Other substances

Gam-COVID-Vac

COVID-19 candidate vaccine

Phase of research

Emergency use authorization

How it helps

Vaccine

Drug status

Experimental

Supporting references

Contradictory references

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	DB entry date
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 2019	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	Feb/03/2021
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	Sep/07/2020
Draft landscape of COVID-19 candidate vaccines	healthy adults			Jul/28/2020	Aug/05/2020

Contradictory references

Link	Tested on	Impact factor	Notes	Publication date	DB entry date
Broadly neutralizing antibodies overcome SARS-CoV-2 Omicron antigenic shift Spike protein Spike variant Protein factor In vitro Antibody	Vero E6-TMPRSS2 cells; SARS-CoV-2 Spike-pseudotyped viruses (including WA1/2020 D614G or Omicron)	49.96 (2020)	In the case of majority of vaccinated patients, the sera were not capable to neutralize SARS-CoV-2 Omicron Spike-pseudotyped virus in vitro. Dosage: 2 doses.	Dec/23/2021	Feb/18/2022

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
Acronym - SPRAY Alternative id - SPRAY vaccine against COVID-19 Interventions - Biological: Gam-COVID-Vac, Other: Placebo Study type - Interventional Study results - No Results Available 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
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 Study 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
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 Study 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
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 Study 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
NCT04954092	Study of Gam-COVID-Vac in Adolescents	Recruiting	Phase 2\|Phase 3	Jul/05/2021	Dec/31/2023
Acronym - OLSTAD Alternative id - OLSTAD Interventions - Biological: Gam-COVID-vac M, Biological: Placebo Study type - Interventional Study results - No Results Available Study 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
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 Study 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.
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 Study 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
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
Acronym - COVID-19 Alternative id - 3876 Study type - Observational Study results - No Results Available Study 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
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
Acronym - SPUTNIK-UAE Alternative id - 06-Gam-COVID-Vac-2020 Interventions - Biological: Gam-COVID-Vac, Other: placebo Study type - Interventional Study results - No Results Available 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
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 Study 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
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
Acronym - VENEZUELA Alternative id - 01V-Gam-COVID-Vac-2020 Interventions - Biological: Gam-COVID-Vac, Biological: Placebo Study type - Interventional Study results - No Results Available 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 Study 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
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 Study 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
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
Acronym - RESIST Alternative id - 04-Gam-COVID-Vac-2020 Interventions - Biological: Gam-COVID-Vac, Other: placebo Study type - Interventional Study results - No Results Available Study 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
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 Study 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
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 Study 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

Gam-COVID-Vac

General information

Marketed as

Supporting references

Contradictory references

Clinical trials

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