Vaxart, Inc.

/ Protocol Number VXA-COV2-201 Part 1 Page 1 of 19

SUBJECT INFORMATION AND INFORMED CONSENT FORM

AND
AUTHORIZATION TO USE AND DISCLOSE PROTECTED
HEALTH INFORMATION
STUDY PART 1

Sponsor / Study Title: Vaxart, Inc. / “A Phase 2, Double-Blind, Multi-Center,

Randomized, Placebo-Controlled, Dose-Ranging Trial
to Determine the Safety, Immunogenicity and Efficacy
of an Adenoviral-Vector Based Vaccine (VXA-CoV2-
1.1-S) Expressing a SARS-CoV-2 S Protein and dsRNA
Adjuvant Administered Orally to Healthy Adult
Volunteers”

Protocol Number: VXA-COV2-201 (Study Part 1)

Principal Investigator: Apinya Vutikullird , DO

(Study Doctor)

Telephone: (562) 997-1000 (24-Hour)

Address: ARK Clinical Research

2600 Redondo Avenue
Suite #400
Long Beach, CA 90806

1. INTRODUCTION
You are being invited to take part in a research study to test a new investigational oral (by
mouth) tablet vaccine. “Investigational” means that the vaccine has not been approved by the
US Food and Drug Administration (FDA).
This informed consent form explains the purpose, procedures, risks and discomforts, and
potential benefits of taking part in this study. It also describes the other options available to you
and your rights to stop being in the study at any time. Please take time to read the following
information carefully and discuss it with friends and family if you wish. Your study doctor will
spend time explaining the study to you. You may ask any questions about what you see in this
document, or any part of this study.
Your participation is voluntary, which means that you may choose not to take part without any
penalty or loss of benefits. If you decide to take part, you will be asked to sign and date this
document and a signed and dated copy will be given to you.
The sponsor for this study is Vaxart, Inc., a pharmaceutical company based in Northern
California, USA. Your study doctor is being paid by Vaxart, Inc. to conduct this study.

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An Institutional Review Board (IRB) called Advarra has reviewed this study and this informed
consent form. An IRB is an independent organization from the sponsor and investigator (study
doctor), formed by a group of scientific and nonscientific people. Its purpose is to provide a
public guarantee of the protection of subjects’ rights during the research study.
The IRB has given the study doctor approval to do the study. This does not mean that Advarra
has approved of you being in the study.
A description of this clinical trial will be available on http://ClinicalTrials.gov as required by U.S.
Law. This Web site will not include information that can identify you. At most, the Web site will
include a summary of the results. You can search this Web site at any time.

2. PURPOSE OF THE STUDY

The purpose of this study is to see how well people tolerate taking the study drug (vaccine),
called VXA-CoV2-1.1-S. The study will also evaluate if the study drug can cause your body to
make an immune response which can protect you from getting infected with COVID-19, and
possibly also protect against COVID-19 disease, a pandemic which continues to spread rapidly
across several continents, with community outbreaks throughout the world.
This study will also look at any possible harmful effects caused by the immune system’s
reaction to the study drug, and the ability to protect the body against infection by VXA-CoV2-
1.1-S.

3. WHAT IS COVID-19?
COVID-19 (Coronavirus Disease-19) is an infectious disease caused by a new virus. The
disease causes respiratory illness (like the flu) with symptoms such as a cough, fever, shortness
of breath, pain or pressure in the chest, and in more severe cases, difficulty breathing. These
symptoms may appear 2-14 days after exposure to the virus, and reported illnesses have
ranged from mild symptoms to severe illness and death. For more up to date symptoms and
findings, please visit the Center for Disease Control and Prevention (CDC) at www.cdc.gov.
The virus is believed to spread mainly between people who are in close contact with one
another (within about 6 feet) through droplets that are released when an infected person coughs
or sneezes. It also may be possible that a person can get COVID-19 by touching a surface or
object that has been contaminated with the virus and then touching their own mouth, nose,
or eyes.

4. STUDY DRUG (VACCINE)

Vaccines (like the flu shot) work by getting the body’s immune system to make proteins called
antibodies, to protect against infection. If the vaccinated person comes into contact with the
disease (like the flu), their immune system’s antibodies will recognize the disease and quickly
work to protect against the infection.

