Immunogenicity and Safety Study of NBP615 in Healthy Female

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: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Biological: NBP615; Biological: Gardasil

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: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Geometric mean titer measured by Enzyme-linked Immunosorbent Assay(ELISA)	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)	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)	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	Solicited local/systemic adverse event after vaccination	7 days after the vaccination

Collaborators and Investigators

• Sponsor: SK Bioscience Co., Ltd.
• Investigators: Principal Investigator: K Zaman, MD, International Centre for Diarrhoeal Disease Research, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2018
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID 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