1997
DOI: 10.1086/516167
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Specific Issues in the Design and Implementation of an Efficacy Trial for a Lyme Disease Vaccine

Abstract: Lyme disease is an emerging infection that has now become the most commonly reported vector-borne disease in the United States. In the 20 years since its initial description, scientific and technological advances have led to candidate vaccines for the prevention of Lyme disease. Recombinant outer surface protein A (OspA) vaccines have been successful in protecting mice in tick-challenge experiments. A candidate OspA vaccine has been found to be safe and immunogenic in phase I and II studies. This article descr… Show more

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Cited by 16 publications
(3 citation statements)
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“…The most-studied B. burgdorferi membrane protein is outer surface protein A (OspA), a lipoprotein antigen expressed by borreliae in resting ticks and the most abundant protein expressed in vitro by most B. burgdorferi sensu lato isolates (2,32). Experimental OspA vaccines have demonstrated efficacy in several animal models (11,19,24,33), and OspA vaccines for human use are the subjects of current clinical evaluations (35,36,57).…”
mentioning
confidence: 99%
“…The most-studied B. burgdorferi membrane protein is outer surface protein A (OspA), a lipoprotein antigen expressed by borreliae in resting ticks and the most abundant protein expressed in vitro by most B. burgdorferi sensu lato isolates (2,32). Experimental OspA vaccines have demonstrated efficacy in several animal models (11,19,24,33), and OspA vaccines for human use are the subjects of current clinical evaluations (35,36,57).…”
mentioning
confidence: 99%
“…19,164,165 Vaccines consisting of recombinant OspA (LYMErix; GlaxoSmithKline, New York, NY) were granted approval in the United States in 1998. [166][167][168] They induced the recipient to make anti-Borrelia antibodies that would subsequently be taken into the tick's gut during feeding.…”
Section: Vaccinationmentioning
confidence: 99%
“…The first OspA vaccine to enter the American market was approved by the Food and Drug Administration (FDA) on 21 December, 1998 (10)(11)(12)(13). This monovalent vaccine consists of a full-length OspA (L-OspA) from one B6 strain (ZS7) expressed in an Escherichia colz ( 3 1 ) .…”
mentioning
confidence: 99%