A Single-Blind, Randomized, Controlled Trial Comparing BNT162b2 vs JNJ-78436735 Vaccine as a Booster Dose After Completion of BNT162b2 Vaccine in Solid Organ Transplant Recipients
Phase: PHASE3
Conditions: Covid19
Sponsor: Giselle Guerra

IRB Study Number: 20210641
Version #4, Date: October 26, 2021
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Protocol Title: A Single-Blind, Randomized, controlled trial comparing BNT162b2 vs 
JNJ-78436735 vaccine as a booster dose after completion of BNT162b2 vaccine in 
Solid Organ Transplant Recipients.
Protocol Number: 20210641
Protocol Version number: 5
Protocol Version Date: March 7, 2022
NCT Number:  NCT05047640
Principal Investigator:
Principal investigator: Giselle Guerra M.D.
Giselle Guerra, MD
Professor of Clinical Medicine, University of Miami, Miller School of Medicine
Medical Director of Transplant Services 
Medical Director Kidney Transplant Program Miami Transplant Institute
1801 NW 9th Avenue, 7th Floor
Suite 700
Miami, Florida 33136
Phone:  305-355-5803
Fax:      305-355-5797
Email:   gguerra@med.miami.edu
Co-principal investigator: 
Yoichiro Natori M.D., M.P.H. Assistant Professor of Clinical Medicine
Division of Infectious Diseases
University of Miami Miller School of Medicine
Miami Transplant Institute
Jackson Health System
Highland Professional Building
1801 N.W. 9th Ave., Suite 733
Miami, FL 33136
Phone 305-243-5000
yxn138@med.miami.edu
Co-investigator: Suresh Pallikkuth
Research Assistant Professor, Department of Microbiology and Immunology
Associate Director, Miami CFAR laboratory Sciences Core
Director, Miami CFAR HIV & Aging Scientific Working Group 
University of Miami Miller School of Medicine
1580NW 10th Avenue BCRI 738, Miami, FL-33136
P: 305-243-5315
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F: 305-243-7211
SPallikkuth@med.miami.edu
Adela Mattiazzi, MD
Associate Professor of Clinical Medicine Transplant Nephrology
Director, Highly Sensitized Kidney and Pancreas Transplant Program
Director, Therapeutic Plasma Exchange for Solid Organ Transplant
University of Miami Miller School of Medicine
Miami Transplant Institute
Highland Professional Building
1801 N.W. 9th Ave. 5th Floor
Miami, FL 33136
Eric Martin, MD
Transplant Hepatology
Assistant Professor of Clinical Medicine
Medical Director of Living Donor Liver Transplant
Transplant Hepatology Fellowship Program Director
University of Miami Miller School of Medicine
Miami Transplant Institute
Highland Professional Building
1801 N.W. 9th Ave. 7th Floor
Miami, FL 33136
1)
Objectives*
The purpose of this study is to investigate the efficacy of the vaccines as a booster dose 
for COVID-19 in solid organ transplant recipients. The aims and objectives of this study 
is to check the immunogenicity after booster dosing of adenovirus vector vs. mRNA 
vaccine as a third dose. We are also going to investigate the safety of the third dosing 
after completion of two doses of mRNA vaccine.
Hypothesis of this study:
Booster dosing with mRNA vaccine should result in a higher rate of immunogenicity, 
defined as positive IgG, as compared to Adenovirus vector vaccine in solid organ 
transplant recipients who completed two doses of mRNA vaccine series.
2)
Background*
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the etiology behind the 
coronavirus disease 2019 (COVID-19) worldwide pandemic, has resulted in significant 
mortality rates worldwide. Among immunocompromised hosts, such as solid organ 
transplant (SOT) recipients, several reports have indicated a significantly higher hospital 
admission rate and mortality1,2; hence the need to provide robust protection in this 
vulnerable population.
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Since the beginning of the pandemic, several vaccines have been developed that have 
demonstrated a significant response in the general population in terms of immunogenicity 
and efficacy3,4. This has been developed to hopefully revolutionize the fight against the 
COVID-19 pandemic5,6. 
It is well known from prior studies that vaccine immunogenicity in other viruses, such as 
influenza, is diminished in SOT recipients due to immunosuppressive medications7, as 
compared to general population. Thus, there have been several attempts to improve 
vaccine efficacy and/or immunogenicity in this special population, such as use of high 
dose vaccines8 and boosted doses9. 
Even though a high efficacy of COVID-19 vaccines has been documented in the general 
population, there is some concern of low immunogenicity among SOT recipients of the 
SARS-CoV-2 vaccines10. At the same time, several reports have already documented 
breakthrough infection after vaccination in SOT recipients11. Thus, we need to develop a 
better way to protect this vulnerable population with an efficient vaccine strategy. 
Already, there are several reports of increased immunogenicity with additional dosing of 
vaccination12. Randomized controlled trial comparing placebo vs. other mRNA vaccine 
as a booster dose study showed some benefit13. However, as of now, there is no 
comparison study between mRNA and adenovirus vector vaccine. This time, we are 
conducting single center randomized controlled trial comparing mRNA vs. Adenovirus 
vector vaccine as a third dose after completion of two doses of mRNA vaccine in solid 
organ transplant recipients.
3)
Inclusion and Exclusion Criteria*
Inclusion Criteria:

Patients 18 years of age and older

Patients who had received a solid organ (kidney, liver, lung, heart, and 
pancreas) transplant patient from living or deceased donors.

