VPM1002 as Prophylaxis Against Severe Respiratory Tract Infections Including Coronavirus Disease 2019 in the Elderly: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study
Abstract Background Bacille Calmette-Guérin (BCG) vaccination can potentially reduce the rate of respiratory infections in vulnerable populations. This study evaluates the safety and efficacy of VPM1002 (a genetically modified BCG) as prophylaxis against severe respiratory tract infections including...
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| Veröffentlicht in: | Clinical infectious diseases 2023-04, Vol.76 (7), p.1304-1310 |
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| creator | Blossey, Alexandra M Brückner, Sina May, Marcus Parzmair, Gerald P Sharma, Hitt Shaligram, Umesh Grode, Leander Kaufmann, Stefan H E Netea, Mihai G Schindler, Christoph |
| description | Abstract
Background
Bacille Calmette-Guérin (BCG) vaccination can potentially reduce the rate of respiratory infections in vulnerable populations. This study evaluates the safety and efficacy of VPM1002 (a genetically modified BCG) as prophylaxis against severe respiratory tract infections including coronavirus disease 2019 (COVID-19) in an elderly population.
Methods
In this phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trial, healthy elderly volunteers (N = 2064) were enrolled, randomized (1:1) to receive either VPM1002 or placebo, and followed up remotely for 240 days. The primary outcome was the mean number of days with severe respiratory infections at hospital and/or at home. Secondary endpoints included the incidence of self-reported fever, number of hospital and intensive care unit (ICU) admissions, and number of adverse events.
Results
A total of 31 participants in the VPM1002 group reported at least 1 day with severe respiratory disease and a mean number of days with severe respiratory disease of 9.39 ± 9.28 while in the placebo group; 38 participants reported a mean of 14.29 ± 16.25 days with severe respiratory disease. The incidence of self-reported fever was lower in the VPM1002 group (odds ratio, 0.46 [95% confidence interval, .28–.74]; P = .001), and consistent trends to fewer hospitalization and ICU admissions due to COVID-19 were observed after VPM1002 vaccination. Local reactions typical for BCG were observed in the VPM1002-vaccinated group, which were mostly of mild intensity.
Conclusions
Vaccination with VPM1002 is well tolerated and seems to have a prophylactic effect against severe respiratory disease in the elderly.
Clinical Trials Registration
NCT04435379.
This elderly study population showed fewer days with respiratory tract infections when vaccinated with VPM1002. A lower incidence of self-reported fever and consistent trends toward a reduction in hospitalizations and ICU admissions due to COVID-19 were seen compared to placebo. |
| doi_str_mv | 10.1093/cid/ciac881 |
| format | Article |
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Background
Bacille Calmette-Guérin (BCG) vaccination can potentially reduce the rate of respiratory infections in vulnerable populations. This study evaluates the safety and efficacy of VPM1002 (a genetically modified BCG) as prophylaxis against severe respiratory tract infections including coronavirus disease 2019 (COVID-19) in an elderly population.
Methods
In this phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trial, healthy elderly volunteers (N = 2064) were enrolled, randomized (1:1) to receive either VPM1002 or placebo, and followed up remotely for 240 days. The primary outcome was the mean number of days with severe respiratory infections at hospital and/or at home. Secondary endpoints included the incidence of self-reported fever, number of hospital and intensive care unit (ICU) admissions, and number of adverse events.
Results
A total of 31 participants in the VPM1002 group reported at least 1 day with severe respiratory disease and a mean number of days with severe respiratory disease of 9.39 ± 9.28 while in the placebo group; 38 participants reported a mean of 14.29 ± 16.25 days with severe respiratory disease. The incidence of self-reported fever was lower in the VPM1002 group (odds ratio, 0.46 [95% confidence interval, .28–.74]; P = .001), and consistent trends to fewer hospitalization and ICU admissions due to COVID-19 were observed after VPM1002 vaccination. Local reactions typical for BCG were observed in the VPM1002-vaccinated group, which were mostly of mild intensity.
Conclusions
Vaccination with VPM1002 is well tolerated and seems to have a prophylactic effect against severe respiratory disease in the elderly.
Clinical Trials Registration
NCT04435379.
