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United States Patent 51695,770
Raychaudhuri, et al.
December 9, 1997
Induction of cytotoxic T-lymphocyte responses
Abstract
Methods and compositions useful for inducing a cytotoxic. T lymphocyte response (M) in a human or domesticated or agriculturally important animal.
The method includes the steps of providing the antigen to which the CTL response is desired and providing an antigen formulation which comprises, consists, or consists essentially of two or more of a stabilizing detergent, a micelle-forming agent, and an oil.
This antigen formulation is preferably lacking in an immunostimulating peptide component, or has sufficiently low levels of such a component that the desired CTL response is not diminished.
This formulation is provided as a stable oil-in-water emulsion.
Inventors: Raychaudhuri; Syamal (San Diego, CA);
Rastetter; William H. (Rancho Santa Fe, CA)
Black; Amelia (Cardiff, CA) Assignee: IDEC Pharmaceuticals Corporation (San Diego, CA)
Appl. No, - 472311 Filed:Jun 7, 1995
U.S. class.. 424/278.1; 424/184.1; 424/204.1; 424/277. 1; 424/283.1
Intern'l Class: A61K 045/05; A61K 039/00; A61K 047/00; A61K
039/39
Field of Search: 424/204. 1, 278.1,277.1,283.1,400,184.1
References Cited [Referenced by)
4770874 U.S. Patent Documents
Sep., 1988
Allison et al. 424/88. 0451216 B1 Foreign Patent Documents
Oct, 1991 Ep.
0682040 A1 Nov, 1995 Ep.
Other
References
Brugh et al 1983 Am J Vet Res 44 (1) pp. 72-75, Jan. 1, 1983.
Mackewicz et al 1991 J Clin Invest 87 pp. 1462-1466, Apr. 1991.
Nicholas et al 19?1 Virology 182 pp, 664-671, Jan. 1, 1991.
Rouse et al. 1988, Reviews 6f Inf. Dis. 10 (1) pp. 16-33, Jan. 1, 1988.
Primary Examiner,
Woodward; michael P.
Assistant examiner Zeman; Mary K.
Attorney, Agent or Firm: Burns, Doane, Swecker & Mathis, LLP
Parent Case Text
This application is a continuation-in-part of pending U.S. Ser. No. 08/351,001 filed Dec. 7, 1994
which is a continuation-in-part of pending U.S. Ser. No, 07/919,787 filed Jul. 24, 1992 U.S. Pat, No. 5,585,103
which is a continuation-in-part of U.S. Ser. No. 07/735,069, filed Jul. 25, 1991, entitled "Induction of Cytotoxic T-Lyrnphocyte Responses," by Syamal Raychaudhuri and William H, Rastetter (now abandoned).
All of these applications are incorporated by reference in their entirety. This invention relates to methods and compositions useful for inducing cytotoxic T-cell mediated responses in humans, and domesticated or agricultural animals.
1. A composition comprising , g a papillomavirus anitigen mixed with a microfluidized antigen formulation comprising:
(a) a stabilizing detergent,
(b) a micelie-forming agent, and
(c) a biodegradable and biocompatible oil,
said antigen formulation being formulated as a stable oil-in-water emulsion,
said antigen formulation being substantially free of immunostimulating peptides and wherein
said composition upon administration to an Animal selected from the group consisting of humans, domesticated animals and agricultural animals is capable of inducing a specific cytotoxic T-lymphocyte response against the papillomavirus antigen contained in the composition.
2. The composition of claim 1, wherein said papillomavirus antigen is selected from the group consisting of HPV16 E6 antigen, HPV16 E7 antigen, HPV18 E6 antigen, HPV18 E7 antigen, HPV6 E4 antigen, HPV6 L I antigen, HPV 11 E4 antigen and HPV 11L 1 antigen.
3. A method for treating cervical cancer comprising administering a therapeutically effective
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