Patients with active graft with at least one immunosuppressive medication

Completed two doses of BNT162b2 vaccination at least 28 days ago
Exclusion Criteria:

Patient with non-active graft

Any significant side effect with previous COVID-19 vaccination

Within 28 days of BNT162b2 vaccine completion

Already received more than and equal to three doses of COVID-19 
vaccination

Previously received COVID-19 vaccine other than BNT162b2 vaccine

Previously received monoclonal Antibody treatment that are specifically 
directed against the spike protein for SARS-CoV-2 such as Mab, 
Bamlanivimab, etesevimab, Casirivimab, imdevimab, Sotrovimab and/or 
any combination.
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
Thrombocytopenia (listed as a medical diagnosis or  less than 50,000 per 
microliter 30 days prior vaccination)

History of Capillary Leak Syndrome

Adults unable to consent

Individuals who are not yet adults (younger than 18 year old)

Vulnerable patients (prisoners)

Pregnant women
4)
Evaluation
Evaluation will be conducted as below schedule. 
Procedures
Screening
Enrollment/Baseline
Visit 1, Day 1
Phone Call Visit 2 
48-96 hours
Phone Call Visit 3
6-8 days
Study Visit 4
Day 28 +/-7 day
Study Visit 5
Month 6 (+/-7 days)
Study Visit for Sub 
study only
At Month 6 (+/- 30 
days)
Informed consent
X
X
Demographics
X
X
Medical history
X
X
Randomization
X
X
Blood sample collection
X
X
X*
Vaccine Administration
X
Symptom checker
X
X
X
X
Phone call follow up 
X
X
X
X
* 50 optional participants only
Blood samples will be obtained from all patients at the time of enrollment (Day 1) and 
day 28 to test IgG and IgM against SARS-CoV-2 spike protein. 
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At month 6, 50 optional patients will join to participate in the sub-study which will 
consist of blood sample collection to measure long term immunogenicity (IgG and IgM).
5)
Sample Size calculation
The primary outcome of this study is IgG positivity after 28 (21-35) days of the booster 
dose of the either vaccine. This IgG should be antibody against spike protein, and 
reported as RBD, measured by Dr. Pallikuh’s lab. We put alfa of 0.05 and beta of 0.2. 
The IgG positivity in JNJ-78436735 should be assumed as 80% and BNT162b2 as 60%. 
6)
Number of Subjects*
The Number needed in this study should be 93 per one arm, which is 186 in total. We 
assume 5-10% follow-up lost so we are going to enroll 200 patients in total.
For sub study to measure long term immunogenicity, we will enroll 50 patients among 
200 participants. 
The participants will be contacted via phone call in 6 months for monitoring.
7)
Description of the study
This is the patient-blinded randomized controlled trial. To monitor patient 
reporting side effect properly, we are going to conduct the patient-blinded. Study 
team member will be aware after randomization, at the time of giving vaccination. 
This is not observer blinded. Also, to minimize bias, Dr. Pallikuh lab members 
will not be notified which vaccine each participant receives. Randomization will 
be conducted via excel by Dr. Natori. Adult transplant recipients will be recruited 
from outpatient clinics. Transplant patients will be randomized in a 1:1 ratio. 
8)
Randomization of vaccine
A randomization schedule will be created using Microsoft Excel. Dr. Natori will 
randomly select 100 numbers out of 200 using excel. The selected number 
patients will receive JNJ-78436735 vaccine. The rest will receive BNT162b2 
vaccine. Those randomized result will put into 200 envelopes. On top of each 
envelope, only study ID, from 001 to 200, will be written. The envelope will be 
filed in each patient’s research chart. Charts will be located at the research office 
located at the Elliot Building. Only the study team will have access to the 
building.
After obtaining consent, study team member, other than Dr. Natori, will open the 
envelope to identify which vaccine to give. Each participant should be 
randomized and will receive one time dosing of either JNJ-78436735 or 
BNT162b2. After vaccination, those patients will need to stay Miami Transplant 
Institute outpatient clinic waiting area for 15minutes (+/- 2 minutes) to be 
monitored.
9)
Discontinuation of patients:

Patients may be discontinued under the following circumstances:

A patient desire for discontinuation for any reason
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
Lost to follow up (every effort must be made to contact the patient)

