RabiesPhase 4RABVAXNCT02374814
Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis
A Phase 4 study testing Rabies vaccine in people with Rabies, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of a two dose versus a three dose schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Rabies vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2015to 22 Sep 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and non-pregnant females aged ≥ 18 to ≤ 60 years on the day of inclusion Able to comprehend and give informed consent Able to attend all scheduled visits and to comply with all trial procedures Subject in good health, based on medical history and physical examination
Who cannot join
- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post- menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination).
- Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- Previous history of receiving the rabies vaccine.
- Previous history of receiving rabies immune globulin.
- Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that is well controlled is not an exclusion criteria.
- Any history of cardiac arrhythmias, such as: Bradycardia, tachycardia, heart block, SVT, PAC, VF, VT, or any other conduction abnormalities.
Show all 11Show fewer
- Use of any immunosuppressive drug , including topical steroids of potency groups I, II or III within 30 days of the study period.
- Any immunosuppressive disorder, such as HIV, common variable, active cancers or chemotherapy.
- History of renal insufficiency or requiring dialysis.
- Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Identified as an employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employee or the Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York, Upstate Medical University (SUNY-UMU)
Syracuse, New York, 13210
About this study
Official title: Immunogenicity of a Two vs Three Dose, Intradermal (ID) vs Intramuscular (IM) Administration of a Licensed Rabies Vaccine for Pre-Exposure Vaccination
The purpose of this study is to compare the effectiveness of a two dose versus a three dose schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.
Read the detailed description
This is an exploratory vaccine trial to evaluate immunogenicity of a non-licensed dosing schedule and route of administration for a currently FDA licensed rabies vaccine for pre-exposure prophylaxis against rabies infection. The goal of this study is to characterize the immune response and persistence of immunity to a shortened dose schedule and intradermal (ID) administration, relative to the current licensed dosing schedule of the rabies vaccine (3 dose (0, 7, 21 days) IM). Rabies virus is endemic throughout the world due to high rates of both wild and domestic animal rabies and the risk to deployed military in endemic areas is considerable. Currently the commonly supported pre-exposure prophylaxis regimen for rabies, in the United States is comprised of three, 1.0 ml intramuscular (IM) injections of the human diploid cell vaccine (HDCV) or purified chick embryo cell (PCEC) rabies vaccine on days 0, 7, and 21 or 28. Modified, two and three dose schedules of intradermal (ID) injections of 0.1 ml of HDCV and PCEC are utilized outside the US. These two and three dose intradermal schedules share a similar safety and immunogenicity profile to intramuscular vaccinations and are easily boosted at one year after vaccination. A death, from rabies, of a US Soldier returned from Afghanistan underscores the importance of rabies pre-exposure prophylaxis for soldiers and the need to evaluate the safest, most effective means of vaccinating large deploying forces. While the current three dose, 1 ml IM rabies series is effective, a shortened, equally effective vaccination series with significantly smaller dose per injection would greatly improve the logistics and cost associated with universal or even targeted coverage of deploying soldiers. Evaluation of a shorter, smaller-dose, pre-exposure vaccination series for rabies is the goal of this study.
- Conditions
- Rabies
- Being tested
- Rabies vaccine, Placebo
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabies vaccineDrug
Also called Rabavert
Compare dose schedule and route of administration
PlaceboDrug
Also called Albumin
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Rabies vaccine IM 3 dose | Active comparator | Intramuscular injection: 1mL at 0, 7 and 21 days. An additional 1 mL intramuscular dose at day 365 Receives: Drug: Rabies vaccine |
| Rabies vaccine ID 3 dose | Experimental | Intradermal injection: 0.1mL at 0, 7 and 21 days. A single intramuscular 1 mL dose at day 365 Receives: Drug: Rabies vaccine |
| Rabies vaccine IM 2 dose | Experimental | Intramuscular injection: 1mL at 0, 7 days. An additional 1 mL intramuscular dose at day 365 Receives: Drug: Rabies vaccine |
| Rabies vaccine ID 2 dose | Experimental | Intradermal injection: 0.1mL at 0, 7 days. A single intramuscular 1 mL dose at day 365 Receives: Drug: Rabies vaccine |
| Placebo IM 1 dose | Placebo comparator | Albumin and saline comparator, Intramuscular injection: 1mL Receives: Drug: Placebo |
| Placebo ID 1 dose | Placebo comparator | Albumin and saline comparator, Intradermal injection: 0.1mL Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protective Humoral Immune Response at 1 Month Post First Vaccination.
Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus
Measured: 1 month post first vaccination
Protective Humoral Immune Response 12 Months Post First Vaccination.
Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus 12 months post vaccinations (prior to boost).
Measured: 12 months post first vaccination
Secondary outcomes (1)
Protective Humoral Immune Response 7 Days Post Booster at 12 Months Post First Vaccination.
Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus at 7 days post boost.
Measured: up to 13 months post first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study start24 Mar 2015
- Primary completion22 Sep 2016
- Study completion22 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Principal investigator, Timothy Endy, MD MPH, State University of New York - Upstate Medical University
- Investigators
- Mark Polhemus, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374814
- Sponsor's protocol ID
- 568085
- Acronym
- RABVAX
- Status last verified
- Jun 2022
- First submitted
- 23 Feb 2015
- Last updated
- 13 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Endy TP, Keiser PB, Wang D, Jarman RG, Cibula D, Fang H, Ware L, Abbott M, Thomas SJ, Polhemus ME. Serologic Response of 2 Versus 3 Doses and Intradermal Versus Intramuscular Administration of a Licensed Rabies Vaccine for Preexposure Prophylaxis. J Infect Dis. 2020 Apr 7;221(9):1494-1498. doi: 10.1093/infdis/jiz645.
PubMed 31802120
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of a Two vs Three Dose, Intradermal (ID) vs Intramuscular (IM) Administration of a Licensed Rabies Vaccine for Pre-Exposure Vaccination
- ClinicalTrials.gov ID
- NCT02374814
- Acronym / sponsor ID
- RABVAX / 568085
- Conditions
- Rabies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- 24 Mar 2015 (actual)
- Primary completion
- 22 Sep 2016 (actual)
- Study completion
- 22 Sep 2016 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Posted 13 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of a two dose versus a three dose schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.
Detailed description
This is an exploratory vaccine trial to evaluate immunogenicity of a non-licensed dosing schedule and route of administration for a currently FDA licensed rabies vaccine for pre-exposure prophylaxis against rabies infection. The goal of this study is to characterize the immune response and persistence of immunity to a shortened dose schedule and intradermal (ID) administration, relative to the current licensed dosing schedule of the rabies vaccine (3 dose (0, 7, 21 days) IM). Rabies virus is endemic throughout the world due to high rates of both wild and domestic animal rabies and the risk to deployed military in endemic areas is considerable. Currently the commonly supported pre-exposure prophylaxis regimen for rabies, in the United States is comprised of three, 1.0 ml intramuscular (IM) injections of the human diploid cell vaccine (HDCV) or purified chick embryo cell (PCEC) rabies vaccine on days 0, 7, and 21 or 28. Modified, two and three dose schedules of intradermal (ID) injections of 0.1 ml of HDCV and PCEC are utilized outside the US. These two and three dose intradermal schedules share a similar safety and immunogenicity profile to intramuscular vaccinations and are easily boosted at one year after vaccination. A death, from rabies, of a US Soldier returned from Afghanistan underscores the importance of rabies pre-exposure prophylaxis for soldiers and the need to evaluate the safest, most effective means of vaccinating large deploying forces. While the current three dose, 1 ml IM rabies series is effective, a shortened, equally effective vaccination series with significantly smaller dose per injection would greatly improve the logistics and cost associated with universal or even targeted coverage of deploying soldiers. Evaluation of a shorter, smaller-dose, pre-exposure vaccination series for rabies is the goal of this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Rabies vaccine IM 3 dose | Active comparator | Drug: Rabies vaccineIntramuscular injection: 1mL at 0, 7 and 21 days. An additional 1 mL intramuscular dose at day 365 |
| Rabies vaccine ID 3 dose | Experimental | Drug: Rabies vaccineIntradermal injection: 0.1mL at 0, 7 and 21 days. A single intramuscular 1 mL dose at day 365 |
| Rabies vaccine IM 2 dose | Experimental | Drug: Rabies vaccineIntramuscular injection: 1mL at 0, 7 days. An additional 1 mL intramuscular dose at day 365 |
| Rabies vaccine ID 2 dose | Experimental | Drug: Rabies vaccineIntradermal injection: 0.1mL at 0, 7 days. A single intramuscular 1 mL dose at day 365 |
| Placebo IM 1 dose | Placebo comparator | Drug: PlaceboAlbumin and saline comparator, Intramuscular injection: 1mL |
| Placebo ID 1 dose | Placebo comparator | Drug: PlaceboAlbumin and saline comparator, Intradermal injection: 0.1mL |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male and non-pregnant females aged ≥ 18 to ≤ 60 years on the day of inclusion Able to comprehend and give informed consent Able to attend all scheduled visits and to comply with all trial procedures Subject in good health, based on medical history and physical examination
Key exclusion criteria (11 listed)
- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post- menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination).
- Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- Previous history of receiving the rabies vaccine.
- Previous history of receiving rabies immune globulin.
- Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that is well controlled is not an exclusion criteria.
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 |
|---|---|---|
| Rabies vaccineAlso: RabavertCompare dose schedule and route of administration | Drug | Rabies vaccine ID 2 dose, Rabies vaccine ID 3 dose, Rabies vaccine IM 2 dose, Rabies vaccine IM 3 dose |
| PlaceboAlso: AlbuminPlacebo | Drug | Placebo ID 1 dose, Placebo IM 1 dose |
Primary outcome
Protective Humoral Immune Response at 1 Month Post First Vaccination.
Time frame: 1 month post first vaccination
Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus
Protective Humoral Immune Response 12 Months Post First Vaccination.
Time frame: 12 months post first vaccination
Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus 12 months post vaccinations (prior to boost).
1 secondary outcome
Protective Humoral Immune Response 7 Days Post Booster at 12 Months Post First Vaccination.
Time frame: up to 13 months post first vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31802120Endy TP, Keiser PB, Wang D, Jarman RG, Cibula D, Fang H, Ware L, Abbott M, Thomas SJ, Polhemus ME. Serologic Response of 2 Versus 3 Doses and Intradermal Versus Intramuscular Administration of a Licensed Rabies Vaccine for Preexposure Prophylaxis. J Infect Dis. 2020 Apr 7;221(9):1494-1498. doi: 10.1093/infdis/jiz645.
- Individual participant dataSharing planned: No
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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.
Mark Polhemus, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rabies vaccine in people with Rabies, run by State University of New York - Upstate Medical University at 1 site in United States.
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 1 inclusion and 11 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 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Protective Humoral Immune Response at 1 Month Post First Vaccination. (time frame: 1 month post first vaccination). The study lists 2 primary outcomes in all. 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 NCT02374814, which also lists 1 linked publication.
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 13 Jun 2022.