Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers

Study Overview
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Brief Summary
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This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic when administered concomitantly to toddlers.

Official Title
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A Phase II, Pilot, Randomized, Open-Label, Single-Center Study to Evaluate Immunogenicity, Safety and Booster Response of 3 Full Intramuscular Doses Versus 3 Half Intramuscular Doses Versus 3 Intradermal Doses Versus 2 Intradermal Doses of PCEC Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine as a Pre-Exposure Regimen in 12 to 18 Months Old Toddlers in Thailand.

Conditions
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Rabies, Japanese Encephalitis, Pre-Exposure Prophylaxis

Intervention / Treatment
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* Biological: Three 1 mL doses of Rabies vaccine and two JE vaccine
* Biological: Three 0.5 mL doses of Rabies vaccine and two JE vaccine
* Biological: Three 0.1mL doses of Rabies Vaccine and two JE vaccine
* Biological: Two 0.1mL doses of Rabies vaccine and two JE vaccine
* Biological: Two doses of JE vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female 12-18 months old toddlers if they are in good health at time of entry into the study are available for all the visits scheduled in the study have been granted a written informed consent, signed by their parents Exclusion Criteria: 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°C (axillary) or/and significant acute or chronic infection requiring antibiotic or antiviral therapy within the past 7 days before enrollment being under treatment with 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 history of allergy to eggs, egg products 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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Three 1 mL doses of Rabies vaccine and two JE vaccine<br>* Vaccination with purified chick embryo cell rabies vaccine 1.0 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)<br>|
| Experimental: 2<br> | Biological: Three 0.5 mL doses of Rabies vaccine and two JE vaccine<br>* Vaccination with purified chick embryo cell rabies vaccine 0.5 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)<br>|
| Experimental: 3<br> | Biological: Three 0.1mL doses of Rabies Vaccine and two JE vaccine<br>* Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)<br>|
| Experimental: 4<br> | Biological: Two 0.1mL doses of Rabies vaccine and two JE vaccine<br>* Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0 and Day 28 (a total of 2 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)<br>|
| Active Comparator: 5<br> | Biological: Two doses of JE vaccine<br>* Vaccination with Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL only subcutaneously on Day 0 and Day 7 (a total of 2 doses)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rabies virus neutralizing antibody concentrations |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Japanese encephalitis virus neutralizing antibody titers |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rabies vaccination, pre-exposure prophylaxis, rabies virus neutralizing antibody