Death

An Investigator’s opinion that continuing the patient in the study is not 
appropriate
10)
Study Timelines*
After consent is obtained, the blood draw for all patients will be done at 
the outpatient clinic phlebotomy room. After that, the participants will 
receive either vaccine. After vaccination, those patients will stay in the 
clinic for 15mins and if they have any symptoms, those patients will notify 
the research team. In the event of any severe reaction, the principal 
investigator will be notified immediately. Medical intervention will be 
address based on each case.
On visit 2, 48-96 hours after administration of the vaccine, the research 
team will call the patient to collect the side effect information. Again, visit 
3, 6-8 days after enrollment, the research team will call the patient to 
collect side effect information. The participants will be back to the Miami 
Transplant Institute outpatient clinic in 28 (21-35) days from enrollment 
for follow-up blood collection. Upon follow up blood collection, the study 
team will ask the patient if they develop any symptoms after booster 
dosing.
We will also collect the blood test at 6 months (20-28 weeks) time period 
for those who are enrolled in the sub-study (50 patients will be enrolled) 
11)
Study Endpoints*
Primary endpoint is the anti-spike protein of SARS-CoV-2 virus IgG 
positive rate in one month after vaccination. Secondary endpoint includes 
the incidence rate of COVID-19 and the severity of COVID-19.
Safety endpoints includes side effect (i.e. pain at injection site, size of 
indwelling, fever, fatigue, and joint pain) at day 2 and 7 after vaccination. 
We also follow up to 6 months for any symptoms. This could also be 
gathered from the Jackson Health System medical record. 
12)
Procedures Involved*
This is a single center single blinded (patient blinded) randomized 
controlled trial comparing BNT162b2 and JNJ-78436735vaccine as a third 
dose after completion of two doses of BNT162b2 vaccine in Solid Organ 
Transplant Recipients. 
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Once informed consent is obtained , 10 ml of blood from the participants 
will be obtained at day 0 and day 28(21-35) to monitor IgG and IgM 
against SARS-CoV-2 spike protein. Then, a Jackson transplant nurse 
and/or medical assistant will intramuscularly inject either vaccine to the 
participants. The source of clinical information will be collected through 
Jackson Health System electronical medical record. 
Blood test will be analyzed Dr. Pallikuh’s lab in University of Miami.
As an optional sub study for 50 participants, we will collect 10 ml of 
blood again at 6months (20-28 weeks) time to monitor IgG and IgM. 
After vaccination, those patients will need to stay Miami Transplant Institute 
outpatient clinic waiting area for 15minutes (+/- 2 minutes) to be monitored.
Unblinding Process:
The vaccine given at the time of enrollment will be unblinded upon patient’s 
request at Day 28. However, if an emergency, the vaccine will be unblinded 
immediately for the patient.  
A potential early unblinding event could occur if the patient’s healthcare provider, 
including Jackson, provides the vaccine records from Florida Shot.
However, the early unblinding event should only affect the study secondary 
outcomes and will not affect primary outcome, i.e. serology data.
13)
Data and Specimen Banking*
Blood specimen will be stored in Dr. Pallikuh’s lab for 5 years. For sub-
study, we will also obtain PBMC and this should also be stored in 5 years. 
Only the research team member will have an access to those specimen. 
For clinical data, we will use a unique ID for each patient that does not include or 
derive from any identifiers. Miami Transplant Institute will retain the key to these 
IDs subject to local IRB review. 
14)
Data Management*
1.1.1
Data Collection and Management Responsibilities 
Data collection is the responsibility of the clinical trial staff at the site under the 
supervision of the Principal Investigator. The Principal Investigator is responsible for 
ensuring the accuracy, completeness, legibility, and timeliness of the data reported.
All source documents should be completed in a neat, legible manner to ensure accurate 
interpretation of data.  
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Data for electronic CRFs will be entered into Velos. A CRF is required for every patient 
who received any amount of study treatment.  The investigator will ensure that the CRF’s 
are accurate, complete, legible and timely. Data recorded in the electronic case report 
form (eCRF) derived from source documents should be consistent with the data recorded 
on the source documents. 
Clinical data (including adverse events (AEs), concomitant medications, and expected 
adverse reactions data) and clinical laboratory data will be entered into Velos, a HIPAA 
AND 21 CFR Part 11-compliant data capture system provided by the University of 
Miami. The data system includes password protection and internal quality checks, such as 
automatic range checks, to identify data that appear inconsistent, incomplete, or 
inaccurate. Clinical data will be entered directly from the source documents.
Study Records Retention
All records and documents relating to research studies and participants must be kept 
confidential to the extent permitted by law; however, records and documents shall be 
available in a timely manner to the University authorized employees or other agents 
authorized by the University including IRB members and HSRO staff and appropriate 
governmental agencies including but not limited to DHHS, OHRP and the FDA.
Although principal investigators are responsible for the creation and maintenance of 
research records and documents, such records and documents (including data collected 
pursuant to research) are the property of the University. Until the temporal requirements 
for record/document retention are met, investigators or others may not remove or destroy 
research records or documents (or copies of such records or documents) without written 
permission from the Vice Provost of Research. This permission requirement extends to 
investigators leaving the University even if they plan to continue the research at another 
institution.
The sample size was based on previous studies, which had indicated a response rate 
of approximately 50% and 70% to  each vaccine. 
Therefore, for an alpha of 0.05 and a power of 80%, a sample size of 93 evaluable 
patients in each study group should be required. As we assume 10% of the patients 
will not be back, we have that margin and going to enroll 200 patients in total. The 
immunogenicity analysis will be only performed in those who received a vaccine 
dose and returned for follow-up serum (per-protocol population). The safety 
analysis will be performed in all patients who received the study vaccine regardless 
of whether they returned for follow-up serum. Demographics will be analyzed 
