Ad26.COV2.S, also referred to as a *study vaccine* in this document, is a COVID 19 vaccine. In this study, the formation of antibodies against the coronavirus is compared at two different dosing volumes. In addition, it will be investigated if it is…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To assess the safety and reactogenicity of Ad26.COV2.S 5x10^10 vp per 0.3 mL
versus 5x10^10 vp per 0.5 mL.
2. To demonstrate non-inferiority (NI) of the immune responses (Geometric mean
concentration (GMC)) 28 days after vaccination with Ad26.COV2.S 5x10^10 vp per
0.3 mL versus 5x10^10 vp per 0.5 mL, as measured by S enzyme-linked
immunosorbent assay (S-ELISA) using a NI margin of 2/3 for the GMC ratio (GMC
of 5x10^10 vp in 0.3 mL/GMC 5x10^10 vp in 0.5 mL).
Secondary outcome
1. To assess the humoral immune response to Ad26.COV2.S across both groups, at
all blood collection timepoints.
2. To further assess the humoral immune response to Ad26.COV2.S in a subset of
participants across both groups, at selected blood collection
timepoints.
Background summary
This study is being done to test the vaccine called Ad26.COV2.S. Doctors and
scientists hope it will prevent or lessen the severity of diseases caused by
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). When the term
*coronavirus* is used in this document, it refers to SARS CoV 2. This virus
causes the disease called COVID-19. SARS-CoV-2 is passed from person to person
primarily by small droplets from the nose or mouth when an infected person
coughs, sneezes or speaks. Most people who are infected have mild disease such
as cough and extreme tiredness, but some people have severe disease and have
difficulty breathing and can even die from this disease.
A vaccine helps to prevent diseases and their spread by allowing the human body
to form an immune response against what causes the disease, such as viruses or
bacteria. This defensive response is a way your body fights infections. The
immune response that Ad26.COV2.S causes is specific for SARS-CoV-2.
Ad26.COV2.S is made from a type of common cold virus called adenovirus. The
adenovirus used to make this vaccine is harmless to people because it cannot
multiply anymore.
The Ad26.COV2.S study vaccine includes genetic material from SARS-CoV-2 virus.
When the study vaccine is injected into your body, the genetic material from
SARS-CoV-2 gets *translated* to produce so called *spike proteins* which are
specific to SARS-CoV-2. Our bodies recognize these proteins and make an immune
response against them. You cannot contract COVID-19 from the study vaccine.
Given the plan to vaccinate a large portion of the global population,
tremendous supplies of vaccine are needed. The purpose of this study is to
determine if a greater number of vaccine doses can be contained in the same
vial if the volume of the vaccine is reduced. This would have a positive impact
on supply.
Ad26.COV2.S is already being used to vaccinate people in Europe, the United
States, and Canada against SARS-CoV-2.
Study objective
Ad26.COV2.S, also referred to as a *study vaccine* in this document, is a COVID
19 vaccine. In this study, the formation of antibodies against the coronavirus
is compared at two different dosing volumes. In addition, it will be
investigated if it is safe, if it can cause side-effects (unexpected or
unwanted reactions from taking a drug), and how well the study vaccine is
tolerated by the healthy participants in the study.
Ad26.COV2.S will be tested in a fixed dose level but with two different
injection volumes in healthy adults aged 18 to 65 years inclusive.
Ad26.COV2.S has been used by humans before and is currently authorized to be
used to vaccinate people in Europe, the United States, and Canada. The dose
used in this study is the same as that used in the large scale phase 3 study
and on the basis of which effectiveness has been demonstrated and authorization
obtained. Both dose volumes contain the same dose of vaccine.
Study design
The study will take 6 months from the screening until the final visit. The
study will consist of a 24-week study period (including administration of 1
dose of study vaccine and a 6-month follow-up period). In total the volunteers
will visit the research center 4 times and the will also be called once. On the
day of vaccination, blood samples will be collected and a nose swab, followed
by only one blood sample. During the study period, the volunteers will be asked
to report information daily in a diary, starting from the day of the study
vaccine administration, and for the 7 days afterwards (for a total of 8 days).
Intervention
Ad26.COV2.S
Study burden and risks
Blood draw
Drawing blood may be painful or cause some bruising. In some individuals, a
blood draw can sometimes cause pallor, nausea, sweating, low heart rate, or
drop in blood pressure with dizziness or fainting.
In total, we will take about 54 milliliters (mL) of blood from the volunteer.
This amount does not cause any problems in adults. If the investigator thinks
it is necessary for the safety of a participant, extra samples might be taken
for possible additional testing. If this happens, the total amount of blood
drawn will be more than the amount indicated above.
Coronavirus test
Samples for the coronavirus test will be taken from the back of the nose using
swabs. Taking the samples only takes a few seconds, but can cause discomfort
and can give an unpleasant feeling. When the sample is taken from the back of
the nose, the volunteer may experience a stinging sensation and their eyes may
become watery.
The following side effects have been observed when the Ad26.COV2.S vaccine was
given to participants:
Very common side effects (affecting more than 10% of participants):
Headache, fatigue, muscle pain, nausea, injection site pain.
Common side effects (affecting 1% to 10% of participants):
Fever, chills, swelling at injection site, reddening of skin at injection site,
joint pain
Uncommon side effects (affecting less than 1% of participants):
Malaise (general not feeling well), muscle weakness, pain in arm/leg, general
weakness
Rare side effects with Ad26COV2.S vaccine (affecting less than 0.1% of
participants):
In a phase 3 trial (study in large group of people to study effectiveness of
the study vaccine) of the Ad26.CoV2.S vaccine, the following rare, serious or
important conditions were reported in study participants receiving the study
vaccine:
Blood clot in a deep vein, blood clot in the lungs, seizures, drooping of the
face, ringing in the ear, Guillain-Barré Syndrome
Risks and possible side effects of vaccines in general
All types of injections can cause:
• Stinging, itching, arm discomfort, pain, soreness, redness, hardness,
bruising and swelling where you receive the injection
• Fever and chills
• Rash
• Itching in other areas of your body
• Aches and pains
• Muscle and joint pain
• Throwing up and nausea
• Headache
• Dizziness
• Feeling very tired
• Fainting
Graaf Engelbertlaan 75
Breda 4837 DS
NL
Graaf Engelbertlaan 75
Breda 4837 DS
NL
Listed location countries
Age
Inclusion criteria
1. Participant must sign an ICF indicating that he or she understands the
purpose, procedures
and potential risks and benefits of the study, and is willing to participate in
the study.
2. Participant is willing and able to adhere to the prohibitions and
restrictions specified in this
protocol.
3. Participant is 18 to 65 years of age, inclusive, on the day of signing the
ICF.
4. Participant must be healthy, in the investigator*s clinical judgment, as
confirmed by medical
history, physical examination, and vital signs performed at screening.
Participant may have
underlying illnesses, as long as the symptoms and signs are medically
controlled and not
considered to be comorbidities related to an increased risk of severe
COVID-19b, except for
smoking, which is allowed (see also exclusion criterion 19). If on medication
for a condition,
the medication dose must have been stable for at least 12 weeks preceding
vaccination and
expected to remain stable for the duration of the study.
Exclusion criteria
1. Participant has a clinically significant acute illness (this does not
include minor illnesses such
as diarrhea or mild upper respiratory tract infection) or temperature >=38.0ºC
within 24 hours
prior to the planned study vaccination; randomization at a later date is
permitted at the
discretion of the investigator and after consultation with the sponsor.
2. Participant has a history of malignancy within 5 years before screening
(exceptions are
squamous and basal cell carcinomas of the skin and carcinoma in situ of the
cervix, or
malignancy, which is considered cured with minimal risk of recurrence).
3. Participant has a known or suspected allergy or history of anaphylaxis or
other serious adverse
reactions to vaccines or their excipients (including specifically the
excipients of the study
vaccine)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-001374-30-NL |
| CCMO | NL77273.000.21 |