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Study of Intradermal Administration of PCEC Rabies Vaccine (Rabies-ID)

Primary Purpose

Rabies Prevention, Rabies Exposure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PCEC rabies vaccine given intradermally
PCEC rabies vaccine administered intramuscularly
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rabies Prevention focused on measuring rabies, rabies vaccine, purified cultured embryo chicken rabies vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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.
  2. Male or nonpregnant females (as indicated by a negative urine pregnancy test prior to first dose of vaccine), aged 18 years and older.
  3. 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.
  4. 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.
  5. Able to understand and comply with planned study procedures.
  6. Provide informed consent prior to any study procedures and be available for all study visits.
  7. Have health insurance.

Exclusion Criteria:

  1. Have a known allergy to PCECV.
  2. Have a known allergy or sensitivity to eggs or latex (in the stopper).
  3. Have a positive urine pregnancy test prior to first vaccine dose (female of childbearing potential age).
  4. Are immunosuppressed as a result of an underlying illness or treatment.
  5. Have active neoplastic disease or a history of any hematologic malignancy.
  6. Are using oral or parenteral steroids, high-dose inhaled steroids (>800 μg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
  7. Have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
  8. Have an acute illness that is accompanied by an oral temperature greater than 100.4°F, within 1 week of vaccination.
  9. 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.
  10. 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.
  11. He/she is a CDC worker under direct supervision of any of the primary study investigators (Dr. Sergio Recuenco, and Dr. Eli Warnock).

Sites / Locations

  • CDC Occupational Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

1: Pre-EP ID

2: Pre-EP IM

3: Booster ID

4: Booster IM

Arm Description

Group of participants receiving PCEC rabies vaccine intradermally with the Pre-Exposure schedule.

Group of participants receiving PCEC rabies vaccine intramuscular with the Pre-Exposure schedule.

Group of participants receiving PCEC rabies vaccine intradermally with the Booster schedule.

Group of participants receiving PCEC rabies vaccine intramuscular with the Booster schedule.

Outcomes

Primary Outcome Measures

Proportion of subjects who have virus-neutralizing antibody titers of at least 1:5 serum dilution by the RFFIT, 14 days after receipt of the last dose of the vaccine.
Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment).

Secondary Outcome Measures

Proportion of subjects who have virus-neutralizing antibody titers of at least 1:5 serum dilution by the RFFIT in each group.
Distribution GMTs of virus-neutralizing antibody titers in each group.

Full Information

First Posted
January 6, 2010
Last Updated
January 28, 2014
Sponsor
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01044199
Brief Title
Study of Intradermal Administration of PCEC Rabies Vaccine
Acronym
Rabies-ID
Official Title
A Single Center, Open-Label, Study of Intradermal Administration of an Inactivated PCEC Rabies Vaccine in Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies Prevention, Rabies Exposure
Keywords
rabies, rabies vaccine, purified cultured embryo chicken rabies vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Pre-EP ID
Arm Type
Experimental
Arm Description
Group of participants receiving PCEC rabies vaccine intradermally with the Pre-Exposure schedule.
Arm Title
2: Pre-EP IM
Arm Type
Active Comparator
Arm Description
Group of participants receiving PCEC rabies vaccine intramuscular with the Pre-Exposure schedule.
Arm Title
3: Booster ID
Arm Type
Experimental
Arm Description
Group of participants receiving PCEC rabies vaccine intradermally with the Booster schedule.
Arm Title
4: Booster IM
Arm Type
Active Comparator
Arm Description
Group of participants receiving PCEC rabies vaccine intramuscular with the Booster schedule.
Intervention Type
Biological
Intervention Name(s)
PCEC rabies vaccine given intradermally
Other Intervention Name(s)
RabAvert
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
PCEC rabies vaccine administered intramuscularly
Other Intervention Name(s)
RabAvert
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of subjects who have virus-neutralizing antibody titers of at least 1:5 serum dilution by the RFFIT, 14 days after receipt of the last dose of the vaccine.
Time Frame
14 days after receipt of the last dose of the vaccine.
Title
Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment).
Time Frame
Imnediately after fisrt dose to completion of the study 6 months later.
Secondary Outcome Measure Information:
Title
Proportion of subjects who have virus-neutralizing antibody titers of at least 1:5 serum dilution by the RFFIT in each group.
Time Frame
14, 60, 120 and 160 days after last dose of vaccine.
Title
Distribution GMTs of virus-neutralizing antibody titers in each group.
Time Frame
14, 60, 120 and 160 after last dose of vaccine.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Recuenco, MD,MPH,DrPH
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
CDC Occupational Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30333
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Intradermal Administration of PCEC Rabies Vaccine

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