Evaluation of Inactivated Vaccine in Healthy Adults Against Coronavirus Disease of 2019 (COVID-19)
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
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 covid19
Started Nov 2021
Longer than P75 for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2021
CompletedStudy Start
First participant enrolled
November 14, 2021
CompletedFirst Posted
Study publicly available on registry
November 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2023
CompletedNovember 22, 2021
November 1, 2021
1.3 years
November 12, 2021
November 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The safety of NRC-VACC-101 Vaccine
To evaluate the safety of the proposed regimens of NRC-VACC-101
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
Follow up for any AE within 28 days of each dose
Secondary Outcomes (2)
The seroconversion rate of neutralizing antibodies
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 will be assessed up to one month of each dose
Study Arms (3)
NRC-VACC-101 vaccine 3 microgram
ACTIVE COMPARATORVolunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart.
NRC-VACC-101 vaccine 6 microgram
ACTIVE COMPARATORVolunteers will receive two IM doses of the vaccine, concentrations of 6 mcg, 28 days apart.
Control arm
PLACEBO COMPARATORVolunteers will receive two IM doses of the placebo (excipients only), 28 days apart.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Research Centre of Excellence National Research Centre
Cairo, Giza Governorate, 12622, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Osama Azmy, MD
Medical Research and Clinical Studies Institute National Research Centre, Dokki, Giza, Egypt.
Central Study Contacts
Clinical Trial Unit Clinical Trial Unit National Research Centre, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2021
First Posted
November 22, 2021
Study Start
November 14, 2021
Primary Completion
February 23, 2023
Study Completion
May 23, 2023
Last Updated
November 22, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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.
Data will be shared upon individual request.