COVID-19Phase 1NCT05128721
Evaluation of Inactivated Vaccine in Healthy Adults Against Coronavirus Disease of 2019 (COVID-19)
A Phase 1 study testing Covi Vax in people with COVID-19 and Vaccine Reaction, run by National Research Centre, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Vaccine Reaction, Vaccine Adverse Reaction
- What is being tested?
- Covi Vax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Nov 2021to 23 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Clinical Trial Unit Clinical Trial Unit National Research Centre, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Medical Research Centre of Excellence National Research Centre
Cairo, Giza Governorate, 12622
Osama Azmy, MD, +201223103084, osamaazmy@yahoo.com
About this study
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
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.
Read the 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
- Conditions
- COVID-19, Vaccine Reaction, Vaccine Adverse Reaction
- Being tested
- Covi Vax
- 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
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covi VaxBiological
Also called NRC-VACC-101 vaccine, Egyptian Inactivated SARS-CoV-2 Vaccine, NRC Inactivated SARS-CoV-2 Vaccine
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.
| Study group | Role | What they receive |
|---|---|---|
| NRC-VACC-101 vaccine 3 microgram | Active comparator | Volunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart. Receives: Biological: Covi Vax |
| NRC-VACC-101 vaccine 6 microgram | Active comparator | Volunteers will receive two IM doses of the vaccine, concentrations of 6 mcg, 28 days apart. Receives: Biological: Covi Vax |
| Control arm | Placebo comparator | Volunteers will receive two IM doses of the placebo (excipients only), 28 days apart. Receives: Biological: Covi Vax |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of NRC-VACC-101 Vaccine
To evaluate the safety of the proposed regimens of NRC-VACC-101
Measured: 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
Measured: Follow up for any AE within 28 days of each dose
Secondary outcomes (2)
The seroconversion rate of neutralizing antibodies
To evaluate the seroconversion rate of neutralizing antibodies resulting from the NRC-VACC-101 Vaccine
Measured: 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
Measured: The evaluation of the Microneutralization Assay will be assessed up to one month of each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start14 Nov 2021
- Primary completion23 Feb 2023 (estimated)
- Study completion23 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Open-label, Phase 1 Clinical trial.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osama Azmy, MD, Principal investigator, Medical Research and Clinical Studies Institute National Research Centre, Dokki, Giza, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128721
- Sponsor's protocol ID
- NO-B041
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon individual request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05128721
- Acronym / sponsor ID
- NO-B041
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 14 Nov 2021 (actual)
- Primary completion
- 23 Feb 2023 (estimated)
- Study completion
- 23 May 2023 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A Randomized, Open-label, Phase 1 Clinical trial.
| Arm | Type | Receives |
|---|---|---|
| NRC-VACC-101 vaccine 3 microgram | Active comparator | Biological: Covi VaxVolunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart. |
| NRC-VACC-101 vaccine 6 microgram | Active comparator | Biological: Covi VaxVolunteers will receive two IM doses of the vaccine, concentrations of 6 mcg, 28 days apart. |
| Control arm | Placebo comparator | Biological: Covi VaxVolunteers will receive two IM doses of the placebo (excipients only), 28 days apart. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covi VaxAlso: NRC-VACC-101 vaccine, Egyptian Inactivated SARS-CoV-2 Vaccine, NRC Inactivated SARS-CoV-2 VaccineInactivated 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. | Biological | Control arm, NRC-VACC-101 vaccine 3 microgram, NRC-VACC-101 vaccine 6 microgram |
Primary outcome
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
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
2 secondary outcomes
The seroconversion rate of neutralizing antibodies
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.
Time frame: The evaluation of the Microneutralization Assay will be assessed up to one month of each dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: Yes. Data will be shared upon individual request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Unit Clinical Trial Unit National Research Centre, MD contact
Osama Azmy, MD principal investigator
Medical Research and Clinical Studies Institute National Research Centre, Dokki, Giza, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Covi Vax in people with COVID-19 and Vaccine Reaction, run by National Research Centre, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osama Azmy, MD (+201223103084, osamaazmy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of NRC-VACC-101 Vaccine (time frame: Follow up for any solicited adverse event(AE) reported within 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.