COVID-19Phase 2NCT04686773
Open-label, Non-randomized, Non-comparative, Phase II Study of Safety and Immunogenicity of Combination of AZD1222 and rAd26-S for COVID-19 Prevention
A Phase 2 study testing AZD1222 and rAd26-S in people with COVID-19, run by R-Pharm at 1 site in Azerbaijan.
Trial summary
The purpose of the study is to assess safety and immunogenicity of heterologous booster vaccine containing combination of AZD1222 and rAd26-S (one of components of Gam-COVID-Vac vaccine) in adult subjects aged ≥ 18 years old to prevent COVID-19 spread. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- AZD1222 and rAd26-S
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAzerbaijan
- Study dates
- 5 Mar 2021to 18 Mar 2022
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are:
- Overtly healthy as determined by medical examination, or
- Medically stable such that, according to the judgment of the investigator, hospitalisation within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow up.
- (A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment.)
- Able to understand and comply with study requirements/procedures based on the assessment of the investigator.
- Female participants
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- Women of childbearing potential must:
- Have a negative pregnancy test on the day of screening and Day 1.
- Use of a highly effective form of birth control for at least 28 days prior to Day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study vaccine. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1 % per year when used consistently and correctly (see the table below). Periodic abstinence, the rhythm method, and withdrawal are NOT acceptable methods of contraception.
- Women are considered of childbearing potential unless they meet either of the following criteria:
- Surgically sterilized (including bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or
- Postmenopausal
- For women aged < 50 years old, postmenopause is defined as having both:
- A history ≥ 12 months amenorrhea prior to the first dosing, without an alternative cause, following cessation of exogenous sex hormone treatment and
- A follicle-stimulating hormone level in post-menopausal range. (Until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential.)
- For women aged ≥ 50 years old, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex hormone treatment.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Known past confirmed SARS-CoV-2 infection less than 6 month prior to screening (the date of diagnosis must be confirmed by an official document).
- Positive SARS-CoV-2 Reverse transcriptase polymerase chain reaction (RT-PCR) test at screening.
- Significant infection or other illness including fever > 37.8 °C on the day prior to or day of vaccination.
- Thrombocytopenia of grade ≥ 2 (i.e., <100,000/ mm3)
- Clinically significant neutropenia (as determined by the investigator).
- Clinically significant anemia (as determined by the investigator).
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- Any confirmed or suspected immunosuppressive or immunodeficient condition including infection caused by human immunodeficiency virus (HIV); asplenia; recurring and severe infections and administration of chronic immunosuppressive drugs within previous 6 months ( ≥ 20 mg/day of prednisone or another steroid at an equivalent dose used daily or every other day for ≥ 15 days within the 30-day period preceding immunization) except for topical/inhalation steroids or short-term oral steroids (courses ≤14 days).
- Note: enrollment of HIV-positive subjects with CD4 levels > 500 cells/mL3 ≥12 months receiving stable antiretroviral therapy for HIV therapy is allowed.
- Note: topical use of tacrolimus is permitted unless it was used within 14 days prior to enrollment.
- History of allergic reactions to any of the product ingredients.
- History of anaphylaxis or angioedema.
- Current diagnosis of a malignant neoplasm and therapy thereof (except for basal-cell skin carcinoma or cervical cancer in situ).
- History of serious mental conditions which are expected to impair participation in this study.
- Bleeding disorders (e.g. coagulation factor deficiency, coagulopathy or impaired platelet disorders) or history of relevant hemorrhages or subcutaneous bruises after intramuscular injections or vein punctures.
- Suspected alcohol or psychoactive drug addiction or a known current addiction.
- History of Guillain-Barre syndrome or other demyelinating conditions.
- Any other relevant diseases, disorders or findings which may significantly increase the risk due to participation in this study, restrict the subject's participation in it or impair interpretation of the study data.
- (Note: upon assessment of the subject for exclusion criterion No. 13, adverse events of special interest should be considered which are outlined in appendix F of the study protocol as these adverse events of special interest, particularly with no treatment or control, may pose a risk for the subject's safety. Restrict his/her participation in the study or impair interpretation of the study data. The investigator should be aware of the list of conditions given in Appendix E of the study protocol and take it into account. If any of these conditions are found in the subject, the Investigator will be asked to use his/her clinical judgement to decide on the subject's eligibility for the study. If a subject with conditions outlined in Appendix E of the study protocol is enrolled into the study, the Investigator will be asked to document the final justification for the enrollment in the site's medical document.)
- Severe and/or uncontrollable cardiovascular diseases, respiratory diseases, gastrointestinal disorders, hepatic, renal, endocrine and nervous system diseases (mild/moderate adequately controlled co-morbidities are acceptable).
- Prior splenectomy.
