None listed
Conditions
Interventions
GROUP 1: AZD1222 ≥
0.7 X 10 11 PV/ML 5 ML VIAL IM Type of group
Participants will receive 2 doses of either AZD1222 (≥
0,7 × 1011 pv/ml))
GROUP 2: PLACEBO FOR AZD1222 Type of group
Participants will receive 2 doses of placebo (0.5ml)
the first dose will be administered on Day 1 and the second dose on Day 29. It is recommended that the study interventions be administered as an IM injection into the deltoid of the non-dominant arm.
Sponsors
AstraZeneca AB,
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:RT-PCR-confirmed SARS-CoV-2 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. Timepoints:one year ; Outcome name:EA reports Measure:a)Incidence of adverse events. b)Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest. Timepoints:28 days post each dose of study Intervention. / b: from Day 1 post-treatment through Day 730 ; Outcome name:Solicited AE e-Diary Measure:Incidence of local and systemic solicited adverse events. Timepoints:7 days post each dose of study intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Serum sample for SARS-CoV-2 nAbs assessment Measure:Proportion of participants positive for SARS-CoV-2 Nucleocapsid antibodies over time. Timepoints:1 year ; Outcome name:RT-PCR positive Measure: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 Timepoints:1 year ; Outcome name:RT-PCR positive Measure: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. Timepoints:1 year ; Outcome name:RT-PCR-positive Measure:The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring ≥ 15 days post second dose of study intervention. Timepoints:1 year ; Outcome name:MSD serology assay Measure:a)Post-treatment GMTs and GMFRs in SARS-CoV-2S, RBD antibodies ; b)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) Timepoints:28 days post each dose ; Outcome name:assay or pseudo-neutralization assay Measure:a)Post-treatment GMTs and GMFRs in SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay); b)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) Timepoints:28 days post each dose | — |
Countries
Chile, Peru, United States
Contacts
Public ContactPaul Toralva
IQVIA RDS Peru S.R.L
Outcome results
None listed