COVID-19 VACCINEPhase 2ECEHeVacNCT04988048
Collaborative Study to Evaluate Heterologous Vaccination Against Covid-19 in Argentina
A Phase 2 study testing COVID-19 vaccines in people with COVID-19 VACCINE and Covid19, run by Ministry of Public Health, Argentina at 4 sites in Argentina.
Trial summary
Randomized, open, multicenter, collaborative and adaptive non-inferiority trial to evaluate the immunogenicity and reactogenicity of the heterologous vaccination schedules made up of the combination of vaccines available in Argentina (Sputnik-V, AstraZeneca, Sinopharm and Moderna); and to compare the immunogenicity… 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 VACCINE, Covid19
- What is being tested?
- COVID-19 vaccines
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,760 participants
- Where
- 4 sitesArgentina
- Study dates
- 3 Aug 2021to 15 Feb 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
- 18 years of age or older, vaccinated with 1 dose of Sputnik V, AstraZeneca or Sinopharm vaccine up to 60 days prior to enrollment (according to the platform of the vaccine received as the first dose) or not vaccinated for the mRNA-1273 / mRNA-1273 Arm
- With and without identified risk factors for COVID-19
- Signature of the informed consent
- Remain in the jurisdiction where your study began until the end of it
- Be able to understand and sign the informed consent
Who cannot join
- Patients with immunocompromise due to underlying disease or immunosuppressive treatment
- Pregnant and breastfeeding people
- Being registered in the National Health Surveillance System for having suffered COVID-19 (symptomatic or asymptomatic) or having a positive IgG result in nucleocapsid ELISA in the sample taken on "DAY 0" for people who had received Sputnik-V or AstraZeneca as the first dose
- Having had a severe allergic reaction (anaphylaxis) to any vaccine
Trial locations and contacts
4 sites in 1 country.
Argentina4 sites, 4 recruiting
- Recruiting
Córdoba
Córdoba
Gabriela Barbás
- Recruiting
Provincia de Buenos Aires
La Plata
Marina Pifano
- Recruiting
La Rioja
La Rioja
Carlos Laino
- Recruiting
San Luis
San Luis
Juan Manuel Talia
About this study
Randomized, open, multicenter, collaborative and adaptive non-inferiority trial to evaluate the immunogenicity and reactogenicity of the heterologous vaccination schedules made up of the combination of vaccines available in Argentina (Sputnik-V, AstraZeneca, Sinopharm and Moderna); and to compare the immunogenicity and reactogenicity of heterologous and homologous vaccination schedules.
Read the detailed description
More than a hundred COVID-19 vaccines based on different technologies are currentlyin the clinical phase of development around the world. More than a dozen derived from different platforms have been approved by regulatory entities in several countries and are used to immunize the world's population.
The dynamics of the COVID-19 pandemic, the emergence of variants, the magnitude and durability of the immune response, the effectiveness of approved vaccination schemes, as well as the possibility of combining vaccines from various platforms, are some of the issues to be facedin public health decision-making, in order to deliver the best protection standards to the population.
Given the dynamics of the disease in Argentina, the access to different COVID-19 vaccination alternatives requires the development of various strategies, such as stratifying the population sampled by the risk of being infected or transmitting the disease, the agreement for the acquisition of vaccines produced by multiple laboratories simultaneously, setting as a priority first dose vaccination to a higher number of people in a shorter period of time and completing the schemes already started.
The pandemic has revealed the capacity of our country to carry out research studies that produce evidence to face the new challenges posed by COVID19 and, particularly,to implement vaccination as one of the main tools to reduce the health impact it generates-for example,six months after the start of the vaccination campaign, results demonstrate the positive impact of this strategy and its effectiveness.
Models based on heterologous immunization schemes with vaccines from different platforms require evaluation by means of clinical trials,in order to show whether they are not less effective than homologous schemes already established. This is achieved through comparative evaluation of their immunogenicity, efficacy and reactogenicity with studies considering implementation possibilities, adaptiveness and response to real life situations.
Hence, the Ministry of Health propoundsthe development of a collaborative network for the integration of studies on vaccination strategies against COVID-19 with the use of heterologous schemes based on the evaluation of their non-inferiority, compared to homologous vaccination schedulesalready implemented worldwide.
The Argentine Ministry of Health looks forward to generating solid scientific evidence that supports decision-making in health policies, with broad federal participation and common objectives.
