Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03084614
Other study ID # 170068
Secondary ID 17-I-0068
Status Terminated
Phase
First received
Last updated
Start date March 28, 2017
Est. completion date November 8, 2019

Study information

Verified date November 2019
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background:

When a person is exposed to something that causes an infection, the body sends a type of cell called CD8 T cells to attack it. Those cells are also found in breast milk. Nursing mothers pass these cells to their child, which helps the child fight infections, too. Researchers want to learn more about how CD8 cells work to keep people healthy.

Objective:

To learn more about how the human body fights off infections.

Eligibility:

People age 18 years and older who either have an infection, are suspected to have an infection, or recently got a vaccine.

The household contacts of these people and people who have not been recently exposed to any infection are also needed.

Design:

Participants will be screened with a medical and health history and physical exam. They may have blood tests.

The first study visit can be the same day as screening. It can be up to 3 months later. For those visits, screening tests will be repeated.

At the first visit, participants will have blood collected from an arm vein.

Participants who are breastfeeding may provide a small sample of breast milk. They may collect it at home or bring a pumping device to NIH to collect it. NIH can also provide a breast pump.

Participants may be contacted for up to 1 year after the first visit to give samples of blood and/or breast milk.

Up to 4 additional visits, which will each take about 1 hour, may be scheduled.

A personal physician or local lab can collect blood from participants and ship it to NIH. Breast milk cannot be shipped.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Chahroudi A, Cartwright E, Lee ST, Mavigner M, Carnathan DG, Lawson B, Carnathan PM, Hashempoor T, Murphy MK, Meeker T, Ehnert S, Souder C, Else JG, Cohen J, Collman RG, Vanderford TH, Permar SR, Derdeyn CA, Villinger F, Silvestri G. Target cell availability, rather than breast milk factors, dictates mother-to-infant transmission of SIV in sooty mangabeys and rhesus macaques. PLoS Pathog. 2014 Mar 6;10(3):e1003958. doi: 10.1371/journal.ppat.1003958. eCollection 2014 Mar. — View Citation

Myles IA, Zhao M, Nardone G, Olano LR, Reckhow JD, Saleem D, Break TJ, Lionakis MS, Myers TG, Gardina PJ, Kirkpatrick CH, Holland SM, Datta SK. CD8+ T cells produce a dialyzable antigen-specific activator of dendritic cells. J Leukoc Biol. 2017 Jan;101(1):307-320. doi: 10.1189/jlb.3A0216-082R. Epub 2016 Aug 11. — View Citation

Viza D, Fudenberg HH, Palareti A, Ablashi D, De Vinci C, Pizza G. Transfer factor: an overlooked potential for the prevention and treatment of infectious diseases. Folia Biol (Praha). 2013;59(2):53-67. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the in vitro and mouse model immune stimulatoryproperties of lysates derived from microbe-specific CDB+ T cellenriched sources. There are no definitive time points in this sample collection study
Secondary To compare how the in vitro and mouse model immune stimulatoryproperties of breast milk vary with the microbe specific CDB+ T cellconcentration. There are no definitive time points in this sample collection study
See also
  Status Clinical Trial Phase
Recruiting NCT05738681 - Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial Phase 2/Phase 3
Recruiting NCT05526885 - Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa N/A
Completed NCT04369326 - Community Initiated Preventive Therapy for TB N/A
Recruiting NCT04568967 - TB-CAPT EXULTANT - HIV N/A
Completed NCT02337270 - Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol Phase 1
Not yet recruiting NCT06253715 - Shortened Regimen for Drug-susceptible TB in Children Phase 3
Recruiting NCT04271397 - Immunological Biomarkers in Tuberculosis Management N/A
Withdrawn NCT03639038 - Tuberculosis Diagnosis by Flow Cytometry
Completed NCT03199313 - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid Phase 1
Recruiting NCT04975178 - Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa Phase 3
Completed NCT04463680 - Rifampin and the Contraceptive Implant Phase 4
Completed NCT03973970 - Assessing the Ability of the T-SPOT®.TB Test (IQ)
Recruiting NCT04230395 - Alcohol Reduction Among People With TB and HIV in India N/A
Completed NCT04874948 - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment Phase 1
Active, not recruiting NCT02906007 - Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV Phase 1/Phase 2
Not yet recruiting NCT05917210 - Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda N/A
Not yet recruiting NCT06017843 - Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding N/A
Not yet recruiting NCT05845112 - Start Taking Action For TB Diagnosis
Active, not recruiting NCT02715271 - Study of TB Lesions Obtained in Therapeutical Surgery
Completed NCT02781909 - Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis Phase 2