Rabies Immunization Concomitant With JEV in Children

NCT00703521 | Completed Phase 2

• 1 other identifier: M49P2
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background. The World Health Organization recommends pre-exposure vaccination (PreP) to protect children living in canine rabies endemic countries. Including PreP in national childhood immunization programs (EPI) is a viable option. Methods. In an open-label phase II clinical trial, 200 healthy toddlers were randomized to receive Purified Chick Embryo Cell Vaccine (PCECV) in a 3-dose Full-IM (1mL), Half-IM (0.5mL), 3-ID (0.1mL), or a 2-dose 2-ID (0.1mL) regimen, all in combination with two doses of Japanese Encephalitis (JEV), or JEV alone. One booster dose of PCECV (IM or ID) and JEV, or JEV alone was administered concomitantly one year after primary vaccination. Safety was evaluated after each injection. Blood was drawn on days 0 and 49, one year later prior to booster and on days 7 and 28 post-booster, and at two and three years post primary vaccination. All sera were analyzed for rabies and JE virus neutralizing antibodies (RVNA, JEVNA).

Conditions

Rabies

Keywords

rabies vaccination; pre-exposure prophylaxis; rabies virus neutralizing antibody; Antibody response; immunologic memory of rabies vaccination; Safety of rabies vaccination administered in pre-exposure regimens both intramuscular and intradermal routes

Study Arms (1)

1,2,3,4,5

PLACEBO COMPARATOR

1. Rabies vaccine 1.0 mL IM on day 0, 7, 28,and 1 year 2. Rabies vaccine 0.5 mL IM on day 0, 7, 28,and 1 year 3. Rabies vaccine 0.1 mL Intradermal on day 0, 7, 28,and 1 year 4. Rabies vaccine 0.1 mL Intradermal on day 0, 28,and 1 year 5. Japanese encephalitis vaccine 0.25 mL subcutaneous

Biological: Rabies vaccine

Interventions

Rabies vaccine BIOLOGICAL

1.0 mL IM day 0,7,28 and 1 year

1,2,3,4,5

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male and female 12-18 months old toddlers will be included in the study if they;
• are in good health at time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;
• are available for all the visits scheduled in the study;
• have been granted a written informed consent signed by their parents

You may not qualify if:

• a history of rabies immunization;
• a history of Japanese encephalitis immunization or disease;
• a significant acute or chronic infectious disease at the time of enrollment;
• fever \> 38.0 degree C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment;
• being under treatment with parenteral, oral and/or inhaled corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment;
• administration of any vaccine within the past 14 days before enrollment;
• known immunodeficiency or an autoimmune disease;
• known hypersensitivity to neomycin, tetracycline, amphotericin-B;
• planned surgery during the study period;
• being enrolled in any other investigational trial contemporaneously;
• the family plans to leave the area of the study site before the end of study period;
• history of febrile convulsions;
• history of wheezing

Sponsors & Collaborators

• Mahidol University: lead
• Chiron company: Clinical Research and Medical Affairs: collaborator

MeSH Terms

Conditions

Rabies

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 20, 2008
• First Posted: June 23, 2008
• Study Start: August 1, 2002
• Primary Completion: October 1, 2002
• Study Completion: September 1, 2005
• Last Updated: October 24, 2008

Record last verified: 2008-06