Protocol summary

Study aim
Evaluation of immunogenicity and safety of Human papillomavirus vaccine (quadrivalent Papilloguard, manufactured by Nivad pharmed Salamat Co.) compared to the Human papillomavirus vaccine (quadrivalent Gardasil, Merck Co.) in healthy volunteers aged 15-25 years.
Design
Phase III, randomized, double-blinded, parallel arms, active-controlled clinical trial on 670 healthy volunteers
Settings and conduct
Phase III, randomized, double-blind, parallel, active controlled, non-inferiority clinical trial with 1:1 allocation in 670 participants at Mehr Hospital in Tehran. After randomization, volunteers will be received quadrivalent HPV vaccine (Nivad pharmed or Merck) on days 0, 60, and 180 and will be followed up for immunogenicity and safety. PI and analyzer are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 15-25 years, ability to understand the process of the study and signing the informed consent, general health, not having fever or acute infectious disease, not having a plan to inject other vaccines in the study period, not being pregnant and agreement to use preventive method for 7 months. Exclusion criteria: prior HPV vaccination, history of severe allergic reactions to vaccine, receiving immunoglobulins or blood products, chronic diseases such as Immunodeficiency, thrombocytopenia or coagulation disorder, history of drug or alcohol abuse, use immunosuppressant medication, chemotherapy, take participation in other clinical trial
Intervention groups
Intervention group: pre-filled syringe of papillomavirus vaccine against types 6 (20 micrograms), 11 (40 micrograms), 16 (40 micrograms) and 18 (20 micrograms) manufactured by Nivad Pharmed Salamat, intramuscular injection (deltoid muscle of the non-dominant hand) to the amount of 0.5 ml in the visit of months 0, 2 and 6
Main outcome variables
Human papillomavirus type 6, 11, 16, and 18 antibody titer, GMT

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240120060741N1
Registration date: 2024-03-26, 1403/01/07
Registration timing: prospective

Last update: 2024-03-26, 1403/01/07
Update count: 0
Registration date
2024-03-26, 1403/01/07
Registrant information
Name
Golara Nikakhtar
Name of organization / entity
Caro Pharmed Alborz
Country
Iran (Islamic Republic of)
Phone
+98 21 9120 0238
Email address
golaranikakhtar97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the immunogenicity and safety of Papilloguard 4 vaccine (quadrivalent manufactured by Nivad Pharmed Salamat company) compared to Gardasil vaccine (quadrivalent, reference product, Merck company) by comparing the ratio of GMT (Geometric Mean Titer) in healthy male and female volunteers 15 to 25 years: a phase 3 randomized, parallel, double-blind, noninferiority clinical trial
Public title
Clinical Trial of quadrivalent Papilloguard4 vaccine (Human Papillomavirus Types 6, 11, 16, 18) manufactured by Nivad Pharmed Salamat in comparison with Gardasil
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Males and females 15 to 25 years old Eligible for general health (through clinical examinations and medical records) Signed the informed consent form (or guardian has signed the informed consent form) It is possible to accompany the visit programs and the study process within 7 months Not having fever (above 37.5°C) or acute infectious disease within 24 hours of participation If the female volunteer had sex within two weeks before entering the study, she must have used a suitable method of prevention (other than emergency pills) Women volunteer must not be pregnant and should agree to use effective preventive method through 7 months of the study Not having a plan to inject other vaccines in the study period (except Meningococcal, hepatitis B, influenza, diphtheria/tetanus vaccines, or injection of diphtheria/tetanus vaccine 8 days before participation with the prior consultation of PI).
Exclusion criteria:
Received any prior doses of HPV vaccine A history of severe allergic reactions (swelling of the mouth and throat, dyspnea, hypotension, urticaria, shock) that require therapeutic interventions. History of alcohol or drug abuse (addiction) within 1 year before entering the study Subjects who are thrombocytopenic or suffering from any coagulation disorder that prohibits intramuscular injection. Breastfeeding women Subjects with immune-mediated disease include: splenectomy, subjects who have immune disorders (e.g. lupus, rheumatoid arthritis), currently taking immunosuppressant medication (including radiation therapy, anti-metabolites, taking systemic corticosteroids in the last three weeks more than 15 mg daily), people who are currently undergoing chemotherapy History of chronic diseases e.g. cancer, liver and kidney diseases, chronic lung disease, heart failure, thyroid disorders, neurologic disorders, diabetes, autoimmune disease Receiving immunoglobulins or blood products within 6 months before participation and not having a plan to receive through 7 months of the study. Any other condition outside of the above that, in the opinion of the researcher/doctor, makes the candidate unsuitable for participating in the clinical trial. Participation in other clinical trials
Age
From 15 years old to 25 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 670
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be stratified block randomization, with stratification based on gender. Two strata will be defined, and within each stratum, permuted block randomization will be performed. Permuted randomized blocks with a size of four and a ratio of 1:1 will be created.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both candidate and reference vaccines are pre-filled syringes, but due to the appearance differences of the studied vaccines, before starting the study, all vaccines are placed in the same packages and depending on the sequence, the unique code from the random chain is created on the corresponding coding vaccine packages. By recruitment of volunteers, the unique code is checked by the executive team at first and the related package is taken from the refrigerator and is opened then the vaccine is injected. All participants are injected by educated nurses. According to the vaccine availability In the drug stock of the site and sticking a research label on vaccines and injections by the nurse, the researcher will not be informed about the type of injected vaccine.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
research ethics committee of national research ethics committee
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
IR.NREC.1402.004

