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1.
J Pharm Sci ; 112(12): 3012-3021, 2023 12.
Article in English | MEDLINE | ID: mdl-37832918

ABSTRACT

BACKGROUND: This study explores the safety and immunogenicity of the Razi-Cov-Pars (RCP) SARS Cov-2 recombinant spike protein vaccine. METHOD: In a randomized, double-blind, placebo-controlled trial, adults aged 18-70 were randomly allocated to receive selected 10 µg/200 µl vaccine strengths or placebo (adjuvant). It included two intramuscular injections at days 0 and 21, followed by an intranasal dose at day 51. Immediate and delayed solicited local and systemic adverse reactions after each dose up to a week, and specific IgG antibodies against SARS Cov-2 spike antigens two weeks after the 2nd dose were assessed as primary outcomes. Secondary safety outcomes were abnormal laboratory findings and medically attended adverse events (MAAE) over six months follow up. Secondary immunogenicity outcomes were neutralizing antibody activity and cell-mediated immune response. RESULT: Between May 27th and July 15th, 2021, 500 participants were enrolled. Participants' mean (SD) age was 37.8 (9.0), and 67.0 % were male. No immediate adverse reaction was observed following the intervention. All solicited local and systemic adverse events were moderate (Grade I-II). Specific IgG antibody response against S antigen in the vaccine group was 5.28 times (95 %CI: 4.02-6.94) the placebo group with a 75 % seroconversion rate. During six months of follow-up, 8 SAEs were reported, unrelated to the study intervention. The participants sustained their acquired humoral responses at the end of the sixth month. The vaccine predominantly resulted in T-helper 1 cell-mediated immunity, CD8+ cytotoxic T-cell increase, and no increase in inflammatory IL-6 cytokine. CONCLUSION: RCP vaccine is safe and creates strong and durable humoral and cellular immunity. TRIAL REGISTRATION: (IRCT20201214049709N2).


Subject(s)
COVID-19 , Severe Acute Respiratory Syndrome , Vaccines , Adult , Humans , Male , Female , COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Antibodies, Neutralizing , Immunoglobulin G , Double-Blind Method , Immunogenicity, Vaccine , Antibodies, Viral
2.
Clin Exp Pediatr ; 64(11): 575-581, 2021 Nov.
Article in English | MEDLINE | ID: mdl-33561339

ABSTRACT

BACKGROUND: Toxocariasis is a zoonotic parasitic disease caused by Toxocara canis and Toxocara cati in humans. Various types of T. canis are important. PURPOSE: The current study aimed to investigate the prevalence of Toxocara spp. in pediatrics in the context of a systematic review and meta-analysis. METHODS: The MEDLINE (PubMed), Web of Sciences, Embase, Google Scholar, Scopus, and Cumulative Index of Nursing and Allied Health databases were searched to identify peer-reviewed studies published between January 2000 and December 2019 that report the prevalence of Toxocara spp. in pediatrics. The evaluation of articles based on the inclusion and exclusion criteria was performed by 2 researchers individually. RESULTS: The results of 31 relevant studies indicated that the prevalence of Toxocara spp. was 3%-79% in 10,676 cases. The pooled estimate of global prevalence of Toxocara spp. in pediatrics was 30 (95% confidence interval, 22%-37%; I2=99.11%; P=0.00). The prevalence was higher in Asian populations than in European, American, and African populations. CONCLUSION: Health policymakers should be more attentive to future research and approaches to Toxocara spp. and other zoonotic diseases to improve culture and identify socioeconomically important factors.

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