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

Mohammad Hossein Fallah Mehrabadi; Monireh Hajimoradi; Ali Es-Haghi; Saeed Kalantari; Mojtaba Noofeli; Ali Rezaei Mokarram; Seyed Hossein Razzaz; Maryam Taghdiri; Ladan Mokhberalsafa; Fariba Sadeghi; Vahideh Mohseni; Safdar Masoumi; Rezvan Golmoradi-Zadeh; Mohammad Hasan Rabiee; Masoud Solaymani-Dodaran; Seyed Reza Banihashemi

doi:10.3390/vaccines12111255

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

Vaccines (Basel). 2024 Nov 5;12(11):1255. doi: 10.3390/vaccines12111255.

Authors

Mohammad Hossein Fallah Mehrabadi¹, Monireh Hajimoradi², Ali Es-Haghi³, Saeed Kalantari⁴, Mojtaba Noofeli⁵, Ali Rezaei Mokarram⁶, Seyed Hossein Razzaz², Maryam Taghdiri², Ladan Mokhberalsafa⁷, Fariba Sadeghi⁸, Vahideh Mohseni⁹, Safdar Masoumi¹⁰, Rezvan Golmoradi-Zadeh¹¹, Mohammad Hasan Rabiee¹, Masoud Solaymani-Dodaran¹², Seyed Reza Banihashemi²

Affiliations

¹ Department of Epidemiology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975/148, Karaj, Iran.
² Department of Immunology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975/148, Karaj, Iran.
³ Department of Physico Chemistry, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975/148, Karaj, Iran.
⁴ Departments of Infectious Diseases and Tropical Medicine, Iran University of Medical Sciences, P.O. Box 354-14665, Tehran, Iran.
⁵ 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.
⁶ 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.
⁷ 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.
⁸ Department of QC, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975/148, Karaj, Iran.
⁹ School of Public Health, Iran University of Medical Sciences, P.O. Box 354-14665, Tehran, Iran.
¹⁰ Department of Biostatistics, Tarbiat Modares University, P.O. Box 14115-111, Tehran, Iran.
¹¹ Department of Microbiology, School of Medicine, Iran University of Medical Sciences, P.O. Box 354-14665, Tehran, Iran.
¹² Department of Epidemiology, Iran University of Medical Sciences, P.O. Box 354-14665, Tehran, Iran.

Abstract

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.

Keywords: COVID-19; Razi Cov Pars; booster; clinical trial; intranasal recombinant protein subunit vaccine; mucosal immunity.

Grants and funding

The study is funded by the Razi Vaccine and Serum Research Institute. The fund was attributed to the material provision and trial performance. The study design, data collection, data management, analysis, interpretation, and writing of the report were done mainly by the Iran University of Medical Sciences Clinical Trial Center (IUMS-CTC). Design and immunogenicity tests were performed with the help of the study’s sponsor, but the process of the trial was blinded for them. IUMS-CTC and the Razi institute decided to submit the paper for publication.