcal conjugate vaccine in Papua New Guinean infants

William S. Pomat, Anita H.J. Van Den Biggelaar, Sandra Wana, Jacinta P. Francis, Vela Solomon, Andrew R. Greenhill, Rebecca Ford, Tilda Orami, Megan Passey, Peter Jacoby, Lea Ann Kirkham, Deborah Lehmann, Peter C. Richmond

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background. There are little data on the immunogenicity of PCV10 and PCV13 in the same high-risk population. Methods. PCV10 and PCV13 were studied head-to-head in a randomized controlled trial in Papua New Guinea in which 262 infants received 3 doses of PCV10 or PCV13 at 1, 2, and 3 months of age. Serotype-specific immunoglobulin G (IgG) concentrations, and pneumococcal and nontypeable Haemophilus influenzae (NTHi) carriage were assessed prevaccination and at 4 and 9 months of age. Infants were followed up for safety until 9 months of age. Results. One month after the third dose of PCV10 or PCV13, 80% of infants had IgG concentrations ≥0.35µg/mL for vaccine serotypes, and 6 months postvaccination IgG concentrations ≥0.35 µg/mL were maintained for 8/10 shared PCV serotypes in > 75% of children vaccinated with either PCV10 or PCV13. Children carried a total of 65 different pneumococcal serotypes (plus nonserotypeable). At 4 months of age, 92% (95% confidence interval [CI] 85–96) of children vaccinated with PCV10 and 81% (95% CI 72–88) vaccinated with PCV13 were pneumococcal carriers (P = .023), whereas no differences were seen at 9 months of age, or for NTHi carriage. Both vaccines were well tolerated and not associated with serious adverse events. Conclusions. Infant vaccination with 3 doses of PCV10 or PCV13 is safe and immunogenic in a highly endemic setting; however, to significantly reduce pneumococcal disease in these settings, PCVs with broader serotype coverage and potency to reduce pneumococcal carriage are needed. Clinical Trials Registration. NCT01619462.

Original languageEnglish
Pages (from-to)1472-1481
Number of pages10
JournalClinical Infectious Diseases
Volume68
Issue number9
DOIs
Publication statusPublished - 1 May 2019

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Conjugate Vaccines
Pneumococcal Vaccines
Randomized Controlled Trials
Safety
Population
Immunoglobulin G
Haemophilus influenzae
Vaccines
Confidence Intervals
Papua New Guinea
13-valent pneumococcal vaccine
10-valent pneumococcal conjugate vaccine
Vaccination
Serogroup
Clinical Trials

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Pomat, William S. ; Van Den Biggelaar, Anita H.J. ; Wana, Sandra ; Francis, Jacinta P. ; Solomon, Vela ; Greenhill, Andrew R. ; Ford, Rebecca ; Orami, Tilda ; Passey, Megan ; Jacoby, Peter ; Kirkham, Lea Ann ; Lehmann, Deborah ; Richmond, Peter C. / Safety and immunogenicity of pneumococcal conjugate vaccines in a high-risk population : A randomized controlled trial of 10-valent and 13-valent pneumococcal conjugate vaccine in Papua New Guinean infants. In: Clinical Infectious Diseases. 2019 ; Vol. 68, No. 9. pp. 1472-1481.
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title = "Safety and immunogenicity of pneumococcal conjugate vaccines in a high-risk population: A randomized controlled trial of 10-valent and 13-valent pneumococcal conjugate vaccine in Papua New Guinean infants",
abstract = "Background. There are little data on the immunogenicity of PCV10 and PCV13 in the same high-risk population. Methods. PCV10 and PCV13 were studied head-to-head in a randomized controlled trial in Papua New Guinea in which 262 infants received 3 doses of PCV10 or PCV13 at 1, 2, and 3 months of age. Serotype-specific immunoglobulin G (IgG) concentrations, and pneumococcal and nontypeable Haemophilus influenzae (NTHi) carriage were assessed prevaccination and at 4 and 9 months of age. Infants were followed up for safety until 9 months of age. Results. One month after the third dose of PCV10 or PCV13, 80{\%} of infants had IgG concentrations ≥0.35µg/mL for vaccine serotypes, and 6 months postvaccination IgG concentrations ≥0.35 µg/mL were maintained for 8/10 shared PCV serotypes in > 75{\%} of children vaccinated with either PCV10 or PCV13. Children carried a total of 65 different pneumococcal serotypes (plus nonserotypeable). At 4 months of age, 92{\%} (95{\%} confidence interval [CI] 85–96) of children vaccinated with PCV10 and 81{\%} (95{\%} CI 72–88) vaccinated with PCV13 were pneumococcal carriers (P = .023), whereas no differences were seen at 9 months of age, or for NTHi carriage. Both vaccines were well tolerated and not associated with serious adverse events. Conclusions. Infant vaccination with 3 doses of PCV10 or PCV13 is safe and immunogenic in a highly endemic setting; however, to significantly reduce pneumococcal disease in these settings, PCVs with broader serotype coverage and potency to reduce pneumococcal carriage are needed. Clinical Trials Registration. NCT01619462.",
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author = "Pomat, {William S.} and {Van Den Biggelaar}, {Anita H.J.} and Sandra Wana and Francis, {Jacinta P.} and Vela Solomon and Greenhill, {Andrew R.} and Rebecca Ford and Tilda Orami and Megan Passey and Peter Jacoby and Kirkham, {Lea Ann} and Deborah Lehmann and Richmond, {Peter C.}",
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Safety and immunogenicity of pneumococcal conjugate vaccines in a high-risk population : A randomized controlled trial of 10-valent and 13-valent pneumococcal conjugate vaccine in Papua New Guinean infants. / Pomat, William S.; Van Den Biggelaar, Anita H.J.; Wana, Sandra; Francis, Jacinta P.; Solomon, Vela; Greenhill, Andrew R.; Ford, Rebecca; Orami, Tilda; Passey, Megan; Jacoby, Peter; Kirkham, Lea Ann; Lehmann, Deborah; Richmond, Peter C.

