Clinical trial NCT03813940: Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
Official title: An Open-Label, Single-Center Phase I Clinical Trial to Estimate Safety of the Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type) (E.Coli) in Healthy Adults Aged 18 to 45 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Condylomata Acuminata
Cervical Cancer
Keywords: human papillomavirus vaccine
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: Xiamen Innovax Biotech Co., Ltd
name: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
First posted: 2019-01-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This phase I clinical study was designed to evaluate the safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.

Detailed description: The study would have 2 stages. In the first stage, around 12 healthy adults aged 18-45 (male vs female,around 1:1)would receive 135μg/0.5ml of the HPV vaccine, the participants would be actively followed up for 7 days, if no vaccine related serious adverse events(SAE) occurred and the vaccine is well tolerated, another group of 12 healthy adults aged 18-45 (male vs female,around 1:1)would be enrolled and would receive 270μg/0.5ml of the HPV vaccine. The vaccine would be administered intramuscularly at day 0, month 1 and month 6. All the participants would be actively monitored for adverse reactions/events for 1 month after each injection. SAE during the trial were followed up. And blood, liver and kidney function changes will be monitored before and 2 days after the first and third vaccination. Serum samples from all the subjects would be collected on day 0 and month 7 to test immunogenicity as exploratory analysis.

Eligibility criteria: Inclusion Criteria:

1. Health people aged between 18 and 45 years.
2. Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
3. Able to comply with the requests of the study.
4. Written informed consent obtained from the participants.
5. Axillary temperature not higher than 37.0°C
6. Men, or non-pregnant women verified by a urine pregnancy test.

Exclusion criteria:

1. Pregnant or breastfeeding or plan to be pregnant within 7 months.
2. Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.
3. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
4. Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine or plan to use within 7 months.
5. Administration of any attenuated live vaccines within 21 days preceding the first dose of the study vaccine or any subunit or inactivated vaccines within 14 days before vaccination.
6. Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
7. Having the plan to participate another clinical trial during the study period.
8. Received another HPV vaccine.
9. Immunodeficiency , primary disease of important organs, malignant tumor, or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
10. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy, urticaria, dyspnea, angioneurotic edema or abdominal pain.
11. Asthma that required emergent treatment, hospitalization, oral or intravenous corticosteroid for unstable condition within the past 2 years.
12. Having serious disease of internal medicine, such as hypertension(systolic blood pressure \> 140mmHg or diastolic blood pressure \>90mmHg), cardiac disease, diabetes, hyperthyroidism et al.
13. Diagnosed coagulant function abnormality or blood coagulation disorder. 14) The results of blood routine test and blood biochemical test were abnormal. The grade was 2 or above.

15) Epilepsy, except fever epilepsy at under 2 years of age, alcohol-induced epilepsy in 3 years before abstinence, or idiopathic epilepsy requiring no treatment in the past 3 years.

16) Past or current two-stage affective psychosis, not well controlled in the past 2 years or requiring drugs, or hve a tendency to commit suicide in the past 5 years.

17) Other medical, psychological, social or occupational factors that, according to the investigators' judgment, might affect the individual's ability to obey the protocol or sign the informed consent.

Primary outcomes:
measure: Solicited local adverse reactions
timeFrame: During the 7-day (Day 0-6) period following each vaccination
measure: Solicited systematic adverse reactions
timeFrame: During the 7-day (Day 0-6) period following each vaccination
measure: Unsolicited adverse events
timeFrame: Within 30 days (Day 0-29) after any vaccination
measure: Serious adverse events
timeFrame: throughout the study period, an average of 7 months
Secondary outcomes:
measure: Clinically Relevant Abnormalities in Blood Biochemistry
timeFrame: Before and the second day after the first and third vaccination
measure: Clinically Relevant Abnormalities in Hematological Parameters
timeFrame: Before and the second day after the first and third vaccination
Other outcomes:
measure: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody)
timeFrame: month 7
measure: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody)
timeFrame: month 7
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Centre for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Xiamen University
name: Jun Zhang, Master
role: STUDY_CHAIR
affiliation: Jiangsu Provincial Centre for Disease Control and Prevention
name: Yue-Mei Hu, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: