RabiesPhase 2NCT02559921
Safety and Immunogenicity Study of Recombinant Human Rabies Immunoglobin (rhRIG) in Combination With Rabies Vaccine for Human Use With Human Rabies Immune Globulin (HRIG) in Combination With Rabies Vaccine for Human Use in Healthy Adult Subjects.
A Phase 2 study testing rhRIG（20 IU/kg）, rhRIG（40 IU/kg） and HRIG（20 IU/kg） in people with Rabies, run by Beijing Chaoyang District Centre for Disease Control and Prevention.
Trial summary
This study evaluates the rabies virus neutralizing antibody (RVNA) activities ,safety and tolerability of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects.The study has 7 groups.Subjects will receive rhRIG（20 IU/kg）only, rhRIG（40 IU/kg）only,HRIG（20 IU/kg）only… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- rhRIG（20 IU/kg）, rhRIG（40 IU/kg） and HRIG（20 IU/kg）
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects aged at least 18 years but not more than 55 years;
- According to medical history, physical examination and clinical judgment of investigator at enrollment, subjects should have no significant health problems, or their health status or medication treatment remain stable;
- Subjects and their spouses should use adequate contraceptive methods from the screening day to Day 90;
- Male subjects must agree not to donate sperm from the first day of enrollment to Day 90;
- Subjects should sign a written Informed Consent Form;
Who cannot join
- Previous exposure or immunization histories of rabies (rabies vaccine and/or immunoglobulin);
- According to the clinical judgment of investigator, subjects had clinically significant acute disease or infection, including pyrexia (>37.0℃) within 2 weeks before the initial dose;
- After review of medical history or physical examination results, it is found that subjects have medical histories of abnormalities of heart, liver, kidney, blood, digestive tract, nervous system, spirit and metabolism;
- Subjects are pregnant or plan to become pregnant or are breast-feeding during the study;
- According to the judgment of investigator, subjects have clinically significant immunodeficiency or medical history and/or family history of autoimmune disease;
- According to the judgment of investigator, subjects have known or suspected clinically significant anaphylaxis or hypersensitivity reactions;
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- Immunization has been arranged for the subjects within the next 3 months after the initial dose;
- Subjects have used immunosuppressive preparations or other immunomodulating agents for more than 14 days within 6 months before the initial dose of study drug;
- Subjects used hormone agents within 3 days before the initial dose;
- Subjects donated blood or lost a lot of blood within 56 days before the initial dose;
- Subjects donated plasma within 7 days before the initial dose;
- Subjects received transfusion of blood or blood products within 6 months before the initial dose;
- It is suspected that subjects do not follow study procedures;
- Intake of alcohol within 12 hours before the initial dose;
- Subjects smoke more than 20 cigarettes a day;
- Subjects are obviously allergic to antibiotics;
- Any other conditions which may affect trial assessment at the discretion of the investigator;
About this study
This study evaluates the rabies virus neutralizing antibody (RVNA) activities ,safety and tolerability of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects.The study has 7 groups.Subjects will receive rhRIG（20 IU/kg）only, rhRIG（40 IU/kg）only,HRIG（20 IU/kg）only, rhRIG（20 IU/kg）in combination with rabies vaccine for human use, rhRIG（40 IU/kg）in combination with rabies vaccine for human use,HRIG（20 IU/kg）in combination with rabies vaccine for human use,and placebo in combination with rabies vaccine for human use,respectively.
- Conditions
- Rabies
- Being tested
- rhRIG（20 IU/kg）, rhRIG（40 IU/kg）, HRIG（20 IU/kg）, rhRIG（20 IU/kg） and vaccine, rhRIG（40 IU/kg） and vaccine
- Keywords
- Recombinant Human Rabies Immunoglobin (rhRIG)
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhRIG（20 IU/kg）Biological
rhRIG（40 IU/kg）Biological
HRIG（20 IU/kg）Biological
rhRIG（20 IU/kg） and vaccineBiological
rhRIG（40 IU/kg） and vaccineBiological
HRIG（20 IU/kg） and vaccineBiological
placebo and vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| rhRIG（20 IU/kg）only | Experimental | Subjects received rhRIG（20 IU/kg） on day 0 Receives: Biological: rhRIG（20 IU/kg） |
| rhRIG（40 IU/kg）only | Experimental | Subjects received rhRIG（40 IU/kg） on day 0 Receives: Biological: rhRIG（40 IU/kg） |
| HRIG（20 IU/kg）only | Active comparator | Subjects received HRIG（20 IU/kg）on day 0 Receives: Biological: HRIG（20 IU/kg） |
| rhRIG（20 IU/kg）+ vaccine | Experimental | Subjects received rhRIG（20 IU/kg）in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28 Receives: Biological: rhRIG（20 IU/kg） and vaccine |
| rhRIG（40 IU/kg）+ vaccine | Experimental | Subjects received rhRIG（40 IU/kg）in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28 Receives: Biological: rhRIG（40 IU/kg） and vaccine |
| HRIG（20 IU/kg）+ vaccine | Experimental | Subjects received HRIG（20 IU/kg）in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28 Receives: Biological: HRIG（20 IU/kg） and vaccine |
| placebo + vaccine | Placebo comparator | Subjects received placebo in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28 Receives: Biological: placebo and vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the detection rate of the rabies virus neutralizing antibody (RVNA) activities of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects
Measured: 42 days
Secondary outcomes (1)
Evaluate the rate of adverse reactions of rhRIG or HRIG in combination with rabies vaccine for human use (Vero cells) in healthy subjects
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chaoyang District Centre for Disease Control and Prevention
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559921
- Sponsor's protocol ID
- cycdc2015-3
- Status last verified
- Sep 2015
- First submitted
- 23 Sep 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
Publications
Li L, Li Y, Bai Y, Li G, Zhang J, Yang L, Zhao W, Zhao W, Luo F, Zhao Q, Zhang Z, Liu Y, Li S, Lu Q, Wang H, Zhang J, Zhang Y, Gao J, Shi N. Neutralizing antibody activity, safety and immunogenicity of human anti-rabies virus monoclonal antibody (Ormutivimab) in Chinese healthy adults: A phase Ⅱb randomized, double-blind, parallel-controlled study. Vaccine. 2022 Oct 6;40(42):6153-6162. doi: 10.1016/j.vaccine.2022.09.022. Epub 2022 Sep 16.
PubMed 36123259Zhang J, Shi N, Li G, Li L, Bai Y, Yang L, Zhao W, Gao J, Wei J, Zhao W, Zhai L, Huo P, Ren L, Yu L, Li Y. Population Pharmacodynamic Analyses of Human Anti-Rabies Virus Monoclonal Antibody (Ormutivimab) in Healthy Adult Subjects. Vaccines (Basel). 2022 Jul 29;10(8):1218. doi: 10.3390/vaccines10081218.
PubMed 36016106
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of Recombinant Human Rabies Immunoglobin (rhRIG) in Combination With Rabies Vaccine for Human Use With Human Rabies Immune Globulin (HRIG) in Combination With Rabies Vaccine for Human Use in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT02559921
- Acronym / sponsor ID
- cycdc2015-3
- Conditions
- Rabies
- Keywords
- Recombinant Human Rabies Immunoglobin (rhRIG)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Beijing Chaoyang District Centre for Disease Control and PreventionUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the rabies virus neutralizing antibody (RVNA) activities ,safety and tolerability of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects.The study has 7 groups.Subjects will receive rhRIG（20 IU/kg）only, rhRIG（40 IU/kg）only,HRIG（20 IU/kg）only, rhRIG（20 IU/kg）in combination with rabies vaccine for human use, rhRIG（40 IU/kg）in combination with rabies vaccine for human use,HRIG（20 IU/kg）in combination with rabies vaccine for human use,and placebo in combination with rabies vaccine for human use,respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| rhRIG（20 IU/kg）only | Experimental | Biological: rhRIG（20 IU/kg）Subjects received rhRIG（20 IU/kg） on day 0 |
| rhRIG（40 IU/kg）only | Experimental | Biological: rhRIG（40 IU/kg）Subjects received rhRIG（40 IU/kg） on day 0 |
| HRIG（20 IU/kg）only | Active comparator | Biological: HRIG（20 IU/kg）Subjects received HRIG（20 IU/kg）on day 0 |
| rhRIG（20 IU/kg）+ vaccine | Experimental | Biological: rhRIG（20 IU/kg） and vaccineSubjects received rhRIG（20 IU/kg）in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28 |
| rhRIG（40 IU/kg）+ vaccine | Experimental | Biological: rhRIG（40 IU/kg） and vaccineSubjects received rhRIG（40 IU/kg）in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28 |
| HRIG（20 IU/kg）+ vaccine | Experimental | Biological: HRIG（20 IU/kg） and vaccineSubjects received HRIG（20 IU/kg）in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28 |
| placebo + vaccine | Placebo comparator | Biological: placebo and vaccineSubjects received placebo in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female subjects aged at least 18 years but not more than 55 years;
- According to medical history, physical examination and clinical judgment of investigator at enrollment, subjects should have no significant health problems, or their health status or medication treatment remain stable;
- Subjects and their spouses should use adequate contraceptive methods from the screening day to Day 90;
- Male subjects must agree not to donate sperm from the first day of enrollment to Day 90;
- Subjects should sign a written Informed Consent Form;
Key exclusion criteria (17 listed)
- Previous exposure or immunization histories of rabies (rabies vaccine and/or immunoglobulin);
- According to the clinical judgment of investigator, subjects had clinically significant acute disease or infection, including pyrexia (>37.0℃) within 2 weeks before the initial dose;
- After review of medical history or physical examination results, it is found that subjects have medical histories of abnormalities of heart, liver, kidney, blood, digestive tract, nervous system, spirit and metabolism;
- Subjects are pregnant or plan to become pregnant or are breast-feeding during the study;
- According to the judgment of investigator, subjects have clinically significant immunodeficiency or medical history and/or family history of autoimmune disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhRIG（20 IU/kg） | Biological | rhRIG（20 IU/kg）only |
| rhRIG（40 IU/kg） | Biological | rhRIG（40 IU/kg）only |
| HRIG（20 IU/kg） | Biological | HRIG（20 IU/kg）only |
| rhRIG（20 IU/kg） and vaccine | Biological | rhRIG（20 IU/kg）+ vaccine |
| rhRIG（40 IU/kg） and vaccine | Biological | rhRIG（40 IU/kg）+ vaccine |
| HRIG（20 IU/kg） and vaccine | Biological | HRIG（20 IU/kg）+ vaccine |
| placebo and vaccine | Biological | placebo + vaccine |
Primary outcome
Evaluate the detection rate of the rabies virus neutralizing antibody (RVNA) activities of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects
Time frame: 42 days
1 secondary outcome
Evaluate the rate of adverse reactions of rhRIG or HRIG in combination with rabies vaccine for human use (Vero cells) in healthy subjects
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Derived from this study: PubMed 36123259Li L, Li Y, Bai Y, Li G, Zhang J, Yang L, Zhao W, Zhao W, Luo F, Zhao Q, Zhang Z, Liu Y, Li S, Lu Q, Wang H, Zhang J, Zhang Y, Gao J, Shi N. Neutralizing antibody activity, safety and immunogenicity of human anti-rabies virus monoclonal antibody (Ormutivimab) in Chinese healthy adults: A phase Ⅱb randomized, double-blind, parallel-controlled study. Vaccine. 2022 Oct 6;40(42):6153-6162. doi: 10.1016/j.vaccine.2022.09.022. Epub 2022 Sep 16.
- Derived from this study: PubMed 36016106Zhang J, Shi N, Li G, Li L, Bai Y, Yang L, Zhao W, Gao J, Wei J, Zhao W, Zhai L, Huo P, Ren L, Yu L, Li Y. Population Pharmacodynamic Analyses of Human Anti-Rabies Virus Monoclonal Antibody (Ormutivimab) in Healthy Adult Subjects. Vaccines (Basel). 2022 Jul 29;10(8):1218. doi: 10.3390/vaccines10081218.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rhRIG（20 IU/kg）, rhRIG（40 IU/kg） and HRIG（20 IU/kg） in people with Rabies, run by Beijing Chaoyang District Centre for Disease Control and Prevention.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the detection rate of the rabies virus neutralizing antibody (RVNA) activities of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02559921, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.