AstraZeneca jab is still in a clinical trial until February 2023

April 28th, 2021

Awake Goy

*** all the covid vaccine on the market are still on trial ***

Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults

ClinicalTrials.gov Identifier: NCT04516746

Recruitment Status : Active, not recruitingFirst Posted : August 18, 2020Last Update Posted : April 13, 2021

Sponsor:AstraZenecaCollaborator:Iqvia Pty LtdInformation provided by (Responsible Party):AstraZeneca

Study DescriptionGo to sections Brief Summary:The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the prevention of COVID-19.

Condition or disease	Intervention/treatment	Phase
COVID-19SARS-CoV-2	Biological: AZD1222Biological: Placebo	Phase 3

Detailed Description:The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no specific treatments available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID-19 prevention would have significant public health impact.Study DesignGo to sections

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	32459 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Participants are assigned to one of two or more groups in parallel for the duration of the study.
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:	Double Blind: two or more parties are unaware of the intervention assignment.
Primary Purpose:	Treatment
Official Title:	A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults, to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
Actual Study Start Date :	August 28, 2020
Actual Primary Completion Date :	March 5, 2021
Estimated Study Completion Date :	February 14, 2023

Arms and InterventionsGo to sections

Arm	Intervention/treatment
Experimental: AZD1222Approximately 20,000 participants randomized to the AZD1222 arm	Biological: AZD1222AZD12222 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2-5 surface glycoprotein.
Placebo Comparator: PlaceboApproximately 10,000 participants randomized to the saline placebo arm	Biological: PlaceboCommercially available 0.9% (n/V) saline for injection.

Outcome MeasuresGo to sections
Primary Outcome Measures :

The efficacy of 2 IM doses of AZD1222 compared to saline placebo for the prevention of COVID-19 [ Time Frame: 1 year ]A binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case.
The safety and tolerability of 2 IM doses of AZD1222 compared to saline placebo [ Time Frame: a: 28 days post each dose of study Intervention. / b: from Day 1 post-treatment through Day 730. ]
1. Incidence of adverse events.
2. Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest.
The reactogenicity of 2 IM doses of AZD1222 compared to saline placebo (Substudy only) [ Time Frame: 7 days post each dose of study intervention. ]Incidence of local and systemic solicited adverse events.

Secondary Outcome Measures :

The efficacy of 2 IM doses of AZD1222 compared tosaline placebo for the prevention of SARS-CoV-2 infection [ Time Frame: 1 year ]The incidence of the first post-treatment response (negative at baseline to positive post treatment with study intervention) for SARS-CoV-2 Nucleocapsid antibodies occurring greater than or equal to 15 days post second dose of study intervention.
The efficacy of 2 IM doses of AZD1222 compared to saline placebo for the prevention of symptomatic COVID-19 using CDC criteria [ Time Frame: 1 year ]The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness for a participant occurring at or after 15 days post second dose of study intervention using criteria from the CDC.
The efficacy of 2 IM doses of AZD1222 compared to saline placebo for the prevention of University of Oxford defined symptomatic COVID-19 [ Time Frame: 1 year ]The incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using University of Oxford defined symptom criteria.
The efficacy of 2 IM doses of AZD12222 compared to saline placebo for the prevention of severe or critical symptomatic COVID-19. [ Time Frame: 1 year ]The incidence of SARS-CoV-RT-PCR-positive severe or critical symptomatic illness occurring 15 days or more post second dose of study intervention. The incidence of SARS-CoV-2 RT-PCR positive severe or critical symptomatic illness occurring post first dose of study intervention
The efficacy of 2 IM doses of AZD1222 compared to saline placebo for the prevention of COVID-19-related Emergency Department visits [ Time Frame: 1 year ]The incidence of COVID-19-related Emergency Department visits occurring ≥ 15 days post second dose of study intervention
Antibody responses to AZD1222 S antigen following 2 IM doses of AZD1222 or saline placebo (Substudy and Illness Visits only) [ Time Frame: 28 days post each dose ]Post-treatment GMTs and GMFRs in SARS-CoV-2 S, RBD antibodies (MSD serology assay); The proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to the S, RBD antigens of AZD1222 (MSD serology assay)
Anti-SARS-CoV-2 neutralizing antibody levels in serum following 2 IM doses of AZD1222 or saline placebo (Substudy and Illness Visits only) [ Time Frame: 28 days post each dose ]Post-treatment GMTs and GMFRs in SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay); Proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to AZD1222 as measured by SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay)
The efficacy of 2 IM doses of AZD1222 compared to saline placebo in the prevention of COVID-19 in all study participants, regardless of evidence of prior SARS-CoV-2 infection [ Time Frame: 1 year ]The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring ≥ 15 days post second dose of study intervention regardless of evidence of prior SARS-CoV-2 infection
The efficacy of AZD1222 compared to saline placebo for the prevention of COVID-19 following the first dose [ Time Frame: 1 year ]The incidence of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring post first dose of study intervention

https://clinicaltrials.gov/ct2/show/NCT04516746

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