Other substances

Gam-COVID-Vac

COVID-19 candidate vaccine

Phase of research

Emergency use authorization

How it helps

Vaccine

Drug status

Experimental

3
 Supporting references
0
 Contradictory references
22
 AI-suggested references
16
 Clinical trials

General information

Gam-COVID-Vac is a COVID-19 candidate vaccine being developed by Gamaleya Research Institute. It is an adeno-based type of candidate vaccine based on the non-replicating viral vector platform. Currently, this COVID-19 candidate vaccine has undergone evaluation in two Phase I/II (1, 2) clinical trials. 

On August 11, 2020, Gam-COVID-Vac was reported to be registered by Russia’s Health Ministry with a civilian circulation start on January 1, 2021. 

On December 21, 2020, the Sputnik V vaccine was registered in Belarus, and on December 23, 2020, the vaccine was granted emergency use authorization in Argentina. Both countries have since started vaccinating their population. 

Marketed as

Sputnik V

 

Supporting references

Link Tested on Impact factor Notes Publication date
Draft landscape of COVID-19 candidate vaccines
healthy adults Jul/28/2020
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
Phase II clinical trial Phase I clinical trial 		Patients 60.39

vaccine has a good safety profile and induced strong humoral and cellular immune responses in participants

 Sep/04/2020
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
Spike protein Viral vector Phase III clinical trial Randomized controlled double-blind trial Mixed substance 		Adult volunteers 60.39

According to an interim analysis, in the phase III clinical trial, the vaccine was well tolerated (no associated serious adverse effects) and displayed 91.6% efficacy in preventing SARS-CoV-2 infection. The efficacy of 91.8% was observed in the 60+ years old participants subgroup. Only mild COVID-19 cases were observed in the vaccine group. High anti-RBD (SARS-CoV-2 Spike protein) IgG and neutralizing antibody titres and IFN-γ immune response was observed in the blood samples of vaccine group members. Sample size: 16,501 + 5,476 placebo. Dosage: Two IM 0.5 ml (10^11 recombinant viral particles) doses 21 days apart (rAD26 prime, rAd5 boost). Endpoint (primary): PCR-confirmed COVID-19 from day 21 after receiving the first dose.



 Feb/02/2021

AI-suggested references

Link Publication date
Evaluation of the Gam-COVID-Vac and vaccine-induced neutralizing response against SARS-CoV-2 lineage P.1 variant in an Argentinean cohort.
Dec/20/2021
Heterologous gam-covid-vac (sputnik V) / mRNA-1273 (moderna) vaccination induces a stronger humoral response than homologous sputnik V in a real-world data analysis.
Dec/12/2020
Immunogenicity and safety of SARS-CoV-2 vaccines in clinical trials.
Sep/29/2021
Immune imprinting, breadth of variant recognition, and germinal center response in human SARS-CoV-2 infection and vaccination.
Jan/25/2022
BNT162b2, mRNA-1273, and Sputnik V Vaccines Induce Comparable Immune Responses on a Par With Severe Course of COVID-19
Jul/13/2021
Prospective Cohort Study of the Kinetics of Specific Antibodies to SARS-CoV-2 Infection and to Four SARS-CoV-2 Vaccines Available in Serbia, and Vaccine Effectiveness: A 3-Month Interim Report.
Sep/17/2021
Immunogenicity of BNT162b2, BBIBP-CorV and Gam-COVID-Vac vaccines and immunity after natural SARS-CoV-2 infection:A comparative study from Novi Sad, Serbia
May/30/2020
Memory B Cells Induced by Sputnik V Vaccination Produce SARS-CoV-2 Neutralizing Antibodies Upon Ex Vivo Restimulation
Nov/19/2020
Early Effectiveness of Four SARS-CoV-2 Vaccines in Preventing COVID-19 among Adults Aged >=60 Years in Vojvodina, Serbia
Apr/30/2020
Sputnik V vaccine elicits seroconversion and neutralizing capacity to SARS-CoV-2 after a single dose.
Jul/09/2021
Drug repurposing for COVID-19 using computational screening: Is Fostamatinib/R406 a potential candidate?
Aug/27/2021
Effectiveness of the first component of Gam-COVID-Vac (Sputnik V) on reduction of SARS-CoV-2 confirmed infections, hospitalisations and mortality in patients aged 60-79: a retrospective cohort study in Argentina
Feb/16/2021
Insight into the Advances in Clinical Trials of SARS-CoV-2 Vaccines
Mar/23/2022
Neutralizing activity of Sputnik V vaccine sera against SARS-CoV-2 variants
Aug/27/2020
Humoral and Cellular Immunogenicity and Safety of Five Different SARS-CoV-2 Vaccines in Patients With Autoimmune Rheumatic and Musculoskeletal Diseases in Remission or With Low Disease Activity and in Healthy Controls: A Single Center Study
Feb/14/2022
IgG Antibody response to the Sputnik V vaccine: previous SARS-CoV-2 seropositive individuals might need just one vaccine dose.
Jul/31/2021
Neutralizing Activity of Sera from Sputnik V-Vaccinated People against Variants of Concern (VOC: B.1.1.7, B.1.351, P.1, B.1.617.2, B.1.617.3) and Moscow Endemic SARS-CoV-2 Variants.
Jul/12/2021
Nationwide effectiveness of five SARS-CoV-2 vaccines in Hungary - The HUN-VE study
Jun/10/2021
Immune responses following the first dose of the Sputnik V (Gam-COVID-Vac)
Feb/02/2022
Development of an Inactivated Vaccine against SARS CoV-2
Nov/02/2021
Longitudinal Study after Sputnik V Vaccination Shows Durable SARS-CoV-2 Neutralizing Antibodies and Reduced Viral Variant Escape to Neutralization over Time
Jan/25/2022
Locally harvested Covid-19 convalescent plasma could probably help combat the geographically determined SARS-CoV-2 viral variants
May/07/2021

