None listed
Conditions
Brief summary
The aim of this study is to assess antibody persistence and cell-mediated immunity post administration of combined diphtheria-tetanus-acellular pertussis vaccine, Boostrix 'Trademark' (dTpa) in healthy adults who have received adult formulation diphtheria-tetanus-pertussis boosters 5-10 previously, compared to those that have not received a pertussis containing vaccine since childhood (<15 years of age). Health care workers (HCWs) in paediatric hospitals have been recommended to receive pertussis booster immunisations (Australian Immunisation Handbook 2013) as they are both at increased exposure to pertussis in the hospital and can cause nosocomial transmission to their patients. A booster dTpa immunisation (Boostrix™) is approved for use in Australia by the Therapeutic Goods Administration (TGA). It is now almost 10 years since Boostrix™ was introduced into Western Australia (2004) with high uptake by employees at Princess Margaret Hospital for Children in Perth and health care workers are being offered revaccination. Little is known about the duration of pertussis immunity in adults. No studies have yet provided an in-depth analysis of the immune responses induced by acellular pertussis vaccines and how fast these may wane over time. This study is a non-randomised cohort study. We propose to recruit a total of 150 healthy adults aged 23-64 years employed in the Child and Adolescent Health Service, University of WA School of Paediatrics and/or Telethon Kids Institute. Participants will be asked to attend 4 clinic visits over a 12 month period. These visits will take place at the Clinical Child Research Facility at Princess Margaret Hospital. Participants will be allocated to one of 2 groups depending upon whether or not they have previously received a booster for pertussis. During the first visit participants will be asked about their medical history, demographic data and previous reactions to vaccinations. Immunisation histories will be confirmed (if required) through hospital and GP records. In addition a brief medical directed medical examination may be conducted and vital signs will be taken. Females of child bearing potential will need to do a urine pregnancy test prior to vaccination. A blood sample of 25-30mls will be taken by trained staff before participants are vaccinated with Boostrix™. Following this, a 7 day diary documenting local reactions and adverse events will need to be completed. Further blood tests of 25-30mls will be taken 1 week, 4 weeks and 1 year post-vaccination. Safety data will be collected at each of these visits.
Interventions
In this study all participants will receive a combined diphtheria-tetanus-acellular pertussis vaccine, Boostrix 'Trademark' (dTpa) single intramuscular injection.
Each dose (0.5 ml) of dTpa contains greater than or equal to 2 IU diphtheria toxoid, greater than or equal to 20 IU tetanus toxoid, 8g pertussis toxin (PT), 8g filamentous haemagglutinin (FHA) and 2.5g pertactin (PRN), adsorbed on 0.5mg aluminium and suspended in isotonic sodium chloride. It also contains formaldehyde, polysorbate 80
In this study all participants will receive a combined diphtheria-tetanus-acellular pertussis vaccine, Boostrix 'Trademark' (dTpa) single intramuscular injection. Each dose (0.5 ml) of dTpa contains greater than or equal to 2 IU diphtheria toxoid, greater than or equal to 20 IU tetanus toxoid, 8g pertussis toxin (PT), 8g filamentous haemagglutinin (FHA) and 2.5g pertactin (PRN), adsorbed on 0.5mg aluminium and suspended in isotonic sodium chloride. It also contains formaldehyde, polysorbate 80 and glycine in residual amounts.
Sponsors
Telethon Kids Institute
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
23 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria: 1. Healthy adults 23 - 64 years of age employed in the Child and Adolescent Health Service, North and South Metro Health Service, University of WA School of Paediatrics and Child Health and/or Telethon Kids Institute, in general good health, available for the duration of the study. 2. Participants will have either received a dTPa vaccine 7-10 years previously or have not received a pertussis containing vaccine since childhood (<15 years of age).
Exclusion criteria
Exclusion criteria: 1. History of pertussis, tetanus or diphtheria vaccination or confirmed pertussis in the previous 5 years; 2. Immunosuppressive therapy or known immunodeficiency; 3. Immunoglobulins and blood products within 3 months prior to or during the trial; 4. Acute febrile illness at the time of enrolment; or previous record, following of serious adverse reaction to diphtheria-tetanus-pertussis vaccination or component antigens. 5. Females will be excluded if they are pregnant/ or nursing. 6. Contraindications to vaccination as listed in the current NHMRC Australian Immunisation Handbook 10th Edition or as listed in the Boostrix 'Trademark' Product Information. dTpa vaccine will not be administered to individuals known to be hypersensitive to any component of the vaccine or residues carried over from manufacture (such as formaldehyde and glutaraldehyde). 7. History of serious chronic illness or condition which in the judgement of the clinical investigator would preclude study participation. 8. History of neurologic disease or seizure (excluding simple febrile seizure).
Outcome results
None listed