A Phase 4 interventional study of Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried in Rabies and HIV Infections, sponsored by Liaoning Chengda Biotechnology CO., LTD. Recruiting at 2 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Liaoning Chengda Biotechnology CO., LTD · Phase 4, Interventional, and Prevention
Among 35 studies in Rabies with a site in China — 7 open to participants now, 10 under way, 5 of them phase 3. Rabies · China.
Among the 35 studies in Rabies with a site in China, this one is the 23rd largest by planned enrollment of the 32 interventional ones that give a count, is one of 5 that started in 2026, is one of 6 in phase 4, and was the 35th registered.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
Browse Rabies studies →7 of the 35 studies in Rabies with a site in China are open now. Recruiting first, the newest first:
Synermore Biologics (Suzhou) Co., Ltd. · Sites in China
Ages 0–17
Changchun BCHT Biotechnology Co. · Sites in China
Ages 10–60 · Healthy volunteers
Sinovac Biotech Co., Ltd · Sites in China
Ages 18–45 · Healthy volunteers
Lanzhou Institute of Biological Products Co., Ltd · Sites in China
Ages 18–60 · Healthy volunteers
Changchun BCHT Biotechnology Co. · Sites in China
Ages 18–50 · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 2 Rabies studies recruiting now, none set no upper age limit and 2 stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
35 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 5 started in 2026.
This study's planned enrollment of 160 is below the median of 201 across 104 interventional studies indexed under Rabies.
Median enrollment 821 across the 32 interventional studies, 200 across the 3 observational. Of the 22 that completed or were terminated, 3 (14%) have results posted.
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24 of 35 have an industry lead sponsor. The 10 most frequent:
Liaoning Chengda Biotechnology CO., LTD is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Liaoning Chengda Biotechnology CO., LTD has 1 study filed under Rabies — fewer than ten, so there is no comparison to draw.
2 of the studies in Rabies with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07275645Phase 3Ab&B Bio-tech Co., Ltd.JSA Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10 to 60 Years | 2026-11-26 |
| NCT07932132Liaoning Chengda Biotechnology CO., LTDImmunogenicity and Safety of Freeze-Dried Human Rabies Vaccine (Vero Cell) in Patients Infected With Human Immunodeficiency Virus (HIV) | 2027-06-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 35 studies in Rabies with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a prospective, open-label, randomized controlled clinical trial designed to evaluate rabies virus neutralizing antibody responses to rabies vaccination among patients infected with human immunodeficiency virus (HIV). Eligible participants will be divided into two groups according to baseline CD4+ T cell count before randomization. Within each group, participants will be randomly assigned to one of two different rabies vaccination regimens for simulated post-exposure prophylaxis. Blood samples will be collected before vaccination and at scheduled time points after vaccination. Rabies virus neutralizing antibody titers will be tested to assess the seroconversion rate and geometric mean concentration (GMC). Adverse events after vaccination will also be recorded.
This prospective, open-label, randomized controlled clinical trial will enroll HIV-infected patients aged 18-60 years who are receiving antiretroviral therapy (ART). A total of 160 eligible participants will be divided into two groups based on baseline CD4+ T cell count (\<350 cells/mm³ vs. ≥350 cells/mm³) before randomization, with 80 subjects in each group. Within each group, participants will be randomized in a 1:1 ratio to receive freeze-dried human rabies vaccine (Vero cell) under the Zagreb regimen or the Essen regimen.
Serum samples will be collected at scheduled time points according to different vaccination regimens. For participants assigned to the Zagreb regimen, blood samples will be obtained on Day 0, Day 14, Day 35, and three months after completion of the full vaccination course. For participants assigned to the Essen regimen, blood samples will be collected on Day 0, Day 14, Day 28, Day 42, and three months after completion of the full vaccination course. Rabies virus neutralizing antibody titers will be measured for all collected serum samples, and seroconversion rate and GMC will be calculated to assess immune responses at each predefined time point.
Participants with rabies virus neutralizing antibody titers lower than 0.5 IU/mL at 14 days after completion of the full vaccination course will receive booster vaccination on Day 0 and Day 3. Blood samples will be collected 14 days after booster administration to measure rabies virus neutralizing antibody titers. Seroconversion rate and GMC will be calculated to evaluate immune responses after booster vaccination.
Adverse events will be monitored throughout the study. All immediate adverse events occurring within 30 minutes after each dose will be recorded. Solicited adverse events will be monitored for 7 days after each dose. Unsolicited adverse events will be monitored from day 8 to day 14 following each dose.
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.
Exclusion Criteria:
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.
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.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible HIV-infected participants on stable antiretroviral therapy and with a baseline CD4+ T cell count ≥350 cells/mm³ will receive 2 doses of rabies vaccine on day 0, 1 dose on day 7, and 1 dose on day 21, for a total of 4 doses.
Biological: Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried
Eligible HIV-infected participants on stable antiretroviral therapy and with a baseline CD4+ T cell count ≥350 cells/mm³ will receive 1 dose of rabies vaccine on day 0, 3, 7, 14, and 28, for a total of 5 doses.
Biological: Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried
Eligible HIV-infected participants on stable antiretroviral therapy and with a baseline CD4+ T cell count \<350 cells/mm³ will receive 2 doses of rabies vaccine on day 0, 1 dose on day 7 and 1 dose on day 21, for a total of 4 doses.
Biological: Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried
Eligible HIV-infected participants on stable antiretroviral therapy and with a baseline CD4+ T cell count \<350 cells/mm³ will receive 1 dose of rabies vaccine on day 0, 3, 7, 14, and 28, for a total of 5 doses.
Biological: Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried
0.5mL for each dose, manufactured by Liaoning Chengda Biotechnology CO., LTD, administered by intramuscular injection into the deltoid muscle of the lateral upper arm.
Also known as: SPEEDA
Seroconversion rate and geometric mean concentration (GMC) of rabies virus neutralizing antibodies at 14 days after completion of the full vaccination course
Seroconversion rate and GMC of rabies virus neutralizing antibodies among HIV-infected participants who are seronegative at baseline (Day 0). Seroconversion is defined as a rabies virus neutralizing antibody titer ≥0.5 IU/mL. Rabies virus neutralizing antibodies will be assessed by the rapid fluorescent focus inhibition test (RFFIT).
Time frame: 14 days after completion of the full vaccination course
Incidence of adverse events after vaccination
Incidence of immediate local and systemic adverse events recorded within 30 minutes after each vaccination; incidence of solicited local and systemic adverse events collected 0-7 days after each dose; incidence of unsolicited adverse events collected 8-14 days after each dose. Adverse events are defined as any untoward medical occurrence in a participant administered vaccine, not necessarily having a causal relationship with vaccination.
Time frame: 30 minutes, 0-7 days, and 8-14 days after each vaccine dose
Seroconversion rate and GMC of rabies virus neutralizing antibodies at 14 days after the first dose of vaccination
Seroconversion rate and GMC of rabies virus neutralizing antibodies at 14 days after the first dose vaccination among HIV-infected participants who are seronegative at baseline (Day 0). Seroconversion is defined as a rabies virus neutralizing antibody titer ≥0.5 IU/mL. Rabies virus neutralizing antibodies will be assessed by RFFIT.
Time frame: 14 days after the first dose of vaccination
Seroconversion rate and GMC of rabies virus neutralizing antibodies at 90 days after completion of the full vaccination course
Seroconversion rate and GMC of rabies virus neutralizing antibodies at 90 days after completion of the full vaccination course among HIV-infected participants who are seronegative at baseline (Day 0). Seroconversion is defined as a rabies virus neutralizing antibody titer ≥0.5 IU/mL. Rabies virus neutralizing antibodies will be assessed by RFFIT.
Time frame: 90 days after completion of the full vaccination course
Seroconversion rate and GMC of rabies virus neutralizing antibodies after booster vaccination
Seroconversion rate and GMC of rabies virus neutralizing antibodies 14 days after booster vaccination, in participants who remain seronegative (titer \<0.5 IU/mL) at 14 days after completion of the full vaccination course. Booster vaccination consists of 2 doses administered on day 0 and day 3 of the booster phase. Seroconversion is defined as a rabies virus neutralizing antibody titer ≥0.5 IU/mL. Rabies virus neutralizing antibodies will be assessed by RFFIT.
Time frame: 14 days after booster vaccination
Seroconversion rate and GMC of rabies virus neutralizing antibodies at Day 28 within the Essen regimen group
Seroconversion rate and GMC of rabies virus neutralizing antibodies at Day 28 among HIV-infected participants who are seronegative at baseline (Day 0) and assigned to the Essen five dose regimen. Seroconversion is defined as a rabies virus neutralizing antibody titer ≥0.5 IU/mL. Rabies virus neutralising antibodies will be assessed by RFFIT.
Time frame: Day 28 within the Essen vaccination regimen
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jun 2027, 10 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Liaoning Chengda Biotechnology CO., LTD