DATA SHEET
CLINICAL TRIAL REGISTRATION (EC)
EC INS No:  PER-054-20
1. ORGANIZATION / APPLICANTE INSTITUTION
Name of Organization / Institution: RPS PERU S.A.C   Type of Organization / Institution : Otro 
Legal Domicile : 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
  ·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 - CNTEIApproved 11/08/2020 11/08/2021127126450  
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
 
URL no disponible
5. CLINICAL TRIAL CONTACT PERSONS INFORMATION
Full Name E-mail Telephone Type of queries to be resolved
Information to general public Administrative Consultations Scientific Consultations
Elizabeth Rospigliosi Lopez rospigliosielizabeth@prahs.com 941490447 Yes Yes Yes
AUTHORIZATION STATUS
AUTHORIZED    ACTIVE
TYPE AND NUMBER OF AUTHORIZATION   DOCUMENT R.D.  312-2020-OGITT-INS AUTHRORIZATION   DOCUMENT DATE (dd/mm/aaaa): 20/08/2020  (Validity date from:20/08/2020)
SUMMARY EVALUATION REPORT
APPROVED PROCEDURES
TYPE OF PROCEDURE TYPE AND NUMBER OF RESOLUTION / OFFICIAL LETTER DATE OF RESOLUTION / OFFICIAL LETTER VALIDITY DATE ANNULATION
FROM

TO

 

Extension / Modification of Supply List
R.D. 371-2020-OGITT-INS
07/09/2020

Extension / Modification of Supply List
R.D. 461-2020-OGITT/INS
29/10/2020

Clinical Trial Amendment Report
 1415-2020-OGITT-INS
14/11/2020

Clinical Trial Progress Report
 
10/12/2020 05:57:15 p.m.

Clinical Trial Progress Report
 
01/03/2021 11:15:00 a.m.