using descriptive statistics. Differences in vaccine response rates between the 2 
arms will be compared using χ2 test. Pre- and post-vaccination titers will be 
compared using Wilcoxon rank-sum test. Univariate analyses will be performed to 
determine significant factors affecting seroconversion using χ2 test for categorical 
variables and Mann-Whitney U test for continuous variables. We will develop 
multivariate model to determine the factor of positive IgG post booster dosing. For 
multivariate analysis, a model should be developed using variables that had a P 
value < 0.2 on univariate analysis. Multivariate analysis will be performed using 
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binary logistic regression. Statistical significance was defined as a P value < 0.05. 
Statistical analysis will be performed using IBM SPSS version 26.0. 
15)
Provisions to Monitor the Data to Ensure the Safety of Subjects*
Study Auditing and Monitoring
This study will be monitored (as applicable) and may be audited according to the 
University of Miami requirements.  See also 
http://research.med.miami.edu/clinical-research/crors/monitoring
Clinical Research Operations & Regulatory Support CRORS will provide internal study 
monitoring compliance. Following the monitoring plan, the monitors will verify that the 
clinical trial is conducted and data are generated and biological specimens are collected, 
documented (recorded), and reported in compliance with the protocol, International 
Conference on Harmonization Good Clinical Practice (ICH GCP), and applicable 
regulatory requirements. 
Trial Monitoring, Auditing, and Inspecting
The investigator will permit trial-related monitoring, quality audits, and inspections by, 
government regulatory authorities, of all trial-related documents (e.g., source documents, 
regulatory documents, data collection instruments, case report forms).  The investigator 
will ensure the capability for inspections of applicable trial-related facilities.  The 
investigator will ensure that the trial monitor or any other compliance or QA reviewer is 
given access to all trial-related documents and trial-related facilities.  
Participation as an investigator in this trial implies the acceptance of potential inspection 
by government regulatory authorities. 
Quality Assurance and Quality Control
In addition to the Clinical Monitoring component of this protocol, Quality Assurance 
(QA) will be implemented to assess compliance with GCP and applicable regulatory 
requirements.  Data or documentation audited shall be assessed for compliance to the 
protocol, accuracy in relation to source documents and compliance to applicable 
regulations.
Publication and Data Sharing 
All information provided regarding the trial, as well as all information 
collected/documented during the course of the trial, will be regarded as confidential.  
The financial disclosure information will be completed prior to trial participation from all 
PIs and Sub-Investigators who are involved in the trial and named on the FDA 1572 
form.
The Sponsor-Investigator will register the trial on www.clinicaltrials.gov.  In addition, 
Sponsor-Investigator will publish the results of the trial.
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16)
Risks to Subjects*
COVID-19 vaccination itself is routine practice at our institution however this 
study includes additional dosing. The major risk would be immediate local and 
systemic reactions. The third dose is not well assessed yet even in general 
population so difficult to foresee. However, given immunosuppressive state of the 
patients, these side effect, which is due to immune reaction, should be low.  
RISK OF BLOOD DRAW
Risks and discomforts associated with having a needle placed in your arm for blood 
sampling include pain, bruising or bleeding at the puncture site, temporary light-
headedness, and in rare cases, fainting or site infection. If faintness is felt, you should lie 
down as soon as possible to avoid possible injury caused by falling and tell study staff.  
WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE? 
Side effects that have been reported with the Janssen COVID-19 Vaccine include: 
• Injection site reactions: pain, redness of the skin and swelling. 
• General side effects: headache, feeling very tired, muscle aches, nausea, and fever. 
There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic 
reaction. A severe allergic reaction would usually occur within a few minutes to one hour 
after getting a dose of the Janssen COVID-19 Vaccine. For this reason, your vaccination 
provider may ask you to stay at the place where you received your vaccine for monitoring 
after vaccination. Signs of a severe allergic reaction can include: 
• Difficulty breathing, 
• Swelling of your face and throat, 
• A fast heartbeat, 
• A bad rash all over your body, 
• Dizziness and weakness. 
These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious 
and unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied 
in clinical trials.
WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE? 
There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a 
severe allergic reaction. A severe allergic reaction would usually occur within a few 
minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. For 
this reason, your vaccination provider may ask you to stay at the place where you 
received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction 
can include: 
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• Difficulty breathing 
• Swelling of your face and throat 
• A fast heartbeat 
• A bad rash all over your body 
• Dizziness and weakness 
Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine 
include: 
• severe allergic reactions 
• non-severe allergic reactions such as rash, itching, hives, or swelling of the face 
• injection site pain 
• tiredness 
• headache 
• muscle pain 
• chills 
• joint pain 
• fever 
• injection site swelling 
• injection site redness 
• nausea 
• feeling unwell 
• swollen lymph nodes (lymphadenopathy) 
• 
• diarrhea 
• vomiting 
• arm pain 
17)
Potential Benefits to Subjects*
The results of this trial have the potential for immediate knowledge translation and could 
lead to early and tangible benefits for transplant patients. If our hypothesis is correct and 
the novel booster vaccine strategy is safe and effective, it could even be implemented for 
transplant patients.  In addition, the results could signal a paradigm shift for vaccination 
strategies in other populations of immunocompromised patients and lay the groundwork 
for future similar studies in these groups.  Since this will be the largest yet reported 
sample size to assess this, the results will alleviate fears among some transplant 
physicians and improve vaccine uptake.
18)
Sharing of Results with Subjects*
The laboratory result will be requested directly to the principal 
investigator. The results will be shared with the patient at the end of the 
study period.
19)
Setting

Research will be done at the following locations:
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
1. MTI Highland Professional building (Clinic) 1801 NW 9th Ave   

2. Jackson Memorial Hospital 1611 NW 12 Ave Miami, FL 33136
20)
Resources Available
This study will be overseen by Doctor Yoichiro Natori, Shweta Anjan, and Giselle Guerra. 
They are physicians managing the care of solid organ transplant patients at the Miami 
Transplant Institute. 
The research office consists of five research coordinators.
All of them have more than three years’ experience conducting transplant clinical studies. 
Besides the extended experience, coordinators attend Research Compliance and Quality 
Assurance training frequently.
21)
Recruitment Methods
Principal Investigator and/or co-investigators will review medical records 
to assess if subject can be consented. Assessment will be done during 
regular clinic evaluation.
Transplant care provider will refer those patients during their clinical visits 
and notify the investigators. Investigators will evaluate their patients. If 
patient is a good candidate, then they discuss the study purpose, 
procedures, benefits and risks.
If patient agrees, an informed consent form will be signed.
Bilingual staff will approach to our Spanish-speaking patients to inform 
patients about the study. 
Flyer will be posted in the MTI clinics as well as that, all MTI transplant 
physicians will be aware of this study prior to initiation.  
22)
Confidentiality
Data will be stored in an electronic password protected database. Patient will be 
identified with a study number and it will be linked to the subject’s JHS MRN. This will 
be kept in a separate location and locked in the research office.
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Choose the statements below that are applicable to this research: 
26(a).  Will the research collect protected health information or personally identifiable 
information from the EMR or from subjects at UHealth and/or JHS?
☒  Yes (If checked go to 26(b))
☐  No (If checked, go to  Section 27)
26(b).  Check the box next to the correct statement below 
☒   Research Subjects will sign a HIPAA Authorization before the research will collect 
this data. 
☐   Research Subjects will not sign a HIPAA Authorization for this data collection and 
the research is requesting a waiver of HIPAA authorization from the IRB.  (If checked, 
complete Section 17 below)
26(c).  How will the research store the data? (See Section 26(e) below)
☐  On a University of Miami electronic device (e.g. encrypted, password-protected 
computer)
☐  On a cloud-based storage system that is approved by the University of Miami 
☒  On the secured JHS SharePoint environment (required for protected health 
information or identifiable information collected from JHS records without a waiver of 
authorization from an IRB.)  
☐  Other, specify:  Click here to enter text.
26(d)  Select one of the following: 
☐  The Principal Investigator (and/or Study Team members) will record (e.g. write down, 
abstract) data acquired in a manner that does not include any indirect or direct identifiers 
(listed in the instructions for Section 26 of this protocol), and the recorded data will not 
be linked to the individual’s’ identity.  
   OR
☒  The Principal investigator (and/or Study Team members) will record (e.g. write down, 
abstract) the data collected in a manner that does not include any direct identifiers (see 
list in the instructions for Section 26 of this protocol) of any subject. Instead, the 
Principal Investigator and/or Study Team members shall will assign a code (that is not 
derived in whole or in part from any direct or indirect identifiers of the individual) to 
each study subject and link the code to the study subject’s identity. The link to each 
subject’s identity and/ or other identifiable information will be maintained on a document 
separate from the research data. 
26(e)  Additional requirement for Jackson Health System Data:
  Not-applicable, no data will be acquired from JHS under a waiver of authorization. 
  JHS data, including Protected Health Information (PHI) and/or Personally Identifiable 
Information (PII), acquired from JHS for this research under a waiver of authorization shall 
only be stored on the secured JHS SharePoint environment made available by JHS. I and 
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the Study Team members shall not copy or store the JHS sourced personally identifiable 
information (PII), including protected health information (PHI) data to any other system, 
including any systems maintained or provided by the University of Miami. I and the Study 
Team shall only copy or transfer JHS-sourced data that has been properly de-identified in 
accordance with all requirements contained in the HIPAA Rules by removing all of the 
identifiers listed in the instructions for Section 26 of this protocol.
27. Biospecimens
  Not applicable.  No biospecimens will be collected
  Bio-Specimens obtained for this research will be stored without any   
direct or indirect identifiers.  
 
 Bio-Specimens obtained for this research will be stored in a de-identified 
coded manner.   
  When required to transport data or bio-specimens for this research, the research 
team will transport the data and bio-specimens in a de-identified (or anonymous) 
manner with a link to the individual subject’s identity maintain separately from the 
data and/or bio-specimen.
23)
Compensation for Research-Related Injury
If the patient gets sick because of being in this study, treatment will be available in most 
cases. The patient’s insurance may or may not pay for these costs. If the patient have 
insurance, or if the patient’s insurance company refuses to pay, patient will need to pay. 
24)
Consent Process
Informed consent will be obtained from subjects who are willing to participate in the 
study. The study team will approach to potential subjects during clinical visits. Clinical 
visits are done at Highland Professional Building. Participants will be given sufficient 
time to consider taking part in the study.  They may take home a consent tor review.
Due to our population, Spanish speaking subjects will also be enrolled in the study. All 
research coordinators are bilingual and they will approach to these subjects. Prior 
consenting, all ICFs will be translated by the certified translator and approval will be 
obtained from the IRB.
Process to Document Consent in Writing Consents are included with this submission.
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25)
Authorization for Use and Disclosure of Protected Health Information 
(HIPAA) 
 If the research team will access patient medical records or other identifiable health 
information for this research, you must obtain a waiver of the requirement for 
written authorization from the patients to access their medical records.  
Type of Request:
 Waiver of Authorization for access to medical record for subject 
identification/recruitment.
 Waiver of Authorization for access to medical record to obtain data for the 
research.
Confirm that you will destroy the Protected Health Information (PHI) you and/or 
your Study Team acquire receive from JHS and/or UHealth at the earliest 
opportunity. 
☒    I confirm 
Confirm that the Protected Health Inform (PHI) you acquire from JHS and/or 
UHealth  will not be re-used or disclosed to any other person or entity, except as 
required by law or for authorized oversight of the research study or for other research 
for which the use or disclosure of PHI is permissible.           
☒     I confirm  
If you are collecting health information from JHS under a waiver of authorization, you 
must read the paragraph below and sign the signature block to indicate your agreement:  
Not applicable.  This research will not collect data from JHS record under a waiver of 
authorization 
Notwithstanding the preceding “I confirm” statements above, I agree that neither I nor 
any member of the study team listed on the IRB submission for this Protocol shall ever 
re-use or re-disclose any of the information acquired from Jackson Health System in any 
format, whether identifiable or de-identified, to any individual or entity without first 
obtaining written permission from Jackson Health System, even if such re-use or re-
disclosure is permissible by law (e.g., HIPAA).
  
 
______________________________________________
PI Signature                                                               Date
26)
Drugs: Pfizer COVID-19 and Janssen COVID-19 Vaccines 
Both vaccines will be provided by the Jackson Health System through the 
Department of Health.
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EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH 
COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-
19)
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use 
Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-
BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in 
individuals 12 years of age and older.
The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular 
injection administered as a series of two doses (0.3 mL each) 3 weeks apart.
The FDA has authorized the emergency use of the Janssen COVID-19 Vaccine to prevent 
COVID-19 in individuals 18 years of age and older under an Emergency Use 
Authorization (EUA).
 The Janssen COVID-19 Vaccine is administered as a single dose, into the muscle
Safety Reporting / AE / SAE Definition: 
For adverse events (AEs) not included in the protocol defined grading system, the 
following guidelines will be used to describe severity. 

Mild – Events require minimal or no treatment and do not interfere with the 
participant’s daily activities. 

Moderate – Events result in a low level of inconvenience or concern with the 
therapeutic measures. Moderate events may cause some interference with 
functioning.

Severe – Events interrupt a participant’s usual daily activity and may require 
systemic drug therapy or other treatment. Severe events are usually potentially 
life-threatening or incapacitating.  Of note, the term “severe” does not 
necessarily equate to “serious”.
1.1.2
Relationship to Study Intervention
All AEs and SAEs whether volunteered by the subject, discovered by study personnel 
during questioning, or detected through physical examination, laboratory test, or other 
means will be reported appropriately. Each reported AE or SAE will be described by its 
duration (i.e., start and end dates), regulatory seriousness criteria if applicable, suspected 
relationship to the study drug (see following guidance), and actions taken.
To ensure consistency of AE and SAE causality assessments, investigators should apply 
the following general guideline:
Yes [Definite, Probable, Possible]
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There is a plausible temporal relationship between the onset of the AE and administration 
of the study drug, and the AE cannot be readily explained by the subject’s clinical state, 
intercurrent illness, or concomitant therapies; and/or the AE follows a known pattern of 
response to the study drug or with similar treatments; and/or the AE abates or resolves 
upon discontinuation of the study drug or dose reduction and, if applicable, reappears 
upon re- challenge.
No [Unrelated, Unlikely etc]
Evidence exists that the AE has an etiology other than the study drug (e.g., preexisting 
medical condition, underlying disease, intercurrent illness, or concomitant medication); 
and/or the AE has no plausible temporal relationship to {study drug} administration (e.g., 
cancer diagnosed 2 days after first dose of study drug).
Expected adverse events are those adverse events that are listed or characterized in the 
Package Insert (P.I) or current Investigator Brochure (I.B).
Unexpected adverse events are those not listed in the P.I or current I.B or not identified. 
This includes adverse events for which the specificity or severity is not consistent with 
the description in the P.I. or I.B. For example, under this definition, hepatic necrosis 
would be unexpected if the P.I. or I.B. only referred to elevated hepatic enzymes or 
hepatitis.
For patients receiving combination therapy, causality will be assessed individually for 
each protocol-mandated therapy.
All adverse events (AEs) must have their relationship to study intervention assessed by 
the clinician who examines and evaluates the participant based on temporal relationship 
and his/her clinical judgment. The degree of certainty about causality will be graded 
using the categories below. In a clinical trial, the study product must always be suspect. 
Definitely Related – There is clear evidence to suggest a causal relationship, and other 
possible contributing factors can be ruled out. The clinical event, including an abnormal 
laboratory test result, occurs in a plausible time relationship to study intervention 
administration and cannot be explained by concurrent disease or other drugs or 
chemicals. The response to withdrawal of the study intervention should be clinically 
plausible. The event must be pharmacologically or phenomenologically definitive, with 
use of a satisfactory procedure if necessary.
Probably Related – There is evidence to suggest a causal relationship, and the influence 
of other factors is unlikely. The clinical event, including an abnormal laboratory test 
result, occurs within a reasonable time after administration of the study intervention, is 
unlikely to be attributed to concurrent disease or other drugs or chemicals, and follows a 
clinically reasonable response on withdrawal 
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Potentially Related – There is some evidence to suggest a causal relationship (e.g., the 
event occurred within a reasonable time after administration of the trial medication). 
However, other factors may have contributed to the event (e.g., the participant’s clinical 
condition, other concomitant events). Although an AE may rate only as “possibly related” 
soon after discovery, it can be flagged as requiring more information and later be 
upgraded to “probably related” or “definitely related”, as appropriate.
Unlikely to be related – A clinical event, including an abnormal laboratory test result, 
whose temporal relationship to study intervention administration makes a causal 
relationship improbable (e.g., the event did not occur within a reasonable time after 
administration of the study intervention) and in which other drugs or chemicals or 
underlying disease provides plausible explanations (e.g., the participant’s clinical 
condition, other concomitant treatments).
Not Related – The AE is completely independent of study intervention administration, 
and/or evidence exists that the event is definitely related to another etiology. There must 
be an alternative, definitive etiology documented by the clinician.
1.1.3
Expectedness
The Sponsor-Investigator will be responsible for determining whether an adverse event 
(AE) is expected or unexpected.  An AE will be considered unexpected if the nature, 
severity, or frequency of the event is not consistent with the risk information previously 
described for the study intervention.
1.1.4
Time Period and Frequency for Event Assessment and Follow-Up
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to 
the attention of study personnel during study visits and interviews of a study participant 
presenting for medical care, or upon review by a study monitor.
All AEs will be captured on the appropriate case report form (CRF) as well as in the 
Adverse Event reporting section in Velos, a HIPAA AND 21 CFR part 11 compliant 
database and will be reported to the University of Miami’s IRB per institutional 
requirements. 
Any medical condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s 
condition deteriorates at any time during the study, it will be recorded as an AE. 
Changes in the severity of an AE will be documented to allow an assessment of the 
duration of the event at each level of severity to be performed. AEs characterized as 
intermittent require documentation of onset and duration of each episode.
Study personnel will record all reportable events with start dates occurring any time after 
informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the 
last day of study participation.  At each study visit, the investigator will inquire about the 
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occurrence of AE/SAEs since the last visit. If the investigator should become aware of 
the development of cancer or a congenital anomaly in a subsequently conceived offspring 
of a female subject, including pregnancy occurring in the partner of a male study subject 
who participated in the study, this should be reported as an SAE adequately to Genentech 
drug Safety during follow up period. Events will be followed for outcome information 
until resolution or stabilization.
1.2
Adverse Event Reporting
Adverse Events may be spontaneously identified by the patient and/or in response to an 
open question from study personnel or revealed by observation, physical examination, or 
other diagnostic procedures.  Any clinically relevant deterioration in laboratory 