This elderly study population showed fewer days with respiratory tract infections when vaccinated with VPM1002. A lower incidence of self-reported fever and consistent trends toward a reduction in hospitalizations and ICU admissions due to COVID-19 were seen compared to placebo.</description><identifier>ISSN: 1058-4838</identifier><identifier>EISSN: 1537-6591</identifier><identifier>DOI: 10.1093/cid/ciac881</identifier><identifier>PMID: 36358012</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Aged ; BCG Vaccine ; COVID-19 - prevention & control ; Double-Blind Method ; Hospitalization ; Humans ; SARS-CoV-2</subject><ispartof>Clinical infectious diseases, 2023-04, Vol.76 (7), p.1304-1310</ispartof><rights>The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 2022</rights><rights>The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c357t-7b0af92dbc204e5f857bc56066c3caa8802b0470da57bfeae37df744cab97d693</citedby><cites>FETCH-LOGICAL-c357t-7b0af92dbc204e5f857bc56066c3caa8802b0470da57bfeae37df744cab97d693</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36358012$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Blossey, Alexandra M</creatorcontrib><creatorcontrib>Brückner, Sina</creatorcontrib><creatorcontrib>May, Marcus</creatorcontrib><creatorcontrib>Parzmair, Gerald P</creatorcontrib><creatorcontrib>Sharma, Hitt</creatorcontrib><creatorcontrib>Shaligram, Umesh</creatorcontrib><creatorcontrib>Grode, Leander</creatorcontrib><creatorcontrib>Kaufmann, Stefan H E</creatorcontrib><creatorcontrib>Netea, Mihai G</creatorcontrib><creatorcontrib>Schindler, Christoph</creatorcontrib><title>VPM1002 as Prophylaxis Against Severe Respiratory Tract Infections Including Coronavirus Disease 2019 in the Elderly: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study</title><title>Clinical infectious diseases</title><addtitle>Clin Infect Dis</addtitle><description>Abstract
Background
Bacille Calmette-Guérin (BCG) vaccination can potentially reduce the rate of respiratory infections in vulnerable populations. This study evaluates the safety and efficacy of VPM1002 (a genetically modified BCG) as prophylaxis against severe respiratory tract infections including coronavirus disease 2019 (COVID-19) in an elderly population.
Methods
In this phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trial, healthy elderly volunteers (N = 2064) were enrolled, randomized (1:1) to receive either VPM1002 or placebo, and followed up remotely for 240 days. The primary outcome was the mean number of days with severe respiratory infections at hospital and/or at home. Secondary endpoints included the incidence of self-reported fever, number of hospital and intensive care unit (ICU) admissions, and number of adverse events.
Results
A total of 31 participants in the VPM1002 group reported at least 1 day with severe respiratory disease and a mean number of days with severe respiratory disease of 9.39 ± 9.28 while in the placebo group; 38 participants reported a mean of 14.29 ± 16.25 days with severe respiratory disease. The incidence of self-reported fever was lower in the VPM1002 group (odds ratio, 0.46 [95% confidence interval, .28–.74]; P = .001), and consistent trends to fewer hospitalization and ICU admissions due to COVID-19 were observed after VPM1002 vaccination. Local reactions typical for BCG were observed in the VPM1002-vaccinated group, which were mostly of mild intensity.
Conclusions
Vaccination with VPM1002 is well tolerated and seems to have a prophylactic effect against severe respiratory disease in the elderly.
Clinical Trials Registration
NCT04435379.
This elderly study population showed fewer days with respiratory tract infections when vaccinated with VPM1002. A lower incidence of self-reported fever and consistent trends toward a reduction in hospitalizations and ICU admissions due to COVID-19 were seen compared to placebo.</description><subject>Aged</subject><subject>BCG Vaccine</subject><subject>COVID-19 - prevention & control</subject><subject>Double-Blind Method</subject><subject>Hospitalization</subject><subject>Humans</subject><subject>SARS-CoV-2</subject><issn>1058-4838</issn><issn>1537-6591</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU1v1DAQhiMEoqVw4o7mxAUCdpwPh9uStlCpFau2cI0m9qRr5LVXtlMRfiE_q1lt4chhNO_ofTSXJ8tec_aBs1Z8VEYvg0pK_iQ75pVo8rpq-dMls0rmpRTyKHsR40_GOJesep4diVpUkvHiOPvzY33FGSsAI6yD321mi79MhNUdGhcT3NA9BYJrijsTMPkww21AleDCjaSS8S4uUdlJG3cHnQ_e4b0JU4RTEwkjQcF4C8ZB2hCcWU3Bzp9gBevNvhRwjU77rflN-j2c-mmwlH-2xi3X2qKiweeddyl4a_fE1WSTUeQSBegWzCi0cJMmPb_Mno1oI7163CfZ9_Oz2-5rfvnty0W3usyVqJqUNwPDsS30oApWUjXKqhlUVbO6VkIhSsmKgZUN07gUIyGJRo9NWSoc2kbXrTjJ3h3-quBjDDT2u2C2GOaes37vo1989I8-FvrNgd5Nw5b0P_avgAV4ewD8tPvvpwcxT5b1</recordid><startdate>20230403</startdate><enddate>20230403</enddate><creator>Blossey, Alexandra M</creator><creator>Brückner, Sina</creator><creator>May, Marcus</creator><creator>Parzmair, Gerald P</creator><creator>Sharma, Hitt</creator><creator>Shaligram, Umesh</creator><creator>Grode, Leander</creator><creator>Kaufmann, Stefan H E</creator><creator>Netea, Mihai