Safety and Immunogenicity of Intranasal Razi Cov Pars as a COVID-19 Booster Vaccine in Adults: Promising Results from a Groundbreaking Clinical Trial.

Autor: Fallah Mehrabadi MH; Department of Epidemiology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975/148, Karaj, Iran., Hajimoradi M; Department of Immunology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975/148, Karaj, Iran., Es-Haghi A; Department of Physico Chemistry, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975/148, Karaj, Iran., Kalantari S; Departments of Infectious Diseases and Tropical Medicine, Iran University of Medical Sciences, P.O. Box 354-14665, Tehran, Iran., Noofeli M; 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., Mokarram AR; 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., Razzaz SH; Department of Immunology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975/148, Karaj, Iran., Taghdiri M; Department of Immunology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975/148, Karaj, Iran., Mokhberalsafa L; 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., Sadeghi F; Department of QC, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975/148, Karaj, Iran., Mohseni V; School of Public Health, Iran University of Medical Sciences, P.O. Box 354-14665, Tehran, Iran., Masoumi S; Department of Biostatistics, Tarbiat Modares University, P.O. Box 14115-111, Tehran, Iran., Golmoradi-Zadeh R; Department of Microbiology, School of Medicine, Iran University of Medical Sciences, P.O. Box 354-14665, Tehran, Iran., Rabiee MH; Department of Epidemiology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975/148, Karaj, Iran., Solaymani-Dodaran M; Department of Epidemiology, Iran University of Medical Sciences, P.O. Box 354-14665, Tehran, Iran., Banihashemi SR; Department of Immunology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975/148, Karaj, Iran.
Jazyk: angličtina
Zdroj: Vaccines [Vaccines (Basel)] 2024 Nov 05; Vol. 12 (11). Date of Electronic Publication: 2024 Nov 05.
DOI: 10.3390/vaccines12111255
Abstrakt: 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.
Databáze: MEDLINE