Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Patent
1996-02-12
2000-09-19
Swartz, Rodney P.
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
435 691, 435 693, 435 695, 4352531, A61K 3904, C12P 2106, C12P 2104, C12N 112
Patent
active
061207764
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a kit comprising as one part of the kit a vaccine containing as the effective component an immunogenic agent (e.g. mycobacteria from the BCG strain: Danish 1331) capable of conferring substantially increased immunity to tuberculosis, and as the other part of the kit at least one diagnostic skin test comprising a pharmaceutical composition containing a polypeptide with which lymphoid cells previously primed with mycobacteria belonging to the tuberculosis-complex are capable of reacting and with which lymphoid cells previously primed with the immunogenic agent are not capable of reacting, or a variant which is immunologically equivalent to the polypeptide, as well as a method of diagnosing tuberculosis caused by Mycobacterium tuberculosis, Mycobacterium africanum or Mycobacterium bovis in a person, comprising intradermally injecting, in the person, the skin test, a positive skin response at the location of injection being indicative of the person having or having had tuberculosis, and a negative skin response at the location of injection being indicative of the person not having or not having had tuberculosis, the polypeptide preferably being MPT64 or an immunologically equivalent variant, analogue or subsequence thereof. The invention further relates to a pharmaceutical composition comprising the polypeptide, a DNA fragment encoding a polypeptide which is an immunological equivalent to MPT64, the polypeptide which is an immunological equivalent to MPT64, as well as a method for vaccinating one or more persons in a population and subsequently subjecting the population to a diagnostic test for tuberculosis by the method described above.
BACKGROUND
Tuberculosis remains a major world health problem. In fact, the incidence is increasing in both the so-called developing part of the world as well as in industrialized countries like the United States of America. Recently, tuberculosis was ranked by the World Health Organization as the most frequent cause of death ascribable to a single infectious agent (Memorandum from a WHO meeting: Tuberculosis control and research strategies for the 1990s. Bulletin of the World Health Organization 70:17-21, 1992).
The means to effectively intervene transmission and thereby ultimately to get the disease under control are based on early diagnosis and treatment combined with vaccination of the populations at risk. The currently available anti-tuberculosis vaccine was developed in the beginning of this century by Calmette and Guerin and is often referred to as "the Bacille Calmette et Guerin (BCG)". The vaccine strain evolved after serial passages of a virulent isolate of M. bovis on a bile containing growth medium. The resultant strain appeared to be avirulent for humans. The nature of the loss of virulence is still not clearly understood at the molecular level. However, the BCG vaccine is estimated to be the most widely used live vaccine in the world and the remarkable low number of serious complications observed as a consequence of the use of BCG clearly demonstrate that the strain is fully attenuated (Lotte et al., Adv. Tuberc. Res. 21, 107-193 (1984)). When the reports of the first successful vaccinations were published, several laboratories and vaccine producers around the world requested the strain from Calmette and Guerin and the strain was subcultured locally under conditions which varied from one laboratory to another. This is the historical background for the occurrence of several substrains of BCG. Modern BCG producers make use of freeze-lot systems which ensure that the genetic composition of the bacteria--the product--has been conserved. Despite the widely accepted use of the BCG vaccine in many countries some countries never introduced it for use in general population vaccination programmes. This is the case in e.g. USA and Belgium. One of the reasons for these countries to be reluctant is that vaccination with BCG interferes with the use of tuberculin skin testings for diagnosing tuberculosis and for use in population surveys.
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REFERENCES:
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Andersen .ANG.se Bengaard
Hasl.o slashed.v Kaare
Oettinger Thomas
Kowalski Thomas J.
Statens Seruminstitut
Swartz Rodney P.
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