Safety and immunogenicity of a combined five-component pertussis-diphtheria-tetanus-inactivated poliomyelitis-Haemophilus b conjugate vaccine administered to infants at two, four and six months of age

doi:10.1016/S0264-410X(97)00241-7

Vaccine

Volume 16, Issue 6, April 1998, Pages 576-585

https://doi.org/10.1016/S0264-410X(97)00241-7 Get rights and content

Abstract

Safety, immunogenicity and lot consistency of five-component pertussis combination vaccine (CPDT-IPV/PRP-T) in infants were compared to that of whole cell pertussis combination vaccine (DPT-IPV//PRP-T), as were separate and combined injections of CPDT-IPV and PRP-T. No significant differences in adverse event rates were observed between lots of CPDT-IPV//PRP-T or between separate or combined injections of CPDT-IPV and PRP-T. Minor differences in antibody responses were observed between lots of component pertussis vaccine. Higher concentrations of diphtheria and tetanus antitoxins were induced by separate than by combined injection of CPDT-IPV and PRP-T, but no other differences in immunogenicity were observed. Adverse reactions were more than twice as frequent after whole cell than after component pertussis vaccines. Antibody responses to pertussis toxoid, filamentous hemagglutin and pertactin were significantly greater after component vaccines, while the response to type 3 poliovirus was higher after whole cell vaccine. No significant differences were observed for other vaccine components. CPDT-IPV//PRP-T was safe and immunogenic in infants. Antibody results were similar to those observed in a Swedish field trial that demonstrated CPDT to be 85% effective in preventing clinical pertussis.

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Administration of multiple simultaneous vaccines to infants, children, and military recruits is not uncommon. However, little research exists to examine associated serological and health effects, especially in adults.
We retrospectively examined 416 paired serum specimens from U.S. military subjects who had received the inactivated polio vaccine (IPV) alone or in combination with either 1 other vaccine (<3 group) or 4 other vaccines (>4 group). Each of the 2 groups was subdivided into 2 subgroups in which Tdap was present or absent.
The >4 group was associated with a higher proportion of polio seroconversions than the <3 group (95% vs. 58%, respectively, p < 0.01). Analysis of the <3 subgroup that excluded Tdap vs. the >4 subgroup that excluded Tdap showed no difference between them (p > 0.1). However, the >4 subgroup that included Tdap had significantly more seroconversions than either the <3 subgroup that excluded Tdap or the >4 subgroup that excluded Tdap (p < 0.01). Overall, at least 98% of subjects were at or above the putative level of seroprotection both pre- and post-vaccination, yet at least 81% of subjects seroconverted. In an analysis of 400 of the subjects in which clinic in- and outpatient encounters were counted over the course of 1 year following vaccinations, there was no significant difference between the 2 groups (p > 0.1).
A combination of >4 vaccines including IPV appeared to have an immunopotentiation effect on polio seroconversion, and Tdap in particular was a strong candidate for an important role. The dose of IPV we studied in our subjects, who already had a high level of seroprotection, acted as a booster. In addition, there appear to be no negative health consequences from receiving few versus more multiple simultaneous vaccinations.
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Francisella tularensis, the causative agent of tularaemia, is a zoonotic intracellular pathogen that can be found in a very large number of species ranging from large mammals and vertebrates to invertebrates, arthropods and amoebas. Disease in humans often occurs in parallel with tularaemia in wild animals. Human infection can occur through aerosolization, direct contact with infected animals via arthropod vectors like ticks, mosquitos and biting flies. F. tularensis subspecies tularensis (type A) is one of the most infectious bacteria known and inhalation of as few as ten organisms can be sufficient to establish an infection in humans that if left untreated could be fatal. The success of F. tularensis as a pathogen lies in its unique ability to adapt a lifestyle as an intracellular pathogen and to very timely subvert host defences both at extracellular and intracellular levels. Key events in the infection process are the ability to rapidly escape the phagosome after uptake by phagocytic cells and the ability to replicate to high levels inside the host cells without evoking a host inflammatory response.
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Citation Excerpt :
The safety and immunogenicity of DTaP5-IPV-Hib after a three-dose primary series at 2, 3 and 4 months of age has been demonstrated in clinical studies conducted in the United Kingdom [1–3] and in France and Poland [4]. In addition, DTaP5-IPV-Hib has been evaluated using a three-dose primary series (2, 4 and 6 months or 6, 10 and 14 weeks) and as a fourth-dose booster in the second year of life in Canada [5,6], Mexico [7,8], Taiwan [9,10], the Philippines [11], and France and Poland [4]. To date, no study has examined the safety and immunogenicity of DTaP5-IPV-Hib vaccine administered as a fourth dose booster to toddlers who had received a primary series with a hexavalent vaccine.
This study compared the safety and immunogenicity of DTaP₅-IPV-Hib vaccine (followed by monovalent hepatitis B vaccine [HBV]) and DTaP₃-HBV-IPV/Hib vaccines, both coadministered with PCV7, as a fourth-dose booster in toddlers 11–18 months who had a hexavalent vaccine primary series. The fever rate within 4 days of DTaP₅-IPV-Hib was noninferior to DTaP₃-HBV-IPV/Hib. DTaP₅-IPV-Hib induced a marked immune response and had a similar safety and immunogenicity profile compared with DTaP₃-HBV-IPV/Hib. Fully liquid DTaP₅-IPV-Hib can be used as a booster after a hexavalent vaccine primary series; where required, a fourth dose of monovalent HBV can be administered after DTaP₅-IPV-Hib (NCT ID: NCT00355654).
Immunogenicity and safety of fully liquid DTaP <inf>5</inf>-IPV-Hib compared with DTaP <inf>3</inf>-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: A phase III, single-blind, randomised, controlled, multicentre study
2011, Vaccine
This study compared immunogenicity and safety of DTaP₅-IPV-Hib to DTaP₃-IPV/Hib coadministered with PCV7 at 2, 3, and 4 months (primary series) and a fourth-dose booster at 12–18 months of age. Seroprotection rates for DTaP₅-IPV-Hib were high (noninferior to DTaP₃-IPV/Hib for the primary series) for antigens common to both vaccines and PCV7 antigens. Geometric mean concentration (GMC) for Hib antibodies were higher in the DTaP₅-IPV-Hib group than the DTaP₃-IPV/Hib group after the primary series and booster dose; GMCs or titers for other antigens were generally similar between groups after the primary series and booster dose. Safety profiles were similar between groups.

