The objective is to evaluate the safety and immunogenicity of AZD1222 given in combination with (either before or after) rAd26-S, for the prevention of COVID 19 in adults ≥ 18 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
100
Participants will receive 1 intramuscular (IM) injection of 5 ×1010 viral particles (vp) (nominal) of AZD1222 on Day 1 followed by rAd26-S 1×1011 viral particles (vp) (nominal) on Day 29 of the study
Participants will receive 1 IM injection of rAd26-S on Day 1 followed by AZD1222 on Day 29
OJSC Clinical and Diagnostic Center Euromedservice
Moscow, Russia
LLC PiterClinica
Saint Petersburg, Russia
Federal State Budgetary Educational Institution of Higher Education " First Saint Petersburg State Medical University named after Academician I. P. Pavlov" of the Ministry of Healthcare of the Russian Federation
Saint Petersburg, Russia
Federal State Budget Institution "Scientific and Research Institute of Flu n.a. A.A. Smorodintseva" of Ministry of Health of Russian Federation
Antibody seroconversion rate (≥ 4-fold increase from baseline) against SARS-CoV-2 neutralising antibodies 29 days post second vaccination.
Immunogenicity
Time frame: Day 29 through Day 57
Incidence of local and systemic solicited AEs for 7 days following each vaccination (Day 1 through Day 7 for first vaccination and Day 29 through Day 35 for second vaccination).
Safety
Time frame: Day 1 through Day 7 and Day 29 through Day 35
Incidence of unsolicited AEs, SAEs and AESIs through 29 days post each vaccination (ie, until Day 29 following the first vaccination and Day 57 following the second vaccination).
Safety
Time frame: 57 days
Incidence of SAEs and AESIs after first vaccination until study end (Day 180).
Safety
Time frame: 180 days
Antibody seroconversion rate (≥ 4-fold increase from baseline) against SARS-CoV-2 Spike protein
Immunogenicity
Time frame: 180 days
Antibody seroconversion rate (≥ 4-fold increase from baseline) against RBD antigen.
Immunogenicity
Time frame: 180 days
GMT and GMFR of immunogenicity against Spike and RBD antigens (MSD serology assay) at the day of vaccination (baseline), Day 15, 29 days post each vaccination and at study end (Day 180).
Immunogenicity
Time frame: 180 days
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Saint Petersburg, Russia
Antibody seroconversion rate (≥ 4-fold increase from baseline) SARS-CoV-2 neutralising antibodies 29 days post first vaccination
Immunogenicity
Time frame: Day 1 through Day 29
GMT and GMFR of immunogenicity as measured by SARS-CoV-2 neutralising antibodies at day of vaccination (baseline), Day 15, 29 days post each vaccination and at study end (Day 180).
Immunogenicity
Time frame: 180 days
Intracellular cytokine staining, including quantification of Th1/Th2 responses, and flow cytometry for B- and T-cell responses from day of dosing baseline to 29 days post each vaccination and until study end
Safety
Time frame: 180 days
A binary response, whereby a participant is defined as a COVID-19 case if their illness (virologically confirmed [RT-PCR positive] and symptomatic) occurs
Efficacy
Time frame: Day 29 through Day 180