{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T18:07:52Z","timestamp":1785434872846,"version":"3.56.0"},"reference-count":29,"publisher":"Elsevier BV","issue":"12","license":[{"start":{"date-parts":[[2023,12,1]],"date-time":"2023-12-01T00:00:00Z","timestamp":1701388800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2023,12,1]],"date-time":"2023-12-01T00:00:00Z","timestamp":1701388800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"content-domain":{"domain":["jpharmsci.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmaceutical Sciences"],"published-print":{"date-parts":[[2023,12]]},"DOI":"10.1016\/j.xphs.2023.09.027","type":"journal-article","created":{"date-parts":[[2023,10,11]],"date-time":"2023-10-11T03:44:02Z","timestamp":1696995842000},"page":"3012-3021","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":15,"title":["Phase II, Safety and Immunogenicity of RAZI Cov Pars (RCP) SARS Cov-2 Vaccine in Adults Aged 18\u201370 Years; A Randomized, Double-Blind Clinical Trial"],"prefix":"10.1016","volume":"112","author":[{"given":"Arash","family":"Mohazzab","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammad Hossein","family":"Fallah Mehrabadi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Es-haghi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saeed","family":"Kalantari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ladan","family":"Mokhberalsafa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seyed Amin","family":"Setarehdan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fariba","family":"Sadeghi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Rezaei Mokarram","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monireh","family":"Haji Moradi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seyad Hossein","family":"Razaz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maryam","family":"Taghdiri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akram","family":"Ansarifar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohsen","family":"Lotfi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akbar","family":"Khorasani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mojtaba","family":"nofeli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Safdar","family":"Masoumi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zahra","family":"Boluki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saeed","family":"Erfanpoor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fahimeh","family":"Bagheri Amiri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neda","family":"Esmailzadehha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Filsoof","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vahideh","family":"Mohseni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neda","family":"Ghahremanzadeh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shiva","family":"Safari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masoumeh","family":"Shahsavan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shnoo","family":"Bayazidi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maryam","family":"Raghami Derakhshani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammad Hasan","family":"Rabiee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rezvan","family":"Golmoradi-Zadeh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Behnam","family":"Khodadoost","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masoud","family":"Solaymani-Dodaran","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seyed Reza","family":"Banihashemi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"1","key":"10.1016\/j.xphs.2023.09.027_bib0001","first-page":"67","article-title":"Advances in the design and development of SARS-CoV-2 vaccines","volume":"8","author":"Peng","year":"2021","journal-title":"Mil Med Res"},{"key":"10.1016\/j.xphs.2023.09.027_bib0002","unstructured":"Basta N., Moodie E. 2020. COVID-19 vaccine development and approvals tracker. ed."},{"key":"10.1016\/j.xphs.2023.09.027_bib0003","unstructured":"WHO. 2023. The COVID-19 vaccine tracker and landscape compiles detailed information of each COVID-19 vaccine candidate in development by closely monitoring their progress through the pipeline."