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Evaluation of Inactivated Vaccine in Healthy Adults Against Coronavirus Disease of 2019 (COVID-19)

Primary Purpose

COVID-19, Vaccine Reaction, Vaccine Adverse Reaction

Status

Recruiting

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Covi Vax

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Inactivated SARS-CoV-2 Vaccine, NRC-VACC-101, Vaccine Safety, Vaccine Tolerability, Vaccine Immunogenicity, Covi Vax, Egyptian Inactivated SARS-CoV-2 Vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adults with age 18 to 50 years.
Willingness.
For married females of childbearing age: Willingness to practice continuous effective contraception for one year from the start of the study.
Agreement to refrain from blood donation during the study.
Body temperature is within the normal range (36.5 - 37.5°C).
General good health as established by medical history, physical and laboratory examinations.

Exclusion Criteria:

Pregnancy or lactation.
Inability to provide informed consent.
Recent receipt of any vaccination within 30 days prior to baseline.
Planning to receive any vaccination during the course of the study.
Prior receipt of Adenovirus vaccine, or any other Coronavirus vaccine.
Recent receipt of any immunoglobulin within 90 days prior to baseline.
Recent receipt of any blood product within 90 days prior to baseline.
Volunteers who are immunosuppressed or receiving immunosuppressive medications, including:
HIV infection, asplenia, recurrent severe infections, and the use of immunosuppressive medications within the past 6 months, except for topical steroids or short-term oral steroids (course lasting < 14 days).
Currently taking any product (investigational or off-label) for prevention of COVID-19 disease.
Having any autoimmune disease.
History of allergic reactions for any of the vaccine components.
History of angioedema.
History of anaphylaxis.
History of cancer.
History of serious psychiatric conditions that are likely to affect participation in the study.
Having bleeding disorders.
Having chronic respiratory diseases.
Having chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorders, and neurological illness.
Volunteers with BMI ≥ 40 Kg/m2 or ≤ 18 Kg/m2.
Current alcohol abuse.
Drug abuse within 5 years prior to baseline.
History of laboratory-confirmed COVID-19 or seropositivity for SARS-CoV-2 or positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) to the SARS CoV-2 or abnormal chest CT-Scan (COVID-19 image) or positive pharyngeal/sputum swabs for SARS-CoV-2.
Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
High-risk population (volunteers who work in front-line health facilities or were in close contact with confirmed COVID-19 cases).
Living in the same household as anyone at high risk of severe COVID-19.
Any condition, according to the judgment of the investigator, that would interfere with the subject's ability to comply with all study requirements or that would place the subject at unacceptable risk by his/her participation in the study or impair the interpretation of the study data.

Sites / Locations

Medical Research Centre of Excellence National Research CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NRC-VACC-101 vaccine 3 microgram

NRC-VACC-101 vaccine 6 microgram

Control arm

Arm Description

Volunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart.

Volunteers will receive two IM doses of the vaccine, concentrations of 6 mcg, 28 days apart.

Volunteers will receive two IM doses of the placebo (excipients only), 28 days apart.

Outcomes

Primary Outcome Measures

The safety of NRC-VACC-101 Vaccine

To evaluate the safety of the proposed regimens of NRC-VACC-101

The tolerability of NRC-VACC-101 Vaccine

To evaluate the tolerability of the proposed regimens of NRC-VACC-101 Vaccine in the healthy population

Secondary Outcome Measures

The seroconversion rate of neutralizing antibodies

To evaluate the seroconversion rate of neutralizing antibodies resulting from the NRC-VACC-101 Vaccine

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

Full Information

NCT ID

NCT05128721

First Posted

November 12, 2021

Last Updated

November 18, 2021

Sponsor

National Research Centre, Egypt

1. Study Identification

Unique Protocol Identification Number

NCT05128721

Brief Title

Evaluation of Inactivated Vaccine in Healthy Adults Against Coronavirus Disease of 2019 (COVID-19)

Official Title

A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Inactivated Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Vaccine Against COVID-19 in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 14, 2021 (Actual)

Primary Completion Date

February 23, 2023 (Anticipated)

Study Completion Date

May 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Research Centre, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Vaccine Reaction, Vaccine Adverse Reaction

Keywords

COVID-19, Inactivated SARS-CoV-2 Vaccine, NRC-VACC-101, Vaccine Safety, Vaccine Tolerability, Vaccine Immunogenicity, Covi Vax, Egyptian Inactivated SARS-CoV-2 Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

A Randomized, Open-label, Phase 1 Clinical trial.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NRC-VACC-101 vaccine 3 microgram

Arm Type

Active Comparator

Arm Description

Volunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart.

