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

NCT05218070 | Unknown Phase 1 DMC

• 1 other identifier: SPHINX22122020
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Safety of EgyVax Vaccine after 1 month from the first vaccination dose

  To evaluate the recorded adverse events (AEs) following vaccine administration

  Up to 1 month of the first vaccination dose

• Safety of EgyVax Vaccine up to 6 months of the first vaccination dose

  To evaluate and follow up the Serious AEs (SAEs) following vaccine administration

  Up to 6 months of the first vaccination dose

Secondary Outcomes (3)

• Evaluation of Neutralizing antibodies (NAB) response following vaccine administration

  Up to 6 month of the first vaccination dose

• Dose Selection

  After 3 months of the first vaccination dose

• Safety of EgyVax Vaccine

  Up to 1 year of the first vaccination dose

Study Arms (3)

Low Dose Vaccine

EXPERIMENTAL

35 mcg dose for both vaccinations at day 0 and day 14 (low dose, 15 subjects)

Drug: EgyVax Vaccine Candidate

High Dose Vaccine

EXPERIMENTAL

70 mcg dose for both vaccinations at day 0 and day 14 (high dose, 15 subjects)

Drug: EgyVax Vaccine Candidate

Placebo

PLACEBO COMPARATOR

Placebo for both injections at day 0 and day 14 (Placebo, 15 subjects)

Drug: Placebo

Interventions

EgyVax Vaccine Candidate DRUG

EgyVax Inactivated SARS-CoV-2 vaccine candidate, equivalent to 70 mcg inactivated SARS-CoV-2 total protein. Alum adjuvant 2% 50 µl (equivalent to 0.5 mg AlOH). Equivalent volume of Saline 0.9% to each vaccine dose. Each vial contains 0.5 ml representing one dose 70 mcg of inactivated SARS-CoV-2 virus with alum adjuvant or two doses of 35 mcg of inactivated SARS-CoV-2 virus with alum adjuvant

High Dose Vaccine; Low Dose Vaccine

Placebo DRUG

0.5ml Saline (0.9%)

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provides proven legal identity.
• Provides written informed consent prior to initiation of any study procedures.
• Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
• Agrees to the collection of venous blood per protocol.
• Male or non-pregnant female subjects, 18-55 years of age at the time of enrollment.
• Male or female of childbearing potential must agree to use or have practiced true abstinence or use at least two acceptable primary form of contraception from first vaccination until 60 days after the last vaccination.
• Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each vaccination.
• Oral temperature is less than 37.5 °C.
• Pulse less than 100 beats per minute.
• Blood pressure (BP) less than 140/90 mm Hg, inclusive. (Appendix I)
• Clinical screening laboratory evaluations (white blood cell (WBC), hemoglobin (Hgb), platelets (PLTs), alanine transaminase (ALT), aspartate transaminase (AST), creatinine (Cr), alkaline phosphatase (ALP), total bilirubin (T. Bili), prothrombin time (PT), partial thromboplastin time (PTT) and HbA1c) are within acceptable normal reference ranges at the clinical laboratory being used.
• Must agree to refrain from donating blood or plasma during the study (outside of this study).

You may not qualify if:

• Positive pregnancy test either at screening or just prior to each vaccine administration.
• Female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
• Individuals at high risk for severe COVID-19, including those with any of the following risk factors:
• Type 1 diabetes (T1D), or type 2 diabetes (T2D) that cannot be controlled by drugs
• Hypertension that cannot be controlled by drugs
• Current smoking
• History of chronic smoking within the prior year
• BMI is ≤ 18 kg/m2 or ≥ 40 kg/m2
• Resident in a long-term facility
• Have any other medical disease/condition or psychiatric condition that, in the opinion of the participating site principal investigator (PI) or appropriate sub-investigator, precludes study participation. (Appendix II)
• History of recent COVID-19 diagnosis; within 6 months prior to enrollment . This should be confirmed with chest computed tomography (CT) scan and or polymerase chain reaction (PCR).
• Has an acute illness, as determined by the participating site PI or appropriate sub-investigator, with or without fever (oral temperature of 37.8 °C or above) within 72 hours prior to each vaccination. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
• Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
• Has participated in another investigational study involving any investigational product (study drug, biologic or device) within 60 days, or 5 half-lives, whichever is longer, before the first vaccine administration.
• Currently enrolled in or plans to participate in another clinical study with an investigational agent that will be received during the study-reporting period.

Sponsors & Collaborators

• Eva Pharma: lead
• Veterinary Serum & Vaccine Research Institute (VSVRI), Egypt: collaborator
• The Supreme Council of University Hospitals, Egypt: collaborator
• Ministry of Higher Education and Scientific Research, Egypt: collaborator

Study Sites (1)

Cairo University Hospitals (Al-Manial Specialized University Hospital)

Cairo, Egypt

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sameera Ezzat, MD

CONTACT

+201001551576; samira.ezzat@evapharma.com

Ahmed Ramadan, MSc

CONTACT

+201150061413; ahmed.ramadan@marc-eg.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 1, 2022
• Study Start: February 6, 2022
• Primary Completion: October 1, 2022
• Study Completion: June 1, 2023
• Last Updated: February 23, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)