Immunogenicity and safety of an inactivated Rift Valley fever vaccine in a 19-year study
Abstract An investigational, formalin-inactivated Rift Valley fever (RVF) vaccine, known as The Salk Institute-Government Services Division (TSI-GSD) 200 vaccine, was administered to 1860 at-risk subjects (5954 doses) between 1986 and 2004 as a three-dose primary series (days 0, 7, and 28) followed...
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| creator | Rusnak, Janice M Gibbs, Paul Boudreau, Ellen Clizbe, Denise P Pittman, Phillip |
| description | Abstract An investigational, formalin-inactivated Rift Valley fever (RVF) vaccine, known as The Salk Institute-Government Services Division (TSI-GSD) 200 vaccine, was administered to 1860 at-risk subjects (5954 doses) between 1986 and 2004 as a three-dose primary series (days 0, 7, and 28) followed by booster doses as needed for declining titers. An initial positive serological response (PRNT80 ≥ 1:40) to the primary series was observed in 90% of subjects. Estimate of the PRNT80 response half-life in initial responders to the primary series by Kaplan–Meier plot was 315 days after the primary series dose 3. Differences in a serological response were observed at 2 weeks after dose 3 of the primary series between vaccine lots and for gender (women > men); a trend was observed for age ( |
| doi_str_mv | 10.1016/j.vaccine.2011.02.037 |
| format | Article |
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An initial positive serological response (PRNT80 ≥ 1:40) to the primary series was observed in 90% of subjects. Estimate of the PRNT80 response half-life in initial responders to the primary series by Kaplan–Meier plot was 315 days after the primary series dose 3. Differences in a serological response were observed at 2 weeks after dose 3 of the primary series between vaccine lots and for gender (women > men); a trend was observed for age (<40 years). When response to the primary series was measured by PRNT50 titer ≥1:40, nearly all subjects (99.1%) responded. In individuals not initially responding to the primary series (PRNT80 < 1:40), a response was observed in most subjects after receiving only one booster dose. Immune response (all subjects) to subsequent booster doses for a declining titer (PRNT80 < 1:40) was 98.4%. The vaccine was well-tolerated; vaccine-related adverse reactions were generally mild and self-limited. Differences in adverse events were observed with vaccine lot and sex. The data support the safety and immunogenicity of the inactivated RVF vaccine, and may serve as a standard of comparison for immunogenicity and safety for future RVF vaccines.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2011.02.037</identifier><identifier>PMID: 21354483</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Adolescent ; Adult ; adverse effects ; Age ; Aged ; Aged, 80 and over ; Allergy and Immunology ; Antibodies, Viral - blood ; Drug dosages ; Female ; gender ; half life ; Hepatitis ; Humans ; Immune response ; Immunization - methods ; Immunization, Secondary - methods ; Immunogenicity ; Injections ; Male ; Middle Aged ; Nervous system ; Rift Valley fever ; Rift Valley Fever - immunology ; Rift Valley Fever - prevention & control ; Rift Valley fever virus - immunology ; Safety ; TSI-GSD 200 RVF vaccine ; Vaccine ; Vaccines ; Vaccines, Inactivated - administration & dosage ; Vaccines, Inactivated - adverse effects ; Vaccines, Inactivated - immunology ; Vector-borne diseases ; Viral hemorrhagic fever ; Viral Vaccines - administration & dosage ; Viral Vaccines - adverse effects ; Viral Vaccines - immunology ; Young Adult</subject><ispartof>Vaccine, 2011-04, Vol.29 (17), p.3222-3229</ispartof><rights>2011</rights><rights>Published by Elsevier Ltd.</rights><rights>Copyright Elsevier Limited Apr 12, 2011</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c503t-31d9df505c26e4876b9bbd915857ea53eeae205858c53801a1474dd264a5913</citedby><cites>FETCH-LOGICAL-c503t-31d9df505c26e4876b9bbd915857ea53eeae205858c53801a1474dd264a5913</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1618943344?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21354483$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rusnak, Janice M</creatorcontrib><creatorcontrib>Gibbs, Paul</creatorcontrib><creatorcontrib>Boudreau, Ellen</creatorcontrib><creatorcontrib>Clizbe, Denise P</creatorcontrib><creatorcontrib>Pittman, Phillip</creatorcontrib><title>Immunogenicity and safety of an inactivated Rift Valley fever vaccine in a 19-year study</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Abstract An investigational, formalin-inactivated Rift Valley fever (RVF) vaccine, known as The Salk Institute-Government Services Division (TSI-GSD) 200 vaccine, was administered to 1860 at-risk subjects (5954 doses) between 1986 and 2004 as a three-dose primary series (days 0, 7, and 28) followed by booster doses as needed for declining titers. An initial positive serological response (PRNT80 ≥ 1:40) to the primary series was observed in 90% of subjects. Estimate of the PRNT80 response half-life in initial responders to the primary series by Kaplan–Meier plot was 315 days after the primary series dose 3. Differences in a serological response were observed at 2 weeks after dose 3 of the primary series between vaccine lots and for gender (women > men); a trend was observed for age (<40 years). When response to the primary series was measured by PRNT50 titer ≥1:40, nearly all subjects (99.1%) responded. In individuals not initially responding to the primary series (PRNT80 < 1:40), a response was observed in most subjects after receiving only one booster dose. Immune response (all subjects) to subsequent booster doses for a declining titer (PRNT80 < 1:40) was 98.4%. The vaccine was well-tolerated; vaccine-related adverse reactions were generally mild and self-limited. Differences in adverse events were observed with vaccine lot and sex. The data support the safety and immunogenicity of the inactivated RVF vaccine, and may serve as a standard of comparison for immunogenicity and safety for future RVF vaccines.</description><subject>Adolescent</subject><subject>Adult</subject><subject>adverse effects</subject><subject>Age</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Allergy and Immunology</subject><subject>Antibodies, Viral - blood</subject><subject>Drug dosages</subject><subject>Female</subject><subject>gender</subject><subject>half life</subject><subject>Hepatitis</subject><subject>Humans</subject><subject>Immune response</subject><subject>Immunization - methods</subject><subject>Immunization, Secondary - methods</subject><subject>Immunogenicity</subject><subject>Injections</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nervous system</subject><subject>Rift Valley fever</subject><subject>Rift Valley Fever - immunology</subject><subject>Rift Valley Fever - prevention & control</subject><subject>Rift Valley fever virus - immunology</subject><subject>Safety</subject><subject>TSI-GSD 200 RVF vaccine</subject><subject>Vaccine</subject><subject>Vaccines</subject><subject>Vaccines, Inactivated - administration & dosage</subject><subject>Vaccines, Inactivated - adverse effects</subject><subject>Vaccines, Inactivated - immunology</subject><subject>Vector-borne diseases</subject><subject>Viral hemorrhagic fever</subject><subject>Viral Vaccines - administration & dosage</subject><subject>Viral Vaccines - adverse effects</subject><subject>Viral Vaccines - immunology</subject><subject>Young Adult</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqNkk2LFDEQhhtR3HH1J6gBD566rcpHd-eiyOLHwoLgqOwtZJLqJWNP927SPdD_3gwzKuxFT0nBUy_11ltF8RyhQsD6zbbaW-fCQBUHxAp4BaJ5UKywbUTJFbYPixXwWpYS4fqseJLSFgCUQP24OOMolJStWBXXl7vdPIw3NAQXpoXZwbNkO8rfscsVC4N1U9jbiTz7GrqJ_bB9TwvraE-RnWbIFLMMdbmQjSxNs1-eFo862yd6dnrPi_XHD98uPpdXXz5dXry_Kp0CMZUCvfadAuV4TbJt6o3ebLxG1aqGrBJEljjkqnVKtIAWZSO9z8as0ijOi9dH1ds43s2UJrMLyVHf24HGOZm2lrpG3qj_IHkNHLTO5Kt75Hac45BNGKyx1VIIKTOljpSLY0qROnMbw87GxSCYQ0Jma07bMYeEDHCTE8p9L07q82ZH_k_X70gy8PIIdHY09iaGZL6vs4ICQKEBIRPvjgTlve4DRZNcoMGRD5HcZPwY_jnE23sKrg_5Amz_kxZKf_2alBvM-nBIhztCBOAKGvEL8WXADg</recordid><startdate>20110412</startdate><enddate>20110412</enddate><creator>Rusnak, Janice