- Conditions
- COVID-19 VACCINE, Covid19
- Being tested
- COVID-19 vaccines
- Keywords
- Interchangeability, Heterologous vaccination
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccinesBiological
Also called SPUTNIK-V (Gam-COVID-Vac), SINOPHARM (BBIBP-CorV), AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222), Moderna (mRNA-1273 or Spikevax)
Gam-COVID-Vac Gamaleya National Center for Epidemiology and Microbiology - Russia. Non-replicative viral vector. Multi-dose vial (5 doses in 3 mL) Single-dose vial (1 dose in 0.5 mL). Intramuscular T° less than -18 ° C
BBIBP-CorV Beijing Institute of Biological Products - People's Republic of China. Inactivated viruses. Single-dose vials (1 dose in 0.5 mL) or multi-dose vial (2 doses per vial). Intramuscular T° 2 to 8 ° C
ChAdOx1 nCoV-19 vaccine AZD1222 AstraZeneca-Oxford - United Kingdom. Non-replicative viral vector. Multi-dose vial (10 doses in 5 mL). Intramuscular T°: 2 to 8 ° C
mRNA-1273 or Spikevax Moderna Switzerland GmbH and the National Institute of Allergy and Infectious Diseases (NIAID) of the United States. mRNA. Multi-dose vial (maximum 15 doses per 0.5ml vial). Intramuscular. T°-15 ° to -50 °
| Study group | Role | What they receive |
|---|---|---|
| Gam-COVID-Vac C1/ ChAdOx1 nCoV-19 | Active comparator | Heterologous: Gam-COVID-Vac C1/ ChAdOx1 nCoV-19 Receives: Biological: COVID-19 vaccines |
| ChAdOx1 nCoV-19 / Gam-COVID-Vac C1 | Active comparator | Heterologous: ChAdOx1 nCoV-19 / Gam-COVID-Vac C1 Receives: Biological: COVID-19 vaccines |
| Gam-COVID-Vac C1/ BBIBP-CorV | Active comparator | Heterologous: Gam-COVID-Vac C1/ BBIBP-CorV Receives: Biological: COVID-19 vaccines |
| BBIBP-CorV / Gam-COVID-Vac C1 | Active comparator | Heterologous: BBIBP-CorV / Gam-COVID-Vac C1 Receives: Biological: COVID-19 vaccines |
| ChAdOx1 nCoV-19 / BBIBP-CorV | Active comparator | Heterologous: ChAdOx1 nCoV-19 / BBIBP-CorV Receives: Biological: COVID-19 vaccines |
| BBIBP-CorV / ChAdOx1 nCoV-19 | Active comparator | Heterologous: BBIBP-CorV / ChAdOx1 nCoV-19 Receives: Biological: COVID-19 vaccines |
| Gam-COVID-Vac C1/ mRNA-1273 | Active comparator | Heterologous: Gam-COVID-Vac C1/ mRNA-1273 Receives: Biological: COVID-19 vaccines |
| ChAdOx1 nCoV-19 / mRNA-1273 | Active comparator | Heterologous: ChAdOx1 nCoV-19 / mRNA-1273 Receives: Biological: COVID-19 vaccines |
| BBIBP-CorV / mRNA-1273 | Active comparator | Heterologous BBIBP-CorV / mRNA-1273 Receives: Biological: COVID-19 vaccines |
| Gam-COVID-Vac C1/ Gam-COVID-Vac C2 | Active comparator | Homologous: Gam-COVID-Vac C1/ Gam-COVID-Vac C2 Receives: Biological: COVID-19 vaccines |
| ChAdOx1 nCoV-19 / ChAdOx1 nCoV-19 | Active comparator | Homologous: ChAdOx1 nCoV-19 / ChAdOx1 nCoV-19 Receives: Biological: COVID-19 vaccines |
| BBIBP-CorV / BBIBP-CorV | Active comparator | Homologous: BBIBP-CorV / BBIBP-CorV Receives: Biological: COVID-19 vaccines |
| mRNA-1273 / mRNA-1273 | Active comparator | Homologous: mRNA-1273 / mRNA-1273 Receives: Biological: COVID-19 vaccines |
| Gam-COVID-Vac C1/ Gam-COVID-Vac C1 | Active comparator | Homologous: Gam-COVID-Vac C1/ Gam-COVID-Vac C1 Receives: Biological: COVID-19 vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody against Spike protein measurement by ELISA test
To assess IgG anti Spike response (UI/ml): To assess the antibody concentration in each arm by ELISA COVIDAR IgG expressed in IU/ml. To determine whether a heterologous vaccination regimen is non-inferior to that observed with currently used homologous regimens.
