Coronavirus 2019NCT04843917
Immunity Against COVID-19 Vaccine in Healthcare Workers in Argentine
An observational study of Coronavirus 2019 and Healthcare Workers, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Vaccination against coronavirus disease 19 (COVID-19) is an essential primary prevention tool to limit the health and economic effects of the pandemic. Objectives: To determine the variation in the levels of Immunoglobulin G (IgG) antibodies in health workers who received a COVID-19 vaccine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus 2019, Healthcare Workers, Vaccine
- What is being tested?
- Immunoglobulin G detection
- How many people
- 100 participants
- Where
- 1 siteArgentina
- Study dates
- 9 Apr 2021to 9 Aug 2023
- Phase
- Observational
- 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
Study population: Health care workers who want to receive any COVID-19 vaccine
Who may be able to join
- Subjects receiving any COVID-19 vaccine.
Who cannot join
- Subjects who do not agree to participate
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., C1199ABB
About this study
Official title: Immunity Against the COVID-19 Vaccine in Healthcare Workers of Buenos Aires, Argentine.
Vaccination against coronavirus disease 19 (COVID-19) is an essential primary prevention tool to limit the health and economic effects of the pandemic. Objectives: To determine the variation in the levels of Immunoglobulin G (IgG) antibodies in health workers who received a COVID-19 vaccine.
Read the detailed description
Vaccination against coronavirus disease 19 (COVID-19) is an essential primary prevention tool to limit the health and economic effects of the pandemic. The Ministry of Health of the Nation, designed the "Strategic Plan for vaccination", which the first line being the health workers " The National Administration of Medicines, Food and Medical Technology authorized two emergency vaccines for administration, Sputnik V and Sinopharm vaccine. It is important to evaluate immunogenicity and its correlation with the long-term efficacy and safety profile of this vaccines.
Objectives: To determine the variation in the levels of Immunoglobulin G (IgG) antibodies in health workers who received a COVID-19 vaccine between the time before the first dose, and after 1 month, 6 months and 12 months after the completion of the immunization, depending on whether they have received the Sputnik V vaccine or the Sinopharm vaccine, and correlate the Immunoglobulin G levels with the presence of adverse events and infection with COVID-19 Methodology: Design: observational and analytical study of a prospective cohort of healthcare workers immunized with some COVID-19 vaccine. The presence of IgG will be determined qualitatively and quantitatively. The immunoglobulin G titer in each period will be compared globally and according to the type of vaccine administered.
- Conditions
- Coronavirus 2019, Healthcare Workers, Vaccine
- Being tested
- Immunoglobulin G detection
- Keywords
- COVID-19 Vaccines, Health Personnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin G detectionDiagnostic test
Detection of immunoglobulin G against Spike Receptor Binding Domain against severe acute respiratory syndrome coronavirus 2
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 1 month, at 6 months and at 12 months after the completion of the immunization in health workers who received a COVID-19 vaccine
To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 1 month, at 6 months and at 12 months after the completion of the immunization in health workers who received a COVID-19 vaccine
Measured: 1 year
To correlate the Immunoglobulin G levels with the presence of adverse events and infection with COVID-19
To correlate the Immunoglobulin G levels with the presence of adverse events and infection with COVID-19
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start9 Apr 2021
- Primary completion9 Jun 2023
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronavirus 2019Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VANINA LAURA PAGOTTO, Hospital Italiano de Buenos Aires
- Investigators
- vanina Pagotto, MSC, Principal investigator, Hospital Italiano de Buenos AiresSilvana Figar, MSC, Study chair, Hospital Italiano de Buenos AiresHernán Garcia Rivello, Pharm, Study director, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843917
- Sponsor's protocol ID
- 3913
- Status last verified
- Sep 2023
- First submitted
- 10 Apr 2021
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, Grousova DM, Erokhova AS, Kovyrshina AV, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Lubenets NL, Egorova DA, Shmarov MM, Nikitenko NA, Morozova LF, Smolyarchuk EA, Kryukov EV, Babira VF, Borisevich SV, Naroditsky BS, Gintsburg AL. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020 Sep 26;396(10255):887-897. doi: 10.1016/S0140-6736(20)31866-3. Epub 2020 Sep 4.
PubMed 32896291Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Egorova DA, Shmarov MM, Nikitenko NA, Gushchin VA, Smolyarchuk EA, Zyryanov SK, Borisevich SV, Naroditsky BS, Gintsburg AL; Gam-COVID-Vac Vaccine Trial Group. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021 Feb 20;397(10275):671-681. doi: 10.1016/S0140-6736(21)00234-8. Epub 2021 Feb 2.
PubMed 33545094Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.
