Vía Central 125, Edificio Real Ocho Piso 16, Urbanización Empresarial Real
District:
San Isidro
Province:
Lima
Departament:
Lima
Single Taxpayer No :
20514703117
Telephone:
2112646
Fax:
2112643
2. CLINICAL TRIAL GENERAL INFORMATION
Scientific title:
COVID-19: A PHASE 2A, PARTIALLY OBSERVER-BLIND, MULTICENTER, CONTROLLED, DOSE-CONFIRMATION CLINICAL TRIAL TO EVALUATE THE SAFETY, REACTOGENICITY AND IMMUNOGENICITY OF THE INVESTIGATIONAL SARS-COV-2 MRNA VACCINE CVNCOV IN ADULTS >60 YEARS OF AGE AND 18 TO 60 YEARS OF AGE
Public Title
COVID-19: A PHASE 2A, PARTIALLY OBSERVER-BLIND, MULTICENTER, CONTROLLED, DOSE-CONFIRMATION CLINICAL TRIAL TO EVALUATE THE SAFETY, REACTOGENICITY AND IMMUNOGENICITY OF THE INVESTIGATIONAL SARS-COV-2 MRNA VACCINE CVNCOV IN ADULTS >60 YEARS OF AGE AND 18 TO 60 YEARS OF AGE
Clinical Trial Registration Date
Most recent Clinical Trial Update
20/08/2020
Principal Sponsor :
1.- CUREVAC AG
Secondary Sponsor :
Funding Source
1.- CUREVAC AG
Executing Company / Institution / Other
- RPS PERU S.A.C
-
Authorized with 312-2020-OGITT-INS Date 20/08/2020
Responsabilities
RPS PERU S.A.C
Others
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:
II
Protocol Code
CV-NCOV-002
Secondary ID(s) :
WHO UTN:
NA
CLINICALTRIALS.GOV:
NA
EUDRACT N°:
NA
Study Design
This is a Phase 2a, partially blind, active-controlled, dose-confirmation trial to assess the safety and immunogenicity of provisionally selected CVnCoV dose levels of 6 and 8 μg in an older adult population. The design of the trial will allow an increase or decrease in dose based on data from Trial CV-NCOV-001 and the initial phase of this trial. An overview of the planned number of subjects to be enrolled per trial group and vaccination schedules is provided in Synopsis Table 1.
Subjects will be recruited independent of their SARS-CoV-2 serology status. Their serostatus will be determined retrospectively by a blood sample drawn at baseline and analyzed to allow post hoc stratified analyses of subjects who are SARS-CoV-2 seronegative or seropositive at baseline.
Initial Phase
Subjects will be enrolled in 3 cohorts divided into 6 groups:
• 6 μg dose level cohorts
o Group 1 (observer-blind): CVnCoV 6 μg on Day 1 and 6 μg on Day 29 (in subjects 18 to 60 years of age)
o Group 2 (observer-blind): CVnCoV 6 μg on Day 1 and 6 μg on Day 29 (in subjects >60 years of age [i.e., 61 years or older])
• 8 μg dose level cohorts
o Group 3 (observer-blind): CVnCoV 8 μg on Day 1 and 8 μg on Day 29
o Group 4 (open-label): simultaneous administration of 2 injections of CVnCoV 4 μg at different administration sites on Day 1 (total dose of 8 μg) followed by a third injection of CVnCoV 4 μg on Day 29
• Active control cohort
o Group 5 (observer-blind): licensed hepatitis A vaccine on Day 1 and on Day 29 (in subjects 18 to 60 years of age)
o Group 6 (observer-blind): licensed pneumococcal vaccine on Day 1 and on Day 29 (in subjects >60 years of age)
A subgroup of subjects in Groups 1, 2, and 3 will receive a booster dose of CVnCoV on Day 180 in an open-label manner.
