In this phase 1 study, the inactivated virus vaccine National Research Centre (NRC) Vaccine-101 (VACC-101) will be investigated for its safety and immunogenicity in healthy volunteers with the aim of providing effective and safe protection against COVID-19.
This is a Phase I, Randomized, Open-Labeled Clinical trial. Eligible volunteers will be randomized in a 1:1:1 allocation ratio, into one of the three study arms using the Interactive Web Response Technology (IWRS). Unscheduled visits can occur at any time during the study period outside the initially planned study visits, all the extra visits will be documented in the subjects' files. Volunteers will be randomized into one of the following arms to receive different doses of the Inactivated SARS-COV-2 Vaccine "NRC-VACC-101" as an intramuscular (IM) Injection or Placebo: Arm One: Volunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart. Arm Two: Volunteers will receive two IM doses of the vaccine, concentrations of 6 mcg, 28 days apart. Arm Three (Control arm): Volunteers will receive two IM doses of the placebo, 28 days apart. The first 9 subjects will be initially vaccinated with their first dose, as per their assigned study arm determined by the randomization procedures and will be followed up until day 14 (visit 03). At this point in the study, the Data Safety and Monitoring Board (DSMB) will review safety data before proceeding with vaccinating the rest of the recruited subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
72
Inactivated SARS-COV-2 Vaccine/alum adjuvant preparation in addition to excipients (NRC-VACC- 101) administered as an IM Injection. NRC-VACC-101 is provided as a single dose of inactivated vaccine of opaque white liquid free from visible particles filled in injection vial (2R) glass vials. Each Dose of Covi Vax Vaccine contains 6 mcg antigen of A human coronavirus (hCoV)-19/Egypt/NRC-03/2020 SARS-CoV-2 strain.
Medical Research Centre of Excellence National Research Centre
Cairo, Giza Governorate, Egypt
RECRUITINGThe safety of NRC-VACC-101 Vaccine
To evaluate the safety of the proposed regimens of NRC-VACC-101
Time frame: Follow up for any solicited adverse event(AE) reported within 7 days
The tolerability of NRC-VACC-101 Vaccine
To evaluate the tolerability of the proposed regimens of NRC-VACC-101 Vaccine in the healthy population
Time frame: Follow up for any AE within 28 days of each dose
The seroconversion rate of neutralizing antibodies
To evaluate the seroconversion rate of neutralizing antibodies resulting from the NRC-VACC-101 Vaccine
Time frame: The evaluation of the antibody will be measured up to one month of each dose
To recommend the dose level of NRC-VACC-101 Vaccine for the phase II trial.
The evaluation of the Microneutralization Assay curve will give an overview of the dose possible suggested dose of NRC-VACC-101 Vaccine for the phase II trial
Time frame: The evaluation of the Microneutralization Assay will be assessed up to one month of each dose
Clinical Trial Unit Clinical Trial Unit National Research Centre, MD
CONTACT
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