CHiRRP: Combating Haemophilus influenzae Related Respiratory Pathology

A multi-centre, double-blind, randomised controlled trial to evaluate the efficacy of 10 valent-pneumococcal-Protein D conjugate vaccine compared to quadrivalent (ACYW135) meningococcal conjugate vaccine in reducing respiratory exacerbations in children aged greater than or equal to 18 months with suppurative lung disease.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000034831

Acronym

CHiRRP

Enrollment

Registered

2012-01-09

Start date

2013-02-01

Completion date

2015-08-14

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chronic suppurative lung diseases in children are major causes of morbidity and mortality worldwide, particularly in disadvantaged populations. Repeated infections in childhood contribute to poor lung health in adulthood. The most common organism associated with infection is non-typeable Haemophilus influenzae (NTHi). This study aims to determine whether a vaccine against NTHi (10v-PHiD) can reduce repeated respiratory infections in children. We will be comparing the number of respiratory exacerbations in the 12 months following vaccinated between children with chronic lung disease vaccinated with 10vPHiD and children who received a meningococcal vaccine (control vaccine).

Interventions

10valent pneumococcal - Protein D conjugate vaccine (10vPHiD), 0.5ml intramuscular injection, 2 doses, 2 months apart

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Months to 18 Years

Healthy volunteers

Inclusion criteria

1. Child aged greater than or equal to 18 months and < 18 years with CSLD. The case definitions for CSLD are: a) CSLD: a clinical syndrome where there are symptoms indicating chronic endobronchial suppuration with or without HRCT evidence of radiological bronchiectasis. The main feature of the clinical syndrome is recurrent (3 or more episodes/yr) chronic (>4 weeks) wet cough responding to antibiotics b) BE: confirmed by chest HRCT scan in last 5 years c) 3 or more episodes of Protracted Bacterial Bronchitis. Protracted bacterial bronchitis is defined as the presence of isolated chronic (>4 weeks) of wet/moist cough that resolves with antibiotics in the absence of pointers suggestive of an alternative specific cause of cough. 2. Receipt of meningococcal C conjugate monovalent vaccine at least 6 months prior to enrolment. 3 Provision of written informed consent from parent/guardian (assent if child aged greater than or equal to10 years) 4. Parent/child willing and able to meet the requirements of the protocol 5. Not planning to move from the study area in the 12 months following enrolment. 6. At least 2 respiratory exacerbations in the preceding 18 months

Exclusion criteria

Prior vaccination with PHiD-CV vaccine; contraindication to PHiD-CV and/or quadrivalent meningococcal conjugate vaccine as per the Australian Immunisation Handbook and product information sheets;10 known hypersensitivity to any component of the vaccines; confirmed or suspected immunosuppressive condition or immunodeficiency disorder; current (or within 90 days prior to receiving study vaccine) or planned (during the active study period) immunosuppressive therapy, including systemic corticosteroids (greater than14 days); administration of immunoglobulins and/or blood products with 90 days prior to receiving study vaccine, or planned administration of such products during the study period.

Outcome results