In: Clinical Infectious Diseases, Vol. 68, No. 9, 01.05.2019, p. 1472-1481.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety and immunogenicity of pneumococcal conjugate vaccines in a high-risk population

T2 - A randomized controlled trial of 10-valent and 13-valent pneumococcal conjugate vaccine in Papua New Guinean infants

AU - Pomat, William S.

AU - Van Den Biggelaar, Anita H.J.

AU - Wana, Sandra

AU - Francis, Jacinta P.

AU - Solomon, Vela

AU - Greenhill, Andrew R.

AU - Ford, Rebecca

AU - Orami, Tilda

AU - Passey, Megan

AU - Jacoby, Peter

AU - Kirkham, Lea Ann

AU - Lehmann, Deborah

AU - Richmond, Peter C.

PY - 2019/5/1

Y1 - 2019/5/1

N2 - Background. There are little data on the immunogenicity of PCV10 and PCV13 in the same high-risk population. Methods. PCV10 and PCV13 were studied head-to-head in a randomized controlled trial in Papua New Guinea in which 262 infants received 3 doses of PCV10 or PCV13 at 1, 2, and 3 months of age. Serotype-specific immunoglobulin G (IgG) concentrations, and pneumococcal and nontypeable Haemophilus influenzae (NTHi) carriage were assessed prevaccination and at 4 and 9 months of age. Infants were followed up for safety until 9 months of age. Results. One month after the third dose of PCV10 or PCV13, 80% of infants had IgG concentrations ≥0.35µg/mL for vaccine serotypes, and 6 months postvaccination IgG concentrations ≥0.35 µg/mL were maintained for 8/10 shared PCV serotypes in > 75% of children vaccinated with either PCV10 or PCV13. Children carried a total of 65 different pneumococcal serotypes (plus nonserotypeable). At 4 months of age, 92% (95% confidence interval [CI] 85–96) of children vaccinated with PCV10 and 81% (95% CI 72–88) vaccinated with PCV13 were pneumococcal carriers (P = .023), whereas no differences were seen at 9 months of age, or for NTHi carriage. Both vaccines were well tolerated and not associated with serious adverse events. Conclusions. Infant vaccination with 3 doses of PCV10 or PCV13 is safe and immunogenic in a highly endemic setting; however, to significantly reduce pneumococcal disease in these settings, PCVs with broader serotype coverage and potency to reduce pneumococcal carriage are needed. Clinical Trials Registration. NCT01619462.

AB - Background. There are little data on the immunogenicity of PCV10 and PCV13 in the same high-risk population. Methods. PCV10 and PCV13 were studied head-to-head in a randomized controlled trial in Papua New Guinea in which 262 infants received 3 doses of PCV10 or PCV13 at 1, 2, and 3 months of age. Serotype-specific immunoglobulin G (IgG) concentrations, and pneumococcal and nontypeable Haemophilus influenzae (NTHi) carriage were assessed prevaccination and at 4 and 9 months of age. Infants were followed up for safety until 9 months of age. Results. One month after the third dose of PCV10 or PCV13, 80% of infants had IgG concentrations ≥0.35µg/mL for vaccine serotypes, and 6 months postvaccination IgG concentrations ≥0.35 µg/mL were maintained for 8/10 shared PCV serotypes in > 75% of children vaccinated with either PCV10 or PCV13. Children carried a total of 65 different pneumococcal serotypes (plus nonserotypeable). At 4 months of age, 92% (95% confidence interval [CI] 85–96) of children vaccinated with PCV10 and 81% (95% CI 72–88) vaccinated with PCV13 were pneumococcal carriers (P = .023), whereas no differences were seen at 9 months of age, or for NTHi carriage. Both vaccines were well tolerated and not associated with serious adverse events. Conclusions. Infant vaccination with 3 doses of PCV10 or PCV13 is safe and immunogenic in a highly endemic setting; however, to significantly reduce pneumococcal disease in these settings, PCVs with broader serotype coverage and potency to reduce pneumococcal carriage are needed. Clinical Trials Registration. NCT01619462.

KW - Antibodies

KW - Carriage

KW - Papua New Guinea

KW - Pneumococcal conjugate vaccine

KW - S. pneumonia

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U2 - 10.1093/cid/ciy743

DO - 10.1093/cid/ciy743

M3 - Article

VL - 68

SP - 1472

EP - 1481

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

IS - 9

ER -