Measured: 28 days
Incidence of adverse events by measurement of the number of reactions after vaccination
Adverse events events presumably attributable to vaccination and immunization (ESAVI) and adverse events of special interest (AESI)
Measured: 28 days
Secondary outcomes (2)
Neutralising Antibody against Spike protein and cellular immune response
Neutralizing antibody titer in the serum of vaccinated individuals, using "Vero" cells as infection targets and cellular immune response It will be studied in heparinized blood samples using mononuclear cells isolated from the blood samples obtained. These cells will be challenged "in vitro" with "pools" of peptides from the Spike and N proteins of SARS-CoV-2, evaluating the production of the cytokines interferon-γ and IL-2 by T cells, by flow cytometry.
Measured: 6 month
Incidence of adverse events by measurement of the number of reactions after vaccination
adverse events events presumably attributable to vaccination and immunization (ESAVI) and adverse events of special interest (AESI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start3 Aug 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion15 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 VACCINEStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open, multicenter, collaborative and adaptive non-inferiority trial
- Masking
- None (open label)
- Enrolment
- 1,760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Public Health, Argentina
- Sponsor type
- Other government
- Collaborators
- Russian Direct Investment Fund
- Responsible party
- Principal investigator, Marina Pasinovich, md, Ministry of Public Health, Argentina
- Investigators
- Marina Pasinovich, MD, Principal investigator, Ministry of Public Health, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988048
- Sponsor's protocol ID
- 0001/2021
- Acronym
- ECEHeVac
- Status last verified
- Sep 2021
- First submitted
- 29 Jul 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nunez NG, Schmid J, Power L, Alberti C, Krishnarajah S, Kreutmair S, Unger S, Blanco S, Konigheim B, Marin C, Onofrio L, Kienzler JC, Costa-Pereira S, Ingelfinger F; InmunoCovidCba; InViV working group; Pasinovich ME, Castelli JM, Vizzotti C, Schaefer M, Villar-Vesga J, Mundt S, Merten CH, Sethi A, Wertheimer T, Lutz M, Vanoaica D, Sotomayor C, Gruppi A, Munz C, Cardozo D, Barbas G, Lopez L, Carreno P, Castro G, Raboy E, Gallego S, Moron G, Cervi L, Acosta Rodriguez EV, Maletto BA, Maccioni M, Becher B. High-dimensional analysis of 16 SARS-CoV-2 vaccine combinations reveals lymphocyte signatures correlating with immunogenicity. Nat Immunol. 2023 Jun;24(6):941-954. doi: 10.1038/s41590-023-01499-w. Epub 2023 Apr 24.
PubMed 37095378
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Study to Evaluate Heterologous Vaccination Against Covid-19 in Argentina
- ClinicalTrials.gov ID
- NCT04988048
- Acronym / sponsor ID
- ECEHeVac / 0001/2021
- Conditions
- COVID-19 VACCINE, Covid19
- Keywords
- Interchangeability, Heterologous vaccination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,760 participants (estimated)
- Lead sponsor
- Ministry of Public Health, ArgentinaOther government
- Collaborators
- Russian Direct Investment Fund
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 3 Aug 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.
Randomized, open, multicenter, collaborative and adaptive non-inferiority trial to evaluate the immunogenicity and reactogenicity of the heterologous vaccination schedules made up of the combination of vaccines available in Argentina (Sputnik-V, AstraZeneca, Sinopharm and Moderna); and to compare the immunogenicity and reactogenicity of heterologous and homologous vaccination schedules.
Detailed description
More than a hundred COVID-19 vaccines based on different technologies are currentlyin the clinical phase of development around the world. More than a dozen derived from different platforms have been approved by regulatory entities in several countries and are used to immunize the world's population.
The dynamics of the COVID-19 pandemic, the emergence of variants, the magnitude and durability of the immune response, the effectiveness of approved vaccination schemes, as well as the possibility of combining vaccines from various platforms, are some of the issues to be facedin public health decision-making, in order to deliver the best protection standards to the population.
Given the dynamics of the disease in Argentina, the access to different COVID-19 vaccination alternatives requires the development of various strategies, such as stratifying the population sampled by the risk of being infected or transmitting the disease, the agreement for the acquisition of vaccines produced by multiple laboratories simultaneously, setting as a priority first dose vaccination to a higher number of people in a shorter period of time and completing the schemes already started.
The pandemic has revealed the capacity of our country to carry out research studies that produce evidence to face the new challenges posed by COVID19 and, particularly,to implement vaccination as one of the main tools to reduce the health impact it generates-for example,six months after the start of the vaccination campaign, results demonstrate the positive impact of this strategy and its effectiveness.
Models based on heterologous immunization schemes with vaccines from different platforms require evaluation by means of clinical trials,in order to show whether they are not less effective than homologous schemes already established. This is achieved through comparative evaluation of their immunogenicity, efficacy and reactogenicity with studies considering implementation possibilities, adaptiveness and response to real life situations.
Hence, the Ministry of Health propoundsthe development of a collaborative network for the integration of studies on vaccination strategies against COVID-19 with the use of heterologous schemes based on the evaluation of their non-inferiority, compared to homologous vaccination schedulesalready implemented worldwide.
The Argentine Ministry of Health looks forward to generating solid scientific evidence that supports decision-making in health policies, with broad federal participation and common objectives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 14
- Model description
- Randomized, open, multicenter, collaborative and adaptive non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Gam-COVID-Vac C1/ ChAdOx1 nCoV-19 | Active comparator | Biological: COVID-19 vaccinesHeterologous: Gam-COVID-Vac C1/ ChAdOx1 nCoV-19 |
| ChAdOx1 nCoV-19 / Gam-COVID-Vac C1 | Active comparator | Biological: COVID-19 vaccinesHeterologous: ChAdOx1 nCoV-19 / Gam-COVID-Vac C1 |
| Gam-COVID-Vac C1/ BBIBP-CorV | Active comparator | Biological: COVID-19 vaccinesHeterologous: Gam-COVID-Vac C1/ BBIBP-CorV |
| BBIBP-CorV / Gam-COVID-Vac C1 | Active comparator | Biological: COVID-19 vaccinesHeterologous: BBIBP-CorV / Gam-COVID-Vac C1 |
| ChAdOx1 nCoV-19 / BBIBP-CorV | Active comparator | Biological: COVID-19 vaccinesHeterologous: ChAdOx1 nCoV-19 / BBIBP-CorV |
| BBIBP-CorV / ChAdOx1 nCoV-19 | Active comparator | Biological: COVID-19 vaccinesHeterologous: BBIBP-CorV / ChAdOx1 nCoV-19 |
| Gam-COVID-Vac C1/ mRNA-1273 | Active comparator | Biological: COVID-19 vaccinesHeterologous: Gam-COVID-Vac C1/ mRNA-1273 |
| ChAdOx1 nCoV-19 / mRNA-1273 | Active comparator | Biological: COVID-19 vaccinesHeterologous: ChAdOx1 nCoV-19 / mRNA-1273 |
| BBIBP-CorV / mRNA-1273 | Active comparator | Biological: COVID-19 vaccinesHeterologous BBIBP-CorV / mRNA-1273 |
| Gam-COVID-Vac C1/ Gam-COVID-Vac C2 | Active comparator | Biological: COVID-19 vaccinesHomologous: Gam-COVID-Vac C1/ Gam-COVID-Vac C2 |
| ChAdOx1 nCoV-19 / ChAdOx1 nCoV-19 | Active comparator | Biological: COVID-19 vaccinesHomologous: ChAdOx1 nCoV-19 / ChAdOx1 nCoV-19 |
| BBIBP-CorV / BBIBP-CorV | Active comparator | Biological: COVID-19 vaccinesHomologous: BBIBP-CorV / BBIBP-CorV |
| mRNA-1273 / mRNA-1273 | Active comparator | Biological: COVID-19 vaccinesHomologous: mRNA-1273 / mRNA-1273 |
| Gam-COVID-Vac C1/ Gam-COVID-Vac C1 | Active comparator | Biological: COVID-19 vaccinesHomologous: Gam-COVID-Vac C1/ Gam-COVID-Vac C1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older, vaccinated with 1 dose of Sputnik V, AstraZeneca or Sinopharm vaccine up to 60 days prior to enrollment (according to the platform of the vaccine received as the first dose) or not vaccinated for the mRNA-1273 / mRNA-1273 Arm
- With and without identified risk factors for COVID-19
- Signature of the informed consent
- Remain in the jurisdiction where your study began until the end of it
- Be able to understand and sign the informed consent
Key exclusion criteria (4 listed)
- Patients with immunocompromise due to underlying disease or immunosuppressive treatment
- Pregnant and breastfeeding people
- Being registered in the National Health Surveillance System for having suffered COVID-19 (symptomatic or asymptomatic) or having a positive IgG result in nucleocapsid ELISA in the sample taken on "DAY 0" for people who had received Sputnik-V or AstraZeneca as the first dose
- Having had a severe allergic reaction (anaphylaxis) to any 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 |
|---|---|---|
