Rabies PreventionRabies-IDNCT01044199
Study of Intradermal Administration of PCEC Rabies Vaccine
A study testing PCEC rabies vaccine given intradermally and PCEC rabies vaccine administered intramuscularly in people with Rabies Prevention and Rabies Exposure, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The purpose of this study is to determine immunogenicity and safety of intradermal administration of the PCEC rabies vaccine in adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rabies Prevention, Rabies Exposure
- What is being tested?
- PCEC rabies vaccine given intradermally and PCEC rabies vaccine administered intramuscularly
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Aug 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Laboratory personnel, epidemiologists, EISOs, veterinary students, interns, and other first responders at CDC; other CDC employees; and healthy volunteer adults. Persons who contact the study coordinator will be assessed for possible occupational exposure to rabies using the risk assessment form (appendix E). The volunteers reporting occupational exposure will be selected to enter the study.
- Male or nonpregnant females (as indicated by a negative urine pregnancy test prior to first dose of vaccine), aged 18 years and older.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, or licensed hormonal methods) for the entire study period.
- Be in good health, as determined by vital signs (pulse, blood pressure, oral temperature), medical history, and a targeted physical examination based on medical history.
- Able to understand and comply with planned study procedures.
- Provide informed consent prior to any study procedures and be available for all study visits.
- Have health insurance.
Who cannot join
- Have a known allergy to PCECV.
- Have a known allergy or sensitivity to eggs or latex (in the stopper).
- Have a positive urine pregnancy test prior to first vaccine dose (female of childbearing potential age).
- Are immunosuppressed as a result of an underlying illness or treatment.
- Have active neoplastic disease or a history of any hematologic malignancy.
- Are using oral or parenteral steroids, high-dose inhaled steroids (>800 μg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
Show all 11Show fewer
- Have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
- Have an acute illness that is accompanied by an oral temperature greater than 100.4°F, within 1 week of vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 1st month of the study period.
- Have 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.
- He/she is a CDC worker under direct supervision of any of the primary study investigators (Dr. Sergio Recuenco, and Dr. Eli Warnock).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open-Label, Study of Intradermal Administration of an Inactivated PCEC Rabies Vaccine in Adult Subjects
The purpose of this study is to determine immunogenicity and safety of intradermal administration of the PCEC rabies vaccine in adults.
Read the detailed description
Approximately 16,000-39,000 persons come in contact with potentially rabid animals and receive rabies postexposure prophylaxis (PEP) each year in the US. To appropriately manage potential human exposures to rabies, the risk for infection must be accurately assessed. Administration of rabies PEP is a medical urgency, not a medical emergency, but decisions must not be delayed. Prophylaxis is occasionally complicated by adverse reactions, but these reactions are rarely severe. Current data on the safety and efficacy of active and passive rabies vaccination were derived from both human and animal studies. Timely and appropriate human pre-exposure prophylaxis (Pre-EP) and PEP will prevent human rabies. Currently in the US, the approved dosage and administration for PEP in previously unvaccinated persons consists of the administration of vaccine (HDCV or PCECV) and HRIG. Vaccine is administered IM on days 0, 3, 7, 21, and 28 (deltoid area). The approved dosage and administration for pre-exposure prophylaxis (Pre-EP) consists of three 1.0-mL injections of vaccine (HDCV or PCECV) administered IM (deltoid area), one injection per day on days 0, 7, and 21 or 28). Intradermal (ID) route of administration of rabies vaccination is used in certain countries both for PEP and Pre-EP, and approved by WHO for modern potent cell culture vaccines. Recent studies outside the USA found the use of PCEC rabies vaccine by ID administration immunogenic and safe.
The primary goals of this study are to obtain additional safety and immunogenicity data on ID administration of 0.1 mL doses of the inactivated PCEC rabies virus vaccine in adults. Given the need to provide alternative routes of administration to the current approved intramuscular route in order to protect a larger number of people facing potential vaccine shortages. The data yielded by this clinical trial will provide evidence to support alternative route of administration and dose of PCECV in the US.
