Safety and immunogenicity of RAZI Cov Pars (RCP) vaccine in children and adolescents aged 5-17 years: An open-label, single arm trial

Abstract

Objective: To investigate the safety and immunogenicity of the RAZI Cov Pars (RCP) vaccine in children and adolescents aged 5-17 years.

Methods: In this open-label, single arm trial, 26 of the 68 registered volunteers met the inclusion criteria. The participants received RCP vaccine twice intramuscularly (on days 0 and 21) and intranasally on day 51. Safety was assessed up to 6 months after the second dose. Immunogenicity was assessed on days 35, 90, and 180 by measuring neutralizing antibody levels as well as anti-RBD and anti-S₁ IgG antibodies.

Results: Among the 26 volunteers, 22 were in the age group of 5-11 years, and 4 were in the age group of 12-17 years. No grade 3 or higher local or systemic adverse reactions were reported one week after vaccination. Six abnormal laboratory findings were observed after both vaccine doses, none of which were classified as grade 3 or higher. During a total follow-up period of 3 875 person- years, 31 adverse events were recorded (incidence rate: 0.008). The seroconversion rates for VNT, anti-RBD and anti-S₁ IgG antibodies two weeks after receiving the second dose were 72.7%, 76.2% and 80.9%, respectively. In the 5-11 year age group, the seroconversion rates for VNT, anti-RBD and anti-S₁ were 78.9%, 83.3% and 88.9%, respectively.

Conclusions: Intramuscular and intranasal administration of the RCP vaccine did not lead to serious adverse events in any of the children or adolescents. The vaccine elicited a robust response in the 5-11 year age group two weeks after the second dose. Considering that this group received half of the adult vaccine dose, these results support the suitability of this dose for the study group.

Keywords

RAZI Cov Pars vaccine / Trial / Children / Adolescent

Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: As an academic CRO, the Iran University of medical sciences clinical trial center (IUMS-CTC) contributed to the conduct of the trial. MHFM, MN, MHR, AE, ARM, SHR, MH, FSF, LM, MT, MB, EG, MRD and SRB are Razi Vaccine and Serum Research Institute, employees. SRB is the inventor of the RCP vaccine.

The study was supported by the Razi Vaccine and Serum Research Institute (RVSRI). The institute contributed to the study design and conducted the immunogenicity tests, but did not participate in other activities. These activities such as data collection, data management, analysis, interpretation, and writing the report, were carried out by the Iran University of Medical Sciences (IUMS) clinical trial center. It should be noted that the immunology laboratory was blinded to the participants’ identities for all blood samples.

Funding

The study was supported by the Razi Vaccine and Serum Research Institute (RVSRI), Karaj, Iran, (No. 17-18-18-063-01047-011130).

Ethic approval

The study was approved by Iran National Committee for Ethics in Biomedical Research (IR.NREC.1401.001) on 6 February, 2022 and performed in accordance with the Declaration of Helsinki and Good Clinical Practice. The trial protocol is registered in www.irct.ir (IRCT20201214049709N5).

Data availability statement

We are committed to sharing the individual participant data. The de-identified individual participant data (including text, tables, figures, and appendices) that form the basis of the results reported in this article will be made available.

Authors’ contributions

MHR, MSD, SRB, MHFM and MN conceived and deigned the trial, and SK is the chief investigator. MHFM, SK, AE, and SRB led the implementation of the study. MHR, MSD, and SM did the statistical analysis and verified the underlying data. MHR, SRB and MSD wrote the first draft of the manuscript. MN, MHR, ARM, FSF, LM, EB, EG, MRD, RG, RM, NG and VM have made substantial contributions to the conduct and data collection. SRB, MHM, SHR, MB and MT were responsible for laboratory analyses. All authors reviewed and approved the fnal report. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication. All authors read and approved the final manuscript.

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Edited by Yan Lei, Qiao Zhang, Yin Pan

Acknowledgments

The researchers are deeply grateful for the invaluable contributions of all the individuals who participated in the clinical trial. They would also like to extend their sincere appreciation to the members of the National Ethics Committee, the Food and Drug Organization of the Ministry of Health, and the Communicable Disease Control department, as well as the dedicated staff of the Razi Vaccine and Serum Research Institute, for their support and collaboration throughout the study.

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