G</creator><creator>Schindler, Christoph</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20230403</creationdate><title>VPM1002 as Prophylaxis Against Severe Respiratory Tract Infections Including Coronavirus Disease 2019 in the Elderly: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study</title><author>Blossey, Alexandra M ; Brückner, Sina ; May, Marcus ; Parzmair, Gerald P ; Sharma, Hitt ; Shaligram, Umesh ; Grode, Leander ; Kaufmann, Stefan H E ; Netea, Mihai G ; Schindler, Christoph</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c357t-7b0af92dbc204e5f857bc56066c3caa8802b0470da57bfeae37df744cab97d693</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Aged</topic><topic>BCG Vaccine</topic><topic>COVID-19 - prevention & control</topic><topic>Double-Blind Method</topic><topic>Hospitalization</topic><topic>Humans</topic><topic>SARS-CoV-2</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Blossey, Alexandra M</creatorcontrib><creatorcontrib>Brückner, Sina</creatorcontrib><creatorcontrib>May, Marcus</creatorcontrib><creatorcontrib>Parzmair, Gerald P</creatorcontrib><creatorcontrib>Sharma, Hitt</creatorcontrib><creatorcontrib>Shaligram, Umesh</creatorcontrib><creatorcontrib>Grode, Leander</creatorcontrib><creatorcontrib>Kaufmann, Stefan H E</creatorcontrib><creatorcontrib>Netea, Mihai G</creatorcontrib><creatorcontrib>Schindler, Christoph</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Clinical infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Blossey, Alexandra M</au><au>Brückner, Sina</au><au>May, Marcus</au><au>Parzmair, Gerald P</au><au>Sharma, Hitt</au><au>Shaligram, Umesh</au><au>Grode, Leander</au><au>Kaufmann, Stefan H E</au><au>Netea, Mihai G</au><au>Schindler, Christoph</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>VPM1002 as Prophylaxis Against Severe Respiratory Tract Infections Including Coronavirus Disease 2019 in the Elderly: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study</atitle><jtitle>Clinical infectious diseases</jtitle><addtitle>Clin Infect Dis</addtitle><date>2023-04-03</date><risdate>2023</risdate><volume>76</volume><issue>7</issue><spage>1304</spage><epage>1310</epage><pages>1304-1310</pages><issn>1058-4838</issn><eissn>1537-6591</eissn><abstract>Abstract
Background
Bacille Calmette-Guérin (BCG) vaccination can potentially reduce the rate of respiratory infections in vulnerable populations. This study evaluates the safety and efficacy of VPM1002 (a genetically modified BCG) as prophylaxis against severe respiratory tract infections including coronavirus disease 2019 (COVID-19) in an elderly population.
Methods
In this phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trial, healthy elderly volunteers (N = 2064) were enrolled, randomized (1:1) to receive either VPM1002 or placebo, and followed up remotely for 240 days. The primary outcome was the mean number of days with severe respiratory infections at hospital and/or at home. Secondary endpoints included the incidence of self-reported fever, number of hospital and intensive care unit (ICU) admissions, and number of adverse events.
Results
A total of 31 participants in the VPM1002 group reported at least 1 day with severe respiratory disease and a mean number of days with severe respiratory disease of 9.39 ± 9.28 while in the placebo group; 38 participants reported a mean of 14.29 ± 16.25 days with severe respiratory disease. The incidence of self-reported fever was lower in the VPM1002 group (odds ratio, 0.46 [95% confidence interval, .28–.74]; P = .001), and consistent trends to fewer hospitalization and ICU admissions due to COVID-19 were observed after VPM1002 vaccination. Local reactions typical for BCG were observed in the VPM1002-vaccinated group, which were mostly of mild intensity.
Conclusions
Vaccination with VPM1002 is well tolerated and seems to have a prophylactic effect against severe respiratory disease in the elderly.
Clinical Trials Registration
NCT04435379.
This elderly study population showed fewer days with respiratory tract infections when vaccinated with VPM1002. A lower incidence of self-reported fever and consistent trends toward a reduction in hospitalizations and ICU admissions due to COVID-19 were seen compared to placebo.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>36358012</pmid><doi>10.1093/cid/ciac881</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| ispartof | Clinical infectious diseases, 2023-04, Vol.76 (7), p.1304-1310 |
| issn | 1058-4838 1537-6591 |
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| recordid | cdi_crossref_primary_10_1093_cid_ciac881 |
| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current); EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Aged BCG Vaccine COVID-19 - prevention & control Double-Blind Method Hospitalization Humans SARS-CoV-2 |
| title | VPM1002 as Prophylaxis Against Severe Respiratory Tract Infections Including Coronavirus Disease 2019 in the Elderly: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study |
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