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Safety and Immunogenicity of Intranasal Razi Cov Pars as a COVID-19 Booster Vaccine in Adults: Promising Results from a Groundbreaking Clinical Trial.
- Source :
-
Vaccines [Vaccines (Basel)] 2024 Nov 05; Vol. 12 (11). Date of Electronic Publication: 2024 Nov 05. - Publication Year :
- 2024
-
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.
Details
- Language :
- English
- ISSN :
- 2076-393X
- Volume :
- 12
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Vaccines
- Publication Type :
- Academic Journal
- Accession number :
- 39591158
- Full Text :
- https://doi.org/10.3390/vaccines12111255