AV. REPUBLICA DE PANAMA Nro. 3533, Int. 1404, Limatambo, San Isidro
District:
SAN ISIDRO, LIMA 27
Province:
LIMA
Departament:
LIMA
Single Taxpayer No :
20507022601
Telephone:
01-2649235, 999484309
Fax:
01-6153225
2. CLINICAL TRIAL GENERAL INFORMATION
Scientific 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
Change of Title for Clinical Trial Amendment Request :R.D. 449-2020-OGITT-INS Date 22/10/2020.
Public 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
Change of Title for Clinical Trial Amendment Request :R.D. 449-2020-OGITT-INS Date 22/10/2020.
Clinical Trial Registration Date
Most recent Clinical Trial Update
17/09/2020
Principal Sponsor :
1.- ASTRAZENECA AB
Secondary Sponsor :
Funding Source
1.- ASTRAZENECA AB
Executing Company / Institution / Other
- IQVIA RDS PERÚ S.R.L
-
Authorized with 391-2020-OGITT-INS Date 17/09/2020
Responsabilities
Others
IQVIA RDS Perú S.R.L
Inform to the OGITT of the NIH when the first subject is enrolled in Peru, and the end date of enrollment in the country.
Inform to the OGITT of the NIH when the first subject is enrolled in Peru, and the end date of enrollment in the country.
Submit progress reports to the National Health Institute during the execution of the Clinical Trial.
Submit to the OGITT of the NIH the final reports as well as the results, conclusions, and publication of the clinical trial
Notify to the OGITT of the NIH the adverse events and deviations as established in the Clinical Trials Regulation.
Inform and describe the reasons for a suspension and cancellation of the clinical trial.
Provide the facilities for the inspection of the execution of the clinical trial by the staff of the General Office of Research and Technology Transfer (OGITT) of the National Institute of Health.
Study clinical phase:
III
Protocol Code
D8110C00001
Secondary ID(s) :
WHO UTN:
NA
CLINICALTRIALS.GOV:
NCT04516746
EUDRACT N°:
NA
Study Design
D8110C00001 is a Phase III randomized, double-blind, placebo-controlled multicenter study
assessing the safety, efficacy, and immunogenicity of AZD1222 compared to saline placebo
for the prevention of COVID-19. Participants will be adults ≥ 18 years of age who are healthy
or have medically-stable chronic diseases, and are at increased risk for SARS-CoV-2
acquisition and COVID-19. Approximately 30 000 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 (n = approximately 10 000) 4 weeks apart, on
Days 1 and 29. Randomization will be stratified by age (≥ 18 and < 65 years, and ≥ 65 years),
with at least 25% of participants to be enrolled in the older age stratum.
Participants who present with at least one of the qualifying symptoms listed below through
Day 360 will be assessed for COVID-19. With the exception of fever, shortness of breath, or
difficulty breathing, the symptom must be present for 2 or more days. Participants with a
COVID-19 qualifying symptom(s) will be tested for SARS-CoV-2, and if positive will
complete illness visit assessments, as presented in Table 4. See Section 8.1 for details on
COVID-19 assessments.
Insurance policy due date
31/08/2022
Assignation method
Randomized
Non randomized
Type of blinding
Assignation
Simple
Double
Triple
Open
Single arm
Parallel
Crossed
Factorial
Others:
Purpose
-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.
-To assess the safety and tolerability of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age.
-To assess the reactogenicity of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age(Substudy only)
Research Product Information
Name of the product
Generic Name
Type of product
ATC
AZD1222 ≥ 0.7 X 10 11 PV/ML 5 ML VIAL IM
AZD1222 ≥ 0.7 x 10 11 pv/ml 5 mL Vial multidosis Solución para inyección Uso IM
V03
Name of the compare
Generic Name
Type of product
ATC
PLACEBO PARA AZD1222
Placebo para AZD1222
V03
Intervention(s) description:
Group name
Type of group
N° of participants
Intervention(s) description
GROUP 1: AZD1222 ≥ 0.7 X 10 11 PV/ML 5 ML VIAL IM
Experimental
Control
20000
Participants will receive 2 doses of either AZD1222 (≥ 0,7 × 1011 pv/ml)); 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. Other injection sites may be used if necessary.
All study participants will be observed in the clinic for at least 15 minutes after vaccination.
Each vial of AZD1222 has a label-claim volume of 5mL and can provide up to ten 0.5mL doses.
Each dose is prepared by withdrawing 0.5mL from a vial of AZD1222 in a sterile 1 mL or equivalent syringe.