Arm Title

NRC-VACC-101 vaccine 6 microgram

Arm Type

Active Comparator

Arm Description

Volunteers will receive two IM doses of the vaccine, concentrations of 6 mcg, 28 days apart.

Arm Title

Control arm

Arm Type

Placebo Comparator

Arm Description

Volunteers will receive two IM doses of the placebo (excipients only), 28 days apart.

Intervention Type

Biological

Intervention Name(s)

Covi Vax

Other Intervention Name(s)

NRC-VACC-101 vaccine, Egyptian Inactivated SARS-CoV-2 Vaccine, NRC Inactivated SARS-CoV-2 Vaccine

Intervention Description

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.

Primary Outcome Measure Information:

Title

The safety of NRC-VACC-101 Vaccine

Description

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

Title

The tolerability of NRC-VACC-101 Vaccine

Description

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

Secondary Outcome Measure Information:

Title

The seroconversion rate of neutralizing antibodies

Description

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

Title

To recommend the dose level of NRC-VACC-101 Vaccine for the phase II trial.

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults with age 18 to 50 years. Willingness. For married females of childbearing age: Willingness to practice continuous effective contraception for one year from the start of the study. Agreement to refrain from blood donation during the study. Body temperature is within the normal range (36.5 - 37.5°C). General good health as established by medical history, physical and laboratory examinations. Exclusion Criteria: Pregnancy or lactation. Inability to provide informed consent. Recent receipt of any vaccination within 30 days prior to baseline. Planning to receive any vaccination during the course of the study. Prior receipt of Adenovirus vaccine, or any other Coronavirus vaccine. Recent receipt of any immunoglobulin within 90 days prior to baseline. Recent receipt of any blood product within 90 days prior to baseline. Volunteers who are immunosuppressed or receiving immunosuppressive medications, including: HIV infection, asplenia, recurrent severe infections, and the use of immunosuppressive medications within the past 6 months, except for topical steroids or short-term oral steroids (course lasting < 14 days). Currently taking any product (investigational or off-label) for prevention of COVID-19 disease. Having any autoimmune disease. History of allergic reactions for any of the vaccine components. History of angioedema. History of anaphylaxis. History of cancer. History of serious psychiatric conditions that are likely to affect participation in the study. Having bleeding disorders. Having chronic respiratory diseases. Having chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorders, and neurological illness. Volunteers with BMI ≥ 40 Kg/m2 or ≤ 18 Kg/m2. Current alcohol abuse. Drug abuse within 5 years prior to baseline. History of laboratory-confirmed COVID-19 or seropositivity for SARS-CoV-2 or positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) to the SARS CoV-2 or abnormal chest CT-Scan (COVID-19 image) or positive pharyngeal/sputum swabs for SARS-CoV-2. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. High-risk population (volunteers who work in front-line health facilities or were in close contact with confirmed COVID-19 cases). Living in the same household as anyone at high risk of severe COVID-19. Any condition, according to the judgment of the investigator, that would interfere with the subject's ability to comply with all study requirements or that would place the subject at unacceptable risk by his/her participation in the study or impair the interpretation of the study data.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Osama Azmy, MD

Phone

+201223103084

osamaazmy@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Clinical Trial Unit Clinical Trial Unit National Research Centre, MD

Phone

+20237623009

ctu.mrce@nrc.sci.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osama Azmy, MD

Organizational Affiliation

Medical Research and Clinical Studies Institute National Research Centre, Dokki, Giza, Egypt.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical Research Centre of Excellence National Research Centre

City

Cairo

State/Province

Giza

ZIP/Postal Code

12622

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Osama Azmy, MD

Phone

+201223103084

osamaazmy@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data will be shared upon individual request.

IPD Sharing Time Frame

About one year after completion of the trial

IPD Sharing Access Criteria

Data will be shared upon individual request by contacting the sponsor of the trial.

Learn more about this trial

Evaluation of Inactivated Vaccine in Healthy Adults Against Coronavirus Disease of 2019 (COVID-19)

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