Immunogenicity and Safety Study of NBP615 in Healthy Female

September 24, 2021 updated by: SK Bioscience Co., Ltd.

A Randomized, Double-Blinded, Active Controlled, Phase I/ II Clinical Trial to Assess the Immunogenicity, Safety, and Tolerability of NBP615 Vaccine in Healthy Female Participants Aged 19 to 26 Years and Adolescent Aged 9 to 13 Years

This was a randomized, double-blind, active-controlled, phase I/II clinical trial to enroll 200 healthy female including 80 healthy adult aged 19 to 26 years and 120 adolescents aged 9 to 13 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In order to confirm the safety, 80 healthy adult were enrolled first. Eligible subjects were randomized into 1:1 ratio to receive three doses of either test vaccine (NPB615) or comparator vaccine (Gardasil). The safety of the test vaccine (NBP615) was confirmed by 2nd vaccination in adult subjects. After that, enrolment of 120 adolescent subjects proceeded. Eligible subjects who previously agreed to participate in the study were screened and only those subjects who met the inclusion/exclusion criteria were randomized in to 1:1 to receive two doses of test vaccine (NBP615) or comparator (Gardasil pre-filled syringe). 0.5 ml Intramuscular injection at were given at each vaccination and two blood sample, pre vaccine and post vaccine 4 weeks after completion of vaccine were collected to assess the immunogenicity of NBP615 and Gardasil, comparator vaccine. Solicited adverse events occurred up to 7 days after each dose of the investigational product were collected in the diary card. Unsolicited adverse events occurred up to 28 days after each dose of the investigational product were collated in the diary card. Serious adverse events were collected during the entire study period. In addition to this safety data was collected through the study period by active contact with the study participants by doing home visit or by telephone contact.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seongnam-si
      • Gyeonggi-do, Seongnam-si, Korea, Republic of, 13494
        • SK Bioscience

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

[Inclusion Criteria]

  • Healthy adult(19 to 26 years)/adolescent(9 to 13 years) of age at the time of the 1st vaccination
  • Participant fully understands study procedures, and voluntarily agrees to participate in the study and follow the study procedure by giving written informed consent

[Exclusion Criteria]

  • Received a marketed Human papillomavirus(HPV) vaccine, or had participated in an HPV vaccine clinical trial and had received either active agent or placebo.
  • History of hypersensitivity to any component of the study vaccines.
  • Currently immunocompromised or was diagnosed as having a congenital or acquired immunodeficiency, Human Immunodeficiency Virus(HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, other autoimmune condition, or other immune disorder which is decided to be medically significant by the investigator.
  • Received immunoglobulins and/or blood product within 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Receiving or had received chemotherapy, immunosuppressive therapies, or radiation therapy in the year prior to enrolment.
  • Chronic administration (>14 days) of immune-suppressants or immune modulating drugs within 3 months prior to the first vaccine dose or planned administration during the study period. Inhaled, nasal and topical steroids are allowed.
  • Participant with severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
  • Subject has active cervical disease or a significant history of cervical disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NBP615
Adult : 3 doses of vaccination Adolescent :2 doses of vaccination
Biological: NBP615
Intramuscular injection, 0.5ml
Active Comparator: GARDASIL
Adult : 3 doses of vaccination Adolescent :2 doses of vaccination
Biological: Gardasil
Intramuscular injection, 0.5ml

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Geometric mean titer measured by Enzyme-linked Immunosorbent Assay(ELISA)
Time Frame: 4 weeks after the vaccination
geometric mean titer against anti-HPV 6, 11, 16, and 18 for each treatment group
4 weeks after the vaccination
seroconversion rate measured by Enzyme-linked Immunosorbent Assay(ELISA)
Time Frame: 4 weeks after the vaccination
proportion of subjects who seroconverted from seronegative at baseline to seropositive at post vaccination for anti-HPV 6, 11, 16, and 18
4 weeks after the vaccination
Geometric mean titer measured by pseudovirion-based neutralization assay(PBNA)
Time Frame: 4 weeks after the vaccination
geometric mean titer against anti-HPV 6, 11, 16, and 18 for each treatment
4 weeks after the vaccination
Incidence rate of Solicited Adverse Event
Time Frame: 7 days after the vaccination
Solicited local/systemic adverse event after vaccination
7 days after the vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SK Bioscience Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: K Zaman, MD, International Centre for Diarrhoeal Disease Research, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PR-18062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings