Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Reexamination Certificate
2001-10-16
2004-10-26
Smith, Lynette R. F. (Department: 1645)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
C424S178100, C424S184100, C424S190100, C424S200100, C530S350000, C536S023100, C536S023700, C435S069100, C435S069300, C435S070100, C435S252300, C435S254110, C435S320100
Reexamination Certificate
active
06808713
ABSTRACT:
FIELD OF INVENTION
The present invention relates to the
Chlamydia
98 KDa outer membrane protein antigen and corresponding DNA molecules, which can be used to prevent and treat
Chlamydia
infection in mammals, such as humans.
BACKGROUND OF THE INVENTION
Chlamydiae
are prokaryotes. They exhibit morphologic and structural similarities to gram-negative bacteria including a trilaminar outer membrane, which contains lipopolysaccharide and several membrane proteins that are structurally and functionally analogous to proteins found in
E coli
. They are obligate intra-cellular parasites with a unique biphasic life cycle consisting of a metabolically inactive but infectious extracellular stage and a replicating but non-infectious intracellular stage. The replicative stage of the life-cycle takes place within a membrane-bound inclusion which sequesters the bacteria away from the cytoplasm of the infected host cell.
C. pneumoniae
is a common human pathogen, originally described as the TWAR strain of
Chlamydia psittaci
but subsequently recognised to be a new species.
C. pneumoniae
is antigenically, genetically and morphologically distinct from other
chlamydia
species (
C. trachomatis, C. pecorum
and
C. psittaci
). It shows 10% or less DNA sequence homology with either of
C. trachomatis
or
C. psittaci.
C. pneumoniae
is a common cause of community acquired pneumonia, only less frequent than
Streptococcus pneumoniae
and
Mycoplasma pneumoniae
(Grayston et al. (1995) Journal of Infectious Diseases 168:1231; Campos et al. (1995) Investigation of Ophthalmology and Visual Science 36:1477). It can also cause upper respiratory tract symptoms and disease, including bronchitis and sinusitis (Grayston et al. (1995) Journal of Infectious Diseases 168:1231; Grayston et al (1990) Journal of Infectious Diseases 161:618; Marrie (1993) Clinical Infectious Diseases. 18:501; Wang et al (1986) Chlamydial infections Cambridge University Press, Cambridge. p. 329. The great majority of the adult population (over 60%) has antibodies to
C. pneumoniae
(Wang et al (1986) Chlamydial infections. Cambridge University Press, Cambridge. p. 329), indicating past infection which was unrecognized or asymptomatic.
C. pneumoniae
infection usually presents as an acute respiratory disease (i.e., cough, sore throat, hoarseness, and fever; abnormal chest sounds on auscultation). For most patients, the cough persists for 2 to 6 weeks, and recovery is slow. In approximately 10% of these cases, upper respiratory tract infection is followed by bronchitis or pneumonia. Furthermore, during a
C. pneumoniae
epidemic, subsequent co-infection with pneumococcus has been noted in about half of these pneumonia patients, particularly in the infirm and the elderly. As noted above, there is more and more evidence that
C. pneumoniae
infection is also linked to diseases other than respiratory infections.
The reservoir for the organism is presumably people. In contrast to
C. psittaci
infections, there is no known bird or animal reservoir. Transmission has not been clearly defined. It may result from direct contact with secretions, from fomites, or from airborne spread. There is a long incubation period, which may last for many months. Based on analysis of epidemics,
C. pneumoniae
appears to spread slowly through a population (case-to-case interval averaging 30 days) because infected persons are inefficient transmitters of the organism. Susceptibility to
C. pneumoniae
is universal. Reinfections occur during adulthood, following the primary infection as a child.
C. pneumoniae
appears to be an endemic disease throughout the world, noteworthy for superimposed intervals of increased incidence (epidemics) that persist for 2 to 3 years.
C. trachomatis
infection does not confer cross-immunity to
C. pneumoniae
. Infections are easily treated with oral antibiotics, tetracycline or erythromycin (2 g/d, for at least 10 to 14 d). A recently developed drug, azithromycin, is highly effective as a single-dose therapy against chlamydial infections.
In most instances,
C. pneumoniae
infection is often mild and without complications, and up to 90% of infections are subacute or unrecognized. Among children in industrialized countries, infections have been thought to be rare up to the age of 5 y, although a recent study (E Normann et al,
Chlamydia pneumoniae
in children with acute respiratory tract infections, Acta Paediatrica, 1998, Vol 87, Iss 1, pp 23-27) has reported that many children in this age group show PCR evidence of infection despite being seronegative, and estimates a prevalence of 17-19% in 2-4 y olds. In developing countries, the seroprevalence of
C. pneumoniae
antibodies among young children is elevated, and there are suspicions that
C. pneumoniae
may be an important cause of acute lower respiratory tract disease and mortality for infants and children in tropical regions of the world.
From seroprevalence studies and studies of local epidemics, the initial
C. pneumoniae
infection usually happens between the ages of 5 and 20 y. In the USA, for example, there are estimated to be 30,000 cases of childhood pneumonia each year caused by
C. pneumoniae
. Infections may cluster among groups of children or young adults (e.g., school pupils or military conscripts).
C. pneumoniae
causes 10 to 25% of community-acquired lower respiratory tract infections (as reported from Sweden, Italy, Finland, and the USA). During an epidemic,
C. pneumonia
infection may account for 50 to 60% of the cases of pneumonia. During these periods, also, more episodes of mixed infections with
S. pneumoniae
have been reported.
Reinfection during adulthood is common; the clinical presentation tends to be milder. Based on population seroprevalence studies, there tends to be increased exposure with age, which is particularly evident among men. Some investigators have speculated that a persistent, asymptomatic
C. pneumoniae
infection state is common.
In adults of middle age or older,
C. pneumoniae
infection may progress to chronic bronchitis and sinusitis. A study in the USA revealed that the incidence of pneumonia caused by
C. pneumoniae
in persons younger than 60 years is 1 case per 1,000 persons per year; but in the elderly, the disease incidence rose three-fold.
C. pneumoniae
infection rarely leads to hospitalization, except in patients with an underlying illness.
Of considerable importance is the association of atherosclerosis and
C. pneumoniae
infection. There are several epidemiological studies showing a correlation of previous infections with
C. pneumoniae
and heart attacks, coronary artery and carotid artery disease (Saikku et al. (1988) Lancet;ii:983; Thom et al. (1992) JAMA 268:68; Linnanmaki et al. (1993), Circulation 87:1030; Saikku et al. (1992)Annals Internal Medicine 116:273; Melnick et al(1993) American Journal of Medicine 95:499). Moreover, the organisms has been detected in atheromas and fatty streaks of the coronary, carotid, peripheral arteries and aorta (Shor et al. (1992) South African. Medical Journal 82:158; Kuo et al. (1993) Journal of Infectious Diseases 167:841; Kuo et al. (1993) Arteriosclerosis and Thrombosis 13:1500; Campbell et al (1995) Journal of Infectious Diseases 172:585; Chiu et al. Circulation, 1997 (In Press)). Viable
C. pneumoniae
has been recovered from the coronary and carotid artery (Ramirez et al (1996) Annals of Internal Medicine 125:979; Jackson et al. Abst. K121, p272, 36
th
ICAAC, 15-18 September 1996, New Orleans). Furthermore, it has been shown that
C. pneumoniae
can induce changes of atherosclerosis in a rabbit model (Fong et al (1997) Journal of Clinical Microbiolology 35:48). Taken together, these results indicate that it is highly probable that
C. pneumoniae
can cause atherosclerosis in humans, though the epidemiological importance of chlamydial atherosclerosis remains to be demonstrated.
A number of recent studies have also indicated an association between
C. pneumoniae
infection and asthma. Infection has been linked to wheezing, asthmatic bronchitis, adult-onset as
Dunn Pamela
Murdin Andrew D.
Oomen Raymond P.
Wang Joe
Aventis Pasteur Limited
Baskar Padma
Foley & Lardner LLP
Smith Lynette R. F.
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