5. STUDY DESIGN
This study has two parts. Part 1 will enroll about 96 subjects who have no history of prior
COVID-19 or SARS-CoV-2 infection across 2 cohorts. Cohort 1 will have 48 subjects that have
no prior vaccination against SARS-CoV-2 infection and Cohort 2 will evaluate 48 subjects who
have received 2 doses of an EUA or FDA approved COVID-19 vaccine 6 months prior to Day 1.
Your study site will determine which Cohort you are assigned based on your screening data.
All subjects will get 2 low or high doses of the study drug. Dose 1 is given at Week 1 and dose 2
is given at Week 4 of the study. About half of the subjects will be between 18-55 years old, and

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the other half will be 56-75 years old. This informed consent form is for Part 1 of the study
only.
Part 2 will occur at a later time. Subjects in Part 1 will not participate in Part 2.

6. LENGTH OF THE STUDY AND NUMBER OF SUBJECTS

A total of about 896 healthy male and female subjects of at least 18 years of age will take part in
this study at clinical research sites around the world; Part 1 of the study will be completed in the
US only. Your participation in this study is expected to last about 14 months. Week 1 through
Week 8 will be considered the “study active period”; from Week 8 through 13 will be considered
the “follow-up period”.
TO TAKE PART IN THE STUDY
Some of the requirements and rules that you are expected to follow for this research study are
listed below. Please go through the list carefully and discuss any questions you have with the
study staff or study doctor.
It is important to be honest about these rules because they are included to protect you, as well
as the people you may come into contact with during your participation in this research study.
To be eligible for this study you must:
1. Cohort 2 ONLY – Have received prior vaccination (both doses) with an EUA or FDA
approved vaccine for the prevention of COVID-19, at least 6 months prior to Day 1.
2. Be between 18 to 75 years of age.
3. Have a body mass index (BMI) between 17 and 32 kg/m2 at the screening visit (study
staff will measure BMI based on your height and weight).
4. Be in good health (in the opinion of the study doctor, determined by medical history,
physical examination, vital signs, and laboratory testing) at the time of screening and
baseline.
5. Have a negative COVID-19 test during the screening visit.
6. Understand the protocol (study plan) procedures and be able to provide written informed
consent (indicated by signing and dating this form).
7. Be available for all planned visits and calls, and willing to complete all required
procedures and assessments (including ability and willingness to swallow multiple small
tablets per study vaccine dose).
8. If you are a female subject, you must not be breast-feeding and have a negative
pregnancy test at screening and on Day 1 and Week 4, before you receive the study
drug dose. You must also meet at least one of the following criteria:
a. At least 1 year post-menopausal (that is, no menstruation for greater than or
equal to 12 months prior to screening). Women under 60 years old will need to
have a follicle-stimulating hormone test (FSH; a test to prove that you are post-
menopausal) if they do not plan to use another option to prevent pregnancy for
30 days prior to the first study vaccination (Day 1) until 60 days after the last
study vaccination (Week 4).
b. Surgically sterile.

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c. Use of oral, implantable, transdermal, or injectable contraceptives for 30 days

prior to the first study vaccination (Day 1) and until 60 days after the last study
vaccination (Week 4).
d. Use of a reliable form of contraception approved by the study doctor: for
example, double barrier method, Depo-Provera, intrauterine device (IUD),
Norplant, oral contraceptives, contraceptive patches.
e. Not be sexually active (abstinent) as part of your preferred or usual lifestyle OR
be in a relationship with a partner who is sterile (discuss this with study staff).
9. Female subjects must not donate eggs (ova, oocytes) from the time of signing and
dating this informed consent through 60 days after the last study vaccination (Week 4).
10. If you are a male subject, you must agree to the following from the time of signing and
dating this informed consent through 60 days after the last dose of study drug:
a. Do not donate sperm, except as required by this study.
b. Agree to use contraception/barrier method (male condom) OR not be sexually
active (abstinent) as part of your preferred or usual lifestyle and agree to remain
abstinent during the study
11. Have no known previous infection with SARS-CoV-2 or receipt of any product for the
prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or
severe acute respiratory syndrome (SARS).
12. Not have a history of or be at high risk for clotting events and/or low platelet counts
based on medical history, lab tests or physical exam results, as determined by the study
doctor
13. Not receive the following therapies during the study (study staff will review your
medication history to make sure that you qualify for the study):
a. Flu vaccine within 14 days prior to Day 1 study vaccination or another vaccine
within 28 days prior to Day 1 study vaccination, or plans to take the flu vaccine
during the study active period (Day 1 through Week 8).
b. Antiviral medications including anti-retrovirals, within 1 week before study
vaccination or planned use during the study active period.
c. Antibiotics, proton pump inhibitors, H2 blockers or antacids within 1 week before
study vaccination or planned use during the study active period.
d. Medications known to affect the immune function (for example systemic
corticosteroids and others) within 14 days before study vaccination or planned
use during the study active period.
e. Daily use of nonsteroidal anti-inflammatory drugs, sulfonylureas, and angiotensin
II blockers within 1 week before study vaccination or planned use during the
study active period.
f. You must have a negative urine drug screen for drugs of abuse at screening,
except for previous marijuana use. You must not plan to use marijuana during
the study active period.
g. Any investigational vaccine, drug, or device within 8 weeks before study
vaccination, or planned use within the duration of the study.
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14. No planned donation or use of blood or blood products within 4 weeks before study
vaccination, or planned donation during the study period.
15. Not have hypersensitivity or allergic reaction to fish gelatin, or any other fish allergies.
Please be honest regarding your medical and medication history throughout the study and
report any new information to the study staff at each visit. Giving false, incomplete, or
misleading information about your medical history, including past and present medication
use, may have serious health consequences.

