Group A Beta Hemolytic Streptococcal (GAS) Infection Clinical Trial
Official title:
Epidemiological Surveillance in India of Group A Streptococcal Infections Including Pharyngitis and Impetigo Supported by Indo-US Vaccine Action Program
| Verified date | February 26, 2014 |
| Source | National Institutes of Health Clinical Center (CC) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Information from this study is needed to plan an eventual trial of a GAS vaccine in India if
and when one is available. A GAS vaccine is currently a priority of the Indian Council for
Medical Research (ICMR), and this project has been approved by the Joint Working Group (US
and Indian Delegates) of the Vaccine Action Program, a joint effort of the ICMR and NIAID to
implement cooperative efforts between the two countries on mutual objectives in vaccine
development. Currently, several GAS vaccines are in development, supported by NIAID, and
other sources, and one candidate is in phase one clinical trial authorized by the FDA.
Information on the antigenic structure of GAS isolated in India will be needed for planning
vaccine composition. It is the view of the Indian Ministry of Health and Indian Council for
Medical Research that eventual prevention and control of rheumatic fever and rheumatic heart
disease in India, now a heavy burden on the children will require a GAS vaccine, which
requires both access to primary health care and a vaccine if and when it is available.
Information on incidence is needed to determine the size of a future vaccine cohort in order
to obtain a statistically significant result on vaccine efficacy. Although unrelated to
vaccine development, information on the incidence of GAS pharyngitis is needed in India to
implement primary and secondary acute rheumatic fever (ARF) and rheumatic heart disease (RHD)
prevention programs as were implemented in the USA and Europe forty years ago.
A vaccine trial is not part of this study, nor is there any intervention, other than
antibiotic treatment of all children volunteers who develop GAS pharyngitis or impetigo.
An additional point should be made about the importance of obtaining epidemiological data on
streptococcal disease in India, and on the emm types of GAS that cause infections. The
population of India is over one billion people, representing nearly twenty five percent of
the world's population. Information on GAS epidemiology from India is scant to say the least,
and it is sorely needed. We now know that streptococcal toxic shock syndrome and fasciitis
that have occurred in the U. S., Europe, Australia, and Japan, with greater frequency in
recent years are caused by several genetically similar emm types of GAS. The implication of
such genetic and epidemiologic data is that these genetically related strains have spread
worldwide, Current information from India is far too limited to know if these virulent
strains of GAS occur in India, and if they do, to what extent might they be the cause of
frequent invasive disease in hospitalized patients.
Equally important, we do not know if a potentially high virulent GAS strain is currently
emerging in some locale(s) in India, and what possible threat it might become, if it were to
be transported to other worldwide geographic regions. Although not a specific aim of this
proposal, the surveillance conducted to accomplish the aims of this protocol will provide
essential information on the possible emergence of an unexpected emm type with pathogenic
potential.
...
| Status | Completed |
| Enrollment | 663 |
| Est. completion date | February 26, 2014 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 20 Years |
| Eligibility |
- INCLUSION CRITERIA: All students (approximately 225-250) attending four classes in four rural schools, grades 2-5, in rural villages near Chandigarh, and all students in classes 2-6 approximately 225-250 attending one rural village school near Vellore were asked to participate. Approximately an equal number of boys and girls participated. Selection of the schools for the study was determined by such factors as the accessibility to a rural regional clinic, housing facilities for medical staff, and passable tertiary roads to the villages and the schools. EXCLUSION CRITERIA: All volunteers had a history of acute rheumatic fever and acute glomerulonephritis and evidence of rheumatic fever and rheumatic heart disease on physical examination at the initial survey were excluded from the study. Excluded also was a child with a compromising illness such as cystic fibrosis that might require frequent or intermittent antibiotic treatment. |
| Country | Name | City | State |
|---|---|---|---|
| India | Post Graduate Institute of Medical and Experimental Research | Chandigarh | |
| India | Christian Medical College | Vellore |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) |
India,
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