Infections, Meningococcal Clinical Trial
Official title:
Assay of the Immunogenicity of Fractional Dose Tetravalent A, C, Y, W135 Meningococcal Polysaccharide Vaccine in Africa
Verified date | December 2006 |
Source | Epicentre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Uganda: National Council for Science and Technology |
Study type | Interventional |
Hypothesis:
Lower doses of each A/C/Y/W135 component of the meningococcal polysaccharide vaccine could
confer a similar functional immunogenic response as the dose of 50 μg currently being used,
and subsequently be equally protective.
The purpose of this study is to evaluate the use of fractional dose tetravalent
meningococcal polysaccharide vaccine to control outbreak especially caused by N.
meningitidis serogroup W135
Primary Objectives:
- To measure the immunogenicity of a dose corresponding to one fifth of the amount of the
licensed meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 10 μg for each
component; and
- To measure the immunogenicity of a dose corresponding to one tenth of the licensed
meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 5 μg for each component.
Status | Completed |
Enrollment | 720 |
Est. completion date | November 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 2 Years to 20 Years |
Eligibility |
Inclusion Criteria: - Volunteers should not be suffering of severe chronic disease or a known congenital or acquired immunodeficiency. A medical exam will be performed by a medical doctor before inclusion. - Volunteers must be living in the Mbarara district and within 15 km from the site of immunization. Volunteers should be residents of the chosen site and should express no plan of moving from this area during the study period. - Volunteers must be available for follow-up for the duration of the study (minimum of 24 months). Exclusion Criteria: - Volunteers with severe chronic disease or with a general condition requiring hospital admission. - Volunteers with a known congenital or acquired immunodeficiency (e.g. HIV). Diagnosis will be presumptive based on the medical background and the clinical examination. No serological HIV testing will be performed. - Evidence of any concomitant infection at the time of presentation (including rashes other than scabies; ear, nose or throat infections; and abnormal respiratory system examination). - The patient has any other underlying diseases that compromise the diagnosis and the evaluation of the response to the study medication. - History of serious adverse reactions to vaccines such as anaphylaxis or related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain. - Malnutrition: The nutritional assessment of children aged 24–59 months, a weight-for-height (W/H) index, will be calculated. This index is expressed in standard deviations of a normalised distribution of a reference population 38 (National Centre for Health Statistics, USA). Children under 5 years old with a Z-score inferior to -2 will be excluded. For children over 5 or adults, the clinical examination will be considered. - Pregnant women and lactating women are not eligible for this trial. All women of child-bearing age must provide a urine sample for pregnancy testing before inclusion and, for sub-group “b”, before the second vaccine injection. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Norway | Norwegian Institute of Public Health | Oslo | |
Uganda | Mbarara Epicentre Research Base | Mbarara |
Lead Sponsor | Collaborator |
---|---|
Epicentre | Medecins Sans Frontieres, Norwegian Institute of Public Health, University of Oslo |
Norway, Uganda,
Granoff DM, Gupta RK, Belshe RB, Anderson EL. Induction of immunologic refractoriness in adults by meningococcal C polysaccharide vaccination. J Infect Dis. 1998 Sep;178(3):870-4. — View Citation
Griffiss JM, Brandt BL, Broud DD, Altieri PL, Berman SL. Relationship of dose to the reactogenicity and immunogenicity of meningococcal polysaccharide vaccines in adults. Mil Med. 1985 Oct;150(10):529-33. — View Citation
Griffiss JM, Brandt BL, Broud DD. Human immune response to various doses of group Y and W135 meningococcal polysaccharide vaccines. Infect Immun. 1982 Jul;37(1):205-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To measure the immunogenicity of a dose corresponding to one fifth of the amount of the licensed meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 10µg for each component | |||
Primary | To measure the immunogenicity of a dose corresponding to one tenth of the licensed meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 5µg for each component | |||
Secondary | To determine the pharyngeal carriage of N. meningitidis and in particular W135 strains in the study population | |||
Secondary | To determine the natural immunity towards N. meningitidis serogroup A, C, Y and W135 before immunisation in the study population | |||
Secondary | To measure a possible waning of immunity at one year and at two years after immunisation | |||
Secondary | To measure the immune response after challenging with a second dose of the commercialised meningococcal A/C/Y/W135 polysaccharide vaccine after one year, in a group of volunteers who have received a reduced dose on day 0 |
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