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CLINICAL DATA ON INVESTIGATIONAL VACCINES PRESENTED AT 95TH GENERAL MEETING OF THE ASM IN WASHINGTON, DC.


BELTSVILLE, Md.--(HealthWire)--May 24, 1995--North American Vaccine (AMEX AMEX

See: American Stock Exchange
:NVX) announced today that the investigators for the clinical trials of the Company's DTaP-IPV and DTaP vaccines presented data at the American Society of Microbiology (ASM (1) (Association for Systems Management) An international membership organization based in Cleveland, Ohio. Founded in 1947 and disbanded in 1996, it sponsored conferences in all phases of administrative systems and management. ) meeting in Washington, DC.

At ASM, Dr. Iver Heron, from Statens Seruminstitut, reported on the results from the clinical study conducted in Denmark on the Company's combined DTaP-IPV vaccine for the prevention of diphtheria diphtheria (dĭfthēr`ēə), acute contagious disease caused by Corynebacterium diphtheriae (Klebs-Loffler bacillus) bacteria that have been infected by a bacteriophage. It begins as a soreness of the throat with fever. , tetanus, pertussis pertussis: see whooping cough.  (whooping-cough) and polio. The trial compared the combined DTaP-IPV vaccine to the standard Danish protocol of giving a DT-IPV vaccine and a whole-cell pertussis vaccine pertussis vaccine
n.
A vaccine containing inactivated Bordetella pertussis bacteria, often used in the diphtheria, tetanus toxoids, and pertussis vaccine to immunize against whooping cough. Also called whooping cough vaccine.
 separately to Danish infants. The data revealed that there were no significant adverse reactions adverse reactions,
n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration.
 attributable to the combined DTaP-IPV vaccine and that there has been no clinically relevant interference among the six different components of the vaccine in eliciting specific immune responses. The study further demonstrated that the combined DTaP-IPV vaccine induced vigorous T-cell stimulation and that cytokine Cytokine

Any of a group of soluble proteins that are released by a cell to send messages which are delivered to the same cell (autocrine), an adjacent cell (paracrine), or a distant cell (endocrine).
 release was specifically induced. T-cell and cytokine stimulation are important because they assist the body in defending against infection and disease. Dr. Heron concluded that the Company's patented acellular pertussis vaccine acellular pertussis vaccine
n. Abbr. DTaP
A diphtheria, tetanus, pertussis vaccine containing two or more antigens but no whole cells.
 induced a vigorous T-cell response after the second and third injections and that high levels of immunity against all components were achieved with no indication of serious immunological interactions.

In his presentation at ASM, Dr. John Taranger, the Swedish co-principal investigator, reported on the results from the Phase III clinical study of the Company's DTaP vaccine for the prevention of diphtheria, tetanus and pertussis. In addition to the efficacy figures previously reported by the National Institutes of Health, Dr. Taranger revealed that the Company's DTaP vaccine successfully ameliorated disease in children who contracted pertussis infection. The data from the clinical trial indicates that of the children who contracted pertussis, those who received the Company's DTaP vaccine had milder, less severe cases of disease and for a shorter period of time. Specifically the data revealed that more than a majority of the children who received the DTaP vaccine had no whooping whoop  
n.
1.
a. A loud cry of exultation or excitement.

b. A shout uttered by a hunter or warrior.

2. A hooting cry, as of a bird.

3. The paroxysmal gasp characteristic of whooping cough.
 attacks or cough with vomiting. Additionally, the median duration in days of whooping and vomiting was zero in the DTaP vaccinated group as compared to greater than or equal to 20 days in the control group that received a combined diphtheria-tetanus (DT) vaccine.

The results of the Phase III clinical study also revealed that the Company's DTaP vaccine had no significant adverse reactions and that the incidence of less severe, local reactions was similar between the DTaP vaccinated group and the DT control group. The presentation revealed that during the course of three injections of the DTaP vaccine, the incidence of redness and swelling greater than or equal to four centimeters was one-tenth of one percent after the first injection, two percent after the second injection, and ten percent or less after the third injection. Rates of fever were nearly identical in the DTaP and DT vaccinated groups both during the first 48 hours and during the week following vaccination.

Dr. Taranger concluded that the Company's DTaP vaccine is safe with no serious vaccine related side-reactions and no child was withdrawn from the study due to vaccine associated safety concerns. Dr. Taranger further concluded that the vaccine is efficacious in that the disease incidence was reduced by 71% in an area with epidemic outbreak of pertussis. The attack rate of disease was 14.4 percent in the control group versus four percent in the DTaP vaccinated group. Moreover, the vaccine significantly attenuated Attenuated
Alive but weakened; an attenuated microorganism can no longer produce disease.

Mentioned in: Tuberculin Skin Test


attenuated

having undergone a process of attenuation.
 the clinical course of disease in those children who received the Company's DTaP vaccine.

North American North American

named after North America.


North American blastomycosis
see North American blastomycosis.

North American cattle tick
see boophilusannulatus.
 Vaccine, Inc. is engaged in the research, development and production of vaccines for the prevention of human infectious diseases.

For further information contact: Sharon Mates, Ph.D., President, North American Vaccine, Inc., 12103 Indian Creek Court, Beltsville, Maryland 20705 (301) 470-6100.

CONTACT: North American Vaccine, Beltsville

Sharon Mates, Ph.D., 301/470-6100
COPYRIGHT 1995 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1995, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:May 24, 1995
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