| COVID-19 vaccinesAlso: SPUTNIK-V (Gam-COVID-Vac), SINOPHARM (BBIBP-CorV), AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222), Moderna (mRNA-1273 or Spikevax)Gam-COVID-Vac Gamaleya National Center for Epidemiology and Microbiology - Russia. Non-replicative viral vector. Multi-dose vial (5 doses in 3 mL) Single-dose vial (1 dose in 0.5 mL). Intramuscular T° less than -18 ° C BBIBP-CorV Beijing Institute of Biological Products - People's Republic of China. Inactivated viruses. Single-dose vials (1 dose in 0.5 mL) or multi-dose vial (2 doses per vial). Intramuscular T° 2 to 8 ° C ChAdOx1 nCoV-19 vaccine AZD1222 AstraZeneca-Oxford - United Kingdom. Non-replicative viral vector. Multi-dose vial (10 doses in 5 mL). Intramuscular T°: 2 to 8 ° C mRNA-1273 or Spikevax Moderna Switzerland GmbH and the National Institute of Allergy and Infectious Diseases (NIAID) of the United States. mRNA. Multi-dose vial (maximum 15 doses per 0.5ml vial). Intramuscular. T°-15 ° to -50 ° | Biological | BBIBP-CorV / BBIBP-CorV, BBIBP-CorV / ChAdOx1 nCoV-19, BBIBP-CorV / Gam-COVID-Vac C1, BBIBP-CorV / mRNA-1273, ChAdOx1 nCoV-19 / BBIBP-CorV, ChAdOx1 nCoV-19 / ChAdOx1 nCoV-19, ChAdOx1 nCoV-19 / Gam-COVID-Vac C1, ChAdOx1 nCoV-19 / mRNA-1273, Gam-COVID-Vac C1/ BBIBP-CorV, Gam-COVID-Vac C1/ ChAdOx1 nCoV-19, Gam-COVID-Vac C1/ Gam-COVID-Vac C1, Gam-COVID-Vac C1/ Gam-COVID-Vac C2, Gam-COVID-Vac C1/ mRNA-1273, mRNA-1273 / mRNA-1273 |
Primary outcome
Antibody against Spike protein measurement by ELISA test
Time frame: 28 days
To assess IgG anti Spike response (UI/ml): To assess the antibody concentration in each arm by ELISA COVIDAR IgG expressed in IU/ml. To determine whether a heterologous vaccination regimen is non-inferior to that observed with currently used homologous regimens.
Incidence of adverse events by measurement of the number of reactions after vaccination
Time frame: 28 days
Adverse events events presumably attributable to vaccination and immunization (ESAVI) and adverse events of special interest (AESI)
2 secondary outcomes
Neutralising Antibody against Spike protein and cellular immune response
Time frame: 6 month
Incidence of adverse events by measurement of the number of reactions after vaccination
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 37095378Nunez NG, Schmid J, Power L, Alberti C, Krishnarajah S, Kreutmair S, Unger S, Blanco S, Konigheim B, Marin C, Onofrio L, Kienzler JC, Costa-Pereira S, Ingelfinger F; InmunoCovidCba; InViV working group; Pasinovich ME, Castelli JM, Vizzotti C, Schaefer M, Villar-Vesga J, Mundt S, Merten CH, Sethi A, Wertheimer T, Lutz M, Vanoaica D, Sotomayor C, Gruppi A, Munz C, Cardozo D, Barbas G, Lopez L, Carreno P, Castro G, Raboy E, Gallego S, Moron G, Cervi L, Acosta Rodriguez EV, Maletto BA, Maccioni M, Becher B. High-dimensional analysis of 16 SARS-CoV-2 vaccine combinations reveals lymphocyte signatures correlating with immunogenicity. Nat Immunol. 2023 Jun;24(6):941-954. doi: 10.1038/s41590-023-01499-w. Epub 2023 Apr 24.
- Individual participant dataSharing planned: No
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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.
Marina Pasinovich, MD principal investigator
Ministry of Public Health, Argentina
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COVID-19 vaccines in people with COVID-19 VACCINE and Covid19, run by Ministry of Public Health, Argentina at 4 sites in Argentina.
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 5 inclusion and 4 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 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Pasinovich, MD (+5491154961973, mpasinovich@msal.gov.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody against Spike protein measurement by ELISA test (time frame: 28 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?
On the ClinicalTrials.gov record for NCT04988048, which also lists 1 linked publication.
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 29 Sep 2021.