7. CORONAVIRUS DISEASE (COVID-19) TESTING

After signing and dating the informed consent, the clinical site will be performing COVID-19
testing on all subjects to confirm that they are not positive for COVID-19, and have not recently
had COVID-19. During your time on the trial, you will be asked about any possible exposure to
COVID-19 or if you feel any COVID-like symptoms. It is extremely important for you to tell us if
you believe you have been exposed or are feeling symptoms. If you have been exposed or are
feeling symptoms, you will be asked to come back into the clinical site for a COVID-19 test,
which will be completed by collecting a nasal swab. If you test positive, we will require you to
repeat the nasal swab sample collection at home every other day until you test negative, to
monitor the duration of your COVID-19 infection. The study doctor may be required by law to
report the result of these tests to the local health authority.

Commonly seen symptoms of COVID-19 may include:

• Upper respiratory infection (symptoms include difficulty breathing, coughing, tight chest,
or fever)
• New loss of taste or smell
• Watery or loose stools/diarrhea
• Fatigue (tiredness)
• Muscle or body aches
• Headache
• Sore throat
• Congestion or runny nose
• Nausea or vomiting

8. STUDY PROCEDURES
You will be asked to read this informed consent form and ask any questions. If you agree to
participate, then you will sign and date this informed consent form. No study-related tests can
be done until you sign and date this form. Procedures will be done during the study at times
described below. The procedures will be done to monitor your health and to assess the safety of
the study drug.

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If the study doctor decides that you are eligible to participate in this study and you are still
interested in participating, you will visit the clinical research center and complete the study
procedures at the following time points:

Table 8.1 Test Procedures During Part 1 Study Active Period

Screening Study Active Period
Test/Procedure
Week-4 to Day 1 Day 1, Weeks 1, 4, 5 and 8
COVID-19 Rapid Ab test (Cohort 1 only) 1 time 1 time (Day 1)
At least 1 time (Day 1); additional tests if
COVID-19 (RT-PCR) test1 0 times
symptomatic or exposed to COVID-19
Blood for HIV and hepatitis C and B
1 time 0 times
testing
Blood draws for safety labs
1 time 5 times (1 at each visit)
(including tests for risk of blood clots)
Urine for safety lab tests 1 time 5 times (1 at each visit)
Urine drug screen 1 time 0 times
Physical examination 1 time 5 times (1 at each visit)
Vital signs 1 time 5 times (1 at each visit)
Pregnancy test (all women who are able
1 time 2 times (Day 1 and Week 4)
to have children)
Receive study drug (one to multiple
0 times 2 times (Day 1 and Week 42)
small oral tablets, depending on dose)
Nasal Swab 0 times 3 times (Day 1, Week 4, Week 8)
Saliva (spit) sample 0 times 3 times (Day 1, Week 4, Week 8)
1
If after receiving study drug you have a positive test for SARS-CoV-2 infection (after
confirmatory testing) you will be asked to provide a nasal swab sample to the clinical
research unit every other day until a negative test is recorded.
2If you do not receive the 2nd study dose, you go into the follow up period.

Table 8.2 Test Procedures During Part 1 Follow-up Period

Follow-up Period Follow-up Period
Test/Procedure
Months 7 and 13 Months 3-6 and 8-12
Telephone contact for COVID-19
0 times 9 times (1 time per month)
exposure or other symptoms
Blood draws 2 times (1 at each visit) 0 times
Nasal Swab 2 times (1 at each visit) 0 times
Saliva (spit) sample 2 times (1 at each visit) 0 times

If you have to come back to the site to see the study staff for a time point not listed above that is
related to the study, it will be an Unscheduled Visit.

