An interventional study of PCEC rabies vaccine given intradermally and PCEC rabies vaccine administered intramuscularly in Rabies Prevention and Rabies Exposure, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Centers for Disease Control and Prevention · Not applicable, Interventional, and Prevention
The purpose of this study is to determine immunogenicity and safety of intradermal administration of the PCEC rabies vaccine in adults.
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.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 130 is below the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Group of participants receiving PCEC rabies vaccine intradermally with the Pre-Exposure schedule.
Biological: PCEC rabies vaccine given intradermally
Group of participants receiving PCEC rabies vaccine intramuscular with the Pre-Exposure schedule.
Biological: PCEC rabies vaccine administered intramuscularly
Group of participants receiving PCEC rabies vaccine intradermally with the Booster schedule.
Biological: PCEC rabies vaccine given intradermally
Group of participants receiving PCEC rabies vaccine intramuscular with the Booster schedule.
Biological: PCEC rabies vaccine administered intramuscularly
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.
Also known as: 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.
Also known as: RabAvert
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).
Time frame: Day 14 after completion of the vaccination regimen (Day 35 for Pre-Exposure groups and Day 14 for Booster groups)
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.
Time frame: Day 14 after vaccination
| Milestone | 1: Pre-EP ID | 2: Pre-EP IM | 3: Booster ID | 4: Booster IM |
|---|---|---|---|---|
| Started | 33 | 33 | 31 | 33 |
| Completed | 33 | 33 | 31 | 31 |
| Not completed | 0 | 0 | 0 | 2 |
| Withdrew: Excluded from immunological analysis | 0 | 0 | 0 | 2 |
Proportion of participants with rabies virus neutralizing antibody titers ≥1:5 (approximately 0.1 IU/mL) measured by rapid fluorescent focus inhibition test (RFFIT).
| Participants | 1: Pre-EP ID | 2: Pre-EP IM | 3: Booster ID | 4: Booster IM |
|---|---|---|---|---|
| Number of Participants With Adequate Rabies Virus Neutralizing Antibody Titers | 33 | 33 | 31 | 33 |
Geometric mean titers (GMTs) of rabies virus neutralizing antibodies measured by RFFIT at Day 14 after vaccination.
| IU/ml | 1: Pre-EP ID | 2: Pre-EP IM | 3: Booster ID | 4: Booster IM |
|---|---|---|---|---|
| Geometric Mean Titers of Rabies Virus Neutralizing Antibodies | 2.5 (2 to 3) | 5.0 (4 to 6) | 15 (12 to 18) | 30 (25 to 35) |
Collected over From vaccination through final study follow-up, approximately 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1: Pre-EP ID | — | 0/33 (0%) | 33/33 (100%) |
| 2: Pre-EP IM | — | 0/33 (0%) | 30/33 (90.9%) |
| 3: Booster ID | — | 0/31 (0%) | 28/31 (90.3%) |
| 4: Booster IM | — | 0/33 (0%) | 26/33 (78.8%) |
| Event | 1: Pre-EP ID | 2: Pre-EP IM | 3: Booster ID | 4: Booster IM |
|---|---|---|---|---|
| ErythemaGeneral disorders | 25/33 | 5/33 | 26/31 | 5/33 |
| IndurationGeneral disorders | 2/33 | 19/33 | 9/31 | 16/33 |
| HeadacheNervous system disorders | 9/33 | 5/33 | 4/31 | 10/33 |
| FatigueGeneral disorders | 4/33 | 7/33 | 5/31 | 8/33 |
Baseline characteristics are reported for all enrolled participants (N=130).
| Age, Categorical(Participants) | 1: Pre-EP ID | 2: Pre-EP IM | 3: Booster ID | 4: Booster IM | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 33 | 33 | 31 | 33 | 130 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | 1: Pre-EP ID | 2: Pre-EP IM | 3: Booster ID | 4: Booster IM | Total |
|---|---|---|---|---|---|
| Median | 36 (22 to 62) | 40 (20 to 57) | 44 (28 to 61) | 43 (28 to 61) | 43 (20 to 62) |
| Sex: Female, Male(Participants) | 1: Pre-EP ID | 2: Pre-EP IM | 3: Booster ID | 4: Booster IM | Total |
|---|---|---|---|---|---|
| Female | 17 | 18 | 14 | 20 | 69 |
| Male | 16 | 15 | 17 | 13 | 61 |
| Ethnicity (NIH/OMB)(Participants) | 1: Pre-EP ID | 2: Pre-EP IM | 3: Booster ID | 4: Booster IM | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 2 | 2 | 5 |
| Not Hispanic or Latino | 32 | 33 | 29 | 31 | 125 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 1: Pre-EP ID | 2: Pre-EP IM | 3: Booster ID | 4: Booster IM | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 0 | 1 |
| Asian | 3 | 0 | 0 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 4 | 0 | 1 | 5 |
| White | 30 | 28 | 31 | 29 | 118 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | 1: Pre-EP ID | 2: Pre-EP IM | 3: Booster ID | 4: Booster IM | Total |
|---|---|---|---|---|---|
| United States | 33 | 33 | 31 | 33 | 130 |
The record gives a start of Feb 2009, a primary completion of Sep 2009 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2026, 16 years 9 months after primary completion.
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rabies virus strain flury LEP antigen (propiolactone inactivated)
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