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A Live Human Parainfluenza Type 3 Virus Vaccine Is Attenuated and Immunogenic in Healthy Infants and Children

Identifieur interne : 001248 ( Istex/Corpus ); précédent : 001247; suivant : 001249

A Live Human Parainfluenza Type 3 Virus Vaccine Is Attenuated and Immunogenic in Healthy Infants and Children

Auteurs : Ruth A. Karron ; Peter F. Wright ; Frances K. Newman ; Mamodikoe Makhene ; Juliette Thompson ; Roberta Samorodin ; Modena H. Wilson ; Edwin L. Anderson ; Mary Lou Clements ; Brian R. Murphy ; Robert B. Belshe

Source :

RBID : ISTEX:08904D8467172BCF456101291CE3C2FE59998F9B

Abstract

The safety, infectivity, immunogenicity, and phenotypic stability of the cold-passaged (cp) candidate vaccine cp-45, a cold-adapted (ca), temperature-sensitive (ts) mutant of the J8 strain of human parainfluenza virus type 3 (HPIV-3), was evaluated in 114 children 6 months to 10 years old in a randomized, placebo-controlled, double-blind trial. The cp-45 vaccine was well tolerated when given intranasally to parainfluenza virus type 3 (PIV-3)-seropositive and -seronegative children. With 104 or 105 TCID50 of cp-45 vaccine, 86% of seronegative vaccinees were infected, 83% of whom shed virus at a mean peak titer of 102.2 pfu/mL. Virus present in respiratory specimens retained the ts phenotype, and each of 86 PIV-3 isolates tested retained both the ca and ts phenotypes. One dose of 105 TCID50 of vaccine induced a serum hemagglutination-inhibiting antibody response in 81% of vaccinees; the geometric mean titer was 1:32. These studies indicate that the cp-45 HPIV-3 vaccine is satisfactorily attenuated, infectious, immunogenic, and phenotypically stable and merits further evaluation in infants and young children.