},{"key":"10.1016\/j.xphs.2023.09.027_bib0004","doi-asserted-by":"crossref","DOI":"10.3389\/fmicb.2022.927306","article-title":"A comprehensive review of the protein subunit vaccines against COVID-19","volume":"13","author":"Heidary","year":"2022","journal-title":"Front Microbiol"},{"issue":"2","key":"10.1016\/j.xphs.2023.09.027_bib0005","doi-asserted-by":"crossref","first-page":"1701","DOI":"10.3390\/ijms24021701","article-title":"Recombinant protein vaccines against human betacoronaviruses: strategies, approaches and progress","volume":"24","author":"Kovalenko","year":"2023","journal-title":"Int J Mol Sci"},{"issue":"10","key":"10.1016\/j.xphs.2023.09.027_bib0006","doi-asserted-by":"crossref","DOI":"10.3390\/pharmaceutics13101612","article-title":"Can the nasal cavity help tackle COVID-19?","volume":"13","author":"Pilicheva","year":"2021","journal-title":"Pharmaceutics"},{"issue":"10","key":"10.1016\/j.xphs.2023.09.027_bib0007","doi-asserted-by":"crossref","first-page":"3535","DOI":"10.1016\/j.jaip.2021.07.016","article-title":"SARS-CoV-2 vaccines: where are we now?","volume":"9","author":"Flanagan","year":"2021","journal-title":"J Allergy Clin Immunol Pract"},{"issue":"1","key":"10.1016\/j.xphs.2023.09.027_bib0008","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1038\/s41392-020-00352-y","article-title":"A systematic review of SARS-CoV-2 vaccine candidates","volume":"5","author":"Dong","year":"2020","journal-title":"Signal Transduct Target Therapy"},{"key":"10.1016\/j.xphs.2023.09.027_bib0009","doi-asserted-by":"crossref","DOI":"10.3389\/fimmu.2022.836745","article-title":"Safety and efficacy of combined intramuscular\/intranasal RAZI-COV PARS vaccine candidate against SARS-CoV-2: a preclinical study in several animal models","author":"Banihashemi","year":"2022","journal-title":"Front Immunol"},{"issue":"2","key":"10.1016\/j.xphs.2023.09.027_bib0010","doi-asserted-by":"crossref","first-page":"455","DOI":"10.3390\/vaccines11020455","article-title":"Immunogenicity and safety of a combined intramuscular\/intranasal recombinant spike protein COVID-19 vaccine (RCP) in healthy adults aged 18 to 55 years old: a randomized, double-blind, placebo-controlled, phase I trial","volume":"11","author":"Dodaran","year":"2023","journal-title":"Vaccines"},{"key":"10.1016\/j.xphs.2023.09.027_bib0011","series-title":"Guidance for industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials","year":"2007"},{"key":"10.1016\/j.xphs.2023.09.027_bib0012","series-title":"The Use of the WHO-UMC System for Standardised Case Causality Assessment","year":"2013"},{"issue":"11","key":"10.1016\/j.xphs.2023.09.027_bib0013","doi-asserted-by":"crossref","first-page":"e3949","DOI":"10.1093\/cid\/ciaa1703","article-title":"Randomized, double-blinded, placebo-controlled phase 2 trial of an inactivated severe acute respiratory syndrome coronavirus 2 vaccine in healthy adults","volume":"73","author":"Che","year":"2021","journal-title":"Clin Infect Dis"},{"issue":"20","key":"10.1016\/j.xphs.2023.09.027_bib0014","doi-asserted-by":"crossref","first-page":"2791","DOI":"10.1016\/j.vaccine.2021.02.007","article-title":"A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine","volume":"39","author":"Chu","year":"2021","journal-title":"Vaccine"},{"issue":"9","key":"10.1016\/j.xphs.2023.09.027_bib0015","doi-asserted-by":"crossref","first-page":"1257","DOI":"10.1016\/S1473-3099(21)00147-X","article-title":"Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 1-2, dose-ranging study","volume":"21","author":"Goepfert","year":"2021","journal-title":"Lancet Infect Dis"},{"issue":"24","key":"10.1016\/j.xphs.2023.09.027_bib0016","doi-asserted-by":"crossref","first-page":"2320","DOI":"10.1056\/NEJMoa2026920","article-title":"Phase 1\u20132 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine","volume":"383","author":"Keech","year":"2020","journal-title":"N Engl J Med"},{"issue":"9","key":"10.1016\/j.xphs.2023.09.027_bib0017","doi-asserted-by":"crossref","first-page":"e1016","DOI":"10.1002\/ctm2.1016","article-title":"A randomized, double-blind, placebo-controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS-CoV-2 vaccine SCoK in adults","volume":"12","author":"Luo","year":"2022","journal-title":"Clin Transl Med"},{"issue":"5","key":"10.1016\/j.xphs.2023.09.027_bib0018","doi-asserted-by":"crossref","first-page":"636","DOI":"10.1016\/S1473-3099(21)00764-7","article-title":"Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study","volume":"22","author":"Sridhar","year":"2022","journal-title":"Lancet Infect Dis"},{"key":"10.1016\/j.xphs.2023.09.027_bib0019","doi-asserted-by":"crossref","DOI":"10.1016\/j.ebiom.2022.104217","article-title":"Evaluation of safety and immunogenicity of receptor-binding domain-based COVID-19 vaccine (Corbevax) to select the optimum formulation