- History of cerebral venous sinus thrombosis or experienced major venous and/or arterial thrombosis.
- Any vaccines (authorized or experimental) other than the investigational ones within 30 days prior to and after each vaccination.
- Previous or scheduled investigational or authorized vaccines or a product which may affect the interpretation of the study data (e.g. adenoviral vector-based vaccines, any coronavirus vaccines).
- Administration of immunoglobulins and/or any blood components within 3 months prior to scheduled administration of the study vaccine.
- Ongoing use of anticoagulants, e.g. coumarin and related ones (i.e. warfarin) or novel oral anticoagulants (e.g. apixaban, rivaroxaban, dabigatran and edoxaban).
- Participation in studies of medicinal products for prevention of COVID-19 throughout the study.
- Participation in planning and/or performance of this study (applicable to both Sponsor's personnel and/or study site personnel).
- According to the Investigator, an individual should not participate in the study if the probability of compliance with study procedures, restrictions and requirements is low.
- Previous participation in this study (undergoing screening and study inclusion procedures).
- Female subjects only: current pregnancy (verified by positive pregnancy test) or breastfeeding.
- Unwilling to refrain from blood donation during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Non-randomized, Non-comparative, Phase II Study in Adult Subjects to Assess Safety and Immunogenicity of Combination of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, and rAd26-S, a Recombinant Adenovirus Type 26 Component of Gam-COVID-Vac Vaccine, for COVID-19 Prevention
The purpose of the study is to assess safety and immunogenicity of heterologous booster vaccine containing combination of AZD1222 and rAd26-S (one of components of Gam-COVID-Vac vaccine) in adult subjects aged ≥ 18 years old to prevent COVID-19 spread.
Read the detailed description
This clinical study is a prospective, single-center, open-label, non-comparative, non-randomized single-arm study. It will enroll adult subjects aged ≥ 18 years old with absence of active COVID-19 infection to be verified by the results of reverse transcription polymerase chain reaction (RT-PCR).
100 subjects meeting inclusion criteria are expected to be screened, 100 of them meeting eligibility criteria will receive one intramuscular injection of AZD1222 vaccine at 5×10^10 viral particles (nominal dose) and at least 90 subjects per one intramuscular injection of rAd26-S at (10±0.5) 1*10^11 viral particles with a 4-week interval on study days 1 and 29, respectively.
Duration of the subject participation in the study will be 6 months (180±10 days) from the day of administration of the first dose of AZD1222 vaccine. 10 visits are scheduled for each subject, 8 of them being obligatory personal visits to the study site.
Safety will be assessed for the duration of the study as follows:
- Solicited adverse events (AEs) (local and systemic) will be assessed for 7 days following each vaccination (ie, on days 1-7 after the first vaccination and on study days 29-35 to account for AEs after second vaccination) at the study visits and based on the results of Subject Diary review.
- Unsolicited AEs will be recorded within 29 days after administration of each dose of AZD1222/rAd26-S vaccine (i.e. on days 1-29 and on days 29 to 57).
- Serious adverse events (SAEs) will be recorded from signing of the informed consent form through Day 180
- Adverse events of special interest (AESI) will be documented from the first vaccination until day 180.
Immunogenicity will also be assessed throughout the study and include serological assay of levels of antibodies specific for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen as well as level of seroconversion, tests for neutralising antibodies.
At least 100 subjects are expected to receive at least one dose of the study product in 1 study site on the territory of Republic Azerbaijan.
- Conditions
- COVID-19
- Being tested
- AZD1222, rAd26-S
- Keywords
- SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2, 2019-nCoV, 2019 novel coronavirus, Respiratory disease, lung disease, COVID-19, coronavirus
- Medical subject headings
- COVID-19, Respiration Disorders, Lung Diseases, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1222Biological
Also called AZ_VACCINE_COVID-19, (previously called ChAdOx1 nCoV-19)
AZD1222 (0.5 ml per dose) contains:
Active substance: ChAdOx1 nCoV-19, a replicant-deficient simian adenoviral vector in the amount of 5 х 10^10 particles per dose.
Solution for intramuscular injection, supplied in vials (5 mL, up to 10 doses per vial) in a carton box.
rAd26-SBiological
Also called Gam-COVID-Vac combined vector vaccine (Component I)
Component I (0.5 ml per dose) contains:
Active substance: recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 10^11 particles per dose.
Solution for intramuscular injection, supplied in vials (3 mL, 5 doses per vial) in a carton box
| Study group | Role | What they receive |
|---|---|---|
| AZD1222 5×10^10 vp + rAd26-S (1.0±0.5) х 10^11vp | Experimental | Subjects will receive 1 intramuscular (IM) injection of 5×10^10 viral particles (nominal) of AZD1222 on Day 1 followed by rAd26-S 1×10^11 viral particles (nominal) on Day 29 of the study. Receives: Biological: AZD1222; Biological: rAd26-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the second vaccination.
Antibody seroconversion rate (≥4-fold increase from baseline) to SARS CoV-2 Spike protein 29 days after the second vaccination.
Measured: Day 57
Secondary outcomes (9)
Incidence of local and systemic solicited Adverse Events (AEs) for 7 days post each dose
Number of Participants Reporting local (Pain at the site of injection, Erythema/hyperemia at the site of injection, Tenderness, Induration/swelling at the site of injection) and systemic (Fever > 37.8°C, Chills, Muscle pains, Fatigue, Headache, Malaise, Nausea, Vomiting) Solicited Adverse Events for 7 days following each vaccination (Day 1 through Day 7 for first vaccination and Day 29 through Day 35 for second vaccination).
Measured: from Day 1 to Day 8 and From Day 29 to Day 36
Incidence of unsolicited AEs, serious adverse events (SAEs) and AEs of special interest
Number of Participants Reporting unsolicited AEs, SAEs and AESIs through 29 days post each vaccination (i.e. up to day 29 after the first vaccination and day 57 after second vaccination).
Measured: up to day 29, up to day 57
Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the first vaccination.
The proportion of participants who have a post treatment seroresponse (defined as: ≥ 4 fold rise in titres from Day 1 baseline value) to the SARS CoV-2 Spike protein 29 days post first vaccination.
Measured: day 29
Antibody seroconversion rate against receptor-binding domain antigen 29 days after each vaccination.
The proportion of participants with post treatment seroresponse (defined as: ≥ 4-fold rise in titres from Day 1 baseline value) to receptor-binding domain antigen 29 days post each vaccination.
Measured: day 29, 57
Change from baseline Geometric mean titre (GMT) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens
Сhange from baseline GMT values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens at day 15, 29, 57, 180.
Measured: Day 1, 15, 29, 57, 180
Change from baseline Geometric mean fold rise (GMFR) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens
Сhange from baseline GMFR values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens at Day 15, 29, 57, 180.
Measured: Day 1, 15, 29, 57, 180
Antibody seroconversion rate of neutralizing antibodies to SARS-CoV-2 antigen - 29 days after each vaccination
The proportion of participants with post treatment seroresponse (defined as: ≥ 4-fold rise in titres day from Day 1 baseline value to 29 days post each vaccination - Day 29 and Day 57), as measured by SARS-CoV-2 neutralising antibodies
Measured: day 29, 57
Change from baseline GMT values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2
Сhange from baseline GMT values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2 at Day 15, 29, 57, 180.
Measured: Day 1, 15, 29, 57, 180
Change from baseline GMFR values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2
Сhange from baseline GMFR values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2 at Day 15, 29, 57, 180.
Measured: Day 1, 15, 29, 57, 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start5 Mar 2021
- Primary completion30 Oct 2021
- Study completion18 Mar 2022
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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca, Russian Direct Investment Fund, The Gamaleya National Center of Epidemiology & Microbiology
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, Chief Medical Officer, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686773
- Sponsor's protocol ID
- CV03872092
- Status last verified
- Jun 2022
- First submitted
- 25 Dec 2020
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Non-randomized, Non-comparative, Phase II Study in Adult Subjects to Assess Safety and Immunogenicity of Combination of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, and rAd26-S, a Recombinant Adenovirus Type 26 Component of Gam-COVID-Vac Vaccine, for COVID-19 Prevention
- ClinicalTrials.gov ID
- NCT04686773
- Acronym / sponsor ID
- CV03872092
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2, 2019-nCoV, 2019 novel coronavirus, Respiratory disease, lung disease, COVID-19, coronavirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca, Russian Direct Investment Fund, The Gamaleya National Center of Epidemiology & Microbiology
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 29 Dec 2020 (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.
The purpose of the study is to assess safety and immunogenicity of heterologous booster vaccine containing combination of AZD1222 and rAd26-S (one of components of Gam-COVID-Vac vaccine) in adult subjects aged ≥ 18 years old to prevent COVID-19 spread.
Detailed description
This clinical study is a prospective, single-center, open-label, non-comparative, non-randomized single-arm study. It will enroll adult subjects aged ≥ 18 years old with absence of active COVID-19 infection to be verified by the results of reverse transcription polymerase chain reaction (RT-PCR).
100 subjects meeting inclusion criteria are expected to be screened, 100 of them meeting eligibility criteria will receive one intramuscular injection of AZD1222 vaccine at 5×10^10 viral particles (nominal dose) and at least 90 subjects per one intramuscular injection of rAd26-S at (10±0.5) 1*10^11 viral particles with a 4-week interval on study days 1 and 29, respectively.
