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Clinical Trials/PER-059-20
PER-059-20Recruiting未知

A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY IN ADULTS TO DETERMINE THE SAFETY, EFFICACY, ANDIMMUNOGENICITY OF AZD1222, A NON-REPLICATING CHADOX1 VECTOR VACCINE, FOR THE PREVENTION OF COVID-19

AstraZeneca AB,0 sites1,470 target enrollmentStarted: September 17, 2020Last updated:
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Conditions

Trial Snapshot

Phase
未知
Status
Recruiting
Enrollment
1,470
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •1 Adult, ≥ 18 years of age at the time of consent
  • •Type of Participant
  • •2 Increased risk of SARS-CoV-2 infection
  • • Defined as adults whose locations or circumstances put them at appreciable risk of
  • •exposure to SARS-CoV-2 and COVID-19, based on available risk assessment
  • •contemporaneous to enrollment (believed to be at risk/exposure)
  • •3 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-upA stable medical
  • •condition is defined as disease not requiring significant change in therapy or
  • •hospitalization for worsening disease during the 3 months prior to enrollmentAble 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
  • •Reproduction
  • •5 Contraceptive use by women should be consistent with local regulations regarding the
  • •methods of contraception for those participating in clinical studies
  • •6 Female participants
  • •(a) Women of childbearing potential must:
  • • Have a negative pregnancy test on the day of screening and on Day 1
  • • Use one highly effective form of birth control for at least 28 days prior to Day 1
  • •and agree to continue using one highly effective form of birth control through
  • •60 days following administration of the second dose of study intervention. A
  • •highly effective method of contraception is defined as one that can achieve a
  • •failure rate of less than 1% per year when used consistently and correctly (see
  • •Table 6). Periodic abstinence, the rhythm method, and withdrawal are NOT
  • •acceptable methods of contraception.
  • •(b) Women are considered of childbearing potential unless they meet either of the
  • •following criteria:
  • • Surgically sterilized (including bilateral tubal ligation, bilateral oophorectomy, or
  • •hysterectomy), or
  • • Post-menopausal
  • • For women aged < 50 years, post-menopausal is defined as having both:
  • •o A history of ≥ 12 months amenorrhea prior to randomization, without
  • •an alternative cause, following cessation of exogenous sex-hormonal
  • •treatment, and
  • •A follicle-stimulating hormone level in the post-menopausal range
  • •Until follicle-stimulating hormone is documented to be within menopausal
  • •range, the participant is to be considered of childbearing potential
  • • For women aged ≥ 50 years, post-menopausal is defined as having a history
  • •of ≥ 12 months amenorrhea prior to randomization, without an alternative
  • •cause, following cessation of exogenous sex-hormonal treatment
  • •Informed Consent
  • •7 Capable of giving signed informed consent as described in Appendix A, which includes
  • •compliance with the requirements and restrictions listed in the ICF and in this protocol

Exclusion Criteria

  • •Participants are excluded from the study if any of the following criteria apply:
  • •Medical Conditions
  • •1 History of allergy to any component of the vaccine
  • •2 History of Guillain-Barre syndrome
  • •3 Significant infection or other acute illness, including fever > 100 ℉ (> 37.8 °C) on the
  • •day prior to or day of randomization
  • •4 History of laboratory-confirmed SARS-CoV-2 infection
  • •5 Any confirmed or suspected immunosuppressive or immunodeficient state, including
  • •6 Recurrent severe infections and use of immunosuppressant medication within the past
  • •6 months (≥ 20 mg/kg/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)
  • • Human immunodeficiency virus-positive stable participants on stable antiretroviral
  • •therapy (Waldrop et al, 2016)
  • •7 History of primary malignancy except for:
  • •(a) Malignancy with low potential risk for recurrence after curative treatment (for
  • •example, history of childhood leukaemia) or metastasis (for example, indolent
  • •prostate cancer) in the opinion of the site investigator.
  • •(b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of
  • •(c) Adequately treated uterine cervical carcinoma in situ without evidence of disease
  • •(d) Localized prostate cancer
  • •8 Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet
  • •disorder), or prior history of significant bleeding or bruising following IM injections or
  • •venepuncture
  • •9 Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal
  • •disease, liver disease, renal disease, endocrine disorder, and neurological illness, as
  • •judged by the Investigator (mild/moderate well-controlled comorbidities are allowed)
  • •10 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
  • •Prior/Concomitant Therapy
  • •11 Receipt of, or planned receipt of investigational products indicated for the treatment or
  • •prevention of SARS-CoV-2 or COVID-19
  • •Note: For participants who become hospitalized with COVID-19, receipt of licensed
  • •treatment options and/or participation in investigational treatment studies is permitted
  • •12 Receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines
  • •within 30 days prior to and after administration of study intervention
  • •13 Receipt of immunoglobulins and/or any blood products within 3 months prior to
  • •administration of study intervention or expected receipt during the period of study
  • •Other Exclusions
  • •14 Involvement in the planning and/or conduct of this study (applies to both Sponsor staff
  • •and/or staff at the study site)
  • •15 For women only - currently pregnant (confirmed with positive pregnancy test) or
  • •breast-feeding
  • •16 Has donated ≥ 450 mL of blood products within 30 days prior to randomization or
  • •expects to donate blood within 90 days of administration of s

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