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You will be asked about your medical history, and your height and weight will be recorded. You
will be asked about your tobacco use. Your vital signs (blood pressure, heart rate [how many
times your heart beats per minute], and respiratory rate [how many breaths you take per
minute]) will be taken at multiple times during your participation in the study.
Before receiving the study drug on Day 1 and Week 4, we will ask you not to eat any solid food
for at least 4 hours before dosing. When you swallow the study drug tablet(s), we will provide
you with 360 to 480 mL (1.5 to 2 cups) of water to drink. After you take the study drug tablet(s),
you will be given a light snack. You will be able to eat normally 90 minutes after swallowing the
tablet(s).
Before leaving the clinical site, you will receive a diary card to fill out for seven days after
receiving each dose of study drug until you return to the clinical site one week later. The diary
asks you to record daily if you have any specific symptoms that are sometimes seen with
vaccines, and to write down how severe those symptoms are. You will need to measure and
record your temperature each morning in the diary as well.
On Week 4, the study doctor may decide, based on the results of your study procedures, that
you do not qualify to receive the study drug on Week 4. If it is determined that you will not
receive the second dose, you will enter the follow up period and continue to receive phone calls
and come in for site visits for the rest of the study.
Your current medications will be reviewed by the study doctor. You should consult with the
study doctor about any medications you are taking. It is very important that you let the study
doctor know what medications you are currently receiving, have received recently, or planning
to take at each visit.
Giving false, incomplete, or misleading information about your medical history, including past
and present medication use, may have serious health consequences.

9. HIV & HEPATITIS B & C TESTING

Part of the blood test that will be done during your screening visit includes a test for HIV and
Hepatitis B and C. HIV is the virus that causes AIDS. A positive test result means that you have
been exposed to the virus and are infected. It does not mean that you have AIDS or that you will
necessarily become sick with AIDS in the future. There are treatment options available for
people who have HIV.
If you take the test for HIV and Hepatitis B and C, your test results are confidential. Your results
can only be given to the people you allow to have it by signing a separate release form;
however, a positive result from these tests may be reported to the local health department as
required by local law. The results from these tests are confidential and results will not be shared
outside of this study except as required by local law.
There is always a chance that people that were not originally supposed to have this information
could see these results. Please speak to the study staff or your personal doctor, if you want to
know more about what it could mean to you if somebody outside of this research study has
access to this information.
Taking the HIV and Hepatitis B and C tests is voluntary. You do not have to take the tests;
however, the tests are needed to participate in this research study. If you decide not to take the
tests, you cannot participate in this study. Your Study Doctor will discuss with you if the test
results are positive and what the local laws require with regard to reporting the test results. The
results of these tests must be negative in order for you to be in this study.

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10. BLOOD SAMPLES

If you complete the entire study, the total amount of blood collected from you across all study
visits will equal up to 550 mL (approximately 112 teaspoons). For comparison, a standard blood
donation at a blood collection center, is about two cups (96 teaspoons) of blood. More blood
may be collected from you if additional follow-up is needed for your safety. These blood
samples will be used to monitor your health and safety.
No one other than the Sponsor (and/or people or companies that the Sponsor works with) will
test your samples. All of your samples will be labeled with a special code and not your name.
Only the study doctor and his/her study staff will be able to link your samples to you. All
information obtained from your samples will be kept confidential as stated in the privacy and
confidentiality section of this form.
Blood samples will be analyzed at a local or central lab depending on the procedure. Biological
material obtained will be used only for the purposes specified for this research study.
Your signature and date at the end of this form means that you allow the study doctor and
his/her study staff to complete the set plan of study procedures, including the collection of
samples. Your signature and date also allows Vaxart, Inc. and its authorized representatives
(including contractors) to use these samples for tests outlined in the study protocol (study plan)
or for tests necessary to ensure your safety.
You can ask the study doctor or his/her study staff about the tests listed in the section titled
“Study Procedures” in this Informed Consent.

11. UNSCHEDULED VISITS

You may be asked to report to the study site for an unscheduled visit if the study doctor feels it
is necessary for your safety. In the event that you are asked to return to the study site for an
unscheduled visit, some or all of the assessments and procedures outlined above may be
performed to ensure your safety throughout.

12. RISKS AND DISCOMFORTS

RISKS ASSOCIATED WITH VXA-COV2-1.1-S
Another Vaxart oral study drug (vaccine) that is similar to the VXA-CoV2-1.1-S vaccine has
been tested in people in an earlier phase 1 study which enrolled 35 healthy adult subjects. At
the start of this phase 2 study, subjects in the phase 1 study had not reported any significant
adverse reactions (side effects).
Since VXA-CoV2-1.1-S is an investigational test vaccine, it may cause all, some, or none of
these side effects. These side effects can be mild but could also be serious or even result in
death.
There may be other risks and side effects that are not known at this time. Please contact your
study doctor if you have any symptoms.