PubMed 33301246Di Pasquale A, Bonanni P, Garcon N, Stanberry LR, El-Hodhod M, Tavares Da Silva F. Vaccine safety evaluation: Practical aspects in assessing benefits and risks. Vaccine. 2016 Dec 20;34(52):6672-6680. doi: 10.1016/j.vaccine.2016.10.039. Epub 2016 Nov 8.
PubMed 27836435Herve C, Laupeze B, Del Giudice G, Didierlaurent AM, Tavares Da Silva F. The how's and what's of vaccine reactogenicity. NPJ Vaccines. 2019 Sep 24;4:39. doi: 10.1038/s41541-019-0132-6. eCollection 2019.
PubMed 31583123Virtanen M, Peltola H, Paunio M, Heinonen OP. Day-to-day reactogenicity and the healthy vaccinee effect of measles-mumps-rubella vaccination. Pediatrics. 2000 Nov;106(5):E62. doi: 10.1542/peds.106.5.e62.
PubMed 11061799Mitchell TC, Casella CR. No pain no gain? Adjuvant effects of alum and monophosphoryl lipid A in pertussis and HPV vaccines. Curr Opin Immunol. 2017 Aug;47:17-25. doi: 10.1016/j.coi.2017.06.009. Epub 2017 Jul 17.
PubMed 28728074Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, Stoop J, Tete S, Van Damme W, Leroux-Roels I, Berghmans PJ, Kimmel M, Van Damme P, de Hoon J, Smith W, Stephenson KE, De Rosa SC, Cohen KW, McElrath MJ, Cormier E, Scheper G, Barouch DH, Hendriks J, Struyf F, Douoguih M, Van Hoof J, Schuitemaker H. Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine. N Engl J Med. 2021 May 13;384(19):1824-1835. doi: 10.1056/NEJMoa2034201. Epub 2021 Jan 13.
PubMed 33440088Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8.
PubMed 33306989Hope JL, Bradley LM. Lessons in antiviral immunity. Science. 2021 Jan 29;371(6528):464-465. doi: 10.1126/science.abf6446. No abstract available.
PubMed 33510014
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunity Against the COVID-19 Vaccine in Healthcare Workers of Buenos Aires, Argentine.
- ClinicalTrials.gov ID
- NCT04843917
- Acronym / sponsor ID
- 3913
- Conditions
- Coronavirus 2019, Healthcare Workers, Vaccine
- Keywords
- COVID-19 Vaccines, Health Personnel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 14 Apr 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.
Vaccination against coronavirus disease 19 (COVID-19) is an essential primary prevention tool to limit the health and economic effects of the pandemic. Objectives: To determine the variation in the levels of Immunoglobulin G (IgG) antibodies in health workers who received a COVID-19 vaccine.
Detailed description
Vaccination against coronavirus disease 19 (COVID-19) is an essential primary prevention tool to limit the health and economic effects of the pandemic. The Ministry of Health of the Nation, designed the "Strategic Plan for vaccination", which the first line being the health workers " The National Administration of Medicines, Food and Medical Technology authorized two emergency vaccines for administration, Sputnik V and Sinopharm vaccine. It is important to evaluate immunogenicity and its correlation with the long-term efficacy and safety profile of this vaccines.
Objectives: To determine the variation in the levels of Immunoglobulin G (IgG) antibodies in health workers who received a COVID-19 vaccine between the time before the first dose, and after 1 month, 6 months and 12 months after the completion of the immunization, depending on whether they have received the Sputnik V vaccine or the Sinopharm vaccine, and correlate the Immunoglobulin G levels with the presence of adverse events and infection with COVID-19 Methodology: Design: observational and analytical study of a prospective cohort of healthcare workers immunized with some COVID-19 vaccine. The presence of IgG will be determined qualitatively and quantitatively. The immunoglobulin G titer in each period will be compared globally and according to the type of vaccine administered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health care workers who want to receive any COVID-19 vaccine
Key inclusion criteria (1 listed)
- Subjects receiving any COVID-19 vaccine.
Key exclusion criteria (1 listed)
- Subjects who do not agree to participate
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 |
|---|---|---|
| Immunoglobulin G detectionDetection of immunoglobulin G against Spike Receptor Binding Domain against severe acute respiratory syndrome coronavirus 2 | Diagnostic test | – |
Primary outcome
To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 1 month, at 6 months and at 12 months after the completion of the immunization in health workers who received a COVID-19 vaccine
Time frame: 1 year
To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 1 month, at 6 months and at 12 months after the completion of the immunization in health workers who received a COVID-19 vaccine
To correlate the Immunoglobulin G levels with the presence of adverse events and infection with COVID-19
Time frame: 1 year
To correlate the Immunoglobulin G levels with the presence of adverse events and infection with COVID-19
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 22 Sep 2023.