in open-label, multicentre, and randomised phase-1\/2 and phase-2 clinical trials","volume":"83","author":"Thuluva","year":"2022","journal-title":"EBioMedicine"},{"issue":"1","key":"10.1016\/j.xphs.2023.09.027_bib0020","doi-asserted-by":"crossref","first-page":"1589","DOI":"10.1080\/22221751.2021.1951126","article-title":"Safety and immunogenicity of a recombinant interferon-armed RBD dimer vaccine (V-01) for COVID-19 in healthy adults: a randomized, double-blind, placebo-controlled, Phase I trial","volume":"10","author":"Zhang","year":"2021","journal-title":"Emerg Microbes Infect"},{"issue":"7889","key":"10.1016\/j.xphs.2023.09.027_bib0021","doi-asserted-by":"crossref","first-page":"517","DOI":"10.1038\/s41586-021-04060-7","article-title":"Anti-SARS-CoV-2 receptor-binding domain antibody evolution after mRNA vaccination","volume":"600","author":"Cho","year":"2021","journal-title":"Nature"},{"issue":"4","key":"10.1016\/j.xphs.2023.09.027_bib0022","doi-asserted-by":"crossref","first-page":"861","DOI":"10.1016\/j.cell.2021.01.007","article-title":"Adaptive immunity to SARS-CoV-2 and COVID-19","volume":"184","author":"Sette","year":"2021","journal-title":"Cell"},{"issue":"10249","key":"10.1016\/j.xphs.2023.09.027_bib0023","doi-asserted-by":"crossref","first-page":"467","DOI":"10.1016\/S0140-6736(20)31604-4","article-title":"Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1\/2, single-blind, randomised controlled trial","volume":"396","author":"Folegatti","year":"2020","journal-title":"Lancet North Am Ed"},{"issue":"655","key":"10.1016\/j.xphs.2023.09.027_bib0024","doi-asserted-by":"crossref","first-page":"eabn3715","DOI":"10.1126\/scitranslmed.abn3715","article-title":"SARS-CoV-2 S2-targeted vaccination elicits broadly neutralizing antibodies","volume":"14","author":"Ng","year":"2022","journal-title":"Sci Transl Med"},{"key":"10.1016\/j.xphs.2023.09.027_bib0025","doi-asserted-by":"crossref","DOI":"10.3389\/fimmu.2021.637651","article-title":"The case for S2: the potential benefits of the S2 subunit of the SARS-CoV-2 spike protein as an immunogen in fighting the COVID-19 pandemic","volume":"12","author":"Shah","year":"2021","journal-title":"Front Immunol"},{"key":"10.1016\/j.xphs.2023.09.027_bib0026","unstructured":"Zhou P., Song G., He W.T., et al. 2022. Broadly neutralizing anti-S2 antibodies protect against all three human betacoronaviruses that cause severe disease. bioRxiv."},{"issue":"7","key":"10.1016\/j.xphs.2023.09.027_bib0027","article-title":"Impact of SARS-CoV-2 variants on the total CD4+ and CD8+ T cell reactivity in infected or vaccinated individuals","volume":"2","author":"Tarke","year":"2021","journal-title":"Cell Rep Med"},{"issue":"40","key":"10.1016\/j.xphs.2023.09.027_bib0028","doi-asserted-by":"crossref","first-page":"5940","DOI":"10.1016\/j.vaccine.2021.07.087","article-title":"Immunisation of ferrets and mice with recombinant SARS-CoV-2 spike protein formulated with Advax-SM adjuvant protects against COVID-19 infection","volume":"39","author":"Li","year":"2021","journal-title":"Vaccine"},{"issue":"1","key":"10.1016\/j.xphs.2023.09.027_bib0029","doi-asserted-by":"crossref","first-page":"5804","DOI":"10.1038\/s41598-021-83930-6","article-title":"Preclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates","volume":"11","author":"Sir Karakus","year":"2021","journal-title":"Sci Rep"}],"container-title":["Journal of Pharmaceutical Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354923004082?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354923004082?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,9,20]],"date-time":"2025-09-20T09:42:43Z","timestamp":1758361363000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0022354923004082"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12]]},"references-count":29,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2023,12]]}},"alternative-id":["S0022354923004082"],"URL":"https:\/\/doi.org\/10.1016\/j.xphs.2023.09.027","relation":{},"ISSN":["0022-3549"],"issn-type":[{"value":"0022-3549","type":"print"}],"subject":[],"published":{"date-parts":[[2023,12]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Phase II, Safety and Immunogenicity of RAZI Cov Pars (RCP) SARS Cov-2 Vaccine in Adults Aged 18\u201370 Years; A Randomized, Double-Blind Clinical Trial","name":"articletitle","label":"Article Title"},{"value":"Journal of Pharmaceutical Sciences","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.xphs.2023.09.027","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}]}}