Duration of the subject participation in the study will be 6 months (180±10 days) from the day of administration of the first dose of AZD1222 vaccine. 10 visits are scheduled for each subject, 8 of them being obligatory personal visits to the study site.
Safety will be assessed for the duration of the study as follows:
- Solicited adverse events (AEs) (local and systemic) will be assessed for 7 days following each vaccination (ie, on days 1-7 after the first vaccination and on study days 29-35 to account for AEs after second vaccination) at the study visits and based on the results of Subject Diary review.
- Unsolicited AEs will be recorded within 29 days after administration of each dose of AZD1222/rAd26-S vaccine (i.e. on days 1-29 and on days 29 to 57).
- Serious adverse events (SAEs) will be recorded from signing of the informed consent form through Day 180
- Adverse events of special interest (AESI) will be documented from the first vaccination until day 180.
Immunogenicity will also be assessed throughout the study and include serological assay of levels of antibodies specific for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen as well as level of seroconversion, tests for neutralising antibodies.
At least 100 subjects are expected to receive at least one dose of the study product in 1 study site on the territory of Republic Azerbaijan.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD1222 5×10^10 vp + rAd26-S (1.0±0.5) х 10^11vp | Experimental | Biological: AZD1222, Biological: rAd26-SSubjects will receive 1 intramuscular (IM) injection of 5×10^10 viral particles (nominal) of AZD1222 on Day 1 followed by rAd26-S 1×10^11 viral particles (nominal) on Day 29 of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participants are:
- (A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment.)
- Able to understand and comply with study requirements/procedures based on the assessment of the investigator.
- Female participants
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Key exclusion criteria (31 listed)
- Known past confirmed SARS-CoV-2 infection less than 6 month prior to screening (the date of diagnosis must be confirmed by an official document).
- Positive SARS-CoV-2 Reverse transcriptase polymerase chain reaction (RT-PCR) test at screening.
- Significant infection or other illness including fever > 37.8 °C on the day prior to or day of vaccination.
- Thrombocytopenia of grade ≥ 2 (i.e., <100,000/ mm3)
- Clinically significant neutropenia (as determined by the investigator).
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 |
|---|---|---|
| AZD1222Also: AZ_VACCINE_COVID-19, (previously called ChAdOx1 nCoV-19)AZD1222 (0.5 ml per dose) contains: Active substance: ChAdOx1 nCoV-19, a replicant-deficient simian adenoviral vector in the amount of 5 х 10^10 particles per dose. Solution for intramuscular injection, supplied in vials (5 mL, up to 10 doses per vial) in a carton box. | Biological | AZD1222 5×10^10 vp + rAd26-S (1.0±0.5) х 10^11vp |
| rAd26-SAlso: Gam-COVID-Vac combined vector vaccine (Component I)Component I (0.5 ml per dose) contains: Active substance: recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 10^11 particles per dose. Solution for intramuscular injection, supplied in vials (3 mL, 5 doses per vial) in a carton box | Biological | AZD1222 5×10^10 vp + rAd26-S (1.0±0.5) х 10^11vp |
Primary outcome
Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the second vaccination.
Time frame: Day 57
Antibody seroconversion rate (≥4-fold increase from baseline) to SARS CoV-2 Spike protein 29 days after the second vaccination.
9 secondary outcomes
Incidence of local and systemic solicited Adverse Events (AEs) for 7 days post each dose
Time frame: from Day 1 to Day 8 and From Day 29 to Day 36
Incidence of unsolicited AEs, serious adverse events (SAEs) and AEs of special interest
Time frame: up to day 29, up to day 57
Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the first vaccination.
Time frame: day 29
Antibody seroconversion rate against receptor-binding domain antigen 29 days after each vaccination.
Time frame: day 29, 57
Change from baseline Geometric mean titre (GMT) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens
Time frame: Day 1, 15, 29, 57, 180
Change from baseline Geometric mean fold rise (GMFR) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens
Time frame: Day 1, 15, 29, 57, 180
Antibody seroconversion rate of neutralizing antibodies to SARS-CoV-2 antigen - 29 days after each vaccination
Time frame: day 29, 57
Change from baseline GMT values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2
Time frame: Day 1, 15, 29, 57, 180
Change from baseline GMFR values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2
Time frame: Day 1, 15, 29, 57, 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
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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.
Mikhail Samsonov study director
Chief Medical Officer, R-Pharm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD1222 and rAd26-S in people with COVID-19, run by R-Pharm at 1 site in Azerbaijan.
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 17 inclusion and 31 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: finished, as of the sponsor's last update on 3 Jun 2022. 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 Azerbaijan. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the second vaccination. (time frame: Day 57). 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 3 Jun 2022.