{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T07:54:48Z","timestamp":1767858888484,"version":"3.49.0"},"reference-count":22,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,7,13]],"date-time":"2022-07-13T00:00:00Z","timestamp":1657670400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100014351","name":"CinnaGen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100014351","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Immunology"],"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>SpikoGen\u00ae is a subunit recombinant spike protein vaccine combined with Advax\u2010CpG55.2\u2122 adjuvant. This COVID\u201019 vaccine was shown to be safe, immunogenic and efficacious in previous clinical trials. This study aimed to assess the safety and immunogenicity of SpikoGen\u00ae vaccine as a homologous and heterologous booster vaccination. This double\u2010blind and randomized placebo\u2010controlled (5:1) trial was performed on 300 already vaccinated participants. SpikoGen\u00ae or saline placebo was administered as a booster dose to participants who had received a full two\u2010dose COVID\u201019 vaccination course. Immunogenicity assessments were done 14\u2009days after the booster dose with the primary immunogenicity outcome seroconversion rate of neutralizing antibodies. Safety outcomes included the incidence of solicited adverse events up to 7\u2009days after the booster dose. SpikoGen\u00ae vaccine induced a robust humoral response both as a homologous and heterologous booster, when compared to the placebo. At Day 14, seroconversion of neutralizing antibodies was 76% (95% confidence interval [CI]: 69%\u201382%) in the SpikoGen\u00ae group versus 3% (95% CI: 0%\u201313%) in the placebo group. The most common local and systemic reported adverse events were injection site pain and fatigue. No serious adverse events were reported. The SpikoGen\u00ae\u2010booster induced cross\u2010neutralization of other SARS\u2010CoV\u20102 variants. Irrespective of the primary vaccine course received, SpikoGen\u00ae vaccine showed promising effects as both a homologous and heterologous booster dose. This vaccine also had a good safety profile with no vaccine\u2010associated serious adverse events. On the basis of these results, SpikoGen\u00ae vaccine has been approved as a booster dose.<\/jats:p>","DOI":"10.1111\/imm.13540","type":"journal-article","created":{"date-parts":[[2022,6,27]],"date-time":"2022-06-27T13:30:00Z","timestamp":1656336600000},"page":"340-353","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":39,"title":["Immunogenicity and safety of SpikoGen\u00ae, an adjuvanted recombinant SARS\u2010CoV\u20102 spike protein vaccine as a homologous and heterologous booster vaccination: A randomized placebo\u2010controlled trial"],"prefix":"10.1111","volume":"167","author":[{"given":"Payam","family":"Tabarsi","sequence":"first","affiliation":[{"name":"Clinical Tuberculosis and Epidemiology Research Centre National Research Institute for Tuberculosis and Lung Disease, Shahid Beheshti University of Medical Sciences  Tehran Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nassim","family":"Anjidani","sequence":"additional","affiliation":[{"name":"Department of Medical Orchid Pharmed Company  Tehran Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ramin","family":"Shahpari","sequence":"additional","affiliation":[{"name":"Department of Medical Orchid Pharmed Company  Tehran Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Khashayar","family":"Roshanzamir","sequence":"additional","affiliation":[{"name":"CinnaGen Medical Biotechnology Research Center Alborz University of Medical Sciences"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Newsha","family":"Fallah","sequence":"additional","affiliation":[{"name":"Department of Medical Orchid Pharmed Company  Tehran Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Greiciely","family":"Andre","sequence":"additional","affiliation":[{"name":"Vaxine Pty Ltd  Adelaide South Australia Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nikolai","family":"Petrovsky","sequence":"additional","affiliation":[{"name":"Vaxine Pty Ltd  Adelaide South Australia Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5620-338X","authenticated-orcid":false,"given":"Saghar","family":"Barati","sequence":"additional","affiliation":[{"name":"Department of Medical Orchid Pharmed Company  Tehran Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,7,13]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2021.101010"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc2113468"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-2600(21)00357-X"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41422-021-00590-x"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc2119641"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2021.07.087"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2022.04.004"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1080\/21645515.2018.1502517"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1021\/acsnano.1c03972"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1080\/22221751.2021.1953403"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-021-01377-8"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.abn8057"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.str.2020.10.001"},{"key":"e_1_2_10_15_1","first-page":"2021.09.03.2126","article-title":"Heterologous prime\u2010boost immunization with CoronaVac and Convidecia","author":"Li J","year":"2021","journal-title":"medRxiv"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)01699-8"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-021-01540-1"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2021.12.006"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cell.2021.02.037"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.2174\/138945007782151360"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.01403-18"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.00480-13"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.3390\/vaccines9111235"}],"container-title":["Immunology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/imm.13540","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/imm.13540","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/imm.13540","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,21]],"date-time":"2023-08-21T10:41:12Z","timestamp":1692614472000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/imm.13540"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,7,13]]},"references-count":22,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2022,11]]}},"alternative-id":["10.1111\/imm.13540"],"URL":"https:\/\/doi.org\/10.1111\/imm.13540","archive":["Portico"],"relation":{},"ISSN":["0019-2805","1365-2567"],"issn-type":[{"value":"0019-2805","type":"print"},{"value":"1365-2567","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,7,13]]},"assertion":[{"value":"2022-04-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-06-22","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-07-13","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}