The aim of this study is confirm that in adults up to 55 years old, the humoral response to the half-dose (15ug) and to the standard dose (30ug) in the two-dose three-week interval schedule would be comparable since half-dose schedule can help limit achieve wide vaccination coverage more quickly and cheaply.
Design
Two arm parallel group not randomised and not blinded single center trial.
Settings and conduct
All participant had the antibody levels measured prior do the first dose of the vaccine. Participants with a positive result were included in the prior COVID-19 infection group and had another antibody measurement on day 8 after the first vaccine dose. Participants with a negative result were included in the no-prior COVID-19 infection group and had antibody levels measured on day 21 after first vaccine dose and day 8 after second vaccine dose.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
-Willingness to take part in the clinical trial
-Age between 18 and 55 years old
Exclusion criteria:
-Age above 55 years old
-Diagnosed with diabetes, hypertension, heart disease, chronic pulmonary diseases, severe allergies
-Obesity as defined by BMI > 30
Intervention groups
Healthy participants aged 18-55 received half-dose (15ug) (HD) and were compared to subjects of similar age who received the full 30ug dose (FD) and were monitored as part of a parallel study (Bioethics Committee opinion at the Regional Medical Chamber in Gdansk KB-4/21).
Main outcome variables
Prior COVID-19 infection:
-Antibody level on day 8 after first vaccine dose
No prior COVID-19 infection:
-Antibody levels on day 21 after first vaccine dose and day 8 after second vaccine dose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210708051820N1
Registration date:2021-08-06, 1400/05/15
Registration timing:retrospective
Last update:2021-08-06, 1400/05/15
Update count:0
Registration date
2021-08-06, 1400/05/15
Registrant information
Name
Amira Podolak
Name of organization / entity
Invicta Research and Development Center
Country
Poland
Phone
+48 58 585 88 10
Email address
amira.podolak@invicta.pl
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-27, 1399/11/08
Expected recruitment end date
2021-04-30, 1400/02/10
Actual recruitment start date
2021-02-01, 1399/11/13
Actual recruitment end date
2021-04-29, 1400/02/09
Trial completion date
2021-05-21, 1400/02/31
Scientific title
Comparison of humoral response in half and full dose of BNT162b2 vaccinated in people under 55 years of age
Public title
Biding antibodies in half and full dose BNT162b2 vaccinated people under 55 years of age
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to take part in the clinical trial
Age between 18 and 55 years old
Exclusion criteria:
Age above 55 years old
Diagnosed with diabetes, hypertension, heart disease, chronic pulmonary diseases, severe allergies
Obesity as defined by BMI > 30
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Actual sample size reached:
42
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee at the Gdansk Regional Medical Board
Street address
Śniadeckich 33
City
Gdańsk
Postal code
80-204
Approval date
2021-03-30, 1400/01/10
Ethics committee reference number
No KB - 4/21 and KB – 14/21
Health conditions studied
1
Description of health condition studied
The humoral response to the half-dose of BNT162b2-vaccine.
ICD-10 code
T80.62
ICD-10 code description
Other serum reaction due to vaccination
Primary outcomes
1
Description
Anti-SARS-CoV-2 antibody level
Timepoint
On the day of dose-2 of the vaccine and 8-10 days later
Method of measurement
IVD Elecsys Anti-SARS-CoV-2 S assay (Roche Diagnostics)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vaccination with BNT162b2 vaccine (Comirnaty, Pfizer/BioNTech), 2 doses at 15ug each, dose interval 21 days. Blood draws for antibody testing: day 1, 8, 21, 28-30 (day 1 is the day of the first dose of the vaccine)
Category
Prevention
2
Description
Control group: Vaccination with BNT162b2 vaccine (Comirnaty, Pfizer/BioNTech), 2 doses at 30ug each, dose interval 21 days. Blood draws for antibody testing: day 1, 8, 21, 28-30 (day 1 is the day of the first dose of the vaccine)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
INVICTA Research and Developmend Center
Full name of responsible person
Krzysztof Łukaszuk
Street address
Polna 64
City
Sopot
Postal code
81740
Phone
+48 58 585 88 10
Email
sekretariatlukaszuk@invicta.pl
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Invicta Research and Development Center
Full name of responsible person
Anna Knight
Street address
Polna 64
City
Sopot
Postal code
81-740
Phone
+48 58 585 88 10
Email
anna.knight@invicta.pl
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Invicta Research and Development Center
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Invicta Research and Development Center
Full name of responsible person
Krzysztof Łukaszuk
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Polna 64
City
Sopot
Province
Pomorskie
Postal code
81740
Phone
+48 58 585 88 10
Email
sekretariatlukaszuk@invicta.pl
Person responsible for scientific inquiries
Contact
Name of organization / entity
Invicta Research and Development Center
Full name of responsible person
Krzysztof Łukaszuk
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Polna 64
City
Sopot
Province
Pomorskie
Postal code
81740
Phone
+48 58 585 88 10
Email
sekretariatlukaszuk@invicta.pl
Person responsible for updating data
Contact
Name of organization / entity
Invicta Research and Development Center
Full name of responsible person
Amira Podolak
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Medical Genetics
Street address
Polna 64
City
Sopot
Province
Pomorskie
Postal code
81740
Phone
+48 58 585 88 10
Email
amira.podolak@invicta.pl
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Deidentified data can be made available upon request
When the data will become available and for how long
Data can be made available starting 6 months after the trial result are published
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Requests will be reviewed on the case-by-case basis.
From where data/document is obtainable
Requests should be sent to anna.knight@invicta.pl
What processes are involved for a request to access data/document
Requests will be reviewed on the case-by-case basis. Requests should included the proposed use of data.