Serological Evaluation of Varicella and Hepatitis A Vaccines Using Injector Delivery (InjHepAVar)

June 22, 2009 updated by: University of Sao Paulo General Hospital

Serological Evaluation of Chickenpox (Varicella) and Hepatitis A Vaccines Using Disposable Needle-Free Syringe Jet Injector (DSJI) Delivery

This study aims to assess immunogenicity and safety of nd influence of the delivery system (needle-free injector or syringe with needle) of fractional doses (dose sparing) of two vaccines (Varicella and Hepatitis A vaccines) in children aged 13 to 30 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the immunogenicity, safety and influence of the delivery system (needle-free injector or syringe with needle) of fractional doses (dose sparing) (23,3 and 43,3 PFU - plaque-forming units - of live attenuated OKA strain of Varicella-zoster virus and 100 radioimmunoassay units HAV) of chickenpox and Hepatitis A ( vaccines, intradermally administered, compared with full dose of 103,3 PFU, subcutaneously administered, in 600 primo (first) vaccinated children aged 13 to 30 months selected at random at day care centers in São Paulo. Vaccines will be tested sequentially (Varicella on day 0 and Hepatitis A on day 45). Only 400 children will be randomized again for Hepatitis A vaccine testing, the remaining 200 children will receive the regular dose of Hepatitis A vaccine without further assessment. Doses will be administered using two systems: Disposable Needle-free Syringe Jet Injector (DSJI), compared with the conventional procedure using syringes and needles. Serial blood samples will be blindly analyzed to detect antibody seroconversion. Local and systemic adverse events will be assessed according to definition established by Brighton Collaboration Group, 24 and 72 hours, 7 days, 14 days, 21 days and 45 days after each vaccination, through clinical evaluation and telephone calls.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403-010
        • Disciplina de Immunologia Clínica e Alergia do HC- FMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children of both genders older than 13 months and younger than 30 months of age.
  • Available for follow-up for at least 45 days at public day care centers funded by São Paulo City local government.
  • Written informed consent signed by parents or legal guardians after reading and explanation

Exclusion Criteria:

  • Suspect/verified diagnosis of congenital or acquired immunodeficiency syndrome (AIDS)
  • Suspect/verified diagnosis of malign neoplasia
  • Children on treatment with high-dose systemic corticosteroids (equivalent to prednisone 2 mg/kg/day, for two or more weeks), or immunosuppressive therapy.
  • Received a vaccine with live attenuated strain of virus within less than 30 days
  • Suspect/verified diagnosis of chickenpox or has already been immunized against chickenpox (varicella).
  • Suspect/verified diagnosis of hypersensibility to any ingredient of the vaccine.
  • One of the parents or legal guardians of the minor does not agree with the study.
  • Any other circumstances that may potentially damage the minor or prevent procedures from being carried out according to evaluation of the research team.
  • Child shows signs or symptoms of an active intercurrent disease (e.g. fever, rash, etc.) that may interfere with the evaluation of adverse events after immunization at the research team's discretion. In this case, the participant may be reevaluated within the following three months in order to verify eligibility.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Varicella (1/5 dose) - ID - Injector
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle-free Syringe Jet Injector
Biological: Varicella Vaccine
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
Other Names:
  • PharmaJet
Experimental: Varicella (1/5 dose) - ID - Syringe
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe
Biological: Varicella Vaccine
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
Other Names:
  • PharmaJet
Experimental: Varicella (2/5 dose) - ID - Injector
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.25 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle-free Syringe Jet Injector
Biological: Varicella Vaccine
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
Other Names:
  • PharmaJet
Experimental: Varicella (2/5 dose) - ID - Syringe
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.25 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe
Biological: Varicella Vaccine
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
Other Names:
  • PharmaJet
Active Comparator: Varicella (full dose) - SC - Injector
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.5 ml Subcutaneous administration with Disposable Needle-free Syringe Jet Injector
Biological: Varicella Vaccine
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
Other Names:
  • PharmaJet
Active Comparator: Varicella (full dose) - SC - Syringe
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.5 ml Subcutaneous administration with Disposable Needle Syringe
Biological: Varicella Vaccine
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
Other Names:
  • PharmaJet
Experimental: Hepatitis A (1/5 dose) ID - Injector
Hepatitis A virus vaccine, inactivated, Single dose, 0.1 ml Intradermal administration with Disposable Needle-free Syringe Jet Injector
Biological: Hepatitis A Vaccine
Hepatitis A virus vaccine, inactivated, Single dose
Experimental: Hepatitis A (1/5 dose) ID - Syringe
Hepatitis A virus vaccine, inactivated, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe
Biological: Hepatitis A Vaccine
Hepatitis A virus vaccine, inactivated, Single dose
Active Comparator: Hepatitis A (full dose) IM - Injector
Hepatitis A virus vaccine, inactivated, Single dose, 0.5 ml Intramuscular administration with Disposable Needle-free Syringe Jet Injector
Biological: Hepatitis A Vaccine
Hepatitis A virus vaccine, inactivated, Single dose
Active Comparator: Hepatitis A (full dose) IM - Syringe
Hepatitis A virus vaccine, inactivated, Single dose, 0.5 ml Intramuscular administration with Disposable Needle Syringe
Biological: Hepatitis A Vaccine
Hepatitis A virus vaccine, inactivated, Single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity: General seroconversion rate 45 days following immunization. Safety: General rate of local and systemic adverse events after immunization according to definition established by Brighton Collaboration Group
Time Frame: 45 days after immunization
45 days after immunization

Secondary Outcome Measures

Outcome Measure
Time Frame
Degree and duration of local and systemic adverse events after immunization according to the Brighton Collaboration Group recommendations.
Time Frame: 45 days after immunization
45 days after immunization
Seroconversion rates and number of local and systemic adverse events after immunization according to delivery system (needle-free injector or syringe with needle) for each dose tested
Time Frame: 45 days after immunization
45 days after immunization
Actual volume administered intradermally according to the delivery system (needle-free injector or syringe with needle) for each fractional dose tested
Time Frame: At immunization
At immunization
Participants' parents or legal guardians acceptability according to the delivery system (needle-free injector or syringe with needle) for each dose tested
Time Frame: 45 days after immunization
45 days after immunization
Distribution of vaccine jet evaluated through ultrasound for the needle-free injector group
Time Frame: 5 minutes after immunization
5 minutes after immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Glacus S Brito, MD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

November 1, 2009

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

June 19, 2009

First Submitted That Met QC Criteria

June 22, 2009

First Posted (Estimate)

June 23, 2009

Study Record Updates

Last Update Posted (Estimate)

June 23, 2009

Last Update Submitted That Met QC Criteria

June 22, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPPesq 0911/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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