Innate Immune Response Clinical Trial
— PPIROfficial title:
Predictors of Poor Immune Response to Rotavirus Vaccine in Infants
This will be a randomized study with the primary objective of assessing the impact of
withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.
Enrolled subjects will all be administered Rotarix®, at ages 6 to 7 weeks, and at10 -14
weeks. The subjects will be randomized into one of the two study arms. In one of the group
caregivers will be advised to breastfeed immediately prior to and after each dose of the
vaccine while in the other group caregivers will be advised to withhold breastfeeding for 30
minutes before and after each dose of the vaccine. The other childhood vaccines i.e. OPV and
Pentavalent will be administered at least 30 minutes after administration of Rotarix®, The
enrolled subjects will be followed up for 4 weeks after the 2nd dose of Rotarix®.
Status | Completed |
Enrollment | 400 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Weeks to 7 Weeks |
Eligibility |
Inclusion Criteria: 1. At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures 2. Subjects aged 6 to 7 weeks at recruitment 3. No plans to move in the next 4 months 4. Weight for age not = -3 SD of WHO child growth standards Exclusion Criteria: 1. Infant not breastfed 2. Administration of rotavirus vaccine in the past 3. Known immunodeficiency disease, including HIV infection in the subject or the mother 4. Known chronic enteric disease 5. Diarrhea on the day of enrollment (temporary exclusion) 6. Any illness requiring hospitalization (temporary exclusion) 7. Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems 'ill', investigators suspects neglect) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
India | Centre for Health Research and Development Society for Applied Studies | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Society for Applied Studies | Christian Medical College, Vellore, India, Norwegian Institute of Public Health |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Concentration of anti-VP6 antibodies in subjects and maternal serum at baseline and in subjects 4 weeks after the second dose of Rotarix®. Geometric mean titers of anti-VP6 IgG antibodies in maternal serum at baseline | upto 14-18 weeks of age | No | |
Primary | Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®. | 14-18 weeks of age | No | |
Secondary | Concentration of anti-VP6 antibodies in saliva of subjects before the first and second dose of Rotarix®. Proportion of subjects with enteric pathogens detected in stools. Vitamin D status of subjects enrolled in the study. | 14-18 weeks of age | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01766414 -
In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II
|
Phase 3 | |
Completed |
NCT02259608 -
γ-irradiated BCG to Train Innate Immunity
|
N/A | |
Completed |
NCT02444611 -
A Trial Investigating the Influence of BCG and Hepatitis B Immunisation at Birth on Neonatal Immune Responses: The Early Life Vaccines and Immunity Study
|
N/A | |
Completed |
NCT01352871 -
The Effects of Concentration/Meditation on the Innate Immune Response During Human Endotoxemia
|
Phase 1 | |
Terminated |
NCT03489577 -
The Role of Post-traumatic Inhibition of the Innate and Adaptive Immune System in the Development of Infectious Complications in Severely Injured Patients
|
||
Completed |
NCT02642237 -
The Effects of Preceding LPS Administration on the Fluenz-induced Immune Response
|
N/A |