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

Recruitment Status:
Not yet recruiting

Sponsor:
AstraZeneca

Collaborator:
IQVIA

Information Provided by (Responsible Party):
AstraZeneca

ClinicalTrials.gov Identifier:
NCT04516746

Verification:
Verified 01 September 2020   by AstraZeneca

History of Changes:
ClinicalTrials.gov

Purpose

The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the prevention of COVID-19.

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
Study Type:Interventional
Overall Recruitment Status:Not yet recruiting
Study Start Date:28 August 2020
Study Start Date Type:Anticipated
Primary Completion Date:22 December 2020
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking Description: Double Blind: two or more parties are unaware of the intervention assignment.
Model Description: Participants are assigned to one of two or more groups in parallel for the duration of the study.
ConditionInterventionPhase
COVID-19
SARS-CoV-2
Biological/Vaccine: AZD1222
Biological/Vaccine: Placebo
Phase 3
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Gender Based: No
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:
• Increased risk of SARS-CoV-2 infection
• Medically stable

Exclusion Criteria:
• confirmed or suspected immunosuppressive or immunodeficient state
• significant disease, disorder, or finding
• Prior or concomitant vaccine therapy for COVID-19


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    information.center@astrazeneca.com  

Sponsors and Collaborators

AstraZeneca
IQVIA

Investigators

Principal Investigator: Ann  Falsey , MD   University of Rochester School of Medicine
Principal Investigator: Magda  Sobieszczyk , MD   Columbia University

Locations

CountryLocationFacilityContactStatus
United States of America , TXResearch Site Austin, TX, United States of America, 78745Not Yet Recruiting
United States of America , TXResearch Site Dallas, TX, United States of America, 75208Not Yet Recruiting
United States of America , TXResearch Site Houston, TX, United States of America, 77030Not Yet Recruiting
United States of America , TXResearch Site San Antonio, TX, United States of America, 78229Not Yet Recruiting
United States of America , TXResearch Site San Antonio, TX, United States of America, 78234Not Yet Recruiting
United States of America , TXResearch Site The Woodlands, TX, United States of America, 77381Not Yet Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10032Not Yet Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10016Not Yet Recruiting
United States of America , NYResearch Site Rochester, NY, United States of America, 14621Not Yet Recruiting
United States of America , NYResearch Site Rochester, NY, United States of America, 14642Not Yet Recruiting
United States of America , NYResearch Site Valhalla, NY, United States of America, 10595Not Yet Recruiting
United States of America , SCResearch Site Charleston, SC, United States of America, 29406Not Yet Recruiting
United States of America , SCResearch Site Charleston, SC, United States of America, 29425Not Yet Recruiting
United States of America , SCResearch Site Spartanburg, SC, United States of America, 29303Not Yet Recruiting
United States of America , GAResearch Site Savannah, GA, United States of America, 31406Not Yet Recruiting
United States of America , GAResearch Site Stockbridge, GA, United States of America, 30281Not Yet Recruiting
United States of America , INResearch Site Indianapolis, IN, United States of America, 46202Not Yet Recruiting
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90095Not Yet Recruiting
United States of America , CAResearch Site San Diego, CA, United States of America, 92134Not Yet Recruiting
United States of America , CAResearch Site San Diego, CA, United States of America, 92103Not Yet Recruiting
United States of America , CAResearch Site San Francisco, CA, United States of America, 94102Not Yet Recruiting
United States of America , CAResearch Site Torrance, CA, United States of America, 90502Not Yet Recruiting
United States of America , FLResearch Site Atlantis, FL, United States of America, 33462Not Yet Recruiting
United States of America , FLResearch Site Coral Gables, FL, United States of America, 33134Not Yet Recruiting
United States of America , FLResearch Site Miami Lakes, FL, United States of America, 33016Not Yet Recruiting
United States of America , FLResearch Site Orlando, FL, United States of America, 32803Not Yet Recruiting
United States of America , SDResearch Site Dakota Dunes, SD, United States of America, 57049Not Yet Recruiting
United States of America , HIResearch Site Honolulu, HI, United States of America, 96814Not Yet Recruiting
United States of America , OHResearch Site Cincinnati, OH, United States of America, 45229Not Yet Recruiting
United States of America , OHResearch Site Columbus, OH, United States of America, 43205Not Yet Recruiting
United States of America , OHResearch Site Columbus, OH, United States of America, 43210Not Yet Recruiting
United States of America , RIResearch Site Warwick, RI, United States of America, 02886Not Yet Recruiting
United States of America , ALResearch Site Birmingham, AL, United States of America, 35294Not Yet Recruiting
United States of America , LAResearch Site Lake Charles, LA, United States of America, 70601Not Yet Recruiting
United States of America , LAResearch Site Monroe, LA, United States of America, 71203Not Yet Recruiting
United States of America , NJResearch Site Berlin, NJ, United States of America, 08009Not Yet Recruiting
United States of America , WIResearch Site Madison, WI, United States of America, 53792-5666Not Yet Recruiting
United States of America , VTResearch Site Burlington, VT, United States of America, 05401Not Yet Recruiting
United States of America , NVResearch Site Henderson, NV, United States of America, 89014Not Yet Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02215Not Yet Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02111Not Yet Recruiting
United States of America , NHResearch Site Portsmouth, NH, United States of America, 03801Not Yet Recruiting
United States of America , MNResearch Site Bloomington, MN, United States of America, 55425Not Yet Recruiting
United States of America , WAResearch Site Seattle, WA, United States of America, 98109Not Yet Recruiting
United States of America , NEResearch Site Omaha, NE, United States of America, 68134Not Yet Recruiting
United States of America , KSResearch Site Kansas City, KS, United States of America, 66160Not Yet Recruiting
United States of America , KSResearch Site Wichita, KS, United States of America, 67207Not Yet Recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60612Not Yet Recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60612Not Yet Recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60611Not Yet Recruiting
United States of America , UTResearch Site West Jordan, UT, United States of America, 84088Not Yet Recruiting
United States of America , MTResearch Site Butte, MT, United States of America, 59701Not Yet Recruiting
United States of America , MDResearch Site Baltimore, MD, United States of America, 21205Not Yet Recruiting
United States of America , MDResearch Site Bethesda, MD, United States of America, 20889Not Yet Recruiting
United States of America , AZResearch Site Phoenix, AZ, United States of America, 85018Not Yet Recruiting
United States of America , ORResearch Site Portland, OR, United States of America, 97239Not Yet Recruiting
United States of America , MIResearch Site Ann Arbor, MI, United States of America, 48109Not Yet Recruiting
United States of America , IAResearch Site Ankeny, IA, United States of America, 50023Not Yet Recruiting
United States of America , NDResearch Site Fargo, ND, United States of America, 58103Not Yet Recruiting
United States of America , OKResearch Site Oklahoma City, OK, United States of America, 73114Not Yet Recruiting
United States of America , PAResearch Site Pittsburgh, PA, United States of America, 15232Not Yet Recruiting
United States of America , NCResearch Site Durham, NC, United States of America, 27710Not Yet Recruiting
United States of America , ARResearch Site Little Rock, AR, United States of America, 72212Not Yet Recruiting

 File nameDescription
D8110C00001_CSPD8110C00001_CSP
.

Purpose

The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the prevention of COVID-19.

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
Study Type:Interventional
Overall Recruitment Status:Not yet recruiting
Study Start Date:28 August 2020
Study Start Date Type:Anticipated
Primary Completion Date:22 December 2020
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking Description: Double Blind: two or more parties are unaware of the intervention assignment.
Model Description: Participants are assigned to one of two or more groups in parallel for the duration of the study.
ConditionInterventionPhase
COVID-19
SARS-CoV-2
Biological/Vaccine: AZD1222
Biological/Vaccine: Placebo
Phase 3
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Gender Based: No
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:
• Increased risk of SARS-CoV-2 infection
• Medically stable

Exclusion Criteria:
• confirmed or suspected immunosuppressive or immunodeficient state
• significant disease, disorder, or finding
• Prior or concomitant vaccine therapy for COVID-19


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    information.center@astrazeneca.com  

Sponsors and Collaborators

AstraZeneca
IQVIA

Investigators

Principal Investigator: Ann  Falsey , MD   University of Rochester School of Medicine
Principal Investigator: Magda  Sobieszczyk , MD   Columbia University

Locations

CountryLocationFacilityContactStatus
United States of America , TXResearch Site Austin, TX, United States of America, 78745Not Yet Recruiting
United States of America , TXResearch Site Dallas, TX, United States of America, 75208Not Yet Recruiting
United States of America , TXResearch Site Houston, TX, United States of America, 77030Not Yet Recruiting
United States of America , TXResearch Site San Antonio, TX, United States of America, 78229Not Yet Recruiting
United States of America , TXResearch Site San Antonio, TX, United States of America, 78234Not Yet Recruiting
United States of America , TXResearch Site The Woodlands, TX, United States of America, 77381Not Yet Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10032Not Yet Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10016Not Yet Recruiting
United States of America , NYResearch Site Rochester, NY, United States of America, 14621Not Yet Recruiting
United States of America , NYResearch Site Rochester, NY, United States of America, 14642Not Yet Recruiting
United States of America , NYResearch Site Valhalla, NY, United States of America, 10595Not Yet Recruiting
United States of America , SCResearch Site Charleston, SC, United States of America, 29406Not Yet Recruiting
United States of America , SCResearch Site Charleston, SC, United States of America, 29425Not Yet Recruiting
United States of America , SCResearch Site Spartanburg, SC, United States of America, 29303Not Yet Recruiting
United States of America , GAResearch Site Savannah, GA, United States of America, 31406Not Yet Recruiting
United States of America , GAResearch Site Stockbridge, GA, United States of America, 30281Not Yet Recruiting
United States of America , INResearch Site Indianapolis, IN, United States of America, 46202Not Yet Recruiting
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90095Not Yet Recruiting
United States of America , CAResearch Site San Diego, CA, United States of America, 92134Not Yet Recruiting
United States of America , CAResearch Site San Diego, CA, United States of America, 92103Not Yet Recruiting
United States of America , CAResearch Site San Francisco, CA, United States of America, 94102Not Yet Recruiting
United States of America , CAResearch Site Torrance, CA, United States of America, 90502Not Yet Recruiting
United States of America , FLResearch Site Atlantis, FL, United States of America, 33462Not Yet Recruiting
United States of America , FLResearch Site Coral Gables, FL, United States of America, 33134Not Yet Recruiting
United States of America , FLResearch Site Miami Lakes, FL, United States of America, 33016Not Yet Recruiting
United States of America , FLResearch Site Orlando, FL, United States of America, 32803Not Yet Recruiting
United States of America , SDResearch Site Dakota Dunes, SD, United States of America, 57049Not Yet Recruiting
United States of America , HIResearch Site Honolulu, HI, United States of America, 96814Not Yet Recruiting
United States of America , OHResearch Site Cincinnati, OH, United States of America, 45229Not Yet Recruiting
United States of America , OHResearch Site Columbus, OH, United States of America, 43205Not Yet Recruiting
United States of America , OHResearch Site Columbus, OH, United States of America, 43210Not Yet Recruiting
United States of America , RIResearch Site Warwick, RI, United States of America, 02886Not Yet Recruiting
United States of America , ALResearch Site Birmingham, AL, United States of America, 35294Not Yet Recruiting
United States of America , LAResearch Site Lake Charles, LA, United States of America, 70601Not Yet Recruiting
United States of America , LAResearch Site Monroe, LA, United States of America, 71203Not Yet Recruiting
United States of America , NJResearch Site Berlin, NJ, United States of America, 08009Not Yet Recruiting
United States of America , WIResearch Site Madison, WI, United States of America, 53792-5666Not Yet Recruiting
United States of America , VTResearch Site Burlington, VT, United States of America, 05401Not Yet Recruiting
United States of America , NVResearch Site Henderson, NV, United States of America, 89014Not Yet Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02215Not Yet Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02111Not Yet Recruiting
United States of America , NHResearch Site Portsmouth, NH, United States of America, 03801Not Yet Recruiting
United States of America , MNResearch Site Bloomington, MN, United States of America, 55425Not Yet Recruiting
United States of America , WAResearch Site Seattle, WA, United States of America, 98109Not Yet Recruiting
United States of America , NEResearch Site Omaha, NE, United States of America, 68134Not Yet Recruiting
United States of America , KSResearch Site Kansas City, KS, United States of America, 66160Not Yet Recruiting
United States of America , KSResearch Site Wichita, KS, United States of America, 67207Not Yet Recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60612Not Yet Recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60612Not Yet Recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60611Not Yet Recruiting
United States of America , UTResearch Site West Jordan, UT, United States of America, 84088Not Yet Recruiting
United States of America , MTResearch Site Butte, MT, United States of America, 59701Not Yet Recruiting
United States of America , MDResearch Site Baltimore, MD, United States of America, 21205Not Yet Recruiting
United States of America , MDResearch Site Bethesda, MD, United States of America, 20889Not Yet Recruiting
United States of America , AZResearch Site Phoenix, AZ, United States of America, 85018Not Yet Recruiting
United States of America , ORResearch Site Portland, OR, United States of America, 97239Not Yet Recruiting
United States of America , MIResearch Site Ann Arbor, MI, United States of America, 48109Not Yet Recruiting
United States of America , IAResearch Site Ankeny, IA, United States of America, 50023Not Yet Recruiting
United States of America , NDResearch Site Fargo, ND, United States of America, 58103Not Yet Recruiting
United States of America , OKResearch Site Oklahoma City, OK, United States of America, 73114Not Yet Recruiting
United States of America , PAResearch Site Pittsburgh, PA, United States of America, 15232Not Yet Recruiting
United States of America , NCResearch Site Durham, NC, United States of America, 27710Not Yet Recruiting
United States of America , ARResearch Site Little Rock, AR, United States of America, 72212Not Yet Recruiting

