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Non-typeable haemophilus influenzae vaccines and their uses

A Haemophilus influenzae and vaccine technology, applied to medical preparations containing active ingredients, antibacterial drugs, antibody medical components, etc., can solve the problems of questionable clinical effect of bacterial vaccines, expensive, useless bacterial vaccines, etc.

Active Publication Date: 2011-08-17
HUNTER IMMUNOLOGY LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Indeed, the clinical efficacy of bacterial vaccines in the treatment of asthma has been questioned, leading the International World Health Organization (WHO) to propose that bacterial vaccines are of no use in modern asthma therapy
[0013] Despite substantial research focussing on therapeutic asthma interventions and therapies, the condition remains a major, expensive and growing problem in modern Western society

Method used

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  • Non-typeable haemophilus influenzae vaccines and their uses
  • Non-typeable haemophilus influenzae vaccines and their uses
  • Non-typeable haemophilus influenzae vaccines and their uses

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0141] Example 1: Selection of non-typeable Haemophilus influenzae strain HI-164

[0142] 1.1

[0143] background

[0144] Multiple NTHi isolates, including strain IDs 164, 165, 167, and 168, were collected from 20 patients cared for at the Respiratory Clinic at the John Hunter Medical School in Newcastle, Australia. This isolate and another study isolate (strain NTHi-166) were characterized for growth conditions, biotype, serotype, presence of B capsular gene and presence of beta-lactamase gene. The results are given in Table 1 below.

[0145] Table 1: Growth characteristics of different NTHi isolates

[0146] Strain ID

growing conditions

Biotype

serotype

B capsular gene

β-lactamase

NTHi-164

aerobic

I

Non-typable

Negative

Negative

NTHi-165

aerobic

I

Non-typable

Negative

Positive

NTHi-166

aerobic

I

Non-typable

Positive

Negative

NTHi-167

aerobic

I...

Embodiment 2

[0216] Example 2: Clinical benefits of HI-164OV

[0217] A placebo-controlled double-blind clinical study was performed in which 64 subjects were recruited and assigned to oral NTHi treatment or placebo treatment in the double-blind study based on smoking at least 10 cigarettes per day for the past two years. Subjects were randomly assigned to placebo and active groups and were given three courses of study drug at monthly intervals. Each course of treatment consists of two tablets per day for three days. Active tablets each contain 45 mg of formalin-inactivated NTHi (equivalent to 10 11 inactivated bacteria). Blood, saliva, mouthwash, throat swabs, and nasal swabs (for microbiological assessment) were collected at 7 biweekly visits.

[0218] 1.13 Detection of NTHi and measurement of NTHi-specific IgG

[0219] Surprisingly, measurements in the placebo-treated and vaccine-treated groups during the winter timeframe detected NTHi in both groups, suggesting random exposure to t...

Embodiment 3

[0226] Example 3 Inactivated NTHi-164 Vaccine (HI-164OV) Orally Administered to Subjects with Mild, Moderate or Severe Airway Disease Reduces Use of Anti-Asthma Therapy

[0227] 140 human subjects with mild to moderate or moderate to severe airway disease were recruited in a double-blind, placebo-controlled study to evaluate the effect of oral inactivated non-typeable Haemophilus influenzae (NTHi) vaccine on Influence of: number and severity of stridor reversible airway obstruction, use of concomitant medications, and presence of NTHi and other bacteria in the airways.

[0228] Reduced use of anti-asthma-type drugs (bronchodilators, steroids, etc.) and NTHi infections were found in the treatment group compared to the control group. In particular, a specific reduction of NTHi in the interior of the airways of subjects with high IgE antibody levels (serum and secretions) to NTHi was obtained, and a reduction in asthma symptoms and consequent reduction in the need for asthma medi...

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Abstract

Provided are non-typeable Haemophilus influenzae vaccines useful for the treatment of chronic obstructive pulmonary disease and asthma in a patient. In certain aspects, the vaccine is a monobacterial vaccine. Bacterial strains for use in the vaccines of the present application are also provided.

Description

technical field [0001] This application relates to non-typeable Haemophilus influenzae vaccines and their use in the treatment of pulmonary diseases such as chronic obstructive pulmonary disease and asthma. The present application also relates to novel strains of Haemophilus influenzae for use in the treatment of pulmonary diseases such as chronic obstructive pulmonary disease and asthma. Background of the invention [0002] Chronic obstructive pulmonary disease (COPD), primarily attributable to tobacco smoke inhalation, is a major cause of morbidity and mortality, being the fourth most common cause of death in the world (Lung Disease Data (2008). American Lung Association). According to the National Heart, Lung, and Blood Institute, the annual cost of COPD in the United States was estimated at $42.6 billion in 2007, including $26.7 million in direct health care costs (Lung Disease Data (2008). American Lung Association). The failure to establish medical therapies aimed at ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/74A61K39/102A61P11/06A61K9/28A61P11/00A61K39/00
CPCA61K9/28A61K39/102A61K2039/521A61K9/20A61K38/00A61P11/00A61P11/06A61P31/04A61P31/16A61P37/04Y02A50/30A61K39/00A61K35/74A61K39/02A61K39/095A61K9/0043A61K9/4891C07K14/285A61K39/39
Inventor M·邓克利R·克兰西
Owner HUNTER IMMUNOLOGY LTD