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Trial of HPV Vaccine in Healthy Adult and Adolescent Female

2019-03-04 02:08:22 | BioPortfolio

Summary

This is a randomized, double-blind, active-controlled, phaseI/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 to assess the safety and immunogenicity of NBP615 in comparison with Gardasil.

In order to confirm the safety, 80 healthy adult should be enrolled first, and the safety of the test product (NBP615) will be confirmed by 2nd vaccination in adults. After that, enrolled of 120 adolescents proceeds. participants who previously agreed to participate in the study will be screened and only those participants who met the inclusion/exclusion criteria will be randomized in to 1:1 to receive test product (NBP615) or reference product (Gardasil pre-filled syringe). Three/ Two doses of 0.5 ml IM injection will be given and two blood sample, pre vaccine and post vaccine 4 weeks after completion of vaccine will be collected to assess the immunogenicity of NBP615 and Gardasil, comparator HPV vaccine. Solicited adverse events occurring up to 7 days after each dose of the investigational product will be collected in the diary card. Unsolicited adverse events occurring up to 28 days after each dose of the investigational product will be collated in the diary card. Serious adverse events will be collected during the entire study period. In addition to this safety data will be collected through the study period by active contact with the study participants by doing home visit or by telephone contact.

Description

Background (brief):

Burden: HPV is one of the most common organism causing sexually transmitted diseases (STDs). 70% of the infections disappear within one year, and 90% disappear within two years. However, if the infection continues, 5-10% of the infected women are at risk for developing precancerous lesions in the cervix, which can lead to invasive cervical cancer. About 500,000 cases are reported annually, which makes it the second most common cancer occurring among women in the world. In developed countries, mortality and incidence rates have declined by about 70% because an early detection system. However, in the countries where screening tests are not commonly provided, incidence rates remain high. Approximately 80% of all reported cases are diagnosed in the developing and least developed countries, and the number of deaths due to cervical cancer has reached 230,000 cases. Almost all cases of cervical cancer are caused by HPV infection. Prevalence of human papillomavirus (HPV) infection among the general populations in South Asian countries like India, Bangladesh, Nepal and Sri Lanka varies from 7-14% and the age-specific prevalence across age groups is constant with no clear peak in young women. Current estimates indicate that every year 11956 women are diagnosed with cervical cancer and 6582 die from the disease. Cervical cancer ranks as the 2nd most frequent cancer among women in Bangladesh and the 2nd most frequent cancer among women between 15 and 44 years of age. A prospective cohort study that was conducted in one urban and one rural area of Bangladesh showed that prevalence of any HPV infection was 7.7% with no significant difference between urban and rural women. Most common high-risk genotypes were HPV16, HPV66, HPV18, HPV45, HPV31 and HPV53.

Cervical cancer can be diagnosed and treated in advance, due to its long development period. However, costs for treating the cancer are high, and since underdeveloped countries do not have an effective early detection system, the incidence rate is higher for the underdeveloped countries. Preventing infection through vaccination is therefore not only cost-effective, but also important for improving the quality of life. A comparison of the safety, tolerability and immunogenicity were performed after vaccination between NBP615 and Gardasil® in 118 healthy female adults and proved as safe, tolerable and immunogenic. Thus, Phase I/ II clinical trial in healthy adult and adolescent female deems warranted to ensure confirmatory safety and immunogenicity results.

Knowledge gap::Two commercially available HPV vaccine, Gardasil, developed by Merck, and Cervarix, developed by GSK, prevent early infections by HPV types 16 and 18, which cause most of the HPV-related cancers. Gardasil also prevents infection by HPV types 6 and 11, both of which genotypes cause 90% of genital warts. Furthermore, Gardasil 9 was approved and available with 5 different serotypes added to Gardasil. Gardasil prevents anal cancer and genital warts, and the vaccine is also effective for men. No efficacy studies were conducted among adolescent population, and duration of protective efficacy were not yet conducted in a controlled manner. Only few safety, and immunogenicity trial has conducted with NBP615 vaccine among children less than 15 years of age.

Relevance: The goal of this phaseI/ II clinical trial is to assess the immunogenicity and safety of NBP615 HPV vaccine among healthy adult female (19-26 years) and adolescent female (9-13 years) to determine the duration of vaccine induced protective efficacy .

Hypothesis (if any): Vaccinating healthy adult aged 19 to 26 and adolescent female aged 9 to 13 with NBP615 human papilloma virus vaccine (HPV) can induce protective immune response.

Objectives:

Primary objective:

1. To assess the safety of NBP615 with respect to solicited (local & systemic) and unsolicited adverse events after each dose of vaccination in healthy adult aged 19 to 26 and adolescent female aged 9 to 13.

2. To assess the immunogenicity of NBP615 focused on the geometric mean titers (GMTs) and seroconversion rates using (SCRs) a VLP (virus-like particle) ELISA and a PBNA (pseudovirion-based neutralization assay) against anti-HPV 6, 11, 16, and 18) in healthy adult aged 19 to 26 and adolescent female aged 9 to 13.

Secondary objectives:

1.To assess the safety of NBP615 with respect to serious AEs during the entire study period in healthy adult aged 19 to 26 and adolescent female aged 9 to 13.

Methods:

This is a randomized, double-blind, active-controlled, phaseI/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. In order to confirm the safety, 80 healthy adult should be enrolled first, and the safety of the test product (NBP615) will be confirmed by 2nd vaccination in adults. After that, enrolled of 120 adolescents proceeds. participants who previously agreed to participate in the study will be screened and only those participants who met the inclusion/exclusion criteria will be randomized in to 1:1 to receive test product (NBP615) or reference product (Gardasil pre-filled syringe). Three/ Two doses of 0.5 ml IM injection will be given and two blood sample, pre vaccine and post vaccine 4 weeks after completion of vaccine will be collected to assess the immunogenicity of NBP615 and Gardasil, comparator HPV vaccine. Solicited adverse events occurring up to 7 days after each dose of the investigational product will be collected in the diary card. Unsolicited adverse events occurring up to 28 days after each dose of the investigational product will be collated in the diary card. Serious adverse events will be collected during the entire study period. In addition to this safety data will be collected through the study period by active contact with the study participants by doing home visit or by telephone contact.

Outcome measures/variables:

Safety

- Incidence rate of solicited local adverse events (AEs) within 7 days after each dose of vaccination.

- Incidence rate of solicited systemic AEs within 7 days after each dose of vaccination.

- Incidence rate of unsolicited AEs within 28 days after each dose of vaccination

- Incidence rate of serious AEs during the entire study period

Immunogenicity

- GMT and Seroconversion rate as measured by VLP ELISA for HPV Types 6, 11, 16, 18

- GMT and Seroconversion rate as measured by PBNA for HPV Types 6, 11, 16, 18

Study Design

Conditions

Human Papilloma Virus Vaccine

Intervention

NBP615 (SK bioscience HPV vaccine) and Gardasil® (Merck & Co)

Location

Clinical Trial Unit, icddr,b
Dhaka
Bangladesh
1212

Status

Recruiting

Source

International Centre for Diarrhoeal Disease Research, Bangladesh

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-03-04T02:08:22-0500

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