Health conditions studied

1

Description of health condition studied
Genital wart prevention
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts

Primary outcomes

1

Description
Antibody titer against papillomavirus 6 with GMT comparison after 7 months.
Timepoint
After 7 months
Method of measurement
ELISA method

2

Description
Antibody titer against papillomavirus 11 with GMT comparison after 7 months.
Timepoint
After 7 months
Method of measurement
ELISA method

3

Description
Antibody titer against papillomavirus 16 with GMT comparison after 7 months.
Timepoint
After 7 months
Method of measurement
ELISA method

4

Description
Antibody titer against papillomavirus 18 with GMT comparison after 7 months.
Timepoint
After 7 months
Method of measurement
ELISA method

Secondary outcomes

1

Description
Seroconversion in human papilloma virus antibody types 6, 11, 16 and 18
Timepoint
Days 60, 180 and 210 after first injection
Method of measurement
Four-fold increase in antibody titer

2

Description
Human papilloma virus type 16 antibody titer, GMT
Timepoint
Days 60 and 180 after first injection
Method of measurement
ELISA method

3

Description
Human papilloma virus type 18 antibody titer, GMT
Timepoint
Days 60 and 180 after first injection
Method of measurement
ELISA method

4

Description
Human papilloma virus type 6 antibody titer, GMT
Timepoint
Days 60 and 180 after first injection
Method of measurement
ELISA method

5

Description
Human papilloma virus type 11 antibody titer, GMT
Timepoint
Days 60 and 180 after first injection
Method of measurement
ELISA method

6

Description
Any solicited local or systemic acute or allergic adverse event
Timepoint
During the first 30 minutes after each vaccine injection
Method of measurement
Direct observation and reporting

7

Description
Any solicited local or systemic adverse event
Timepoint
During the first 7 days after each vaccine injection
Method of measurement
Direct observation and reporting

8

Description
Any unsolicited adverse events
Timepoint
During the first 30 days after each vaccine injection
Method of measurement
Direct observation and reporting

9

Description
Any serious adverse event
Timepoint
During the first 30 days after each vaccine injection
Method of measurement
Direct observation and reporting

Intervention groups

1

Description
Intervention group: intramuscular injection of 0.5ml of quadrivalent papilloma virus vaccine (Nivad pharmed Co.) in days 0, 60 and 180
Category
Prevention

2

Description
Control group: Intervention group: intramuscular injection of 0.5ml of quadrivalent Gardasil vaccine (Merck Co.) in days 0, 60 and 180
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehr Hospital
Full name of responsible person
Masoud Mardani
Street address
Mehr Hospital, West Zartosht St., Valiasr Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1415755415
Phone
+98 21 8898 2000
Fax
+98 21 8896 9155
Email
info@mehrhospitaltehran.com
Web page address
https://mehrhospitaltehran.com/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nivad Pharmed Salamat
Full name of responsible person
Dr.Mohammad Amin Ghobadi
Street address
National Institute of Genetic Engineering and Biotechnology (NIGEB), Shahrak-e Pajoohesh,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
3164949682
Phone
+98 21 9120 0238
Fax
+98 21 7105 7279
Email
info@nivadpharmed.com
Web page address
https://www.nivadpharmed.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nivad Pharmed Salamat
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
Caro Pharmed Alborz
Full name of responsible person
Setayesh Sadeghi
Position
مدیر عامل
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
National Institute of Genetic Engineering and Biotechnology (NIGEB), Shahrak-e Pajoohesh, km 15, Tehran - Karaj Highway, Tehran, Iran CaRO Pharmed
City
تهران
Province
Tehran
Postal code
1497719830
Phone
+98 21 9120 0238
Email
s.sadeghi@caropharmed.com
Web page address
https://caropharmed.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoud Mardani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Makhsus St ,Qazvin St ,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5000
Email
drmasoudmardani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
CaRo Pharmed Alborz
Full name of responsible person
Golara Nikakhtar
Position
Clinical Trial Project Manager
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
National Institute of Genetic Engineering and Biotechnology (NIGEB), Shahrak-e Pajoohesh, km 15, Tehran - Karaj Highway, Tehran, Iran CaRO Pharmed
City
Tehran
Province
Tehran
Postal code
1497719830
Phone
+98 21 9120 0238
Email
g.nikakhtar@caropharmed.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The individual data of the participants will not be published publicly except to the relevant authorities and legal organizations.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...