Study of Intradermal Administration of PCEC Rabies Vaccine

NCT01044199 | Completed

• 3 other identifiers: CDC-NCEZID-5506IND-13814CDC-IRB 5506
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rabies Prevention; Rabies Exposure

Keywords

rabies; rabies vaccine; purified cultured embryo chicken rabies vaccine

Outcome Measures

Primary Outcomes (2)

• 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.

  Proportion of subjects achieving rabies virus-neutralizing antibody titers ≥1:5 as measured by the rapid fluorescent focus inhibition test (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).

  Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) following vaccination, assessed through clinical evaluation and subject-reported outcomes.

  Imnediately after fisrt dose to completion of the study 6 months later.

Secondary Outcomes (2)

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

  14, 60, 120 and 160 days after last dose of vaccine.

• Distribution GMTs of virus-neutralizing antibody titers in each group.

  14, 60, 120 and 160 after last dose of vaccine.

Study Arms (4)

1: Pre-EP ID

EXPERIMENTAL

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

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.

Biological: PCEC rabies vaccine administered intramuscularly

3: Booster ID

EXPERIMENTAL

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

Biological: PCEC rabies vaccine given intradermally

4: Booster IM

ACTIVE COMPARATOR

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

Biological: PCEC rabies vaccine administered intramuscularly

Interventions

PCEC rabies vaccine given intradermally BIOLOGICAL

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

1: Pre-EP ID; 3: Booster ID

PCEC rabies vaccine administered intramuscularly BIOLOGICAL

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

2: Pre-EP IM; 4: Booster IM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead

Study Sites (1)

CDC Occupational Clinic

Atlanta, Georgia, 30333, United States

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Sergio Recuenco, MD,MPH,DrPH

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 7, 2010
• Study Start: February 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: August 1, 2013
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)