- Conditions
- Rabies Prevention, Rabies Exposure
- Being tested
- PCEC rabies vaccine given intradermally, PCEC rabies vaccine administered intramuscularly
- Keywords
- rabies, rabies vaccine, purified cultured embryo chicken rabies vaccine
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCEC rabies vaccine given intradermallyBiological
Also called RabAvert
PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
PCEC rabies vaccine administered intramuscularlyBiological
Also called RabAvert
PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
| Study group | Role | What they receive |
|---|---|---|
| 1: Pre-EP ID | Experimental | Group of participants receiving PCEC rabies vaccine intradermally with the Pre-Exposure schedule. Receives: Biological: PCEC rabies vaccine given intradermally |
| 2: Pre-EP IM | Active comparator | Group of participants receiving PCEC rabies vaccine intramuscular with the Pre-Exposure schedule. Receives: Biological: PCEC rabies vaccine administered intramuscularly |
| 3: Booster ID | Experimental | Group of participants receiving PCEC rabies vaccine intradermally with the Booster schedule. Receives: Biological: PCEC rabies vaccine given intradermally |
| 4: Booster IM | Active comparator | Group of participants receiving PCEC rabies vaccine intramuscular with the Booster schedule. Receives: Biological: PCEC rabies vaccine administered intramuscularly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adequate Rabies Virus Neutralizing Antibody Titers
Proportion of participants with rabies virus neutralizing antibody titers ≥1:5 (approximately 0.1 IU/mL) measured by rapid fluorescent focus inhibition test (RFFIT).
Measured: Day 14 after completion of the vaccination regimen (Day 35 for Pre-Exposure groups and Day 14 for Booster groups)
Secondary outcomes (1)
Geometric Mean Titers of Rabies Virus Neutralizing Antibodies
Geometric mean titers (GMTs) of rabies virus neutralizing antibodies measured by RFFIT at Day 14 after vaccination.
Measured: Day 14 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startFeb 2009
- Primary completionSep 2009
- Study completionAug 2013
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.
- Other trials for Rabies PreventionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sergio Recuenco, MD,MPH,DrPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044199
- Sponsor's protocol ID
- CDC-NCEZID-5506
- Other IDs
- IND-13814, CDC-IRB 5506
- Acronym
- Rabies-ID
- Status last verified
- May 2026
- First submitted
- 6 Jan 2010
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-Label, Study of Intradermal Administration of an Inactivated PCEC Rabies Vaccine in Adult Subjects
- ClinicalTrials.gov ID
- NCT01044199
- Acronym / sponsor ID
- Rabies-ID / CDC-NCEZID-5506
- Conditions
- Rabies Prevention, Rabies Exposure
- Keywords
- rabies, rabies vaccine, purified cultured embryo chicken rabies vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Feb 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Posted 24 Jun 2026
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 determine immunogenicity and safety of intradermal administration of the PCEC rabies vaccine in adults.
Detailed description
Approximately 16,000-39,000 persons come in contact with potentially rabid animals and receive rabies postexposure prophylaxis (PEP) each year in the US. To appropriately manage potential human exposures to rabies, the risk for infection must be accurately assessed. Administration of rabies PEP is a medical urgency, not a medical emergency, but decisions must not be delayed. Prophylaxis is occasionally complicated by adverse reactions, but these reactions are rarely severe. Current data on the safety and efficacy of active and passive rabies vaccination were derived from both human and animal studies. Timely and appropriate human pre-exposure prophylaxis (Pre-EP) and PEP will prevent human rabies. Currently in the US, the approved dosage and administration for PEP in previously unvaccinated persons consists of the administration of vaccine (HDCV or PCECV) and HRIG. Vaccine is administered IM on days 0, 3, 7, 21, and 28 (deltoid area). The approved dosage and administration for pre-exposure prophylaxis (Pre-EP) consists of three 1.0-mL injections of vaccine (HDCV or PCECV) administered IM (deltoid area), one injection per day on days 0, 7, and 21 or 28). Intradermal (ID) route of administration of rabies vaccination is used in certain countries both for PEP and Pre-EP, and approved by WHO for modern potent cell culture vaccines. Recent studies outside the USA found the use of PCEC rabies vaccine by ID administration immunogenic and safe.
The primary goals of this study are to obtain additional safety and immunogenicity data on ID administration of 0.1 mL doses of the inactivated PCEC rabies virus vaccine in adults. Given the need to provide alternative routes of administration to the current approved intramuscular route in order to protect a larger number of people facing potential vaccine shortages. The data yielded by this clinical trial will provide evidence to support alternative route of administration and dose of PCECV in the US.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: Pre-EP ID | Experimental | Biological: PCEC rabies vaccine given intradermallyGroup of participants receiving PCEC rabies vaccine intradermally with the Pre-Exposure schedule. |
| 2: Pre-EP IM | Active comparator | Biological: PCEC rabies vaccine administered intramuscularlyGroup of participants receiving PCEC rabies vaccine intramuscular with the Pre-Exposure schedule. |
| 3: Booster ID | Experimental | Biological: PCEC rabies vaccine given intradermallyGroup of participants receiving PCEC rabies vaccine intradermally with the Booster schedule. |
| 4: Booster IM | Active comparator | Biological: PCEC rabies vaccine administered intramuscularlyGroup of participants receiving PCEC rabies vaccine intramuscular with the Booster schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Laboratory personnel, epidemiologists, EISOs, veterinary students, interns, and other first responders at CDC; other CDC employees; and healthy volunteer adults. Persons who contact the study coordinator will be assessed for possible occupational exposure to rabies using the risk assessment form (appendix E). The volunteers reporting occupational exposure will be selected to enter the study.
- Male or nonpregnant females (as indicated by a negative urine pregnancy test prior to first dose of vaccine), aged 18 years and older.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, or licensed hormonal methods) for the entire study period.
- Be in good health, as determined by vital signs (pulse, blood pressure, oral temperature), medical history, and a targeted physical examination based on medical history.
- Able to understand and comply with planned study procedures.
Key exclusion criteria (11 listed)
- Have a known allergy to PCECV.
- Have a known allergy or sensitivity to eggs or latex (in the stopper).
- Have a positive urine pregnancy test prior to first vaccine dose (female of childbearing potential age).
- Are immunosuppressed as a result of an underlying illness or treatment.
- Have active neoplastic disease or a history of any hematologic malignancy.
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 |
|---|---|---|
| PCEC rabies vaccine given intradermallyAlso: RabAvertPCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past. | Biological | 1: Pre-EP ID, 3: Booster ID |
| PCEC rabies vaccine administered intramuscularlyAlso: RabAvertPCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past. | Biological | 2: Pre-EP IM, 4: Booster IM |
Primary outcome
Number of Participants With Adequate Rabies Virus Neutralizing Antibody Titers
Time frame: Day 14 after completion of the vaccination regimen (Day 35 for Pre-Exposure groups and Day 14 for Booster groups)
Proportion of participants with rabies virus neutralizing antibody titers ≥1:5 (approximately 0.1 IU/mL) measured by rapid fluorescent focus inhibition test (RFFIT).
1 secondary outcome
Geometric Mean Titers of Rabies Virus Neutralizing Antibodies
Time frame: Day 14 after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sergio Recuenco, MD,MPH,DrPH principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCEC rabies vaccine given intradermally and PCEC rabies vaccine administered intramuscularly in people with Rabies Prevention and Rabies Exposure, run by Centers for Disease Control and Prevention 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 7 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 24 Jun 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2026). 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?
Number of Participants With Adequate Rabies Virus Neutralizing Antibody Titers (time frame: Day 14 after completion of the vaccination regimen (Day 35 for Pre-Exposure groups and Day 14 for Booster groups)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2026.