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.

Autor: Dodaran MS; Clinical Trial Center, Iran University of Medical Science, Tehran 1449614535, Iran.; Division of Epidemiology and Public Health, University of Nottingham, Nottingham NG7 2UH, UK.; Minimally Invasive Surgery Research Center, Hazrat-e-Rasool Hospital, Iran University of Medical Science, Tehran 1445613113, Iran., Banihashemi SR; Department of Immunology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj P.O. Box 31975/148, Iran., Es-Haghi A; Department of Physico Chemistry, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj P.O. Box 31975/148, Iran., Mehrabadi MHF; Department of Epidemiology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj P.O. Box 31975/148, Iran., Nofeli M; Department of Research and Development, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj P.O. Box 31975/148, Iran., Mokarram AR; Department of QA, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj P.O. Box 31975/148, Iran., Mokhberalsafa L; Department of Health, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization, Karaj P.O. Box 31975/148, Iran., Sadeghi F; Department of Health, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization, Karaj P.O. Box 31975/148, Iran., Ranjbar A; Institute of Interventional Allergology and Immunology, Bonn/Cologne, 53115 Bonn, Germany., Ansarifar A; School of Public Health, Iran University of Medical Science, Tehran 1449614535, Iran., Mohazzab A; School of Public Health, Iran University of Medical Science, Tehran 1449614535, Iran.; Reproductive Biotechnology Research Center, Avicenna Research Institute Tehran, ACECR, Tehran 1983969412, Iran., Setarehdan SA; Minimally Invasive Surgery Research Center, Hazrat-e-Rasool Hospital, Iran University of Medical Science, Tehran 1445613113, Iran.; School of Public Health, Iran University of Medical Science, Tehran 1449614535, Iran., Bagheri Amiri F; Department of Epidemiology and Biostatistics, Research Centre for Emerging and Reemerging Infectious Diseases, Pasteur Institute of Iran, Tehran 1316943551, Iran., Mohseni V; School of Public Health, Iran University of Medical Science, Tehran 1449614535, Iran., Hajimoradi M; Department of Immunology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj P.O. Box 31975/148, Iran., Ghahremanzadeh N; School of Public Health, Iran University of Medical Science, Tehran 1449614535, Iran., Razzaz SH; Department of Immunology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj P.O. Box 31975/148, Iran., Masoomi S; Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran P.O. Box 14115/111, Iran., Taghdiri M; Department of Immunology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj P.O. Box 31975/148, Iran., Bagheri M; Department of Physico Chemistry, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj P.O. Box 31975/148, Iran., Lofti M; Department of QA, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj P.O. Box 31975/148, Iran., Khorasani A; Department of Research and Development, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj P.O. Box 31975/148, Iran., Ghader M; Department of Physico Chemistry, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj P.O. Box 31975/148, Iran., Safari S; School of Public Health, Iran University of Medical Science, Tehran 1449614535, Iran., Shahsavn M; School of Public Health, Iran University of Medical Science, Tehran 1449614535, Iran., Kalantari S; Departments of Infectious Diseases and Tropical Medicine, Iran University of Medical Sciences, Tehran 1449614535, Iran.
Jazyk: angličtina
Zdroj: Vaccines [Vaccines (Basel)] 2023 Feb 16; Vol. 11 (2). Date of Electronic Publication: 2023 Feb 16.
DOI: 10.3390/vaccines11020455
Abstrakt: Objectives : This study aimed to determine the safety and immunogenicity of a combined intramuscular/intranasal recombinant spike protein COVID-19 vaccine (RCP). Methods : We conducted a randomized, double-blind, placebo-controlled, phase I trial. Three vaccine strengths were compared with an adjuvant-only preparation. It included two intramuscular and a third intranasal dose. Eligible participants were followed for adverse reactions. Specific IgG, secretory IgA, neutralizing antibodies, and cell-mediated immunity were assessed. Results : A total of 153 participants were enrolled (13 sentinels, 120 randomized, 20 non-randomized open-labeled for IgA assessment). No related serious adverse event was observed. The geometric mean ratios (GMRs) and 95% CI for serum neutralizing antibodies compared with placebo two weeks after the second injection were 5.82 (1.46-23.13), 11.12 (2.74-45.09), and 20.70 (5.05-84.76) in 5, 10, and 20 µg vaccine groups, respectively. The GMR for anti-RBD IgA in mucosal fluid two weeks after the intranasal dose was 23.27 (21.27-25.45) in the 10 µg vaccine group. The humoral responses were sustained for up to five months. All vaccine strengths indicated a strong T-helper 1 response. Conclusion : RCP is safe and creates strong and durable humoral and cellular immunity and good mucosal immune response in its 10 µg /200 µL vaccine strengths. Trial registration : IRCT20201214049709N1.
Databáze: MEDLINE