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

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
Addis Ababa University
LSHTM,UK
Information provided by:
Armauer Hansen Research Institute, Ethiopia
ClinicalTrials.gov Identifier:
NCT00994695
First received: October 13, 2009
Last updated: October 15, 2009
Last verified: October 2009
  Purpose

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

Condition Intervention Phase
Meningococcal Meningitis
Biological: Mencevax ACW Vaccine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Armauer Hansen Research Institute, Ethiopia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the incidence of adverse events following vaccination at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination. [ Time Frame: 28days ] [ Designated as safety issue: Yes ]
  • To assess the immunogenicity at 11 months and 23 months (inclusive) postvaccination. [ Time Frame: 23 month ] [ Designated as safety issue: No ]

Enrollment: 412
Study Start Date: November 2005
Study Completion Date: November 2007
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Mencevax ACW Vaccine
    Mencevax ACW polysaccharide vaccine subcutaneously in the left arm at 50 μg in 0.5ml(reconstituted).
    Other Name: Mencevax ACW polysaccharide vaccine
  Eligibility

Ages Eligible for Study:   2 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00994695

Locations
Ethiopia
Butajira Hospital
Butajira, Southern Nationality, Ethiopia
Sponsors and Collaborators
Armauer Hansen Research Institute, Ethiopia
World Health Organization
Addis Ababa University
LSHTM,UK
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
  More Information

Publications:
Responsible Party: Dr.Ahmed Bedru Omer, One of the Principal Investigators., Armauer Hansen Research Institute
ClinicalTrials.gov Identifier: NCT00994695     History of Changes
Other Study ID Numbers: AHRI/WHO/IVB-1
Study First Received: October 13, 2009
Last Updated: October 15, 2009
Health Authority: Switzerland:WHO-ERC
Ethiopia:Ethiopian national Ethical review Committee
Ethiopia: Ministry of Health
Ethiopia: Drug Administration and regulatory Authority

Keywords provided by Armauer Hansen Research Institute, Ethiopia:
Trivalent meningococcal polysaccharide vaccine
Children
Safety
Immunogenicity
To assess Safety of trivalent meningococcal polysaccharide vaccine in children
To assess the immunogenicity of the trivalent polysaccharide vaccine in children

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis, Bacterial
Meningococcal Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on October 20, 2014