Diarrhoea Clinical Trial
Official title:
A Randomised Controlled Trial in HIV-1 Exposed Ugandan Infants to Estimate Additional Benefits (Non-specific Effects) of BCG
BCG vaccination may have non-specific effects (NSE) i.e., additional benefits on childhood morbidity and mortality that are separate the vaccine's effect on the incidence of disseminated tuberculosis. Though the available literature is mostly from observational study designs, and is fraught with controversy, BCG vaccination at birth, in a high risk population of HIV exposed children, may protect infants against serious infections other than TB. Yet, other studies indicate that giving BCG later in infancy, when the immune system is more mature, may offer even greater protection. The appropriate timing of BCG vaccination could therefore be up for revision. This study will therefore compare BCG vaccination at birth with BCG vaccination at 14 weeks of age in HIV exposed (HE) babies. Methods: This is an individually randomized clinical trial in 4,500 HIV exposed infants. The intervention is an intra-dermal administration of 0.05 ml of BCG vaccine within 24 hours of birth while the comparator will be an intra-dermal administration of 0.05ml of BCG vaccine at 14 weeks of age. The main study outcomes include: 1. Severe illness in the first 14 weeks of life, 2. Innate and adaptive immune responses to mycobacterial, non-mycobacterial antigens and TLR-agonists 3. Severe illness in the first 14-52 weeks and 0-52 weeks of life. The study will be carried in two health centers and one district hospital in Uganda. Implications: A well-timed BCG vaccination could have important additional benefits in HE infants. This trial could inform the development of programmatically appropriate timing of BCG vaccination for HE infants.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01214785 -
Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India
|
N/A | |
Recruiting |
NCT05073003 -
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
|
Phase 1/Phase 2 | |
Completed |
NCT01969214 -
Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea
|
N/A | |
Completed |
NCT01202383 -
Double-blinded Trial of Household-based Chlorination in India
|
Phase 3 | |
Completed |
NCT01087892 -
Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
|
N/A | |
Completed |
NCT00979056 -
Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
|
Phase 3 | |
Completed |
NCT02072629 -
HCU: Can VHVs Trained in ICCM Improve Care for Children
|
N/A | |
Completed |
NCT00408356 -
Immunological and Clinical Responses to Zinc in Children With Diarrhoea
|
Phase 3 | |
Completed |
NCT01517230 -
Can Mass Media Campaigns Reduce Child Mortality
|
N/A | |
Completed |
NCT02858609 -
Improving the Diagnosis of Diarrhoea in Emergency Rooms
|
N/A | |
Completed |
NCT01306383 -
Solar Disinfection (SODIS) of Drinking Water for Use in Developing Countries or in Emergency Situations
|
N/A | |
Completed |
NCT00352716 -
Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children
|
Phase 3 | |
Completed |
NCT00352989 -
Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children
|
Phase 3 | |
Completed |
NCT00324285 -
Oral Rehydration SolutionContaining Amylase Resistant Starch in Severely Malnourished Children.
|
Phase 3 | |
Recruiting |
NCT02144168 -
The Effect of Enteral Nutrition Supplemented With Prebiotics on Colonic Microbiota in the Critically Ill Patients
|
N/A | |
Completed |
NCT02797353 -
Strengthening Maternal Neonatal and Child Health Services in a Rural District of Pakistan
|
N/A | |
Withdrawn |
NCT01491659 -
A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
|
Phase 4 | |
Completed |
NCT01557673 -
Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow
|
Phase 1/Phase 2 | |
Completed |
NCT00823056 -
The Effect of Probiotics on Infections in Toddlers
|
Phase 3 | |
Completed |
NCT01154803 -
Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection
|
N/A |