Url:
DOI: 10.1093/infdis/172.6.1445

Links to Exploration step

ISTEX:08904D8467172BCF456101291CE3C2FE59998F9B

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<div type="abstract">The safety, infectivity, immunogenicity, and phenotypic stability of the cold-passaged (cp) candidate vaccine cp-45, a cold-adapted (ca), temperature-sensitive (ts) mutant of the J8 strain of human parainfluenza virus type 3 (HPIV-3), was evaluated in 114 children 6 months to 10 years old in a randomized, placebo-controlled, double-blind trial. The cp-45 vaccine was well tolerated when given intranasally to parainfluenza virus type 3 (PIV-3)-seropositive and -seronegative children. With 104 or 105 TCID50 of cp-45 vaccine, 86% of seronegative vaccinees were infected, 83% of whom shed virus at a mean peak titer of 102.2 pfu/mL. Virus present in respiratory specimens retained the ts phenotype, and each of 86 PIV-3 isolates tested retained both the ca and ts phenotypes. One dose of 105 TCID50 of vaccine induced a serum hemagglutination-inhibiting antibody response in 81% of vaccinees; the geometric mean titer was 1:32. These studies indicate that the cp-45 HPIV-3 vaccine is satisfactorily attenuated, infectious, immunogenic, and phenotypically stable and merits further evaluation in infants and young children.</div>
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<p>The safety, infectivity, immunogenicity, and phenotypic stability of the cold-passaged (cp) candidate vaccine cp-45, a cold-adapted (
<hi rend="italic">ca</hi>
), temperature-sensitive (
<hi rend="italic">ts</hi>
) mutant of the J8 strain of human parainfluenza virus type 3 (HPIV-3), was evaluated in 114 children 6 months to 10 years old in a randomized, placebo-controlled, double-blind trial. The cp-45 vaccine was well tolerated when given intranasally to parainfluenza virus type 3 (PIV-3)-seropositive and -seronegative children. With 10
<hi rend="superscript">4</hi>
or 10
<hi rend="superscript">5</hi>
TCID
<hi rend="subscript">50</hi>
of cp-45 vaccine, 86% of seronegative vaccinees were infected, 83% of whom shed virus at a mean peak titer of 10
<hi rend="superscript">2.2</hi>
pfu/mL. Virus present in respiratory specimens retained the
<hi rend="italic">ts</hi>
phenotype, and each of 86 PIV-3 isolates tested retained both the
<hi rend="italic">ca</hi>
and
<hi rend="italic">ts</hi>
phenotypes. One dose of 10
<hi rend="superscript">5</hi>
TCID
<hi rend="subscript">50</hi>
of vaccine induced a serum hemagglutination-inhibiting antibody response in 81% of vaccinees; the geometric mean titer was 1:32. These studies indicate that the cp-45 HPIV-3 vaccine is satisfactorily attenuated, infectious, immunogenic, and phenotypically stable and merits further evaluation in infants and young children.</p>
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<journal-title>Journal of Infectious Diseases</journal-title>
<abbrev-journal-title>J Infect Dis.</abbrev-journal-title>
<issn pub-type="ppub">0022-1899</issn>
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<article-title>A Live Human Parainfluenza Type 3 Virus Vaccine Is Attenuated and Immunogenic in Healthy Infants and Children</article-title>
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<name>
<surname>Karron</surname>
<given-names>Ruth A.</given-names>
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<contrib contrib-type="author">
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<contrib contrib-type="author">
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<given-names>Frances K.</given-names>
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<contrib contrib-type="author">
<name>
<surname>Makhene</surname>
<given-names>Mamodikoe</given-names>
</name>
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<contrib contrib-type="author">
<name>
<surname>Thompson</surname>
<given-names>Juliette</given-names>
</name>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Samorodin</surname>
<given-names>Roberta</given-names>
</name>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Wilson</surname>
<given-names>Modena H.</given-names>
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<contrib contrib-type="author">
<name>
<surname>Anderson</surname>
<given-names>Edwin L.</given-names>
</name>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Clements</surname>
<given-names>Mary Lou</given-names>
</name>
</contrib>
<contrib contrib-type="author">
<name>
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<given-names>Brian R.</given-names>
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<contrib contrib-type="author">
<name>
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<given-names>Robert B.</given-names>
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<aff>
<institution>Center for Immunization Research, Department of International Health, School of Hygiene and Public Health</institution>
,
<institution>Departments of Pediatrics and Medicine, School of Medicine, Johns Hopkins University</institution>
,
<addr-line>Baltimore</addr-line>
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<aff>
<institution>Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health</institution>
,
<addr-line>Bethesda, Maryland</addr-line>
</aff>
<aff>
<institution>Vaccine Evaluation Unit, Department of Pediatrics, Vanderbilt University School of Medicine</institution>
,
<addr-line>Nashville, Tennessee</addr-line>
</aff>
<aff>
<institution>Center for Vaccine Development, Division of Infectious Diseases, Departments of Internal Medicine and Pediatrics, Saint Louis University, and St. Louis VA Medical Center</institution>
,
<addr-line>St. Louis, Missouri</addr-line>
</aff>
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<corresp id="cor1">Reprints or correspondence: Dr. Ruth A. Karron, Center for Immunization Research, Johns Hopkins University School of Hygiene and Public Health, Hampton House 125,624 N. Broadway, Baltimore, MD 21205.</corresp>
</author-notes>
<pub-date pub-type="ppub">
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<year>1995</year>
</pub-date>
<volume>172</volume>
<issue>6</issue>
<fpage>1445</fpage>
<lpage>1450</lpage>
<history>
<date date-type="received">
<day>7</day>
<month>5</month>
<year>1995</year>
</date>
<date date-type="rev-recd">
<day>1</day>
<month>8</month>
<year>1995</year>
</date>
</history>
<copyright-statement>© 1995 by The University of Chicago</copyright-statement>
<copyright-year>1995</copyright-year>
<abstract>
<p>The safety, infectivity, immunogenicity, and phenotypic stability of the cold-passaged (cp) candidate vaccine cp-45, a cold-adapted (
<italic>ca</italic>
), temperature-sensitive (
<italic>ts</italic>
) mutant of the J8 strain of human parainfluenza virus type 3 (HPIV-3), was evaluated in 114 children 6 months to 10 years old in a randomized, placebo-controlled, double-blind trial. The cp-45 vaccine was well tolerated when given intranasally to parainfluenza virus type 3 (PIV-3)-seropositive and -seronegative children. With 10
<sup>4</sup>
or 10
<sup>5</sup>
TCID
<sub>50</sub>
of cp-45 vaccine, 86% of seronegative vaccinees were infected, 83% of whom shed virus at a mean peak titer of 10
<sup>2.2</sup>
pfu/mL. Virus present in respiratory specimens retained the
<italic>ts</italic>
phenotype, and each of 86 PIV-3 isolates tested retained both the
<italic>ca</italic>
and
<italic>ts</italic>
phenotypes. One dose of 10
<sup>5</sup>
TCID
<sub>50</sub>
of vaccine induced a serum hemagglutination-inhibiting antibody response in 81% of vaccinees; the geometric mean titer was 1:32. These studies indicate that the cp-45 HPIV-3 vaccine is satisfactorily attenuated, infectious, immunogenic, and phenotypically stable and merits further evaluation in infants and young children.</p>
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<abstract>The safety, infectivity, immunogenicity, and phenotypic stability of the cold-passaged (cp) candidate vaccine cp-45, a cold-adapted (ca), temperature-sensitive (ts) mutant of the J8 strain of human parainfluenza virus type 3 (HPIV-3), was evaluated in 114 children 6 months to 10 years old in a randomized, placebo-controlled, double-blind trial. The cp-45 vaccine was well tolerated when given intranasally to parainfluenza virus type 3 (PIV-3)-seropositive and -seronegative children. With 104 or 105 TCID50 of cp-45 vaccine, 86% of seronegative vaccinees were infected, 83% of whom shed virus at a mean peak titer of 102.2 pfu/mL. Virus present in respiratory specimens retained the ts phenotype, and each of 86 PIV-3 isolates tested retained both the ca and ts phenotypes. One dose of 105 TCID50 of vaccine induced a serum hemagglutination-inhibiting antibody response in 81% of vaccinees; the geometric mean titer was 1:32. These studies indicate that the cp-45 HPIV-3 vaccine is satisfactorily attenuated, infectious, immunogenic, and phenotypically stable and merits further evaluation in infants and young children.</abstract>
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