Elsevier

Vaccine

Volume 29, Issue 1, 10 December 2010, Pages 45-50
Vaccine

A decennial booster dose of reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (Boostrix™) is immunogenic and well tolerated in adults

https://doi.org/10.1016/j.vaccine.2010.10.025Get rights and content

Abstract

Reduced-antigen-content diphtheria–tetanus–acellular-pertussis (dTpa) vaccines are predominantly recommended for once-in-a-lifetime use. A second dTpa (Boostrix™, GlaxoSmithKline Biologicals) administration in 164 adults previously vaccinated with dTpa 10 years previously was evaluated. Before the decennial booster, 89.4% and 94.8% subjects were seroprotected (antibodies ≥0.1 IU/mL) for diphtheria and tetanus, respectively. One-month post-booster, all subjects were seroprotected/seropositive against all vaccine antigens. Robust GMC increases indicated a booster response similar to the first booster. The decennial booster was well tolerated without serious adverse events, consistent with product experience. This study supports replacing traditional Td boosters with dTpa, and use of Boostrix™ as a decennial booster.

This study is registered at www.clinicaltrials.comNCT00548171.

Introduction

It is estimated that between 13 and 20% of prolonged cough illnesses in adults are due to pertussis [1], [2]. Although hospitalization and permanent sequelae infrequently occur, the socio-economic consequences of adult pertussis are substantial [3]. Adults are frequently implicated as the pertussis source in infants who develop pertussis disease [4], [5], [6]. In Australia, United States, Canada and in many European countries, the highest rates of pertussis disease are observed in infants less than six months of age [7]. Infant pertussis is typically severe, with high rates of hospitalization and intensive care admission. In an Australian study of infant pertussis cases from 1997 to 2006, 64% of hospitalised cases were less than 3 months of age [8]. Almost 30% of infants under 3 months required intensive care admission and all deaths occurred in this age group. Notably, few infants (9%) were identified as overdue for pertussis immunization according to the Australian schedule at 2, 4 and 6 months of age.

Prevention of pertussis in older populations, with interruption of transmission to vulnerable infants, is possible with the availability of reduced antigen-content diphtheria–tetanus–acellular pertussis (dTpa) vaccines, either alone or in combination with an inactivated polio component as a dTpa–IPV combination. dTpa vaccines may be administered using various strategies, including vaccination of close contacts of newborns (‘cocooning’), routine immunization of adolescents and/or adults, and vaccination of healthcare workers [9].

In Australia, a booster dose of dTpa is recommended for all adolescents 12–17 years of age, parents and other family members (before planning or as soon as possible after delivery of an infant), adults working with young children, healthcare workers, and for any adult expressing an interest in receiving a booster dose of dTpa [10]. To date, few studies have assessed the immunogenicity and tolerability of repeated dTpa doses and the optimal interval for boosting is not yet known. Thus, in Australia and in most other countries with pertussis booster recommendations for older populations, only a single lifetime dose is currently recommended.

Boostrix™ (GlaxoSmithKline [GSK] Biologicals, Belgium) is a 3-pertussis component dTpa vaccine for booster immunization of adults, adolescents and children from the age of four years. The immunogenicity, reactogenicity and safety of dTpa have been established in clinical trials conducted in children, adolescents and adults [11], [12], [13], [14], [15], [16]. This study assessed the immunogenicity and reactogenicity of a booster dose of dTpa (Boostrix™) in adults. Participants had been vaccinated with Boostrix™ in a clinical trial setting 10 years previously.

Section snippets

Study design and study subjects

Adults vaccinated in a clinical trial conducted at the same centre 10 years previously [16] were invited to participate in the Phase IV, open, non-randomised, vaccination study at Year 10 (www.clinicaltrials.comNCT00548171). Subjects at Year 10 were to be in good health and were excluded if they had received a booster dose against diphtheria, tetanus, or pertussis since the previous study, or if they had been diagnosed with diseases due to these pathogens since the previous booster dose.

In the

Results

The study took place between November 2007 and April 2008. A total of 203 subjects were enrolled in the decennial booster study, of which 164 received two dTpa doses at a 10 year interval (Fig. 1). The mean age of subjects was 50.3 years (standard deviation 9.74 years) and 69.0% were female.

Discussion

To our knowledge, this is the first study exploring the feasibility of repeated decennial booster vaccination with reduced-antigen-content acellular pertussis vaccines in adults. The adults in this study were at least 18 years of age when they were initially recruited. All had been previously vaccinated with whole-cell pertussis (Pw) vaccines, or had been born before the onset of routine infant immunization programs in Australia [21]. Robust responses against all vaccine antigens were observed

Acknowledgements

The authors thank the study subjects, Valérie Haezebroeck for performance of serological assays, the doctors and nurses at the study centre (Dr Leon Heron, Dr Sandeep Wasankar, Annemarie Egan, Rosemary Joyce, Carol Shineberg, Pamela Cheung, Laura Rost, Jennifer Murphy, Elizabeth Clarke) and Drs Joanne Wolter and Julia Donnelly for assistance in preparation of the manuscript.

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