Clinical trials

ID Title Status Phase Start date Completion date
NCT05248373 Safety, Tolerability and Immunogenicity of Gam-COVID-Vac Vaccine in a Nasal Spray Not yet recruiting Phase 1|Phase 2 Mar/08/2022 Dec/30/2023
  • Alternative id - SPRAY vaccine against COVID-19
  • Interventions - Biological: Gam-COVID-Vac|Other: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
  • Enrollment - 400
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Change from baseline in geometric mean titer of IgGs specific to S protein|Change from baseline in number of participants with detected specific IgGs|Change from baseline in Number of participants with detected specific IgAs|Change from baseline in Geometric mean titer of neutralizing antibodies to SARS-Cov-2 virus|Change from baseline in Number of participants with detected neutralizing antibodies to SARS-Cov-2 virus|Proportion of participants with any adverse events|Proportion of participants with severe adverse events|Efficacy of symptomatic COVID-19 prevention
NCT04983537 Study to Evaluate the Immunogenicity and Safety of Heterologous SARS-CoV-2 Vaccine Schemes in an Elderly Population Recruiting Phase 2 Jul/26/2021 Sep/26/2021
  • Alternative id - 5143_2
  • Interventions - Drug: Gam-COVID-Vac / Gam-COVID-Vac
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hospital Ramos Mejía, Ciudad Autonoma de Buenos Aire, CBA, Argentina|Ministerio de Salud de la Ciudad Autónoma de Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Health Services Research
  • Enrollment - 120
  • Age - 66 Years to 100 Years   (Older Adult)
  • Outcome measures - ELISA assessment of IgG anti Spike (UI/ml)|Serious adverse events Adverse events of special interest|Neutralising antibodies against SARS-CoV-2
NCT04738435 Safety of the Sputnik V Vaccine in Health Personnel of Private Effectors of the City of Buenos Aires, Argentina Completed Jan/05/2021 Mar/01/2021
  • Alternative id - 3876
  • Interventions -
  • Study type - Observational
  • Study results - No Results Available
  • Locations - Hospital Italiano de Buenos Aires, Buenos Aires, Caba, Argentina
  • Study designs - Observational Model: Cohort|Time Perspective: Prospective
  • Enrollment - 600
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Incidence of events supposedly attributed to vaccines and immunizations after Sputnik V
NCT04530396 Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 Active, not recruiting Phase 3 Sep/07/2020 May/01/2021
  • Alternative id - 04-Gam-COVID-Vac-2020
  • Interventions - Biological: Gam-COVID-Vac|Other: placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - ARCHIMED V Clinic of new medical technologies limited liability company, Moscow, Russian Federation|Hadassah LTD, Moscow, Russian Federation|Medsi Group of companies joint-stock company", Moscow, Russian Federation|Niarmedic Plus, Moscow, Russian Federation|State budgetary healthcare institution of the city of Moscow "City clinical hospital No. 52 of the Moscow city health Department", Moscow, Russian Federation|State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department, Moscow, Russian Federation|State Budgetary Healthcare Institution, Moscow, M. Konchalovsky Municipal Clinical Hospital, Moscow Healthcare Department, Moscow, Russian Federation|State Budgetary Healthcare Institution, Moscow, M. Zhadkevich Municipal Clinical Hospital, Moscow Healthcare Department, Moscow, Russian Federation|State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 115, Moscow Healthcare Department, Moscow, Russian Federation|State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 2, Moscow Healthcare Department, Moscow, Russian Federation|State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department, Moscow, Russian Federation|State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 212, Moscow Healthcare Department, Moscow, Russian Federation|State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department, Moscow, Russian Federation|State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 220, Moscow Healthcare Department, Moscow, Russian Federation|State Budgetary Healthcare Institution, Municipal Polyclinic No. 62, Moscow Healthcare Department, Moscow, Russian Federation|State budgetary institution of health care of the city of Moscow " city polyclinic No. 109 Of the Department of health of the city of Moscow", Moscow, Russian Federation|State budgetary institution of health care of the city of Moscow " city polyclinic No. 170 Of the Department of health of the city of Moscow", Moscow, Russian Federation|State budgetary institution of health care of the city of Moscow " city polyclinic No. 36 Of the Department of health of the city of Moscow", Moscow, Russian Federation|State budgetary institution of health care of the city of Moscow " city polyclinic No. 46 Of the Department of health of the city of Moscow", Moscow, Russian Federation|State budgetary institution of health care of the city of Moscow " city polyclinic No. 6 Of the Department of health of the city of Moscow", Moscow, Russian Federation|State budgetary institution of health care of the city of Moscow " city polyclinic No. 68 Of the Department of health of the city of Moscow", Moscow, Russian Federation|State budgetary institution of health care of the city of Moscow "Diagnostic center No. 5 with polyclinic Department Of the Department of health of the city of Moscow", Moscow, Russian Federation|State budgetary institution of health care of the city of Moscow "Diagnostic clinical center No. 1 Of the Department of health of the city of Moscow", Moscow, Russian Federation
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
  • Enrollment - 33758
  • Age - 18 Years to 111 Years   (Adult, Older Adult)
  • Outcome measures - percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose|the severity of the clinical course of COVID-19|Changing of antibody levels against the SARS-CoV-2 glycoprotein S|Changing of antigen-specific cellular immunity level|Changing of of virus neutralizing antibody titer|Incidence of adverse events in trial subjects|Severity of adverse events in trial subjects|estimation of the proportion of study subjects with antibodies to the N-protein of the virus SARS-CoV-2
NCT04564716 Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 in Belarus Active, not recruiting Phase 3 Sep/28/2020 Apr/10/2021
  • Alternative id - 04-Gam-COVID-Vac-2020-RB
  • Interventions - Biological: Gam-COVID-Vac|Other: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Health Institution "14th Central Regional Polyclinic of the Partisan district of Minsk", Minsk, Belarus|Health Institution "19th Central Regional Polyclinic of the Pervomaysk district of Minsk", Minsk, Belarus|Health Institution "1st Central Regional Clinical Polyclinic of the Central district of Minsk", Minsk, Belarus|Health Institution "28th Regional Polyclinic of Minsk", Minsk, Belarus|Health Institution "4th City Polyclinic of Minsk", Minsk, Belarus|Health Institution "5th City Clinical Polyclinic of Minsk", Minsk, Belarus|Health Institution "Minsk Order of the Red Banner of Labor Regional Clinical Hospital, Minsk, Belarus|Health Institution "Vitebsk Regional Clinical Hospital", Vitebsk, Belarus
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
  • Enrollment - 100
  • Age - 18 Years to 60 Years   (Adult)
  • Outcome measures - percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose|the severity of the clinical course of COVID-19|Changing of antibody levels against the SARS-CoV-2 glycoprotein S|Incidence of adverse events in trial subjects|Severity of adverse events in trial subjects
NCT04954092 Study of Gam-COVID-Vac in Adolescents Recruiting Phase 2|Phase 3 Jul/05/2021 Dec/31/2023
  • Alternative id - OLSTAD
  • Interventions - Biological: Gam-COVID-vac M|Biological: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Children's City Clinical Hospital named after Z.A. Bashlyaeva of the Moscow Department of Health, Moscow, Russian Federation|Morozovskaya Children's City Clinical Hospital of the Moscow Department of Health, Moscow, Russian Federation
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 3000
  • Age - 12 Years to 17 Years   (Child)
  • Outcome measures - Geometric mean titer of antigen-specific IgGs|Geometric mean titer of neutralizing antibodies|IFN-gamma secretion by T lymphocytes|Frequency of adverse reactions|Severity of adverse reactions|Incidence of COVID-19 cases
NCT04834869 COVID-19 Vaccines Safety Tracking (CoVaST) Recruiting Apr/01/2021 Jan/31/2022
  • Alternative id - CoVaST
  • Interventions - Biological: BNT162b2|Biological: mRNA-1273|Biological: AZD1222|Biological: CoronaVac|Biological: Sinopharm|Biological: Gam-COVID-Vac|Biological: JNJ-78436735|Biological: CVnCoV|Biological: NVX-CoV2373|Biological: BBV152