Oversight


Is FDA regulated intervention: No 
Is IND/IDE protocol: Yes 
IND/IDE Grantor: CBER 
IND/IDE Number: 23522 
Has Expanded Access: No 
U.S. FDA-regulated Drug: Yes 
U.S. FDA-regulated Device: No 

More Information


D8110C00001_CSP

Publications:


Responsible Party:AstraZeneca
ClinicalTrials.gov Identifier:NCT04516746
Other Study ID Numbers:D8110C00001

Keywords provided by AstraZeneca
COVID-19 Vaccine

Additional Relevant MeSH terms:
COVID-19SARS-CoV-2

Primary Outcome Measures:

  • To estimate the efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults ≥ 18 years of age [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    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.

  • To assess the safety and tolerability of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age [ Time Frame: a: 28 days post each dose of study Intervention. / b: from Day 1 post-treatment through Day 730. ] [ Designated as safety issue:  ]
    a. Incidence of adverse events.
    b. Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest.

  • To assess the reactogenicity of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age (Substudy only) [ Time Frame: 7 days post each dose of study intervention. ] [ Designated as safety issue:  ]
    Incidence of local and systemic solicited adverse events.

Secondary Outcome Measures:

  • To estimate the efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of severe or critical symptomatic COVID-19 [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring ≥ 15 days post second
    dose of study intervention.

  • To estimate the efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of SARS-CoV-2 asymptomatic infection [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    Proportion of participants positive for SARS-CoV-2
    Nucleocapsid antibodies over time.

  • To estimate the efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of symptomatic COVID-19 using CDC criteria [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    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 CDC criteria

  • To estimate the efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of University of Oxford defined symptomatic COVID-19 [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    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

  • To estimate the efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19-related Emergency Department visits [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    The incidence of COVID-19-related Emergency Department visits occurring ≥ 15 days post second dose of study intervention

  • To assess antibody responses to AZD1222 S antigen following 2 IM doses of AZD1222 or placebo (Substudy and Illness Visits only) [ Time Frame: 28 days post each dose ] [ Designated as safety issue:  ]
    Post-treatment GMTs and GMFRs in SARS-CoV-2S, 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)

  • To determine anti-SARS-CoV-2 neutralizing antibody levels in serum following 2 IM doses of AZD1222 or placebo (Sub-study and Illness Visits only) [ Time Frame: 28 days post each dose ] [ Designated as safety issue:  ]
    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)

Other Pre-specified Outcome Measures:

  • [ Time Frame:  ] [ Designated as safety issue:  ]

ArmsAssigned Interventions
Experimental: AZD1222
2 IM doses of 5 × 10^10 vp (nominal, ± 1.5 × 10^10 vp) AZD1222 4 weeks apart
Biological/Vaccine: AZD1222
Participants will be randomized in a 2:1 ratio to receive 2 IM doses of either 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) AZD1222 (n = approximately 20,000) or saline placebo (the control group, n = approximately 10 000) 4 weeks apart
 
Placebo Comparator: Placebo
2 IM doses of saline placebo 4 weeks apart
Biological/Vaccine: Placebo
Participants will be randomized in a 2:1 ratio to receive 2 IM doses of either 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) AZD1222 (n = approximately 20,000) or saline placebo (the control group, n = approximately 10 000) 4 weeks apart