Safety and Immunogenicity Study of EgyVax Vaccine Candidate for Prophylaxis of COVID-19 Infection

Summary

This is a phase I, prospective, three-arm, open-label, randomized, first in human (FIH) clinical trial to assess the safety and immunogenicity of EgyVax vaccine candidate for prophylaxis of SARS-CoV-2 infection (COVID-19).

Timeline

Start

2022-02-06

Primary completion

2022-10

Completion

2023-06

Publications

• Background World Health Organization. WHO Director-General's opening remarks at the media briefing on COVID-19. Available from: https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020 World Health Organization. Coronavirus disease 2019 (COVID-19) situation report - 70. In: Data as reported by national authorities by 10:00 CET 30 March 2020. Geneva, Switzerland: World Health Organization; 2020. Rauch S, Jasny E, Schmidt KE, et al. New vaccine technologies to combat outbreak situations. Front Immunol 2018;9:1963. Saad MA, Saleh AA, Islam Ryan MA, Saleh MS, Abdulaal T, Hassan WA, et al. Preliminary Step towards COVID-19 Inactivated Vaccine Development in Egypt. Archives of Clinical Trials. 2021 Jul 28;1(1). Ali AA, Saad MA, Ryan I, Amin M, Shindy MI, Hassan WA, et al. Safety and Immunogenicity Evaluation of Inactivated whole-virus-SARS-COV-2 In Mice As Emerging Vaccine Development In Egypt. bioRxiv. 2021 Jan 1. US Food and Drug Administration. Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Rockville, MD: Center for Biologics Evaluation and Research; September 2007. Hobohm L, Becattini C, Ebner M, et al. Definition of tachycardia for risk stratification of pulmonary embolism. European Journal of Internal Medicine. 2020 Dec 1;82:76-82. Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH). European heart journal. 2018 Sep 1;39(33):3021-104.

Drugs

Indications