Common
• Headache
• Diarrhea (loose, watery stool)
• Muscle Pain
• Nausea
• Fatigue (tiredness)
• Stomach pain
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Less common
• Loss of appetite/ Not eating
• Fever (any temperature 100.4°F or higher)
• Vomiting

There may also be side effects and discomforts that are not yet known nor yet seen in
previous studies which may include the following:
Risk of allergic reaction; symptoms may include
• Rash
• Wheezing and difficulty breathing
• Dizziness and fainting
• Swelling around the mouth, throat or eyes
• A fast pulse
• Sweating

Risk of Clotting Events with Adenovirus Vaccines (such as VXA-CoV2-1.1-S)

In this study for Part 1, you will receive two doses of the VXA-CoV2-1.1-S oral vaccine. This
vaccine is made using a type of virus (adenovirus) to transport the vaccine to the cells in your
body. Blood clots involving blood vessels in the brain, lungs, abdomen, and legs along with low
levels of platelets (blood cells that help your body stop bleeding), have occurred in some people
who have received COVID-19 vaccines that also use adenoviruses: the AstraZeneca COVID-19
vaccine (ChAdOx1) and the Johnson and Johnson COVID-19 vaccine (Ad26.COV2.S).
These events were rare; however, some of these cases have been fatal. The cause for these
events is still being studied. It is possible that they could be related to the virus used in the
vaccine (adenovirus), which is similar to the one used in the vaccine in the study you are
participating in. In most people who developed these blood clots and low levels of platelets,
symptoms began approximately one to two-weeks following vaccination, although cases with
later onset after vaccination have been reported. Most people who developed these blood clots
and low levels of platelets were women under 60 years of age, although cases have also been
reported in men and women older than 60 years of age. Please seek immediate medical
attention if you develop any of the following symptoms:
• Shortness of breath
• Chest pain
• Leg pain
• Leg swelling
• Severe or persistent abdominal pain
• Severe or persistent headaches
• Blurred vision or other vision changes
• Mental status changes or seizures (fits)
• Easy bruising and/or bleeding
• Tiny blood spots under the skin beyond the site of vaccination

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Risk of Vaccine Induced Enhanced Disease:

There is some data from studies in animal models to indicate that vaccination for COVID-19
may cause enhanced disease upon future exposure to the virus that causes COVID-19.
Therefore, it is important that you contact the site immediately and return to have a test to
confirm whether you have the infection.

RISKS ASSOCIATED WITH PROCEDURES DONE IN THIS STUDY

The possible risks and/or discomforts associated with the procedures in this study may include:
• Blood draw – Removal of blood by a needle may produce pain, bruising, bleeding,
swelling at injection site or dizziness. Although rare, in some instances fainting or
infection at the injection site may occur.
NASAL SWAB SAMPLE FOR COVID-19 TESTING – A NASAL SWAB TEST HAS MINOR RISKS. YOU MAY
GAG A LITTLE DURING THE TEST. YOU MAY FEEL SOME IRRITATION, DISCOMFORT, AND SOME PAIN.
YOU MAY ALSO EXPERIENCE EYE WATERING, SNEEZING, MILD INCREASE IN NASAL SECRETIONS,
HAVE SMALL AMOUNT OF BLOOD ON THE SWAB AND/OR A MINOR NOSEBLEED AFTERWARDS.

RISKS TO A PREGNANT WOMAN OR UNBORN BABY

The risk of the study drug to a pregnant mother and unborn fetus is unknown. If you are of
childbearing potential, you will be required to have a pregnancy test during the screening visit,
which must be negative in order for you to take part in the study. You will be given regular
pregnancy tests during the course of your participation as listed above in the “Test Procedures
During Part 1 Study Active Period” table.
Women who are pregnant, planning to become pregnant, or breastfeeding will not be allowed in
this study.
Female subjects must have a negative pregnancy test during the study and meet one of the
criteria below:
a. At least 1 year post-menopausal;
b. Surgically sterile; or
c. Not be sexually active (abstinent) or not be in a heterosexual relationship with potential
of pregnancy (must be discussed with study staff and documented).
d. Use of oral, implantable, transdermal or injectable contraceptives for 30 days prior to
initial study vaccination and until 60 days after the last study vaccination.
e. Use a reliable form of contraception approved by the Investigator (for example, double
barrier method, Depo-Provera, intrauterine device, Norplant, oral contraceptives,
contraceptive patches).

