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
- Conditions
- -J98J98
- Registration Number
- PER-059-20
- Lead Sponsor
- AstraZeneca AB,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1470
Age
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
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
asplenia
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
disease
(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
follow-up
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:RT-PCR-confirmed SARS-CoV-2<br>Measure: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.<br>Timepoints:one year<br>;<br>Outcome name:EA reports<br>Measure:a)Incidence of adverse events.<br>b)Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest.<br>Timepoints:28 days post each dose of study Intervention. / b: from Day 1 post-treatment through Day 730<br>;<br>Outcome name:Solicited AE e-Diary<br>Measure:Incidence of local and systemic solicited adverse events.<br><br>Timepoints:7 days post each dose of study intervention<br>
- Secondary Outcome Measures
Name Time Method