SARS-COV-2 infection (COVID-19) MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Vaxzevria
Product Code: AZD1222
Pharmaceutical Form: Solution for injection
CAS Number: 2420395-83-9
Current Sponsor code: AZD1222
Other descriptive name: ChAdOx1 nCoV-19
Concentration uni
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Adult, = 18 years of age at the time of consent For inclusion in the SARS-CoV-2 seronegative population: 2 No history of laboratory-confirmed SARS-CoV-2 infection (ie, no positive nucleic acid amplification test and no positive antibody test). 3 Seronegative for SARS-CoV-2 at screening (lateral flow test to detect reactivity to the nucleoprotein). 4 Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up 5 Able to understand and comply with study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative) based on the assessment of the investigator 6 Signed informed consent obtained before conducting any study-related procedures 7 Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Previously COVID-19 Vaccinated Participants 8 Prior completion of a 2-dose primary homologous vaccination regimen against the original SARSCoV-2 Wuhan-hu-1 strain with either AZD1222 (2 standard doses as authorized vaccine or as investigational product in a clinical trial with a 4 to 12-week dosing interval) or with an mRNA vaccine approved for emergency or conditional use (eg, BNT162b2 vaccine [Pfizer-BioNTech] with a 3- to 12-week dosing interval or mRNA-1273 vaccine [Moderna] with a 4- to 12- week dosing interval). The second dose in all cases should have been administered at least 90 days prior to first administration of study intervention. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2137 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 712
Exclusion criteria
Exclusion criteria: 1 History of allergy to any component of AZD1222/AZD2816. 2 History of Guillain-Barré syndrome, any demyelinating disease, or any other neuroimmunologic condition 3 Significant infection or other acute illness, including fever > 100 °F (> 37.8 °C) on the day prior to or day of randomization 4 Any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia or HIV/AIDS. 5 Recurrent severe infections and use of immunosuppressant medication within the past 6 months (= 20 mg per day of prednisone or its equivalent, given daily or on alternate days for = 15 days within 30 days prior to administration of study intervention). The following exceptions are permitted: Topical/inhaled steroids or short-term oral steroids (course lasting = 14 days) 6 History of primary malignancy (see protocol) 7 History of thrombocytopenia and/or thrombosis, including participants who have experienced major venous and/or arterial thrombosis in combination with thrombocytopenia following vaccination with any COVID-19 vaccine 8 History of heparin-induced thrombocytopenia, congenital thrombophilia (ie, factor V Leiden, prothrombin G20210A, antithrombin III deficiency, protein C deficiency and protein S deficiency, factor XIII mutation, familial dysfibrinogenemia), auto-immune thrombophilia (antiphospholipid syndrome, anti-cardiolipin antibodies, anti-ß2- glycoprotein 1 antibodies), or paroxysmal nocturnal haemoglobinuria. 9 Clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture 10 Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged by the Investigator (note, mild/moderate well-controlled comorbidities are allowed) 11 Any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data 12 Any autoimmune conditions, except mild psoriasis and vitiligo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Previously Unvaccinated Participants Receiving a 2-Dose Primary Vaccination To characterize the safety and tolerability of a 2-dose primary vaccination with AZD2816 with a 4-week dosing interval in previously unvaccinated seronegative participants. Previously Vaccinated Participants Receiving a 1-Dose Booster To characterize the safety and tolerability of 1 booster dose of AZD2816 in participants previously vaccinated with AZD1222. Immunogenicity objectives: see protocol;Secondary Objective: Previously Unvaccinated Participants Receiving a 2-Dose Primary Vaccination - To characterize the safety and tolerability of a heterologous primary vaccination with 1 dose of AZD1222 followed by 1 dose of AZD2816 administered with a 4-week dosing interval in previously unvaccinated seronegative participants - To characterize the safety and tolerability of a 2-dose primary vaccination with AZD2816 with a 12-week dosing interval in previously unvaccinated seronegative participants - To characterize the extended safety of a 2-dose primary vaccination with AZD2816 with a 4-week dosing interval in previously unvaccinated seronegative participants (see more in protocol) Previously Vaccinated Participants Receiving a 1-Dose Booster - To characterize the safety and tolerability of 1 booster dose of AZD1222 in seronegative participants previously vaccinated with AZD1222 (see more in protocol) Immunogenicity objectives: see protocol;Primary end point(s): Nadve unvaccinated cohort receiving a 2-dose primary vaccination and Previously vaccinated cohort receiving a 1-dose booster vaccination -Incidence of local and systemic solicited AEs for 7 days post-dose - Incidence of unsolicited AEs, including MAAEs, SAEs, and AESIs, for 28 days post-dose -The change from baseline for safety laboratory measures for 28 days post-dose Immunogenicity endpoints: for Nadve unvaccinated cohort receiving a 2-dose primary vaccination -GMT ratio of pseudoneutralizing antibodies for AZD2816 vac | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Incidence of local and systemic solicited AEs for 7 days post-dose - Incidence of unsolicited AEs, including MAAEs, SAEs, and AESIs for 28 days post-dose - Incidence of MAAEs, SAEs, and AESIs from Day 1 through 6 months post-vaccination Secondary immunogenicity endpoints: Both cohorts: - GMT ratio of pseudoneutralizing antibodies for B.1.351/Wuhan-hu-1 - Difference in seroresponse (>4-fold increase from baseline in pseudoneutralizing antibodies) against B.1.351 versus Wuhan-hu-1 Nadve unvaccinated cohort receiving a 2-dose primary vaccination - GMT ratio of pseudoneutralizing antibodies for AZD2816 vaccination/AZD1222 vaccination -Difference in seroresponse (>4-fold increase from baseline in pseudoneutralizing antibodies) for AZD2816 vaccination - AZD1222 vaccination - GMT ratio of pseudoneutralizing antibodies for AZD1222+AZD2816 vaccination/AZD1222 vaccination -Difference in seroresponse (>4-fold increase from baseline in pseudoneutralizing antibodies) for AZD1222+AZD2816 vaccination - AZD1222 vaccination Previously vaccinated cohort receiving a 1-dose booster vaccination - GMT ratio of pseudoneutralizing antibodies for AZD2816 booster/AZD1222 booster - GMT ratio of pseudoneutralizing antibodies for AZD1222 booster/AZD1222 vaccination - GMT ratio of pseudoneutralizing antibodies for AZD2816 booster/AZD1222 vaccination - Difference in seroresponse (>4-fold increase from baseline in pseudoneutralizing antibodies) for AZD2816 booster versus AZD1222 primary vaccination -Difference in seroresponse (>4-fold increase from baseline in pseudoneutralizing antibodies) for AZD2816 booster versus AZD1222 booster;Timepoint(s) of evaluation of this end point: for 7 and 28 days post-dose until 6 months post vaccination for immunogenicity objectives - 56 days post-dose (2nd dose), 28 days post booster | — |
Countries
Brazil, Poland, South Africa, United Kingdom
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed