Biological Samples Obtained by Leukapheresis Induced by Two BCG Vaccinations in BCG-naïve Healthy Adults in the US

NCT03175380 | Completed Early Phase 1 FDA Drug

• 1 other identifier: A-051
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol will use leukapheresis to collect lymphocytes to study immune responses following vaccination with BCG in BCG-naïve participants. These studies will include, but not necessarily be limited to: anti-T-cell and anti-Natural Killer (NK) T-cell responses, anti-lipid responses, and antibody responses to BCG following re-vaccination. These responses will provide a detailed framework characterizing the immune responses that are induced and responses that are not induced in humans by BCG, a partially protective TB vaccine. This framework will allow new hypotheses to be formulated and tested regarding what new and more effective TB vaccines should target for optimal protective immunity.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Biological samples

  Obtain biological samples through leukapheresis and cryopreservation of cells for the future study, by in vitro assay, of immune responses after two doses of BCG in BCG-naïve healthy adults.

  8 months

Study Arms (1)

bacillus Calmette-Guérin

EXPERIMENTAL

All participants will receive a total of two doses of bacillus Calmette-Guérin (BCG), by intradermal injection, approximately 6 months apart. They will be observed for 284 days

Biological: bacillus Calmette-Guérin

Interventions

bacillus Calmette-Guérin BIOLOGICAL

BCG injection for prevention of tuberculosis

Also known as: BCG

bacillus Calmette-Guérin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Has completed the written informed consent process.
• Is age ≥18 years and ≤55 years on Study Day 0.
• Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study.
• Agrees to avoid elective surgery during the study.
• Willingness to receive HIV test results.
• For female participants: agrees to avoid pregnancy from 21 days prior to Study Day 0 and for the full duration of the study. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide.
• Has general good health, confirmed by medical history and physical examination.
• Has not received vaccination or immunotherapy with a BCG product at any time prior to Study Day 0.
• Body weight of \> 110 pounds
• Absence of previous risk factors for HIV infection including:
• History of IV drug abuse
• History of unprotected intercourse with known HIV infected individual
• Men having sex with men

You may not qualify if:

• Participants must have none of the following at the time of study entry:
• Acute illness on Study Day 0.
• HIV-1/2 positive
• Oral temperature ≥37.5°C on Study Day 0.
• Abnormal laboratory values per local laboratory parameters from most recent blood collection prior to Study Day 0 as follows:
• hemoglobin, hematocrit, absolute neutrophil count, or absolute lymphocyte count below lower limit of normal (LLN)
• white blood cell count above upper limit of normal (ULN) or below LLN (i.e., must be within normal limits)
• ALT, AST, GGT, total bilirubin, alkaline phosphatase (ALP), blood urea nitrogen (BUN), creatinine \>1.25 times institutional upper limit of normal
• Calcium not within institutional normal limits
• Fibrinogen level \<100 mg/dL.
• Evidence of significant active infection.
• Evidence of central nervous system tuberculosis or pleural tuberculosis.
• Positive QuantiFERON TB Gold in-Tube (or equivalent).
• History of treatment for active or latent tuberculosis infection.
• History or evidence of active tuberculosis.

Sponsors & Collaborators

• Aeras: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Daniel Hoft, PhD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants (N=17) will receive BCG on Study Day 0 and Study Day 180 by intradermal administration.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: June 5, 2017
• Study Start: August 8, 2017
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)