Trial Title:
A Phase I Clinical Trial to Evaluate the Safety of 15-valent HPV Vaccine in Healthy Chinese People Aged 18-45 Years
NCT ID:
NCT06454175
Condition:
HPV Infection
HPV-Related Carcinoma
Genital Wart
HPV-Related Intraepithelial Neoplasia
Conditions: Official terms:
Papillomavirus Infections
Condylomata Acuminata
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Biological
Intervention name:
Placebo
Description:
immunization schedule：Month 0，Month 2，Month 6
Arm group label:
Placebo group
Intervention type:
Biological
Intervention name:
15-valent recombinant human papillomavirus vaccine (Hansenulapolymorpha)
Description:
immunization schedule：Month 0，Month 2，Month 6
Arm group label:
HPV-vaccine group
Summary:
To evaluate the safety and tolerability of 15-valent HPV vaccine in 9-45year-old
participants.
Detailed description:
A phase 1 random, double blind, placebo control trail was plan to conducted in 72 healthy
participants in the 2 age groups(18-45 years old and 9-17 years old). The 72 subjects to
be inoculated with middle and high dose vaccine first in sequence if there was no safety
issue.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participants aged 9-45；
2. Participans aged 18-45 who can provide legal identification，participants aged 9-17
and their guardian can provide legal identification；
3. Participants and/or their guardian sign an informed consent form (a 9-17 year old
participant signs an informed notification);
4. Axillary temperature was less than 37.3 ℃（>14 years old）or less than 37.5℃（≤14 years
old）at the time of enrollment；
5. Be able to comply with study protocol requirements；
6. Women were not pregnant at the time of enrollment (negative blood pregnancy test),
did not have lactation period，had no birth plan within the 30 days after receiving
the whole vaccination;
7. Women with reproductive age take effective contraceptive measures within 2 weeks
before enrollment in the study;
8. Agree to take effective contraceptive measures within 30 days after receiving the
whole vaccination (effective contraceptives include: oral contraceptives, injection
or embedding contraceptives, sustained release topical contraceptives, hormone
patches, intrauterine devices), sterilization, abstinence, condoms (male),
diaphragms, cervical caps, etc.
9. Women who receiving hormone test has a regular menstruation for more than one year
Exclusion Criteria:
1. Have been vaccinated with other HPV vaccines or planned to vaccinate other HPV
vaccines during the study period；
2. Plan to participate other clinical trials during the study period，or participated
other clinical trials within 3 months before enrollment, including vaccine or drug;
3. Before the first dose is vaccinated, the laboratory test indicators specified in the
program are abnormal, except for NCS determined by the clinician;
4. History of CIN2/AIS/Cervical Cancer/Pelvic radiation therapy;
5. History of HPV-related external genital diseases (such as genital warts, Vulvar
intraepithelial neoplasia, Vaginal intraepithelial neoplasia,
Penis/perianal/perineum intraepithelial neoplasia, Penile/perianal/perineal cancer)
、anal intraepithelial neoplasia and related cancer, or head and neck cancer；history
of sexually transmitted diseases (including syphilis， Gonorrhea, genital chlamydia
infection, genital herpes, soft chancre, sexually transmitted lymphogranuloma,
inguinal granuloma, etc.);
6. Has been diagnosed as having congenital or acquired immunodeficiency, human
immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus
erythematosu, rheumatoid arthritis, juvenile Rheumatoid arthritis, Pernicious
Anemia, Ulcerative colitis or other autoimmune conditions (such as Type 1 diabetes,
Graves' disease, hashimoto thyroiditi, etc.);
7. History of convulsions, epilepsy, except of febrile convulsions in children 5 years
of age and younger;
8. History of severe allergy that requires medical intervention, including but not
limited to severe adverse reactions caused by vaccine or drug, eg anaphylactic
shock, allergic laryngeal edema, allergic purpura, thrombocytopenia sexual purpura,
local allergic necrosis (Arthus reaction), widespread urticaria, dyspnea,
angioedema, etc.; History of severe side effect caused by vaccination or severe
allergy to any of the components of the investigational vaccine, including
histidine, sodium chloride, aluminium phosphate, Polysorbate 80 and water for
injection;
9. Suffering from severe cardiovascular disease, severe liver and kidney disease,
malignant tumor, and serious infectious disease, such as: tuberculosis, viral
hepatitis, etc.;
10. Before the enrollment, the physical examination was untreatment or uncontrolled
hypertension, (18-45 year olds: systolic blood pressure ≥140mmHg and / or diastolic
blood pressure ≥90mmHg, 9-17 year olds: systolic blood pressure ≥120mmHg and / or
diastolic blood pressure ≥80mmHg);
11. Coagulation disorders: such as Congenital or acquired hemophilia, Coagulation factor
deficiency, clotting disorders, thrombocytopenia, etc.;
12. No spleen or functional spleen, and no spleen caused by any condition;
13. Receive any Immunosuppressive therapy product within 1 month prior to the first
vaccination, or plan to receive such product from Day 0 to Month 7 (30 days after
receiving the third dose of vaccination)，e.g. systemic medication for glucocorticoid
(>20mg/day or 2mg/kg/day, continuous use ≥2 weeks), but local medication can be used
(such as ointment, eye drops, inhalants) Or nasal spray);
14. Receive any immunoglobulin or blood product within 3 months prior to the first
injection, or plan to receive such product from Day 0 to Month 7 (30 days after
receiving the third dose of vaccination);
15. 3 days before vaccination, suffering from acute illness or acute exacerbation of
chronic disease; using fever reducer, Antihistamines, and Analgesics(such as:
Acetaminophen, Ibuprofen, Aspirin, loratadine, Cetirizine, etc. )
16. Receiving inactivated vaccine or recombinant vaccine or live-attenuated vaccine or
nucleic acid vaccine or adenovirus vaccine within 14 days before vaccination;
17. History of mental disorders or family history of mental health disorder (immediate
family)
18. Plan to move out of the city before the end of the study or leave the local area for
a long time during the scheduled study visit;
19. The investigator believes that the participant has any condition that may interfere
with the assessment of the purpose of the study.
Gender:
All
Minimum age:
9 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Address:
City:
Guangxi
Country:
China
Status:
Recruiting
Contact:
Last name:
LIRONG HUANG, Master
Email:
hlr620@126.com
Start date:
August 3, 2024
Completion date:
July 5, 2025
Lead sponsor:
Agency:
Shanghai Bovax Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Shanghai Bovax Biotechnology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06454175
