Health Condition 1: null- This study group consists of HIV positive Children in the age group (6-15 Years of age)
Conditions
Interventions
Intervention1: Vaccines used : Pneumococcal Conjugate Vaccine (PCV-13 manufactured by Wyeth/Pfizer) and Hib Conjugate Vaccine (HibCV , manufactured by Serum Institute -India): Schedule :
Two doses of
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children 6-15 years of age known to have HIV infection with normal to moderate immune suppression who have not had the Hib or pneumococcal conjugate vaccine 2.Adult household member of child vaccinee 3.Sibling of child vaccinee
Exclusion criteria
Exclusion criteria: 1. Hospitalized children, 2. Child who presents with an acute illness on study day requiring hospitalization or inpatient short stay observation will be excluded. 3. Children with severe immune suppression 4. Children with an acute febrile illness with fever over 38 degrees Celsius will be excluded for vaccine on that study day. 5. Known previous immunization with HibCV or PCV. 6. Known contraindication to HibCV or PCV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Nasopharyngeal carriage rate of Hib and Pneumococcus for all vaccine recipients, adult household member and sibling living with vaccine recipient 2.Serotypes of pneumococcus isolated 3. Reported adverse events to vaccine recipientsTimepoint: All outcomes will be evaluated at 0, 2, 4, 6, 8, 10, 12 months after the 1st Visit (which is expected to be same as day of 1st dose of vaccines. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Immune response to the Hib Conjugate Vaccine based on ELISA 2. Antibiotic susceptibility of Hib and Pneumococcal isolates 3. Carriage rates of other co-colonizers in the nasopharynx specifically S. aureusTimepoint: All outcomes will be evaluated at 0, 2, 4, 6, 8, 10, 12 months after the 1st Visit (which is expected to be same as day of 1st dose of vaccines). | — |
Countries
India
Contacts
Public ContactDr Subhasish Bhattacharyya MD DCH DNB
School of Medical Science and Technology , Indian Institute of Technology â??Kharagpur
Outcome results
None listed