Registration - Meningococcal vaccine (ACWYX) Clinical Trial
Please read the READ ME section before registering.
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This is a form to show your interest in participating in the Meningococcal Vaccine (ACWYX) clinical trial (PI: Dr. Sandeep Kumar Panigrahi). IMS and SUM Hospital is one of the approved trial sites in this study. Please read the information carefully for a better understanding.
About Meningococcal meningitis:
Meningococcal meningitis is a bacterial form of meningitis, a serious infection of the thin lining that surrounds the brain and spinal cord. It is associated with high fatality (up to 50% when untreated) and high frequency (more than 10%) of severe sequelae.

It is caused by Neisseria meningitidis bacteria and has potential to cause large epidemics. Twelve types of N. meningitides, called serogroups, have been identified, six of which (A, B, C, W, X and Y) can cause epidemics.

Neisseria meningitidis only infects humans; there is no animal reservoir. The bacteria are transmitted from person-to-person through droplets of respiratory or throat secretions from carriers. Smoking, close and prolonged contact – such as kissing, sneezing or coughing on someone, or living in close quarters with a carrier – facilitates the spread of the disease. Transmission of N. meningitidis is facilitated during mass gatherings. The bacteria can be carried in the throat and sometimes overwhelms the body's defences allowing the bacteria to spread through the bloodstream to the brain. It is believed that 1% to 10% of the population carries N. meningitidis in their throat at any given time.

Even when the disease is diagnosed early and adequate treatment is started, 8% to 15% of patients die, often within 24 to 48 hours after the onset of symptoms. If untreated, meningococcal meningitis is fatal in 50% of cases and may result in brain damage, hearing loss or disability in 10% to 20% of survivors.

Meningococcal disease is potentially fatal and should always be viewed as a medical emergency.

About Meningococcal vaccine:
Vaccine in India is already in use. One of them is Menactra, that was first licensed in 2005 and received FDA approval to be administered as a 2nd dose to adolescents and adults in 2014. This, however, contains only four strains, ACW and Y). Currently there is no licensed vaccine that is protective against Neisseria meningitidis group X which has caused multiple recent outbreaks in Africa and suggest a hyperendemicity and high capacity for localised epidemics.

About Meningococcal vaccine trial (ACYWX):
Trial is expected to start from 5th August 2020. Healthy Individuals 18-85 Years of Age can register here. Subjects in 18-29 years age will be recruited in high numbers as compared to other age groups. A physical examination will be done and vaccine given on the same day, if found suitable. A basic travel expense will be provided. You need to follow up only thrice, after 7 days, 28 days, and again 6 months. 5 ml of blood (around a teaspoon), will be collected during visits. By registering, you will be giving the consent to be contacted in person through your phone number or e-mail id. Your registration does not give you the right to participate in the study. Participation will be on a first come first serve basis, and after screening for being a healthy human subject and meeting some inclusion and exclusion criteria.
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