Antibody persistence, PRP-specific immune memory, and booster responses in infants immunised with a combination DTPa–HBV–IPV/Hib vaccine

A new single-injection combination vaccine against six diseases has been developed to accommodate the growing number of recommended paediatric vaccines. A pentavalent liquid diphtheria, tetanus, acellular pertussis (3-component), hepatitis B, and inactivated polio (types 1–3) combined vaccine (DTPa–...

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Veröffentlicht in:Vaccine 2004-11, Vol.23 (1), p.14-20
Hauptverfasser: Nolan, T., Altmann, A., Skeljo, M., Streeton, C., Schuerman, L.
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Altmann, A.
Skeljo, M.
Streeton, C.
Schuerman, L.
description A new single-injection combination vaccine against six diseases has been developed to accommodate the growing number of recommended paediatric vaccines. A pentavalent liquid diphtheria, tetanus, acellular pertussis (3-component), hepatitis B, and inactivated polio (types 1–3) combined vaccine (DTPa–HBV–IPV) is extemporaneously mixed with a lyophilized Haemophilus influenza type B (Hib) conjugate vaccine (polyribosyl-ribitol phosphate (PRP)–T) and given as a single-injection. A cohort of 368 healthy infants was initially studied to evaluate the immunogenicity and reactogenicity of this hexavalent combination given as a primary course at 2, 4, and 6 months of age. At 15 months of age, from this cohort, 219 children received a booster dose of a licensed DTPa/Hib (PRP–T) vaccine to assess the booster response, while 70 received a challenge dose of unconjugated PRP (PRP) vaccine (to evaluate Hib-specific memory) plus a separate DTPa vaccine. Seven to 10 days following plain PRP challenge, anti-PRP geometric mean antibody concentrations (GMCs) had increased 13-fold to 5.67 μg/ml, and thirty days after conjugated PRP booster vaccination, anti-PRP antibody GMCs increased 102-fold. Both responses are indicative of immune memory. Vaccination was well tolerated following all primary and booster doses, although 10.5% of booster recipients experienced >50-mm local swelling at the site of DTPa vaccination. We conclude that DTPa–HBV–IPV/Hib is safe and immunogenic for primary vaccination, and that Hib-specific memory is induced by primary vaccination.
doi_str_mv 10.1016/j.vaccine.2004.06.017
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A pentavalent liquid diphtheria, tetanus, acellular pertussis (3-component), hepatitis B, and inactivated polio (types 1–3) combined vaccine (DTPa–HBV–IPV) is extemporaneously mixed with a lyophilized Haemophilus influenza type B (Hib) conjugate vaccine (polyribosyl-ribitol phosphate (PRP)–T) and given as a single-injection. A cohort of 368 healthy infants was initially studied to evaluate the immunogenicity and reactogenicity of this hexavalent combination given as a primary course at 2, 4, and 6 months of age. At 15 months of age, from this cohort, 219 children received a booster dose of a licensed DTPa/Hib (PRP–T) vaccine to assess the booster response, while 70 received a challenge dose of unconjugated PRP (PRP) vaccine (to evaluate Hib-specific memory) plus a separate DTPa vaccine. Seven to 10 days following plain PRP challenge, anti-PRP geometric mean antibody concentrations (GMCs) had increased 13-fold to 5.67 μg/ml, and thirty days after conjugated PRP booster vaccination, anti-PRP antibody GMCs increased 102-fold. Both responses are indicative of immune memory. Vaccination was well tolerated following all primary and booster doses, although 10.5% of booster recipients experienced &gt;50-mm local swelling at the site of DTPa vaccination. 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A pentavalent liquid diphtheria, tetanus, acellular pertussis (3-component), hepatitis B, and inactivated polio (types 1–3) combined vaccine (DTPa–HBV–IPV) is extemporaneously mixed with a lyophilized Haemophilus influenza type B (Hib) conjugate vaccine (polyribosyl-ribitol phosphate (PRP)–T) and given as a single-injection. A cohort of 368 healthy infants was initially studied to evaluate the immunogenicity and reactogenicity of this hexavalent combination given as a primary course at 2, 4, and 6 months of age. At 15 months of age, from this cohort, 219 children received a booster dose of a licensed DTPa/Hib (PRP–T) vaccine to assess the booster response, while 70 received a challenge dose of unconjugated PRP (PRP) vaccine (to evaluate Hib-specific memory) plus a separate DTPa vaccine. 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Psychology</subject><subject>Haemophilus influenzae</subject><subject>Haemophilus influenzae type b</subject><subject>Haemophilus Vaccines - administration &amp; dosage</subject><subject>Haemophilus Vaccines - adverse effects</subject><subject>Haemophilus Vaccines - immunology</subject><subject>Health facilities</subject><subject>Hepatitis</subject><subject>Hepatitis B</subject><subject>Hepatitis B Vaccines - administration &amp; dosage</subject><subject>Hepatitis B Vaccines - adverse effects</subject><subject>Hepatitis B Vaccines - immunology</subject><subject>Hib immune response</subject><subject>Human bacterial diseases</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunization</subject><subject>Immunization Schedule</subject><subject>Immunization, Secondary</subject><subject>Immunogenicity</subject><subject>Immunologic Memory</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Infants</subject><subject>Infectious diseases</subject><subject>Injection</subject><subject>Laboratories</subject><subject>Maternal &amp; 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Seven to 10 days following plain PRP challenge, anti-PRP geometric mean antibody concentrations (GMCs) had increased 13-fold to 5.67 μg/ml, and thirty days after conjugated PRP booster vaccination, anti-PRP antibody GMCs increased 102-fold. Both responses are indicative of immune memory. Vaccination was well tolerated following all primary and booster doses, although 10.5% of booster recipients experienced &gt;50-mm local swelling at the site of DTPa vaccination. We conclude that DTPa–HBV–IPV/Hib is safe and immunogenic for primary vaccination, and that Hib-specific memory is induced by primary vaccination.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>15519702</pmid><doi>10.1016/j.vaccine.2004.06.017</doi><tpages>7</tpages></addata></record>
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subjects Antibodies, Bacterial - analysis
Antibodies, Bacterial - biosynthesis
Antibodies, Viral - analysis
Antibodies, Viral - biosynthesis
Antigens
Applied microbiology
Babies
Bacterial diseases
Biological and medical sciences
Cohort Studies
Combination vaccines
Confidence intervals
Diphtheria
Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage
Diphtheria-Tetanus-Pertussis Vaccine - adverse effects
Diphtheria-Tetanus-Pertussis Vaccine - immunology
Ent and stomatologic bacterial diseases
Fever
Fundamental and applied biological sciences. Psychology
Haemophilus influenzae
Haemophilus influenzae type b
Haemophilus Vaccines - administration & dosage
Haemophilus Vaccines - adverse effects
Haemophilus Vaccines - immunology
Health facilities
Hepatitis
Hepatitis B
Hepatitis B Vaccines - administration & dosage
Hepatitis B Vaccines - adverse effects
Hepatitis B Vaccines - immunology
Hib immune response
Human bacterial diseases
Human viral diseases
Humans
Immunization
Immunization Schedule
Immunization, Secondary
Immunogenicity
Immunologic Memory
Infant
Infant, Newborn
Infants
Infectious diseases
Injection
Laboratories
Maternal & child health
Medical sciences
Microbiology
Miscellaneous
Pain
Pertussis
Poliomyelitis
Public health
Single-Blind Method
Tetanus
Tetanus Toxoid - immunology
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Vaccines, Combined - immunology
Vaccines, Conjugate
Viral diseases
Viral hepatitis
Virology
Whooping cough
title Antibody persistence, PRP-specific immune memory, and booster responses in infants immunised with a combination DTPa–HBV–IPV/Hib vaccine
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