Lyme Disease Vaccine - ImuLyme; recombinant Borrelia burgdorferi outer surface protein A (OspA)
Status: BLA withdrawn; never approved; abandoned
Organizations involved:
Connaught Laboratories, Inc. – Former
Sanofi Pasteur S.A. – R&D; Tech.; Parent
Cross ref.: See the entry below for a recently marketed Lyme disease vaccine, LYMErix, for further background Lyme disease and vaccine information.
Description: Lyme Disease Vaccine or ImuLyme is a monovalent recombinant Borrelia burgdorferi outer surface protein A (OspA) vaccine similar in many respects to a recently marketed vaccine, LYMErix (see entry below). Aventis Pasteur (now Sanofi Pasteur S.A.) discontinued the development of ImuLyme in early 2000, and is now developing a multivalent (multiple antigen) vaccine. Presumably, recombinant OspA was expressed by Escherichia coli (E. coli), like LYMErix.
Nomenclature: Lyme Vaccine, rDNA/Aventis [BIO]; Lyme Disease Vaccine [FDA]; ImuLyme [SY]; Borrelia burgdorferi outer surface protein A (OspA), recombinant [SY]
Status: Connaught Labs., now Sanofi Pasteur Inc., submitted a BLA in Sept.1997 after conducting clinical studies in more than 10,000 patients. However, the application was withdrawn in Feb. 2000.
Aventis Pasteur’s (now Sanofi Pasteur) decision to halt development of ImuLyme was taken following the lower than expected market acceptance of LYMErix (from SmithKline Beecham, now GlaxoSmithKline), which was launched in the U.S. at the start of 1999. Like LYMErix, ImuLyme had also shown unexplained age-related variations in immunogenicity in Phase III trials. In patients aged 59 years or younger, it reduced the incidence of disease by 100%, but this dropped to 75% in those aged over 60 years, with all non-responders being males. Concerns had also been raised about the dosing regimens for both ImuLyme and LYMErix, each requiring three doses over a period of one year before a satisfactory immune response. The first two doses are given one month apart and result in relatively poor immunity. It is only after the third dose one year later that the subject has full immunity.
R&D: Sanofi Pasteur S.A. has been reported to be working on development of a second-generation multiple antigen vaccine that will include B. burgdorferi decorin binding protein (DbpA; licensed from MedImmune Inc.) in combination with other recombinant surface antigens.
Companies involvement:
Full monograph
229 Lyme Vaccine, rDNA/Aventis
Nomenclature:
Lyme Vaccine, rDNA/Aventis [BIO]
Lyme Disease Vaccine [FDA]
Borrelia burgdorfi outer surface protein A (OspA), recombinant [SY]
ImuLyme [SY]
FDA Class: Biologic BLA
Year of approval (FDA) = 1997
Date of 1st FDA approval = 19970915
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
exempt from CBER lot release requirements
recombinant DNA
vaccines, bacterial
vaccines, subunit
bacterial culture <!-- bacterialculture -->
Bordetella pertussis
Escherichia coli (E. coli)
virus culture
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
FD&C Yellow 5
North American coral snake
North American coral snake
EU000 Not yet/Never filed with EU
UM999 Not Available/Not Marketed in US
US01 FDA application withdrawn or rejected
EM999 Not Available/Not Marketed in EU
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