- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01288950
Vitamin D Supplementation Enhances Immune Response to Bacille-Calmette-Guerin (BCG) Vaccination in Infants (BCG-25-D)
Vitamin D Supplementation Enhances Immune Response to BCG Vaccination in Infants
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
In 2000, there were an estimated 884,000 cases of tuberculosis (TB) in children with many developing severe, disseminated disease. Widespread immunization with Bacille-Calmette-Guerin (BCG) vaccine has not been effective in preventing primary TB infection or in halting the progression from latent to active disease. Poor vaccine efficacy has prompted investigators to develop novel TB vaccines and to experiment with enhancing the immune response to the current BCG vaccine.
Increasing data indicate that children with low vitamin D levels and specific genetic variants that lower functional levels of vitamin D are at increased risk for severe tuberculosis. Elegant studies investigating Mycobacterium tuberculosis (Mtb) infection have shown that mycobacteria are able to reside in endosomes within macrophages by preventing endosome-lysosome fusion; a critical step in autophagy, a cellular process used to recycle cytoplasmic organelles and proteins, and to degrade microbial organisms including Mtb. In-vitro studies have shown that vitamin D increases autophagy and triggers the production of antimicrobial peptides including cathelicidin. This leads to increased intracellular killing of Mtb and increased Mtb antigen presentation to the immune system. Anti-tuberculous vaccines that over-express Mtb antigens generate a stronger immune response than wild type BCG vaccine.
The investigators hypothesis is that a single oral dose of vitamin D3 (cholecalciferol) given to infants prior to BCG administration will enhance the immune response to vaccination through improved MHC class I and class II presentation of the vaccine.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Baja California
-
Tijuana, Baja California, Mexiko
- Tijuana General Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Healthy mothers > 18 years of age
- Term, healthy infants eligible to receive the Bacille-Calmette- Guerin (BCG) vaccine
Exclusion Criteria:
- Recent maternal history of tuberculosis (within 1 year) or active tuberculosis
- Known maternal human immuno-deficiency virus (HIV) infection
- Maternal fever or chorio-amnionitis
- Maternal use of vitamin D, steroids or immuno-regulatory medications
- Household member with active tuberculosis
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Placebo
|
|
Experimentell: Vitamin D3
|
A single oral dose of 50,000 IU of vitamin D3 (cholecalciferol) will be given prior to Bacille-Calmette-Guerin (BCG) vaccination
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Bacille-Calmette-Guerin (BCG) vaccine efficacy
Tidsram: 2 months
|
BCG vaccine efficacy will be assessed by measuring the host immune response against BCG at 2 months, 6 months and one year after BCG immunization.
A whole blood assay will be used to measure multiple cytokines and mycobacterial growth suppression.
|
2 months
|
Bacille-Calmette-Guerin (BCG) vaccine efficacy
Tidsram: 6 months
|
6 months
|
|
Bacille-Calmette-Guerin (BCG) vaccine efficacy
Tidsram: 1 year
|
1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Effect of a single dose of 50,000 IU vitamin D3 on serum vitamin D levels
Tidsram: 2 months
|
Serum 25 hydroxy (OH) vitamin D levels will be measured prior to vitamin D supplementation and at 2 months, 6 months and one year after BCG immunization.
The investigators will also determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect baseline vitamin D levels and alter the response to vitamin D supplementation.
|
2 months
|
Bacille-Calmette-Guerin (BCG) vaccine efficacy
Tidsram: 1 year
|
The investigators will determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect the response to BCG vaccine in infants receiving either vitamin D or placebo.
|
1 year
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Stephen Spector, MD, University of California, San Diego
- Huvudutredare: Amaran Moodley, M.D, University of California, San Diego
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Infektioner
- Bakteriella infektioner
- Bakteriella infektioner och mykoser
- Gram-positiva bakteriella infektioner
- Actinomycetales infektioner
- Mycobacterium infektioner
- Tuberkulos
- Läkemedels fysiologiska effekter
- Mikronäringsämnen
- Bendensitetsbevarande medel
- Kalciumreglerande hormoner och medel
- Vitamin D
- Kolekalciferol
- Vitaminer
- Ergocalciferoler
Andra studie-ID-nummer
- NR-0138
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