  • Study type - Observational
  • Study results - No Results Available
  • Locations - American College of Physicians, Philadelphia, Pennsylvania, United States|McMaster University, Hamilton, Ontario, Canada|University of Split, Split, Croatia|Masaryk University, Brno, Czechia|University of Tartu, Tartu, Estonia|Jimma University, Jimma, Ethiopia|Justus-Liebig University Giessen, Giessen, Germany|University of Ghana, Accra, Ghana|Sinaloa's Pediatric Hospital, Culiacán, Mexico|Medical University of Silesia, Katowice, Poland|Nursing School of Coimbra, Coimbra, Portugal|Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences, Irkutsk, Russian Federation|University of Belgrade, Belgrade, Serbia|University of Ljubljana, Ljubljana, Slovenia
  • Study designs - Observational Model: Other|Time Perspective: Prospective
  • Enrollment - 30000
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Local Side Effects|Systemic Side Effects|Unrecognized Side Effects
NCT04642339 Clinical Trial of the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Vaccine Against COVID-19 in Venezuela Not yet recruiting Phase 3 Nov/01/2020 Dec/01/2021
  • Alternative id - 01V-Gam-COVID-Vac-2020
  • Interventions - Biological: Gam-COVID-Vac|Biological: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
  • Enrollment - 2000
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Seroconversion rate|Incidence and severity of adverse events|Virus-neutralizing antibody levels against the SARS-CoV-2|Antibody levels against the SARS-CoV-2 glycoprotein|Percentage of trial subjects with coronavirus disease 2019 (COVID-19)
NCT04587219 The Study of "Gam-COVID-Vac" Vaccine Against COVID-19 With the Participation of Volunteers of 60 y.o and Older Active, not recruiting Phase 2 Oct/22/2020 Apr/30/2021
  • Alternative id - 05-Gam-COVID-Vac-2020
  • Interventions - Biological: Gam-COVID-Vac
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation, Moscow, Russian Federation
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 110
  • Age - 60 Years to 111 Years   (Adult, Older Adult)
  • Outcome measures - Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days|Number of Participants With Adverse Events|Changing of of virus neutralizing antibody titer|Changing of antigen-specific cellular immunity level
NCT05027672 Strategies for Combining the First Component of Sputnik V With Other Adenoviral or mRNA-based Vaccines. Active, not recruiting Phase 2 Jul/30/2021 Sep/06/2021
  • Alternative id - 5143_3
  • Interventions - Drug: Gam-COVID-Vac (rAd26) / Gam-COVID-Vac (rAd5)
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Ministerio de Salud de la Ciudad Autónoma de Buenos Aires, Ciudad Autonoma de Buenos Aires, CBA, Argentina|Ministerio de Salud de la Ciudad Autónoma de Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Health Services Research
  • Enrollment - 348
  • Age - 21 Years to 65 Years   (Adult, Older Adult)
  • Outcome measures - ELISA assessment of concentration of IgG anti Spike (UI/ml) at 28 days.|Serious adverse events Adverse events of special interest|Neutralising antibodies against SARS-CoV-2
NCT04436471 An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac" Vaccine Against COVID-19 Completed Phase 1|Phase 2 Jun/17/2020 Aug/10/2020
  • Alternative id - 02-Gam-COVID-Vac-2020
  • Interventions - Biological: Gam-COVID-Vac
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Main military clinical hospital named after academician N. N. Burdenko, Moscow, Russian Federation
  • Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 38
  • Age - 18 Years to 60 Years   (Adult)
  • Outcome measures - Changing ofantibody levels against the SARS-CoV-2 glycoprotein S in 42 days|Number of Participants With Adverse Events|Changing of of virus neutralizing antibody titer|Changing of antigen-specific cellular immunity level
NCT04437875 An Open Study of the Safety, Tolerability and Immunogenicity of "Gam-COVID-Vac Lyo" Vaccine Against COVID-19 Completed Phase 1|Phase 2 Jun/17/2020 Aug/10/2020
  • Alternative id - 03-Gam-COVID-Vac Lyo-2020
  • Interventions - Biological: Gam-COVID-Vac Lyo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Sechenov First Moscow State Medical University, Moscow, Russian Federation
  • Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 38
  • Age - 18 Years to 60 Years   (Adult)
  • Outcome measures - The changing of antibody levels against the SARS-CoV-2 glycoprotein S at 42 days|Number of Participants With Adverse Events|The changing of virus neutralizing antibody titer|The changing of antigen-specific cellular immunity level
NCT04640233 Clinical Trial to Assess Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Сov-2) Infection Active, not recruiting Phase 2|Phase 3 Nov/30/2020 Sep/01/2021
  • Alternative id - RDI-GCV-001|CTRI/2020/11/029234
  • Interventions - Biological: Gam-COVID-Vac|Other: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - S N Medical College, Agra, India|MGM Medical College and Hospital, Aurangabad, India|KLE Prabhakar Kore Hospital, Belgaum, India|Apollo Hospital, Delhi, India|Batra Hospital, Delhi, India|HIMSR with CHRD-SAS, Delhi, India|ESIC Medical College & Hospital, Faridabad, India|AIG hospital, Hyderabad, India|Maharaja Agrasen Superspecialty Hospital, Jaipur, India|GSVM Medical College, Kanpur, India|Peerless Hospital, Kolkata, India|Atharva Hospital, Lucknow, India|St. George's Hospital, Mumbai, India|JSS Hospital, Mysore, India|INCLEN trust and Gurunanak Hospital, Palwal, India|PIMS, Puducherry, India|BJ Sassoon Hospital, Pune, India|KEM Hospital, Pune, India|Noble Hospital Private Limited, Pune, India|BAPS hospital, Sūrat, India|Rhythm Heart Institute, Vadodara, India|Sumandeep Vidyapeeth, Vadodara, India|Christian Medical College, Vellore, India
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
  • Enrollment - 1600
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Adverse Events|Immunogenicity|Immunogenicity assessment|Percentage of subjects with mild, moderate, severe coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose of the vaccine/placebo|Incidence of coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose in trial subjects
NCT04962906 Study to Evaluate the Immunogenicity and Safety of Heterologous SARS-CoV-2 Vaccine Schemes Completed Phase 2 Jul/05/2021 Aug/15/2021
  • Alternative id - 5143
  • Interventions - Drug: Gam-COVID-Vac / Gam-COVID-Vac
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Ministerio de Salud de la Ciudad Autónoma de Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Health Services Research
  • Enrollment - 192
  • Age - 21 Years to 65 Years   (Adult, Older Adult)
  • Outcome measures - ELISA assessment of IgG anti Spike (UI/ml)|Serious adverse events Adverse events of special interest|Neutralising antibodies against SARS-CoV-2
NCT04871841 Study of Sputnik V COVID-19 Vaccination in Adults in Kazakhstan Active, not recruiting Apr/05/2021 Dec/05/2021
  • Alternative id - 128/36-21-23
  • Interventions - Biological: Sputnik V
  • Study type - Observational
  • Study results - No Results Available
  • Locations - Karaganda Medical University, Karaganda, Kazakhstan
  • Study designs - Observational Model: Case-Only|Time Perspective: Prospective
  • Enrollment - 82
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Number of Participants with Solicited Adverse Events (AEs) for 21 Days after First Vaccination|Number of Participants with Solicited Adverse Events (AEs) for 42 Days after First Vaccination|Change in the Titres of Systemic SARS-CoV-2 Binding Antibodies|Change in the Titres of Mucosal SARS-CoV-2 Binding Antibodies|Change in the Titres of Systemic SARS-CoV-2 Neutralizing Antibodies|Change in the titres of Mucosal SARS-CoV-2 Neutralizing Antibodies|Change in the concentration of systemic cytokines|Difference in the study outcomes between participants with and without prior COVID-19 exposure.
NCT04656613 A Phase III Clinical Trial of the Immunogenicity and Safety of the Gam-COVID-Vac Vaccine Against COVID-19 in the UAE Not yet recruiting Phase 3 Dec/01/2020 Dec/01/2021
  • Alternative id - 06-Gam-COVID-Vac-2020
  • Interventions - Biological: Gam-COVID-Vac|Other: placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Prevention
  • Enrollment - 1000
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - SARS-CoV-2 glycoprotein-specific antibodies titer|Seroconversion rate|IFN-gamma antigen-specific release|CD4+/CD8+ proliferating cells|Virus-neutralizing antibodies titer|Incidence and severity of adverse events
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