{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,3]],"date-time":"2026-04-03T03:12:11Z","timestamp":1775185931973,"version":"3.50.1"},"reference-count":30,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2024,11,5]],"date-time":"2024-11-05T00:00:00Z","timestamp":1730764800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Razi Vaccine and Serum Research Institute"},{"name":"Iran University of Medical Sciences Clinical Trial Center (IUMS-CTC)"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Protective antibodies in the upper respiratory tract prevent the spread of COVID-19 in the community. Intranasal vaccines could raise the specific secretory IgA and IgG levels. This is a single-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and immunogenicity of Razi Cov Pars (RCP) intranasal recombinant protein subunit COVID-19 vaccine as a booster in adults. We compared specific IgG and IgA levels in the intranasal RCP group (n = 97) versus placebo (n = 96) in serum, saliva, and nasal mucosal secretions on days 0 and 14 and reported their Geometric Mean Ratios (GMR) and 95% confidence intervals (CI). We showed significant increases in IgA and IgG anti-RBD in the nasal mucosa in the RCP group, but their increase was not detectable in the serum and saliva. Anti-spike IgA in the nasal mucosa also increased in the RCP group compared to the placebo. This increase against the COVID-19 variant Omicron was also similar to that of the Wuhan. We detected no serious adverse reactions or anaphylaxis and all adverse events resolved completely during the follow-up period and were similar in both groups. Intranasal RCP is safe, stimulates the respiratory mucosal immunity, and could be a booster on various COVID-19 vaccines and be effective against new virus variants.<\/jats:p>","DOI":"10.3390\/vaccines12111255","type":"journal-article","created":{"date-parts":[[2024,11,5]],"date-time":"2024-11-05T05:30:53Z","timestamp":1730784653000},"page":"1255","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Safety and Immunogenicity of Intranasal Razi Cov Pars as a COVID-19 Booster Vaccine in Adults: Promising Results from a Groundbreaking Clinical Trial"],"prefix":"10.3390","volume":"12","author":[{"given":"Mohammad Hossein","family":"Fallah Mehrabadi","sequence":"first","affiliation":[{"name":"Department of Epidemiology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975\/148, Karaj, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0197-3993","authenticated-orcid":false,"given":"Monireh","family":"Hajimoradi","sequence":"additional","affiliation":[{"name":"Department of Immunology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975\/148, Karaj, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6533-3656","authenticated-orcid":false,"given":"Ali","family":"Es-haghi","sequence":"additional","affiliation":[{"name":"Department of Physico Chemistry, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975\/148, Karaj, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Saeed","family":"Kalantari","sequence":"additional","affiliation":[{"name":"Departments of Infectious Diseases and Tropical Medicine, Iran University of Medical Sciences, P.O. Box 354-14665, Tehran, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mojtaba","family":"Noofeli","sequence":"additional","affiliation":[{"name":"Department of Recombinant Antigens Research, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975\/148, Karaj, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3777-4854","authenticated-orcid":false,"given":"Ali Rezaei","family":"Mokarram","sequence":"additional","affiliation":[{"name":"Department of Adjuvant and formulation Research, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975\/148, Karaj, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seyed Hossein","family":"Razzaz","sequence":"additional","affiliation":[{"name":"Department of Immunology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975\/148, Karaj, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6825-9006","authenticated-orcid":false,"given":"Maryam","family":"Taghdiri","sequence":"additional","affiliation":[{"name":"Department of Immunology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975\/148, Karaj, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9437-4067","authenticated-orcid":false,"given":"Ladan","family":"Mokhberalsafa","sequence":"additional","affiliation":[{"name":"Clinical Trial and Ethics Group, Department of QA, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975\/148, Karaj, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fariba","family":"Sadeghi","sequence":"additional","affiliation":[{"name":"Department of QC, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975\/148, Karaj, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vahideh","family":"Mohseni","sequence":"additional","affiliation":[{"name":"School of Public Health, Iran University of Medical Sciences, P.O. Box 354-14665, Tehran, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Safdar","family":"Masoumi","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Tarbiat Modares University, P.O. Box 14115-111, Tehran, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rezvan","family":"Golmoradi-Zadeh","sequence":"additional","affiliation":[{"name":"Department of Microbiology, School of Medicine, Iran University of Medical Sciences, P.O. Box 354-14665, Tehran, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8355-1478","authenticated-orcid":false,"given":"Mohammad Hasan","family":"Rabiee","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975\/148, Karaj, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masoud","family":"Solaymani-Dodaran","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Iran University of Medical Sciences, P.O. Box 354-14665, Tehran, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seyed Reza","family":"Banihashemi","sequence":"additional","affiliation":[{"name":"Department of Immunology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975\/148, Karaj, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2024,11,5]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"365","DOI":"10.1080\/10408363.2020.1783198","article-title":"The COVID-19 pandemic","volume":"57","author":"Ciotti","year":"2020","journal-title":"Crit. Rev. Clin. Lab. Sci."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Bagchi, B., Chatterjee, S., Ghosh, R., and Dandapat, D. (2020). Impact of COVID-19 on global economy. 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