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Male subjects must:

• Refrain from donating sperm, except for the purpose of fertility analysis
PLUS:
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle
(abstinent on a long-term and persistent basis) and agree to remain abstinent
OR
• Must agree to use contraception/barrier (a male condom) throughout the study and for
60 days after the last study vaccination
You should ask your study doctor if the method you are using is considered medically
acceptable for this study. The study doctor will analyze and advise you of the most appropriate
contraceptive method to ensure a safe contraception and will ensure the access to it throughout
the study.
Women who are surgically sterile or at least one year post-menopausal are not considered to be
able to have children.
If you or your partner (if you are a man) becomes pregnant during the study, you must contact
the study doctor immediately. You will be removed from the study after appropriate safety follow
up. You will be monitored throughout your pregnancy and a report on the course of your
pregnancy, including the birth of your child, will be provided to the study sponsor (Vaxart, Inc.).

13. DESCRIPTION OF BENEFITS

You may gain a measure of immunity from the investigational vaccine, but there may be no
benefit to you from participating in this research study. Knowledge gained from this study may
help to develop an oral tablet vaccine against COVID-19 disease.

14. ALTERNATIVES TO PARTICIPATION

There are other FDA authorized vaccines available at this time from other vaccine
manufacturers. You will be withdrawn from the study if you opt to get one of these vaccines
during the study period. There will be no penalties or loss of benefits if you decide to do so.

15. CONFIDENTIALITY OF MEDICAL RECORDS

Every effort will be made to keep your medical records private. You will be identified using your
initials and/or a number on all documents. If the results of this study are published, your name
and identity will be kept secret. Your medical information will be kept private to the extent
permitted by law.
You agree that the sponsor of the study, Vaxart, Inc., their representatives, Advarra IRB, and
the FDA or other regulatory authorities may have access to your medical records.
In the rare event that your information is required to be disclosed by law to another entity,
privacy laws may not apply, and the Sponsor may not be able to protect your information.
Throughout the study, you will have the right to request information regarding the personal data
that has been collected from you, including what kind of data has been recorded about you, who
is responsible for the safekeeping of this data, and who has access to it. This information must
be supplied in a clear and accessible manner, and no information about other people’s recorded
data may be granted.

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16. COSTS
There will be no cost to you for taking part in this study. The study sponsor, Vaxart, Inc. will
cover all costs for tests, clinical study visits, examinations, study procedures and associated
costs of the study.
You will receive the study drug at no cost to you. You will remain responsible for the costs of
your regular, non-study required, medical care.
The study doctor will be paid for his/her work on the study. You are not responsible for this
payment.
The sponsor will not pay for medical expenses to treat pre-existing conditions or other
conditions not related to receiving the study drug or study procedures.

17. PAYMENT
For your time related to your participation in this study, you will be paid $200 per active study
visit and $150 per safety follow up visit you complete. If you do not complete the study, for any
reason, you will be paid per study visit and procedures that you do complete. If you have any
questions regarding your compensation for participation, please contact the study doctor at the
telephone number listed on the first page of this form.
By accepting payment for participating in this study, certain identifying information about you
may be made available to professional auditors to satisfy audit and federal reporting
requirements, but confidentiality will be preserved.
Please note that if you earn $600 or over in a calendar year as a research subject, you may
have to pay taxes on these earnings.

18. FUTURE USE

The sponsor may conduct additional future research with your coded study related information
and/or samples. You will not know the results of any future study-related research performed
with your personal health information or samples and such information will not be placed in your
medical records.

19. INJURY COMPENSATION

Medical care will be offered to you in the event of an illness or injury as a direct result of your
taking part in this study. In the event that you have an illness or injury as a direct result of taking
part in this study, your reasonable medical expenses will be paid by the study sponsor, Vaxart,
Inc. No other form of compensation will be routinely provided for other than what is listed in this
informed consent form. You do not lose any of your legal rights as a research subject by signing
and dating this form.
- A study-related injury is a physical injury that is directly caused by the study drug
administered as described in the study protocol (study plan).
- A study-related injury does not include injuries directly caused by any of the following:
o The natural course of an existing underlying disease or medical condition.
o Not following the instructions provided in this informed consent form or by study
doctor and/or study staff.
The Sponsor Vaxart, Inc agrees, in case you suffer any damage, namely, any lesion, adverse
effect or consequences for your health related to the medication administered or to the
procedures performed as part of this clinical study, to provide immediate and necessary
treatment and medical care.
The expenses derived from the medical care and treatment will be in charge of Vaxart, Inc.
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To this end, please contact the study doctor at the telephone number listed on the first page of
this form.
The costs for any other medical problems not directly caused by your participation in this
research study are your responsibility.

