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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05128721
Recruitment Status : Recruiting
First Posted : November 22, 2021
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
National Research Centre, Egypt

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.

Condition or disease Intervention/treatment Phase
COVID-19 Vaccine Reaction Vaccine Adverse Reaction Biological: Covi Vax Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Randomized, Open-label, Phase 1 Clinical trial.
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : November 14, 2021
Estimated Primary Completion Date : February 23, 2023
Estimated Study Completion Date : May 23, 2023


Arm Intervention/treatment
Active Comparator: NRC-VACC-101 vaccine 3 microgram
Volunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart.
Biological: Covi Vax
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.
Other Names:
  • NRC-VACC-101 vaccine
  • Egyptian Inactivated SARS-CoV-2 Vaccine
  • NRC Inactivated SARS-CoV-2 Vaccine

Active Comparator: NRC-VACC-101 vaccine 6 microgram
Volunteers will receive two IM doses of the vaccine, concentrations of 6 mcg, 28 days apart.
Biological: Covi Vax
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.
Other Names:
  • NRC-VACC-101 vaccine
  • Egyptian Inactivated SARS-CoV-2 Vaccine
  • NRC Inactivated SARS-CoV-2 Vaccine

Placebo Comparator: Control arm
Volunteers will receive two IM doses of the placebo (excipients only), 28 days apart.
Biological: Covi Vax
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.
Other Names:
  • NRC-VACC-101 vaccine
  • Egyptian Inactivated SARS-CoV-2 Vaccine
  • NRC Inactivated SARS-CoV-2 Vaccine




Primary Outcome Measures :
  1. The safety of NRC-VACC-101 Vaccine [ Time Frame: Follow up for any solicited adverse event(AE) reported within 7 days ]
    To evaluate the safety of the proposed regimens of NRC-VACC-101

  2. The tolerability of NRC-VACC-101 Vaccine [ Time Frame: Follow up for any AE within 28 days of each dose ]
    To evaluate the tolerability of the proposed regimens of NRC-VACC-101 Vaccine in the healthy population


Secondary Outcome Measures :
  1. The seroconversion rate of neutralizing antibodies [ Time Frame: The evaluation of the antibody will be measured up to one month of each dose ]
    To evaluate the seroconversion rate of neutralizing antibodies resulting from the NRC-VACC-101 Vaccine

  2. To recommend the dose level 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 ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnancy or lactation.
  2. Inability to provide informed consent.
  3. Recent receipt of any vaccination within 30 days prior to baseline.
  4. Planning to receive any vaccination during the course of the study.
  5. Prior receipt of Adenovirus vaccine, or any other Coronavirus vaccine.
  6. Recent receipt of any immunoglobulin within 90 days prior to baseline.
  7. Recent receipt of any blood product within 90 days prior to baseline.
  8. 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).

  9. Currently taking any product (investigational or off-label) for prevention of COVID-19 disease.
  10. Having any autoimmune disease.
  11. History of allergic reactions for any of the vaccine components.
  12. History of angioedema.
  13. History of anaphylaxis.
  14. History of cancer.
  15. History of serious psychiatric conditions that are likely to affect participation in the study.
  16. Having bleeding disorders.
  17. Having chronic respiratory diseases.
  18. Having chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorders, and neurological illness.
  19. Volunteers with BMI ≥ 40 Kg/m2 or ≤ 18 Kg/m2.
  20. Current alcohol abuse.
  21. Drug abuse within 5 years prior to baseline.
  22. 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.
  23. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
  24. High-risk population (volunteers who work in front-line health facilities or were in close contact with confirmed COVID-19 cases).
  25. Living in the same household as anyone at high risk of severe COVID-19.
  26. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05128721


Contacts
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Contact: Osama Azmy, MD +201223103084 osamaazmy@yahoo.com
Contact: Clinical Trial Unit Clinical Trial Unit National Research Centre, MD +20237623009 ctu.mrce@nrc.sci.eg

Locations
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Egypt
Medical Research Centre of Excellence National Research Centre Recruiting
Cairo, Giza, Egypt, 12622
Contact: Osama Azmy, MD    +201223103084    osamaazmy@yahoo.com   
Sponsors and Collaborators
National Research Centre, Egypt
Investigators
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Principal Investigator: Osama Azmy, MD Medical Research and Clinical Studies Institute National Research Centre, Dokki, Giza, Egypt.
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Responsible Party: National Research Centre, Egypt
ClinicalTrials.gov Identifier: NCT05128721    
Other Study ID Numbers: NO-B041
First Posted: November 22, 2021    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared upon individual request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: About one year after completion of the trial
Access Criteria: Data will be shared upon individual request by contacting the sponsor of the trial.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Research Centre, Egypt:
COVID-19
Inactivated SARS-CoV-2 Vaccine
NRC-VACC-101
Vaccine Safety
Vaccine Tolerability
Vaccine Immunogenicity
Covi Vax
Egyptian Inactivated SARS-CoV-2 Vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs