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Haemophilus influenzae oral whole cell vaccination for preventing acute exacerbations of chronic bronchitis

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Abstract

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Background

Acute bronchitis leading to ongoing exacerbations is a serious condition predisposed to by viruses, bacteria or environmental factors. It can be fatal. Antibiotic therapy is not particularly useful. An oral Haemophilus influenzae vaccine has been developed.

Objectives

To assess the effects of an oral, monobacterial whole‐cell, killed, nontypeable H. influenzae vaccine in protecting against recurrent acute episodes in chronic bronchitis.

Search methods

In this updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2006), MEDLINE (1966 to January Week 4 2006), EMBASE (1990 to September 2005) and ISI Current Contents (2004 to May 2006).

Selection criteria

Randomised controlled trials (RCTs) comparing the effects of the H. influenzae vaccine on patients with recurrent acute exacerbations of chronic bronchitis were included when there was overt matching of the vaccine and placebo groups on clinical grounds.

Data collection and analysis

Three authors extracted data and assessed trial quality independently from original records and publications for incidence and severity of bronchitis episodes and carriage rate of nontypeable H. influenzae measured in the upper respiratory tract every three months following vaccination.

Main results

Six trials were included in the study with a total of 440 participants. The vaccine reduced the incidence of bronchitic episodes at three months after vaccination (rate ratio is 0.69; 95% CI 0.41 to 1.14) and at six months after vaccination (rate ratio 0.82; 95% CI 0.62 to 1.09). If these results been statistically significant, they would have represented a reduction in acute bronchitic attacks for vaccinated individuals of 31% at three months, and 18% at six. The effect had disappeared by nine months.
The severity of exacerbations in the treatment group, as measured by requirement to prescribe antibiotics, was likewise reduced by 58% at three months (Peto odds ratio = 0.42; 95% CI 0.16 to 1.13), and by 65% at six months (Peto odds ratio = 0.35; 95% CI 0.16 to 0.75).

Authors' conclusions

Vaccinating patients with recurrent acute exacerbations of chronic bronchitis in the autumn may reduce the number and severity of exacerbations over the following winter. A large clinical trial is needed.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Plain language summary

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Vaccination against acute exacerbations of chronic bronchitis in autumn may reduce the number and severity of attacks during winter

Acute attacks of bronchitis often increase in frequency and severity during winter, especially among people who have chronic obstructive pulmonary disease (COPD) or chronic bronchitis. These attacks are commonly associated with nontypeable Haemophilus influenzae. The oral vaccine described in this review is of particular interest because it decreases carriage of nontypeable Haemophilus influenzae in the upper respiratory tract. The review of trials found that people with COPD or chronic bronchitis who were orally immunised in autumn had a not significant trend to fewer and less severe attacks of bronchitis during the following winter.