By signing and dating this informed consent, you do not waive any rights you have in relation to
civil responsibility for damages that may correspond in case you suffer any damage derived
from your participation in this study.
A new public health declaration, called the Public Readiness and Emergency Preparedness
Declaration (PREP), was issued by the Department of Health and Human Services on
March 10, 2020. This declaration limits the legal rights of a subject participating in a COVID-
19 clinical study that uses a drug, device or vaccine designed to treat, diagnose, cure or
prevent COVID-19. This includes the study drug, VXA-CoV2-1.1-S used in this
study. Subjects using VXA-CoV2-1.1-S in this study will have limits on their right to sue the
manufacturers, the study sponsor, healthcare providers and others for significant injuries
and adverse reactions.
To pay medical expenses, the sponsor will need to know some information about you like your
name, date of birth, and Medicare Beneficiary Identifier (MBI). This is because the sponsor has
to check to see if you receive Medicare and if you do, report the payment it makes to Medicare.

20. WHOM TO CONTACT ABOUT THE STUDY

During the study, if you experience any medical problems, suffer a research-related injury, or
have questions, concerns or complaints about the study, please contact the study doctor and/ or
study staff at the telephone number listed on the first page of this consent document. If you seek
emergency care, or hospitalization is required, please visit your nearest hospital’s emergency
room and alert the treating physician that you are participating in this research study.
An institutional review board (IRB) is an independent committee established to help protect the
rights of research subjects. If you have any questions about your rights as a research subject,
and/or concerns or complaints regarding this research study, contact:
• By mail:
Study Subject Adviser
Advarra IRB
6100 Merriweather Dr., Suite 600
Columbia, MD 21044
• or call toll free: 877-992-4724
• or by email: adviser@advarra.com
Please reference the following number when contacting the Study Subject Adviser:
Pro00055265

21. ABILITY TO WITHDRAW FROM THE STUDY

Your part in the study is voluntary and you are free to stop taking part in the study at any time.
Your refusal to take part or withdrawal from the study will not involve any penalty or loss of
benefits to which you are otherwise entitled. If you decide to withdraw from this study, you
should notify the study doctor and/or study staff immediately.

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You will be informed of any new findings during your participation related to the research study.
These findings may affect your willingness to participate or to continue to participate in the
study. The study doctor and/or study staff will make the decision and let you know if it is not
possible for you to continue. The decision may be made to protect your safety and welfare, or
because it is part of the research plan that people who develop certain conditions may not
continue to participate.
If you choose not to stay in the study, we ask that you contact the study doctor or study
coordinator. You may be asked to come back for a final visit, so we can collect information
about your general health.

22. REMOVAL FROM THE STUDY

The study doctor or the study sponsor can remove you from the study at any time without your
consent for any of the following reasons:
• If it appears to be medically harmful to you;
• If you fail to follow directions for taking part in the study;
• If it is discovered that you do not meet the study requirements;
• In the judgment of the study doctor;
• If the study is canceled or stopped; or
• For administrative reasons (the number of subjects needed for the study has been
reached).

23. PRIMARY CARE PHYSICIAN/SPECIALIST NOTIFICATION OPTION

Taking part in this study should not be thought of as a substitute for treatment by your primary
care doctor or specialist. We strongly encourage you to ask the study staff or the study doctor
questions about the results of your laboratory tests and other test procedures. At your request,
we will provide copies of the results from these tests and procedures for you to review with your
primary care doctor or specialist.

Please indicate below whether you want us to notify your Primary Care Physician or your
specialist that you are taking part in this study by initialing one of the following options after you
have made your decision:

_______ N/A, I do not have a Primary Care Physician.

_______ No, I would not like the study staff to inform my Primary Care Physician of my
participation in this study.
_______ Yes, I would like the study staff to inform my Primary Care Physician of my
participation in this study. Please provide the following information:

Name of Primary Care Physician: ______________________________________

Contact details of Primary Care Physician: ____________________________________

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24. CONSENT
You have been asked to take part in a clinical research study for Vaxart, Inc., protocol VXA-
COV2-201 for prevention of COVID-19 disease. Before you write and sign your name, and date
below, please read the rest of this form. Ask any questions you might have. By signing and
dating this form, you agree to the following:

• I have thoroughly read, understood, and had full explanation of all

the information in this consent form

• All of my questions have been answered to my satisfaction.

