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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01044199
First received: January 6, 2010
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine immunogenicity and safety of intradermal administration of the PCEC rabies vaccine in adults.


Condition Intervention
Rabies Prevention
Rabies Exposure
Biological: PCEC rabies vaccine given intradermally
Biological: PCEC rabies vaccine administered intramuscularly

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Single Center, Open-Label, Study of Intradermal Administration of an Inactivated PCEC Rabies Vaccine in Adult Subjects

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

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. [ Time Frame: 14 days after receipt of the last dose of the vaccine. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 14, 60, 120 and 160 days after last dose of vaccine. ] [ Designated as safety issue: No ]
  • Distribution GMTs of virus-neutralizing antibody titers in each group. [ Time Frame: 14, 60, 120 and 160 after last dose of vaccine. ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: February 2009
Study Completion Date: August 2013
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Pre-EP ID
Group of participants receiving PCEC rabies vaccine intradermally with the Pre-Exposure schedule.
Biological: PCEC rabies vaccine given intradermally
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.
Other Name: RabAvert
Active Comparator: 2: Pre-EP IM
Group of participants receiving PCEC rabies vaccine intramuscular with the Pre-Exposure 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.
Other Name: RabAvert
Experimental: 3: Booster ID
Group of participants receiving PCEC rabies vaccine intradermally with the Booster schedule.
Biological: PCEC rabies vaccine given intradermally
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.
Other Name: RabAvert
Active Comparator: 4: Booster IM
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.
Other Name: RabAvert

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044199

Locations
United States, Georgia
CDC Occupational Clinic
Atlanta, Georgia, United States, 30333
Sponsors and Collaborators
Investigators
Principal Investigator: Sergio Recuenco, MD,MPH,DrPH Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01044199     History of Changes
Other Study ID Numbers: CDC-NCEZID-5506, IND-13814, CDC-IRB 5506
Study First Received: January 6, 2010
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:
rabies
rabies vaccine
purified cultured embryo chicken rabies vaccine

Additional relevant MeSH terms:
Rabies
Mononegavirales Infections
RNA Virus Infections
Rhabdoviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014