A Phase 1 interventional study of Freeze-dried Human Rabies Vaccine(Human Diploid Cell), Essen and Freeze-dried Human Rabies Vaccine(Human Diploid Cell),Zagreb in Rabies, sponsored by Ningbo Rongan Biological Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 10 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Ningbo Rongan Biological Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Prevention
The Phase 1 clinical trial of the freeze-dried human rabies vaccine (human diploid cells) will be conducted on participants aged 10 to 60. This study will design a single-arm, randomized, open-access trial with different immunization schedules (5-dose schedule and 2-1-1 schedule) to evaluate the safety and tolerability of the vaccine in participants aged 10 to 60
This trial will adopt a single-arm, randomized, open-label experimental design, with a planned enrollment of 60 participants, comprising 30 individuals aged 10-17 years and 30 aged 18-60 years. Initially, 30 participants in the 18-60 age group will be enrolled and randomly assigned in a 1:1 ratio to either the 5-dose schedule group or the 2-1-1 schedule group. Participants in the 5-dose schedule group will receive five doses of the trial vaccine according to the immunization schedule of days 0, 3, 7, 14, and 28. Those in the 2-1-1 schedule group will receive four doses of the trial vaccine according to the immunization schedule of day 0 (two doses), day 7, and day 21. Following the administration of the first dose, safety will be monitored for 7 days among participants aged 18-60 years. If no criteria for trial suspension/termination are met, an additional 30 participants in the 10-17 age group will be enrolled and randomly assigned in a 1:1 ratio to either the 5-dose schedule group or the 2-1-1 schedule group, following the same immunization schedules as described above.
Adverse events (AEs) that occur from the first dose of vaccination through 30 days post-completion of the full vaccination regimen will be collected. Serious adverse events (SAEs), pregnancy-related events (including pregnancy outcomes, delivery characteristics, neonatal conditions, and growth and development within one month postpartum for female participants), reported from the first dose of vaccination through 6 months post-completion of the full vaccination regimen, will also be recorded.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's planned enrollment of 60 is below the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →Ningbo Rongan Biological Pharmaceutical Co., Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(1) The participants' ages range from 10 to 60 years old (≥10 years old and \<61 years old).
(2) Participants aged 10 to 17 and their guardians can provide valid identification documents, and participants aged 18 to 60 can provide their own valid identification documents.
(3) Participants aged 10 to 17 and their guardians, as well as participants aged 18 to 60, can sign the form voluntarily to participate in the trial, fully understand the trial procedures, the risks of participating in the trial, and other intervention measures that can be chosen if they do not participate in the trial, etc.
(4) Possess basic reading and writing skills, and be capable of reading, understanding and filling in diary cards and contact cards; (5) Female participants with fertility must also meet the following conditions: 1) They have taken effective measures within two weeks prior to participating in this trial; 2) Have no plans to have children within 6 months from the start of participating in this trial until the full vaccination. 3) Understand and agree to take effective contraceptive measures during the trial period (from the first dose to within 6 months after the full vaccination). Effective contraceptive measures include: condoms (for men), intrauterine devices, oral contraceptives (excluding emergency contraceptives), sterilization, abstention, injection or implantable contraception, sustained-release local contraceptives, hormone patches, diaphragms, cervical caps, etc. External ejaculation and safe period contraception are not regarded as effective contraceptive measures.
Exclusion Criteria:
For the standards marked with *, if the participants have the circumstances stipulated in the standard, the visit can be rescheduled when they no longer have these circumstances
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Participants received 1 dose of AIM2301 on day 0, 3, 7, 14 and 28, a total of 5 doses
Biological: Freeze-dried Human Rabies Vaccine(Human Diploid Cell), Essen
The Participants received 2 dose of AIM2301 on day 0, 1 dose of AIM2301 on day7 and 21, a total of 4 doses
Biological: Freeze-dried Human Rabies Vaccine(Human Diploid Cell),Zagreb
This vaccine is produced by Ningbo Rongyu Biological Pharmaceutical Co., Ltd.. Participants will receive AIM2301 by intramuscular injection. Receive on the day 0, 3, 7, 14 and 28, a total of 5 doses
Also known as: AIM2301
This vaccine is produced by Ningbo Rongyu Biological Pharmaceutical Co., Ltd.. Participants will receive AIM2301 by intramuscular injection. Receive 2 doses on day 0, 1 dose on day 7 and day 21, a total of 4 doses.
Also known as: AIM2301
The occurrence of AE and AR within 30 minutes after each dose of vaccination
After each dose of the investigational vaccine is administered, participants should be observed on-site for 30 minutes. The contents of safety observation include any medical events occurring in participants. The severity and relevance of AEs shall be determined in accordance with the guidance for adverse event grading criteria and the guidance for relevance determination.
Time frame: within 30 minutes after each dose of vaccination
The occurrence of AE and AR within 7 days after each dose of vaccination
After each dose of vaccine is administered, a Diary Card will be issued to participants. Participants and/or their guardians should measure body temperature daily from Day 0 to Day 7 and observe/record all adverse events (AEs) as well as concomitant medications/vaccines according to the requirements of the Diary Card. The severity and relevance of AEs shall be determined in accordance with the guidance for adverse event grading criteria and the guidance for relevance determination.
Time frame: within 7 days after each dose of vaccination
The occurrence of AE and AR within 30 days from the first dose of vaccination to the full course of vaccination
Solicited and unsolicited adverse events from the first dose vaccination to 30 days after full-course vaccination shall be collected through diary cards and contact cards. The severity and relevance of AEs shall be determined in accordance with the guidance for adverse event grading criteria and the guidance for relevance determination.
Time frame: within 30 days from the first dose of vaccination to the full course of vaccination
Abnormal changes /Occurrence of clinically significant abnormal changes in laboratory test indicators
Abnormal changes /Occurrence of clinically significant abnormal changes in laboratory test indicators (blood biochemistry, blood routine and urine routine) on the third day after the first dose of vaccination
Time frame: the third day after the first dose of vaccination
The occurrence of serious adverse events
The occurrence of serious adverse events within 6 months from the first dose of vaccination to the full course of vaccination. SAE assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient.
Time frame: within 6 months from the first dose of vaccination to the full course of vaccination.
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Jul 2025, 2 months after the start.
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Ningbo Rongan Biological Pharmaceutical Co., Ltd.