Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Fusion protein or fusion polypeptide
Patent
1997-09-22
1999-12-21
Mosher, Mary E.
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Fusion protein or fusion polypeptide
4241991, 4242041, 4241861, 4353201, 435 691, 4352351, 435 697, 536 2372, 536 231, 536 243, A61K 3900, A61K 3912, C12N 700
Patent
active
060045574
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention relates generally to variants of human papilloma virus (HPV) antigens, and in particular it relates to non-transforming variants of HPV antigens which are suitable for use in vaccines. The invention also extends to vaccine compositions which include these variants of HPV antigens as active immunogens, as well as to methods of use of these variants to elicit an immune response against HPV.
BACKGROUND OF THE INVENTION
Papillomaviruses are small DNA viruses that infect a variety of animal species. Some are associated with the development of malignancies in their natural hosts. Over 60 types of human papillomavirus (HPV) have been identified. These infect humans at a variety of body locations and are responsible for common skin warts, laryngeal papillomas, genital warts and other wart-like lesions. Genital HPV infections are particularly common and a number of HPV types, but most frequently types 6, 11, 16 and 18, infect the genital tract in both men and women. In women, HPVs infect various portions of the genital tract including the cervix.
Genital HPVs are a significant clinical problem. HPV infection of the ano-genital region is now regarded as the most common form of viral sexually-transmitted disease (STD). The viruses cause genital infections which become manifest in one of three ways: detectable using special viewing techniques; and
Subclinical infections are common. It is estimated that 2 to 4% of Papanicolaou (Pap.) smears show evidence of HPV. Latent infections are even more frequent and the majority of adults harbour one or more types of genital HPV.
Carcinoma of the uterine cervix (CaCx) is a common cancer in women. Two forms of cervical cancer are recognised; squamous cell carcinoma (SCC) is by far the most frequent representing about 90% of observed cases; adenocarcinoma, a cancer of the secretion cells, accounts for about 10%. Cancer of the cervix develops through pre-cancerous intermediate stages to invasive forms (the carcinoma) which can become life threatening. The pre-cancerous stages of increasing severity are known as cervical intraepithelial neoplasia (CIN) grades 1 to 3. Over a 20 year period about 40% of the untreated CIN3 patients develop invasive cancer, the increasingly serious forms of which are known as stage I to IV. Invasive cancer frequently leads to death.
Cervical cancer in both its pre-cancerous and invasive stages is one of the few cancers for which a highly reliable and relatively cheap screening method is available. The Papanicolaou (Pap.) smear involves cytological examination of cervical scrapes to test for the presence of abnormal cervical cells which are indicative of pre- or invasive cancer. Detection of abnormalities leads to further investigation and treatment if necessary.
To be effective at reducing the number of cervical cancers and resultant deaths, Pap. smear screening is undertaken on a mass scale and ideally includes all women of sexually-active age. Detection and subsequent treatment of CIN has a very high success rate in the prevention of invasive cancer, while early detection of the latter can have a marked effect on mortality.
Most developed countries have highly developed Pap. smear screening programs which have resulted in a 30% drop in age-specific mortality due to CaCx between 1960 and 1980. However, apart from the Scandinavian countries, few developed countries screen more than 50 to 60% of women, allowing CaCx and resultant deaths to remain a significant problem. In the developing world the situation is even worse as few organised screening programs exist, resulting in 400,000 new cases of invasive cancer annually in these countries.
As outlined earlier, a variety of types of HPV cause genital infections in humans, although four types (6, 11, 16, 18) predominate. Evidence collected over the past 15 years strongly suggests that several of the HPVs are associated with the development of cervical cancer. Indeed many researchers have concluded that specific HPV types are the essential aetiologic factor responsi
REFERENCES:
patent: 5719054 (1998-02-01), Boursnell et al.
Stoeppler et al., "Transforming Proteins of the Papillomaviruses", Intervirology, vol. 37:168-179, (1994).
Cox John Cooper
Edwards Stirling John
Frazer Ian
Webb Elizabeth Ann
CSL Limited
Mosher Mary E.
Salimi Ali R.
The University of Queensland
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