assessments or other clinical finding is considered an AE.  When possible, signs and 
symptoms indicating a common underlying pathology should be noted as one 
comprehensive event.  
The Sponsor-Investigator, is responsible for reporting adverse events (AEs) to any 
regulatory agency, to the Sponsor-Investigator’s IRB and to the Investigational Drug 
Sponsor.  
1.3
Serious Adverse Event Reporting
Generally, any AE considered serious by the PI or Sub-investigator or which meets the 
definition of an SAE included in Section 12.2, Definition of Serious Adverse Events. 
SAEs will be captured on the appropriate case report form (CRF) as well as in the Serious 
Adverse Event reporting section in Velos, a HIPAA AND 21 CFR part 11 compliant 
database and will be reported to the University of Miami’s IRB per institutional 
requirements. 
According to 21 CFR 312.32(c)(1), “the sponsor must notify FDA in an IND safety 
report of potential serious risks, from clinical trials or any other source, as soon as 
possible, but in no case later than 15 calendar days after the sponsor determines that the 
information qualifies for reporting… In each IND safety report, the sponsor must identify 
all IND safety reports previously submitted to FDA concerning a similar suspected 
adverse reaction and must analyze the significance of the suspected adverse reaction in 
light of previous, similar reports or any other relevant information. The sponsor must 
report any suspected adverse reaction that is both serious and unexpected. The sponsor 
must report an adverse event as a suspected adverse reaction only if there is evidence to 
suggest a causal relationship between the drug and the adverse event, such as:
(A) A single occurrence of an event that is uncommon and known to be strongly 
associated with drug exposure (e.g., angioedema, hepatic injury, Stevens-Johnson 
Syndrome);
(B) One or more occurrences of an event that is not commonly associated with 
drug exposure, but is otherwise uncommon in the population exposed to the drug 
(e.g., tendon rupture);
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(C) An aggregate analysis of specific events observed in a clinical trial (such as 
known consequences of the underlying disease or condition under investigation or 
other events that commonly occur in the study population independent of drug 
therapy) that indicates those events occur more frequently in the drug treatment 
group than in a concurrent or historical control group.”
Furthermore, according to 21 CFR 312.32(c)(2), “the sponsor must also notify FDA of 
any unexpected fatal or life-threatening suspected adverse reaction as soon as possible 
but in no case later than 7 calendar days after the sponsor's initial receipt of the 
information.”
Serious Adverse Events 
Serious criteria are applied by the Investigator to each AE as specifically defined 
below. These criteria are used to determine whether an AE is serious or non-
serious. The assessment is made independently of severity assessment. For 
example, the development of a severe rash that occurs after signing of the ICF 
may not meet serious criteria as defined below and therefore would be considered 
a severe, non-serious AE. 
Any AE that meets any 1 of the following 6 criteria is considered an SAE: 
• The outcome of the AE is death 
• The AE is immediately life threatening. Life threatening means that the patient 
is, in the opinion of the Investigator, at immediate risk of death from the reaction 
as it occurred. This does not include an AE that, if more severe, might have 
caused death 
• The AE results in persistent or significant disability/incapacity. Disability means 
a substantial disruption of a person’s ability to conduct normal life functions 
• The AE requires or prolongs hospitalization Inpatient hospitalization is defined 
as any stay in the hospital of more than 24 hours, or any admission to a hospital 
ward or unit as an inpatient.
 • The AE is an important medical event. Important medical events may meet 
serious criteria should the Investigator assess that they may significantly 
jeopardize the patient, represent a significant hazard, or require medical/surgical 
intervention.
As below, we will contact to the participants at 48-96 hours and 6-8 days after 
enrollment. At that time, we will collect below information.
Side effect(day2)
LOCAL
Erythema(y/n)
Induration(y/n) 
Tenderness(y/n)
SYSTEMIC
Fever(defined as higher than and equal to 38.3 degrees Celsius)(y/n)
Gastrointestinal(diarrhea or nausea) (y/n)
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Arthralgia(y/n)
Fatigue(y/n)
Muscle ache(y/n)
Side effect(day7)
LOCAL
Erythema(y/n)
Induration(y/n) 
Tenderness(y/n)
SYSTEMIC
Fever(defined as higher than and equal to 38.3 degrees Celsius)(y/n)
Gastrointestinal(diarrhea or nausea) (y/n)
Arthralgia(y/n)
Fatigue(y/n)
Muscle ache(y/n)
Within 6months post vaccination
Hospitalization(y/n, reason for admission)
COVID-19(y/n, if yes, date of diagnosis, symptom at the time of diagnosis)
Rejection(y/n)(if yes, type of rejection, date)
CMV infection(y/n)
BK infection(y/n)
27)
Protocol Compliance
The study team shall implement and maintain quality control and quality assurance 
procedures to ensure that the study is conducted, and that data are generated, 
documented, and reported in compliance with the protocol, ICH, GCP, and applicable 
regulatory requirements. This study shall be conducted in accordance with the provisions 
of the Declaration of Helsinki (October 1996) and all revisions thereof, and in accordance 
with the US Food and Drug Administration (FDA) regulations (Code of Federal 
Regulations, Sections 312.50 and 312.56) and with ICH GCP (CPMP 135/95). The 
Investigator may not deviate from the protocol without a formal protocol amendment 
having been established and approved by an appropriate competent authority and 
IEC/IRB, except when necessary to eliminate immediate hazards to the patient or when 
the change(s) involve(s) only logistical or administrative aspects of the study. Any 
deviations may result in the patient having to be discontinued from the study and render 
that patient non evaluable.
28)
References
1.
Raja et. al. Transplant Rev (Orlando). 2021 Jan;35(1):100588. doi: 
10.1016/j.trre.2020.100588. Epub 2020 Nov 14.
2.
Mendoza et. al. Am J Transplant. 2021 Apr;21(4):1670-1671. doi: 
10.1111/ajt.16370. Epub 2020 Nov 4
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3.
Polack et. al. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 
10.1056/NEJMoa2034577. Epub 2020 Dec 10
4.
Jackson et. al. N Engl J Med. 2020 Nov 12;383(20):1920-1931. doi: 
10.1056/NEJMoa2022483.
5.
Dagan et. al. N Engl J Med. 2021 Apr 15;384(15):1412-1423. doi: 
10.1056/NEJMoa2101765. Epub 2021 Feb 24.
6.
Chodic et. al. Clin Infect Dis. 2021 May 17;ciab438. doi: 
10.1093/cid/ciab438. 
7.
Haddadin et.al. Am J Transplant. 2021 Mar;21(3):938-949. doi: 
10.1111/ajt.16295.
8.
Natori et. al. Clin Infect Dis. 2018 May 17;66(11):1698-1704.
9.
Cordero et.al. Clin Infect Dis. 2017 Apr 1;64(7):829-838. doi: 
10.1093/cid/ciw855.
10. Ison et. al. Am J Transplant. 2021 Jul 9. doi: 10.1111/ajt.16758.
11. Anjan et. al. Transplantation 2021 Jul 27. doi: 
10.1097/TP.0000000000003902
12. Kamar et. al. N Engl J Med 2021 Jun 23;NEJMc2108861. doi: 
10.1056/NEJMc2108861.
13. Hall et.al. N Engl J Med 2021 Aug 11: DOI: 10.1056/NEJMc2111462
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