Investigation of the Immunogenicity and Safety of Lactococcus Lactis Vaccine Containing Codon-Optimized Full-Length E7 and E6 Oncoproteins of HPV-16 in Healthy Women
The Main Objective of This Study Was to Evaluate the Immunogenicity and Safety of Oral Vaccines Containing E7 and E6 Oncoproteins of Human Papillomavirous type 16, In Order to Eventually Use These Vaccines to Treat Cervical Cancer Caused by Human Papillomavirus type 16.
Design
One Hundred Sixty Healthy Iranian Non-Pregnant Volunteer Women Aged 18 to 59 Years Were Vaccinated at the Keyvan Virology Specialty Laboratory (KVSL). Upon Enrollment, Written Consent Was Obtained From Each Participant or Her Legal Guardian.
Settings and conduct
Keyvan Virology Specialty Laboratory
Participants/Inclusion and exclusion criteria
1- People Voluntarily Participate in the Research.
2- The Informed Consent Form Is Completed and Signed by the Person or Her companion.
3- Women PCR positive test for Papilloma Virus Infection.
4. Women Don't Have other sexually transmitted diseases.
Women Don't be Pregnant
6. Women in Pap smear Test Don't Have Abnormal Conditions.
7. People Don't Have Other Cancerous Disease During the Course of Treatment.
8. Failure to Complete a Course of Treatment by Individuals Will Result in Their Exclusion from Study.
9- Getting Pregnant During the Course of Treatment Will Leave Women Out of Study.
Intervention groups
In This Study, There Are Six Target Groups That All Groups Are Identical in Terms of Health Standards, But Differ in Terms of Drug Use. This Will be Given to Three Groups (Test Groups) of the E7 and E6 Vaccine and Will be Given to the Following Three (Control Groups) Groups of Placebo.
Main outcome variables
Immunogenicity and Safety of Vaccines
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190504043464N1
Registration date:2019-05-19, 1398/02/29
Registration timing:retrospective
Last update:2019-05-19, 1398/02/29
Update count:0
Registration date
2019-05-19, 1398/02/29
Registrant information
Name
Sedigheh Taghinezhad Saroukalaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8854 9747
Email address
s.taghinezhad@srbiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2019-02-19, 1397/11/30
Trial completion date
2019-02-20, 1397/12/01
Scientific title
Investigation of the Immunogenicity and Safety of Lactococcus Lactis Vaccine Containing Codon-Optimized Full-Length E7 and E6 Oncoproteins of HPV-16 in Healthy Women
Public title
Investigating of the Immunogenicity and Safety of Lactococcus Lactis Vaccine Related to Human Papillomavirus Type 16
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- People Voluntarily Participate in the Research.
2- The Informed Consent Form Is Completed and Signed by the Person or Her companion.
3- Women PCR positive test for Papilloma Virus Infection.
4. Women Don't Have other sexually transmitted diseases.
Women Don't be Pregnant
6. Women in Pap smear Test Don't Have Abnormal Conditions.
Exclusion criteria:
1. People Don't Have Cancerous Disease During the Course of Treatment.
2. Failure to Complete a Course of Treatment by Individuals Will Result in Their Exclusion from Study.
3- Getting Pregnant During the Course of Treatment Will Leave Women Out of Study.
Age
From 18 years old to 59 years old
Gender
Female
Phase
1
Groups that have been masked
Participant
Sample size
Target sample size:
200
Actual sample size reached:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Volunteers Who Met eligibility Criteria Were Randomized Into Six Clinical Groups in a 2:1 Correlation Using Randomizer Software (Version 3.0) To Receive Four Rounds of Oral Vaccination using the E7 or E6 Vaccine or a Placebo at Weeks 1, 2, 4, and 8. Each Dose of Vaccine was Administered Orally, Once Each Morning After Fasting For Five Days, Each Treatment Week.
Blinding (investigator's opinion)
Single blinded
Blinding description
In This Study, Healthy Women Are Divided Into Six Groups. In This Phase, All Groups Are Treated and Simultaneously Given to Three Groups of Vaccines and Given to the Other Three Groups of Placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Siences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2016-12-20, 1395/09/30
Ethics committee reference number
1395.95-04-30-29914
Health conditions studied
1
Description of health condition studied
Genital Wart
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts
Primary outcomes
1
Description
Change in Antibody and Interferon Levels
Timepoint
At the Beginning of the Study, 30, 60 and 90 Days After Taking the Vaccine.
Method of measurement
ELISA And ELISPOT KITS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Volunteers Receive Four Rounds of Oral Vaccine (1 mL) at Weeks 1, 2, 4, and 8. Each Dose of Vaccine Was Administered Orally, Once Each Morning After Fasting For Five Days, Each Treatment Week. If No Side Effects Were Detected in Arms Given the Lower Dose (10000000000 CFU/mL), the Dose Was Escalated to 50000000000 CFU/mL and 100000000000 CFU/mL.
Category
Treatment - Other
2
Description
Control group: Control Groups Receive Four Rounds of Placebo (1 mL) at Weeks 1, 2, 4, and 8. Each Dose of Placebo Was Administered Orally, Once Each Morning After Fasting For Five Days, Each Treatment Week. If No Side Effects Were Detected in Arms Given the Lower Dose (10000000000 CFU/mL), the Dose Was Escalated to 50000000000 CFU/mL and 100000000000 CFU/mL.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Keyvan Virology Specialty Laboratory
Full name of responsible person
Hossein Keyvani
Street address
Floor 1, Number 498, Beheshti Avenue
City
Tehran
Province
Tehran
Postal code
1596983911
Phone
+98 21 8870 6556
Fax
+98 21 8870 6555
Email
keyvani.h@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malakoti
Street address
Tehran, Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
s.taghinezhad@srbiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
50
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Hossein Mohseni
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Floor 1, Number 498, Shahid Beheshti ave, Tehran.
City
Tehran
Province
Tehran
Postal code
1596983911
Phone
+98 21 8871 6556
Fax
+98 21 8871 6555
Email
amho.mohseni@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sedigheh Taghinezhad Saroukalaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Floor 1, No. 498, Shahid Beheshti Ave., Tehran.
City
Tehran
Province
Tehran
Postal code
1596983911
Phone
+98 21 8871 6556
Fax
+98 21 8871 6555
Email
taghinezhad.m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Hossein Mohseni
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Floor 1, No. 498, Shahid Beheshti Ave., Tehran.
City
Tehran
Province
Tehran
Postal code
1596983911
Phone
+98 21 8871 6556
Fax
+98 21 8871 6555
Email
amho.mohseni@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available