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Immunogenicity and Safety Study of NBP615 in Healthy Female

Primary Purpose

Cervical Cancer

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

NBP615

Gardasil

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

9 Years - 26 Years (Child, Adult)FemaleAccepts Healthy Volunteers

[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.

Sites / Locations

SK Bioscience

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NBP615

GARDASIL

Arm Description

Adult : 3 doses of vaccination Adolescent :2 doses of vaccination

Outcomes

Primary Outcome Measures

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

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

Geometric mean titer measured by pseudovirion-based neutralization assay(PBNA)

geometric mean titer against anti-HPV 6, 11, 16, and 18 for each treatment

Incidence rate of Solicited Adverse Event

Solicited local/systemic adverse event after vaccination

Secondary Outcome Measures

Full Information

NCT ID

NCT04453241

First Posted

June 26, 2020

Last Updated

September 24, 2021

Sponsor

SK Bioscience Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04453241

Brief Title

Immunogenicity and Safety Study of NBP615 in Healthy Female

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

December 22, 2018 (Actual)

Primary Completion Date

December 30, 2019 (Actual)

Study Completion Date

December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SK Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NBP615

Arm Type

Experimental

Arm Description

Adult : 3 doses of vaccination Adolescent :2 doses of vaccination

Arm Title

GARDASIL

Arm Type

Active Comparator

Arm Description

Adult : 3 doses of vaccination Adolescent :2 doses of vaccination

Intervention Type

Biological

Intervention Name(s)

NBP615

Intervention Description

Intramuscular injection, 0.5ml

Intervention Type

Biological

Intervention Name(s)

Gardasil

Intervention Description

Intramuscular injection, 0.5ml

Primary Outcome Measure Information:

Title

Geometric mean titer measured by Enzyme-linked Immunosorbent Assay(ELISA)

Description

geometric mean titer against anti-HPV 6, 11, 16, and 18 for each treatment group

Time Frame

4 weeks after the vaccination

Title

seroconversion rate measured by Enzyme-linked Immunosorbent Assay(ELISA)

Description

proportion of subjects who seroconverted from seronegative at baseline to seropositive at post vaccination for anti-HPV 6, 11, 16, and 18

Time Frame

4 weeks after the vaccination

Title

Geometric mean titer measured by pseudovirion-based neutralization assay(PBNA)

Description

geometric mean titer against anti-HPV 6, 11, 16, and 18 for each treatment

Time Frame

4 weeks after the vaccination

Title

Incidence rate of Solicited Adverse Event

Description

Solicited local/systemic adverse event after vaccination

Time Frame

7 days after the vaccination

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

26 Years

Accepts Healthy Volunteers

Eligibility Criteria

[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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

k Zaman, MD

Organizational Affiliation

International Centre for Diarrhoeal Disease Research, Bangladesh

Official's Role

Principal Investigator

Facility Information:

Facility Name

SK Bioscience

City

Gyeonggi-do

State/Province

Seongnam-si

ZIP/Postal Code

13494

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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Immunogenicity and Safety Study of NBP615 in Healthy Female

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