(Additional information, please review the protocol)
Insurance policy due date
01/01/2022
Assignation method
Randomized
Non randomized
Type of blinding
Assignation
Simple
Double
Triple
Open
Single arm
Parallel
Crossed
Factorial
Others:
Purpose
Primary
• To evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
• To evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV.
Research Product Information
Name of the product
Generic Name
Type of product
ATC
CV07050101
R9515
J07
Name of the compare
Generic Name
Type of product
ATC
AVAXIM 160 U
Vacuna antihepatitis A, virus entero inactivo
J07
PREVENAR ® 13 VALENTE
Vacuna conjugada Neumocócica de polisacáridos purificados
J07
VAQTA® 50U/1 ML
Vacuna antihepatitis A, virus entero inactivado
J07
Intervention(s) description:
Group name
Type of group
N° of participants
Intervention(s) description
Arm 1
Experimental
Control
90
• Group 1 (6 mcg dose of CVnCoV vaccine (COVID-19 vaccine)). This group of people, from 18 to 60 years of age, will receive a 6-mcg dose of the vaccine on Day 1 and on Day 29 of the study.
Subject Follow up Time: 180 days (booster dose)
Arm 2
Experimental
Control
60
• Group 2 (6 mcg dose of CVnCoV vaccine (COVID-19 vaccine)). This group of people, 61 years of age and older, will receive a 6-mcg dose of the vaccine on Day 1 and on Day 29 of the study.
Subject Follow up Time: 180 days (booster dose)
Arm 3
Experimental
Control
60
•Group 3 (8 mcg dose of CVnCoV vaccine (COVID-19 vaccine)). This group of people, 61 years of age and older, will receive an 8-mcg dose of the vaccine on Day 1 and on Day 29 of the study.
Subject Follow up Time: 180 days (booster dose)
Arm 4
Experimental
Control
20
•Group 4 (8 mcg dose of CVnCoV vaccine (COVID-19 vaccine)). This group of people, 61 years of age and older, will receive two injections with a 4-mcg dose of the vaccine, one in the shoulder of the left arm and one in the shoulder of the right arm, on day 1 of the study (total 8 mcg). On day 29 of the study, they will only receive one injection with a 4-mcg dose of the vaccine. Because they are a different group than the others, the participants in this group will know that they received the CVnCoV vaccine (they will not continue to be “blind” to the type of vaccine they received in the study).
Subject Follow up Time: 29 days
Arm 5
Experimental
Control
9
·Group 5 (control group with hepatitis A vaccines). This group of people, 18 to 60 years of age, will receive an injection with the hepatitis A control vaccine on Day 1 and Day 29 of the study.
Subject Follow up Time: 29 days
Arm 6
Experimental
Control
12
•Group 6 (control group with the pneumococcal vaccine). This group of people, 61 years of age and older, will receive an injection with the pneumococcal control vaccine on Day 1 and Day 29 of the study.
Inclusion Criteria
Subjects will be enrolled in this trial only if they meet all of the following criteria:
1. Healthy male and female subjects ≥18 years of age.
A healthy subject is defined as an individual who is in good general health, according to the Investigator’s assessment. Chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the Investigator.
2. Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
3. Physical examination without clinically significant findings according to the Investigator’s assessment.
4. Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2.
5. Female subjects of childbearing potential: at the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was performed more than 3 days before).
Additional information, please see the study protocol
Exclusion Criteria
Subjects will not be enrolled in this trial if they meet any of the exclusion criteria.
1. Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period.
2. Receipt of any other vaccines within 28 days prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration.
3. Receipt of any investigational SARS-CoV-2 or other coronavirus vaccine prior to the administration of the trial vaccine.
4. Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals, and methotrexate) within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of topically-applied, inhaled, or intranasal steroids.
5. Use of hormonal therapy for gender reassignment.
6. Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis B virus infection, and hepatitis C virus infection.
Additional information, please see the study protocol
Worldwide enrolment start date
17/08/2020
Enrolment start date in Peru (Initial)
10/09/2020
Enrolment start date in Peru
28/09/2020
Peru enrolment status
Without starting enrollment
Enrollment stopped
In enrollment
Enrollment closed
Clinical Trial Total Duration
13 months
Medical Speciality
INFECTOLOGY
Studied Condition (CIE-10 code)
-B342 Coronavirus infection, unspecified site
Number of subjects to be included in all the countries
700
Number of subjects to be included in Peru (initial)
Number of subjects to be included in Peru (posterior)
270
270
Countries where the enrolment is conducted :
- Brazil
- Panama
- Peru
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
180
day(s)
Subjects' follow up time
180 day(s)
Primary Outcome
Name of the outcome
Metric or method of measurement
Time point for the outcome
Primary
• The frequencies, intensities, and duration of solicited local AEs on each vaccination day and the following 7 days by dose and group.
• The frequencies, intensities, duration, and relationship to trial vaccination of solicited systemic AEs on each vaccination day and the following 7 days by dose and group.
• The occurrence, intensities and relationship to trial vaccination of unsolicited AEs on each vaccination day and the following 28 days by dose and group.
• The occurrence and relationship to trial vaccination of SAEs and AESIs throughout the trial.
On Day 29 and Day 43:
• The proportion of subjects seroconverting for SARS-CoV-2 spike protein antibodies, as measured by enzyme-linked immunosorbent assay (ELISA).
• Individual SARS-CoV-2 spike protein-specific antibody levels in serum, as measured by ELISA.
• Geometric mean titers (GMTs) of serum SARS-CoV-2 spike protein antibodies, as measured by ELISA.
• The proportion of subjects seroconverting for SARS-CoV-2 neutralizing antibodies, as measured by an activity assay.Individual SARS-CoV-2 neutralizing antibody levels in serum.
• GMTs of serum SARS-CoV-2 neutralizing antibodies, as measured by an activity assay
Collection of solicited local AEs (injection site pain, redness, swelling, and itching) and systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using diary cards (electronic or paper). In addition, other indicators of safety will be collected (e.g., body temperature).
day 29 and day 43
Secondary Outcome
Name of the outcome
Metric or method of measurement
Time point for the outcome
Secondary
On Day 180, Day 208, and Day 393 (Months 6, 7, and 13):
• The proportion of subjects seroconverting for SARS-CoV-2 spike protein antibodies, as measured by ELISA.
• Individual SARS-CoV-2 spike protein-specific antibody levels in serum, as measured by ELISA.
• GMTs of serum SARS-CoV-2 spike protein antibodies, as measured by ELISA.
• The proportion of subjects seroconverting for SARS-CoV-2 neutralizing antibodies, as measured by an activity assay.
• Individual SARS-CoV-2 neutralizing antibody levels in serum.
• GMTs of serum SARS-CoV-2 neutralizing antibodies, as measured by an activity assay.
Safety and reactogenicity data reported during an observation period of at least 24 hours after vaccination will be collected and reviewed by the iSRC. In this review, the iSRC will review all available safety data, but focus specifically on Grade 3 adverse reactions. Based on this review, the iSRC will decide on continuation of enrollment of subjects at this dose level.
In case additional dose levels are investigated in this trial, such a dose level will be initiated in additional sentinel subjects in the same manner. Reactogenicity will be assessed daily on each vaccination day and the following 7 days via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using diary cards (electronic or paper). In addition, other indicators of safety will be collected (e.g., body temperature).Diaries will also be used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, subjects will receive a prompt (by e.g., a phone call, software application, or text message) to verify whether they had any health concerns since the last visit.
Day 180, day 208, and day 393 (Months 6, 7, and 13)
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
INSTITUTO DE INVESTIGACIÓN NUTRICIONAL
RCI 3003
CONSULTORIO IIN
CLAUDIO FRANCO LANATA DE LAS CASAS
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
11/08/2020
11/08/2021
12
7126450
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
