Human Papilloma Virus Vaccine Clinical Trial
Official title:
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 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.
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
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05065840 -
Advancing HPV Vaccination Among HIV Positive Adults: The CHAMPS Study
|
N/A |