• I know that joining the study is voluntary.

• I know that I can call the study doctor or study staff if I have any
questions or side effects

• I do not know of any medical conditions I may have that would

prevent me from joining the study

• I am free to not participate in this research study or to withdraw at

any time, and that my current medical care will not be affected by
this decision.

• I understand that I will receive and may keep an original of this

signed and dated consent form.

• By signing and dating this consent form, I have not waived any of
the legal rights that I would have, if I were not a participant in a
research study.

• I agree to fully cooperate with my study doctor and to inform

her/him about on any side effects or drugs I have been taking
before the study or will take during the study

• I understand that this study has been reviewed by an Institutional

Review Board.

• I understand that sections of my medical notes may be looked at

by responsible individuals of Vaxart, Inc., their representatives, or
by Ethics Committees, Institutional Review Boards and/or
Regulatory Authorities, where it is relevant to my taking part in the
research. I give permission to these persons to have access to my
records. I am aware that they are responsible to maintain privacy
and that applicable data protection laws will be observed

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• I consent to permit: (i) the recording of my coded personal data,

including information relating to my health; and (ii) the transfer of
these data for research purposes of the study to (a) the sponsor
and its representatives, (b) the health authorities and (c) ethics
committees for review to determine that the study has been
performed according to applicable rules. I understand that the
personal data collected will be treated with strict confidentiality by
all persons involved in the treatment of such and will not be
disclosed, and that said confidentiality obligations will survive my
participation in the study.

• I understand that Vaxart, Inc. has provided insurance coverage in

keeping with the law on clinical studies

• I understand that Vaxart, Inc., may stop the study at any time. If
this happens, I will no longer receive the study drug and planned
evaluations

• I certify that I will receive a signed and dated original copy of the
Subject Information and Informed Consent Form.

Subject:

Name and Last Name: _____________________________ Signature: ______________

Date: _____________________

For Study Doctor Use:

I certify that I have explained to this subject the nature and implications of this research study. I
have answered all of the subject’s questions and have encouraged him/her to ask any additional
questions at any time during the course of the study.

Name and Last Name: _______________________Signature: ______________________

Date: ____________________

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AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH

INFORMATION

If you decide to be in this study, the study doctor and study staff will use
and share health data about you to conduct the study. Health data may
include:
• Your name.
• Address.
• Phone number.
• Date of birth.
• Medical history.
• Information from your study visits, including all test results.

Health data may come from your study records or from existing records
kept by your doctor or other health care workers.

For this study, the study staff may share health data about you with
authorized users. Authorized users may include:
• Representatives of Vaxart Inc
• Representatives of ICON Government and Public Health Solutions
(ICONGPHS)
• Representatives of Advarra IRB (an Institutional Review Board that
reviews this study).
• The Food and Drug Administration (FDA) and other US federal and
state agencies.
• Government agencies to whom certain diseases (like HIV, hepatitis,
and STDs) must be reported.
• Governmental agencies of other countries.
• Outside individuals and companies, such as laboratories and data
storage companies, that work with the researchers and sponsor and
need to access your information to conduct this study.
• Other research doctors and medical centers participating in this
study, if applicable.
• A data safety monitoring board which oversees this study, if
applicable.

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Your health data will be used to conduct and oversee the research,
including for instance:
• To see if the study drug works and is safe.
• To compare the study drug to other vaccines
• For other research activities related to the study drug.

Once your health data has been shared with authorized users, it may no
longer be protected by federal privacy law and could possibly be used or
disclosed in ways other than those listed here.

Your permission to use and share health data about you will end in 50
years unless you revoke it (take it back) sooner.

You may revoke (take back) your permission to use and share health data
about you at any time by writing to the study doctor at the address listed on
the first page of this form. If you do this, you will not be able to stay in this
study. No new health data that identifies you will be gathered after your
written request is received. However, health data about you that has
already been gathered may still be used and given to others as described
in this form.

Your right to access your health data in the study records will be
suspended during the study to keep from changing the study results. When
the study is over, you can access your study health data.

If you decide not to sign and date this form, you will not be able to take part
in the study.

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STATEMENT OF AUTHORIZATION
I have read this form and its contents were explained. My questions have
been answered. I voluntarily agree to allow study staff to collect, use and
share my health data as specified in this form. I will receive a signed and
dated copy of this form for my records. I am not giving up any of my legal
rights by signing and dating this form.

__________________________________
Printed Name of Subject

__________________________________ __________
Signature of Subject Date

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