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Vaccine

Abstract

References (27)

Safety and immunogenicity of an acellular pertussis diphtheria tetanus vaccine given as a single injection with Haemophilus influenzae b conjugate vaccine

Vaccine

Comparison of acellular and whole-cell pertussis acellular diphtheria-tetanus-pertussis vaccines in infants

J. Pediatr.

Randomized trial of the effect of co-administration with acellular pertussis DTP vaccine on immunogenicity of Haemophilus influenzae type b conjugate vaccine

Lancet

Antibody response to Bordetella pertussis antigens after immunization with American and Canadian whole-cell vaccines

J. Pediatr.

Safety and efficacy of a five-component acellular pertussis vaccine with varying antigen quantities

Arch. Pediatr. Adolesc. Med.

Acellular pertussis vaccine as a booster dose for seventeen- to nineteen-month-old children immunized with either whole-cell or acellular pertussis vaccine at two, four and six months of age

Pediatr. Infect. Dis. J.

Safety and immunogenicity of two acellular pertussis vaccines with different pertussis toxoid and filamentous hemagglutinin content in infants 2–6 months old

Scand. J. Infect. Dis.

Comparison of 13 acellular pertussis vaccines, adverse reactions

Pediatrics

Comparison of 13 acellular pertussis vaccines, overview and serologic response

Pediatrics

A controlled trial of a two-component acellular, a five-component acellular and a whole-cell pertussis vaccine

N. Engl. J. Med.

Placebo-controlled trial of two acellular pertussis vaccines in Sweden, protective efficacy and adverse events

Lancet

Differences in reactogenicity and antigenicity of acellular and standard pertussis vaccine combined with diphtheria and tetanus in infants

J. Infect. Dis.

Pertussis antibodies protection and vaccine efficacy after household exposure

Am. J. Dis. Child.

Cited by (63)

Combination Vaccines

Effect of multiple, simultaneous vaccines on polio seroresponse and associated health outcomes

Francisella

Combination vaccines

Immunogenicity and safety of fully liquid DTaP <inf>5</inf>-IPV-Hib compared with DTaP <inf>3</inf>-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: A phase III, single-blind, randomised, controlled, multicentre study

PaperSafety and immunogenicity of a combined five-component pertussis-diphtheria-tetanus-inactivated poliomyelitis-Haemophilus b conjugate vaccine administered to infants at two, four and six months of age

Abstract

Vaccine

J. Pediatr.

Lancet

J. Pediatr.

Safety and efficacy of a five-component acellular pertussis vaccine with varying antigen quantities

Arch. Pediatr. Adolesc. Med.

Acellular pertussis vaccine as a booster dose for seventeen- to nineteen-month-old children immunized with either whole-cell or acellular pertussis vaccine at two, four and six months of age

Pediatr. Infect. Dis. J.

Safety and immunogenicity of two acellular pertussis vaccines with different pertussis toxoid and filamentous hemagglutinin content in infants 2–6 months old

Scand. J. Infect. Dis.

Comparison of 13 acellular pertussis vaccines, adverse reactions

Pediatrics

Comparison of 13 acellular pertussis vaccines, overview and serologic response

Pediatrics

A controlled trial of a two-component acellular, a five-component acellular and a whole-cell pertussis vaccine

N. Engl. J. Med.

Placebo-controlled trial of two acellular pertussis vaccines in Sweden, protective efficacy and adverse events

Lancet

Differences in reactogenicity and antigenicity of acellular and standard pertussis vaccine combined with diphtheria and tetanus in infants

J. Infect. Dis.

Pertussis antibodies protection and vaccine efficacy after household exposure

Am. J. Dis. Child.

Paper
Safety and immunogenicity of a combined five-component pertussis-diphtheria-tetanus-inactivated poliomyelitis-Haemophilus b conjugate vaccine administered to infants at two, four and six months of age