M</creator><creator>Gibbs, Paul</creator><creator>Boudreau, Ellen</creator><creator>Clizbe, Denise P</creator><creator>Pittman, Phillip</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>FBQ</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7RV</scope><scope>7T2</scope><scope>7T5</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20110412</creationdate><title>Immunogenicity and safety of an inactivated Rift Valley fever vaccine in a 19-year study</title><author>Rusnak, Janice M ; Gibbs, Paul ; Boudreau, Ellen ; Clizbe, Denise P ; Pittman, Phillip</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c503t-31d9df505c26e4876b9bbd915857ea53eeae205858c53801a1474dd264a5913</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>adverse effects</topic><topic>Age</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Allergy and Immunology</topic><topic>Antibodies, Viral - 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Academic</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rusnak, Janice M</au><au>Gibbs, Paul</au><au>Boudreau, Ellen</au><au>Clizbe, Denise P</au><au>Pittman, Phillip</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Immunogenicity and safety of an inactivated Rift Valley fever vaccine in a 19-year study</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2011-04-12</date><risdate>2011</risdate><volume>29</volume><issue>17</issue><spage>3222</spage><epage>3229</epage><pages>3222-3229</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><abstract>Abstract An investigational, formalin-inactivated Rift Valley fever (RVF) vaccine, known as The Salk Institute-Government Services Division (TSI-GSD) 200 vaccine, was administered to 1860 at-risk subjects (5954 doses) between 1986 and 2004 as a three-dose primary series (days 0, 7, and 28) followed by booster doses as needed for declining titers. An initial positive serological response (PRNT80 ≥ 1:40) to the primary series was observed in 90% of subjects. Estimate of the PRNT80 response half-life in initial responders to the primary series by Kaplan–Meier plot was 315 days after the primary series dose 3. Differences in a serological response were observed at 2 weeks after dose 3 of the primary series between vaccine lots and for gender (women > men); a trend was observed for age (<40 years). When response to the primary series was measured by PRNT50 titer ≥1:40, nearly all subjects (99.1%) responded. In individuals not initially responding to the primary series (PRNT80 < 1:40), a response was observed in most subjects after receiving only one booster dose. Immune response (all subjects) to subsequent booster doses for a declining titer (PRNT80 < 1:40) was 98.4%. The vaccine was well-tolerated; vaccine-related adverse reactions were generally mild and self-limited. Differences in adverse events were observed with vaccine lot and sex. The data support the safety and immunogenicity of the inactivated RVF vaccine, and may serve as a standard of comparison for immunogenicity and safety for future RVF vaccines.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>21354483</pmid><doi>10.1016/j.vaccine.2011.02.037</doi><tpages>8</tpages></addata></record> |
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| subjects | Adolescent Adult adverse effects Age Aged Aged, 80 and over Allergy and Immunology Antibodies, Viral - blood Drug dosages Female gender half life Hepatitis Humans Immune response Immunization - methods Immunization, Secondary - methods Immunogenicity Injections Male Middle Aged Nervous system Rift Valley fever Rift Valley Fever - immunology Rift Valley Fever - prevention & control Rift Valley fever virus - immunology Safety TSI-GSD 200 RVF vaccine Vaccine Vaccines Vaccines, Inactivated - administration & dosage Vaccines, Inactivated - adverse effects Vaccines, Inactivated - immunology Vector-borne diseases Viral hemorrhagic fever Viral Vaccines - administration & dosage Viral Vaccines - adverse effects Viral Vaccines - immunology Young Adult |
| title | Immunogenicity and safety of an inactivated Rift Valley fever vaccine in a 19-year study |
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