Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine (ETH-TVT)

October 15, 2009 updated by: Armauer Hansen Research Institute, Ethiopia

A Phase II Open and Parallel Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Polysaccharide Vaccine Comparing Three Groups: 2 - 4 Year, 5 - 14 Year and 15 - 29 Year Old Ethiopians

Primary objective:

To assess the immunogenicity of the Mencevax ACW135 polysaccharide vaccine at 28 days (+6days) post vaccination in 2-4, 5-14, 15-29 year age groups and compare the immunogenicity between these age groups.

Secondary Objectives:

  • To estimate the incidence of common adverse events following immunization (AEFI) of GSK Nm ACW135 polysaccharide vaccine at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination
  • To assess the persistence of antibody against meningitis A, C and W135 at 11 and 23 months post vaccination in 2-4, 5-14, 15-29 year age groups

Study site:Two rural communities (Kebele) in Butajira district, Ethiopia.

Methods:

  • Phase II, open and parallel safety and immunogenicity trial.
  • 234 younger children (2-4 years), 145 older children (5-14 years) and 33 adults (15-29 years of age) were randomly selected from the demographic surveillance database and enrolled after screening and consenting.
  • Study participant received Mencevax ACW polysaccharide vaccine 50 mg in 0.5ml subcutaneously.
  • Blood samples for measuring SBA titres were collected at pre vaccination and on day 28 (+6 days) post vaccination.
  • Active follow up for AEFI on post vaccination day 0, 1, 2, 3, 7, & 28.
  • Primary end point was vaccine response defined as sero-conversion (in subjects initially seronegative) or a 4 fold increase (in subjects initially seropositive) in serum bactericidal antibodies (SBA) against serogroups Men A, C and W135) on post vaccination day 28. In addition seroconversion was assessed by ELISA Men A IgG on day 0 and day 28 post vaccination.
  • Secondary endpoints were incidence of general and local symptoms and other adverse events following immunisation during the post vaccination period day 0 to 28 and immune persistence on post vaccination month-11 and month-23.

Results:

  • No significant difference in the incidence of general or local AEFI was observed between the age groups
  • The statistical analysis for the Immunogenicity data is in progress

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

412

Phase

  • Phase 2

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

    • Southern Nationality
      • Butajira, Southern Nationality, Ethiopia
        • Butajira Hospital

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

2 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 2-29 years, both sexes, living in the selected villages of Butajira area
  2. A written informed consent signed by the individual (>=18y) or caretaker/guardian (2 to 17 years of age) as 18 is the legal age of maturity in Ethiopia. Assent from children/adolescents aged 12-17 years old.
  3. Free of obvious health problems ascertained by medical history and clinical examination on the day of enrolment

Exclusion Criteria:

  1. Those who are unlikely to complete the follow up at 4-weeks post-vaccination.
  2. Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  3. Administration of blood transfusion within 2 years prior to enrolment or planned use during the study period.
  4. Verbal report of previous vaccination with meningococcal serogroup A, C, Y or W135 vaccines since 1999.
  5. Confirmed or suspected immunosuppressive or immunodeficient condition including HIV infection.
  6. A family history of congenital or hereditary immunodeficiency.
  7. History of allergic reaction to any component of the vaccine
  8. Presence of any fever (defined as axillary temperature of 37.5 degree centigrade or more) and/or severe illness on the day of enrolment/ vaccination.
  9. Pregnancy.
  10. lactation

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
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate point estimates and trends in immunogenicity after not less than 28 days (+6 days) among children 2 - 4 years as compared to children 5 - 14 years and adolescents/adults 15 - 29 years (all ages inclusive)
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the incidence of adverse events following vaccination at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination.
Time Frame: 28days
28days
To assess the immunogenicity at 11 months and 23 months (inclusive) postvaccination.
Time Frame: 23 month
23 month

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Abraham Aseffa Aseffa, M.D, PhD, Senior Sientist,Deputy Director, AHRI
  • Principal Investigator: Ahmed Bedru Omer, M.D,Pediatrician, Clinical Trial coordinator,AHRI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

November 1, 2005

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

October 16, 2009

Last Update Submitted That Met QC Criteria

October 15, 2009

Last Verified

October 1, 2009

More Information

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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