GROUP 2: PLACEBO FOR AZD1222
Experimental
Control
10000
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. Other injection sites may be used if necessary. All study participants will be observed in the clinic for at least 15 minutes after vaccination
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
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-Barré 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 second dose of study
intervention
Worldwide enrolment start date
14/11/2020
Enrolment start date in Peru (Initial)
03/11/2020
Enrolment start date in Peru
14/11/2020
Peru enrolment status
Without starting enrollment
Enrollment stopped
In enrollment
Enrollment closed
Clinical Trial Total Duration
24 months
Medical Speciality
INFECTOLOGY
Studied Condition (CIE-10 code)
-J98
Number of subjects to be included in all the countries
30000
Number of subjects to be included in Peru (initial)
Number of subjects to be included in Peru (posterior)
5000
5000
Countries where the enrolment is conducted :
- Chile
- Peru
- United States
Number of participants per gender (Initial)
Female:
0
Male
:
0
Number of participants per gender (Posterior)
Female:
0
Male
:
0
Range of age of subjects to be included :
- Adults (18-64 years)
Yes
No
- Elderly (>= 65 years)
Yes
No
- Under 18 years
Yes
No
If yes, specify:
- In Utero
Yes
No
- Preterm newborn infants (up to gestational age < 37 weeks)
Yes
No
- Newborns (0-27 días)
Yes
No
- Infants and toddlers (28 days-23 months)
Yes
No
- Children (2 - 11 years)
Yes
No
- Adolescents (12 - 17 years)
Yes
No
Subjects' treatment time
30
day(s)
Subjects' follow up time
24 month(s)
Primary Outcome
Name of the outcome
Metric or method of measurement
Time point for the outcome
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.
RT-PCR-confirmed SARS-CoV-2
one year
a)Incidence of adverse events.
b)Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest.
EA reports
28 days post each dose of study Intervention. / b: from Day 1 post-treatment through Day 730
Incidence of local and systemic solicited adverse events.
Solicited AE e-Diary
7 days post each dose of study intervention
Secondary Outcome
Name of the outcome
Metric or method of measurement
Time point for the outcome
Proportion of participants positive for SARS-CoV-2 Nucleocapsid antibodies over time.
Serum sample for SARS-CoV-2 nAbs assessment
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 CDC criteria
RT-PCR positive
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.
RT-PCR positive
1 year
The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring ≥ 15 days post second dose of study intervention.
RT-PCR-positive
1 year
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)
MSD serology assay
28 days post each dose
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)
assay or pseudo-neutralization assay
28 days post each dose
3. RESEARCH SITE, PRINCIPAL INVESTIGATOR, ETHICS COMMITTEE
Research site where the clinical trial will be conducted
Principal Investigator
Institutional Research Ethics Committee (CIEI) that approved the trial for the site
Observations
Research Institution
RCI
Research site
Full name
RCEI
Ethics Committe Name
Status
Approval date
End approval date
Term
Telephone number
Email addrees
POLICLÍNICO ESPECIALIZADO EN NEUROLOGÍA S.A.C.
RCI 1038
Centro de Investigaciones Médicas
SERGIO ELI RECUENCO CABRERA
Cambio de Investigador por :
- EDWIN JAVIER PRETELL ALVA (Resolución Directoral 194-2021-OGITT/INS del 23/04/2021)
RCEI-305
COMITÉ NACIONAL TRANSITORIO DE ÉTICA EN INVESTIGACIÓN PARA LA EVALUACIÓN Y SUPERVISIÓN DE ÉTICA DE LOS ENSAYOS CLÍNICOS DE LA ENFERMEDAD COVID-19 - CNTEI
Approved
31/08/2020
31/08/2020
0
7126450
Co-Investigator
- Cesar Augusto Gamarra Ayarza
CLÍNICA INTERNACIONAL S.A.
RCI-307
UNIDAD DE INVESTIGACIÓN DE LA CLÍNICA INTERNACIONAL
ALFREDO GILBERTO GUERREROS BENAVIDES
RCEI-305
COMITÉ NACIONAL TRANSITORIO DE ÉTICA EN INVESTIGACIÓN PARA LA EVALUACIÓN Y SUPERVISIÓN DE ÉTICA DE LOS ENSAYOS CLÍNICOS DE LA ENFERMEDAD COVID-19 - CNTEI
Approved
10/09/2020
10/09/2021
- Research Site Extension R.D. 471-2020-OGITT-INS with date 03/11/2020
Co-Investigator
ADMINISTRADORA CLÍNICA RICARDO PALMA S.A.
RCI-759
CENTRO DE INVESTIGACIÓN RICARDO PALMA
JUAN VICENTE GUANIRA CARRANZA
RCEI-305
COMITÉ NACIONAL TRANSITORIO DE ÉTICA EN INVESTIGACIÓN PARA LA EVALUACIÓN Y SUPERVISIÓN DE ÉTICA DE LOS ENSAYOS CLÍNICOS DE LA ENFERMEDAD COVID-19 - CNTEI
Approved
10/09/2020
10/09/2021
- Research Site Extension R.D. 471-2020-OGITT-INS with date 03/11/2020
Co-Investigator
COMPLETION DATE:
4. IPD SHARING STATEMENT
Is there a plan for sharing of deidentified individual clinical trial participant-level data (IPD) to other researchers (including data dictionaries)?
Yes
No
Non decided
In case the answer is affirmative, describe the Plan.
Additional information that will be shared.
Study protocol
Statistical Analysis Plan
Informed Consent Form
Clinical Study report
Others:
________________
Describe briefly when this information will be available and how it can be obtained
