Duration of Pertussis Immunity in Adults: a study of Healthcare Workers.

Phase 4

Completed

• Conditions: A study analysing the duration of Immunity to Pertussis booster vaccine in Health Care workers to establish guidelines when boosters are required.; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12615001262594
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pertussis toxin IgG antibody response as measured by multiplex fluorescent bead assay.<br>[Pre vaccine, 1 and 12 months post-dTap booster.<br><br>];Filamentous haemagglutinin IgG antibody response as measured by multiplex fluorescent bead assay. <br>[Pre vaccine, 1 and 12 months post-dTap booster.<br><br>];Pertactin IgG antibody response as measured by multiplex fluorescent bead assay.<br><br>[Pre vaccine, 1 and 12 months post-dTap booster.<br><br>]

Secondary Outcome Measures

Name	Time	Method
Pertussis-specific T-cell memory response as measured using cytokine and qRT PCR.<br><br><br>[Pre vaccine, 1 week and 1 month post-dTap booster.<br>];Pertussis specific B-cell memory response as measured using ELISpot.[Pre vaccine, 1 week and 1 month post-dTap booster];Frequency of injection site redness or swelling > 50mm as measured by analysis of clinical data. Subjects will complete a 7-day diary documenting solicited local reactions and systemic symptoms and provided with ruler and thermometer. <br><br>[1-7 days post vaccination<br>]