- Results publication: PubMed 32896291Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, Grousova DM, Erokhova AS, Kovyrshina AV, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Lubenets NL, Egorova DA, Shmarov MM, Nikitenko NA, Morozova LF, Smolyarchuk EA, Kryukov EV, Babira VF, Borisevich SV, Naroditsky BS, Gintsburg AL. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020 Sep 26;396(10255):887-897. doi: 10.1016/S0140-6736(20)31866-3. Epub 2020 Sep 4.
- Results publication: PubMed 33545094Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Egorova DA, Shmarov MM, Nikitenko NA, Gushchin VA, Smolyarchuk EA, Zyryanov SK, Borisevich SV, Naroditsky BS, Gintsburg AL; Gam-COVID-Vac Vaccine Trial Group. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021 Feb 20;397(10275):671-681. doi: 10.1016/S0140-6736(21)00234-8. Epub 2021 Feb 2.
- Results publication: PubMed 33301246Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.
- Results publication: PubMed 27836435Di Pasquale A, Bonanni P, Garcon N, Stanberry LR, El-Hodhod M, Tavares Da Silva F. Vaccine safety evaluation: Practical aspects in assessing benefits and risks. Vaccine. 2016 Dec 20;34(52):6672-6680. doi: 10.1016/j.vaccine.2016.10.039. Epub 2016 Nov 8.
- Results publication: PubMed 31583123Herve C, Laupeze B, Del Giudice G, Didierlaurent AM, Tavares Da Silva F. The how's and what's of vaccine reactogenicity. NPJ Vaccines. 2019 Sep 24;4:39. doi: 10.1038/s41541-019-0132-6. eCollection 2019.
- Results publication: PubMed 11061799Virtanen M, Peltola H, Paunio M, Heinonen OP. Day-to-day reactogenicity and the healthy vaccinee effect of measles-mumps-rubella vaccination. Pediatrics. 2000 Nov;106(5):E62. doi: 10.1542/peds.106.5.e62.
- Results publication: PubMed 28728074Mitchell TC, Casella CR. No pain no gain? Adjuvant effects of alum and monophosphoryl lipid A in pertussis and HPV vaccines. Curr Opin Immunol. 2017 Aug;47:17-25. doi: 10.1016/j.coi.2017.06.009. Epub 2017 Jul 17.
- Results publication: PubMed 33440088Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, Stoop J, Tete S, Van Damme W, Leroux-Roels I, Berghmans PJ, Kimmel M, Van Damme P, de Hoon J, Smith W, Stephenson KE, De Rosa SC, Cohen KW, McElrath MJ, Cormier E, Scheper G, Barouch DH, Hendriks J, Struyf F, Douoguih M, Van Hoof J, Schuitemaker H. Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine. N Engl J Med. 2021 May 13;384(19):1824-1835. doi: 10.1056/NEJMoa2034201. Epub 2021 Jan 13.
- Results publication: PubMed 33306989Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8.
- Results publication: PubMed 33510014Hope JL, Bradley LM. Lessons in antiviral immunity. Science. 2021 Jan 29;371(6528):464-465. doi: 10.1126/science.abf6446. No abstract available.
- World Health Organization. COVID-19 vaccinesLink provided by the sponsor.
- National Drug, Food, and Medical Technology Administration report on the Sputnik V vaccineLink provided by the sponsor.
- Ministry of Health, Argentina. COVID-19 vaccineLink provided by the sponsor.
- Ministry of Health, Argentina. Strategic Plan for vaccination against COVID-19 in ArgentinaLink provided by the sponsor.
- Bank of Communication Resources of the Ministry of Health of the Nation. Fifth Vaccine Safety ReportLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Coronavirus 2019
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)
RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
RecruitingObservational study
Physiological Finding in Management of COVID 19 Patients
COVID-19 (Coronavirus Disease 2019)
Active, not recruitingObservational study
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
COVID-19, Coronavirus Disease 2019
Active, not recruiting
Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use
Liver Diseases, Alcohol Use Disorder
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.
vanina Pagotto, MSC principal investigator
Hospital Italiano de Buenos Aires
Silvana Figar, MSC study chair
Hospital Italiano de Buenos Aires
Hernán Garcia Rivello, Pharm study director
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus 2019 and Healthcare Workers, run by Hospital Italiano de Buenos Aires at 1 site 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 1 inclusion and 1 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 22 Sep 2023. 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 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.
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?
To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 1 month, at 6 months and at 12 months after the completion of the immunization in health workers who received a COVID-19 vaccine (time frame: 1 year). 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 NCT04843917, which also lists 10 linked publications.
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 Sep 2023.