Actively Recruiting
Open-label, Randomized Study to Evaluate Safety and Tolerability of Freeze-dried Human Rabies Vaccine (Human Diploid Cells) Using Different Immunization Schedules
Led by Ningbo Rongan Biological Pharmaceutical Co., Ltd. · Updated on 2025-06-15
60
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1 clinical trial to study a freeze-dried human rabies vaccine made from human diploid cells. This trial aims to evaluate the safety and tolerability of this vaccine in participants aged 10 to 60 years. The study is designed as a single-arm, randomized, and open-label trial, enrolling 60 participants split evenly between younger (10-17 years) and adult (18-60 years) age groups. The trial compares two different immunization schedules to assess their effects. Participants in the adult group are randomly assigned to receive either a 5-dose schedule with vaccine doses on days 0, 3, 7, 14, and 28, or a 2-1-1 schedule with doses on day 0 (two doses), day 7, and day 21. Safety is closely monitored for seven days after the first dose in the adult group. After confirming safety, the younger group follows the same randomization and dosing schedules. Vaccinations are given by intramuscular injection. Throughout the study, researchers collect information on any adverse events occurring from the first dose through 30 days after completing the full vaccination. Serious adverse events and pregnancy-related outcomes are monitored for six months after vaccination completion. Safety assessments include monitoring reactions within 30 minutes and 7 days after each dose, laboratory tests on the third day after the first dose, and ongoing observations for serious events. The total duration of participation includes vaccination and follow-up safety monitoring.
CONDITIONS
Brief Title
A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 10 to 60 years (10 years or older and under 61 years)
- Participants aged 10 to 17 and their guardians can provide valid ID; participants aged 18 to 60 can provide their own valid ID
- Participants and guardians voluntarily sign informed consent and understand the trial procedures and risks
- Ability to read, write, and complete diary and contact cards
- Female participants of childbearing potential must use effective contraception starting two weeks before the trial until six months after full vaccination, and have no plans to become pregnant during this period
You will not qualify if you...
- History of rabies vaccination or use of passive rabies immunization
- Previous injury from animals susceptible to rabies (e.g., cats, dogs) before first vaccination
- Body temperature of 37.3°C or higher on enrollment day
- Clinically significant abnormal test results during screening
- Positive pregnancy test or breastfeeding women
- Uncontrolled hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg) in adults
- Allergy to any vaccine components such as human albumin, sucrose, or maltose
- History of severe allergic reactions (e.g., anaphylaxis, severe urticaria)
- Diagnosed congenital or acquired immune diseases like HIV, lymphoma, lupus, rheumatoid arthritis
- Serious uncontrolled diseases including respiratory, liver, kidney, cardiovascular, cerebrovascular diseases, and malignancies
- Abnormal blood clotting or coagulation disorders
- Absence or removal of spleen (anplenia or splenectomy)
- Diagnosed neurological or mental disorders unsuitable for participation
- Planned long-term systemic glucocorticoid therapy within 30 days after first vaccination
- Use of immunoenhancers, immunoglobulins, or blood products within 3 months prior to enrollment
- Receipt of live attenuated vaccines within 14 days or inactivated/subunit vaccines within 7 days before enrollment
- Acute illness or chronic disease flare-up within 3 days before enrollment
- Use of antipyretic, analgesic, or antihistamine drugs within 3 days before enrollment
- Participation in other clinical trials during this trial
- Any condition judged by researchers to interfere with trial compliance or safety
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 28 days
Participants receive the rabies vaccine by intramuscular injection according to one of two immunization schedules: either five doses on days 0, 3, 7, 14, and 28, or four doses with two doses on day 0, then on days 7 and 21.
5 vaccination visits depending on schedule
Duration - 6 months after full vaccination
After the full vaccination regimen, participants are monitored for adverse events for up to 6 months.
Regular follow-up visits during 6 months post-vaccination
Trial Site Locations
Total: 1 location
1
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
Z
Zhiqiang Q Xie
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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