Immunogenicity and Safety Study of NBP615 in Healthy Female

NCT04453241 | Completed Phase 1 DMC

• 1 other identifier: PR-18062
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

NBP615

EXPERIMENTAL

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

Biological: NBP615

GARDASIL

ACTIVE COMPARATOR

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

Biological: Gardasil

Interventions

NBP615 BIOLOGICAL

Intramuscular injection, 0.5ml

NBP615

Gardasil BIOLOGICAL

Intramuscular injection, 0.5ml

GARDASIL

Eligibility Criteria

• Age: 9 Years - 26 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SK Bioscience Co., Ltd.: lead

Study Sites (1)

SK Bioscience

Gyeonggi-do, Seongnam-si, 13494, South Korea

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• k Zaman, MD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 1, 2020
• Study Start: December 22, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: October 1, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)