An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04713488|
Recruitment Status : Active, not recruiting
First Posted : January 19, 2021
Last Update Posted : February 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Prevention||Biological: Sputnik Light||Phase 1 Phase 2|
Screening Period = up to 7 days All screening procedures must be executed within the shortest possible time frame before the scheduled date for Visit 1 (drug administration). The laboratory and instrumental examination data obtained within 14 days before the screening will be recorded as the screening data.
The trial will include 110 volunteers that will be administered the study drug. Outpatient observation will be done over the course of 4 visits: on day 10, 28, and 42 following drug administration Along with that, the study will be continued in accordance with the Protocol, accompanied by all the prescribed procedures and visits up to 180 days of observation.
Visit No. 0 (outpatient): screening Visit No. 1 (outpatient): vaccination Visits No. 2, 3, 4, 5, and 8: follow-up on days 10, 28, 42, 90, and180 after vaccination.
On days 120 and 150, visits 6 and 7 will be accomplished by telephone contact / telemedicine conference or, if necessary, in the form of an in-person visit.
Any volunteer who received a dose of the study drug will be registered as a trial participant, and his/her data will be used to help assess the drug's safety and tolerability.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" t Vaccine for Prevention of Coronavirus Infection Caused by the SARS-CoV-2 Viruso|
|Actual Study Start Date :||January 15, 2021|
|Estimated Primary Completion Date :||July 20, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Experimental: Sputnik Light Vaccine
solution for intramuscular injection Composition for 1 dose (0.5 ml): Active substance: recombinant serotype 26 adenoviral particles containing the SARS-CoV-2 S protein gene, in the amount of (1.0±0.5) x 10*11 particles per dose.
Biological: Sputnik Light
solution for intramuscular injection Composition for 1 dose (0.5 ml)
Other Name: vector vaccine to help prevent the SARS-CoV-2-induced coronavirus infection
- Changing of antibody levels against the SARS-CoV-2 glycoprotein S [ Time Frame: at days 0,10, 28, 42, 180 ]Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
- Number of Participants With Adverse Events [ Time Frame: through the whole study, an average of 180 days ]Determination of Number of Participants With Adverse Events
- Changing of of virus neutralizing antibody titer [ Time Frame: at days 0, 28, 42 ]Determination of changing of virus neutralizing antibody titer from baseline scores and at day 28 and 42
- Changing of antigen-specific cellular immunity level [ Time Frame: at days 0, 10 ]Determination of antigen-specific cellular immunity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713488
|Sankt Peterburg, Russian Federation|