Comparative Study of Bacille Calmette Guerin (BCG) Delivery Via Disposable Syringe Jet Injector and Needle & Syringe

NCT01742364 | Completed Results DMC

• 1 other identifier: HS 645
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to test the hypothesis that BCG administration via jet injector will produce a comparable immune response and that there will be no significant differences in safety or reactogenicity between BCG administration via jet injector and needle and syringe. The primary objectives of this study are to...

1. 1.Compare the safety and reactogenicity of BCG administered intradermally by a jet injector device in adults and infants, to BCG administered intradermally by needle and syringe;
2. 2.Compare the specific T cell immunity in neonates vaccinated with BCG via the jet injector device to infants vaccinated with BCG via needle and syringe.

Conditions

Tuberculosis

Keywords

disposable syringe jet injector (DSJI); DSJI; BCG; tuberculosis; intradermal delivery; South Africa

Outcome Measures

Primary Outcomes (4)

• Injection Site Adverse Events (Following Injection)

  Injection site adverse events including redness, swelling, induration, tenderness, ulceration, fluctuation , drainage, laceration, bruising, and scarring will be monitored for up to fourteen weeks following vaccination.

  14 weeks

• Systemic Adverse Events

  Systemic adverse events, solicited and unsolicited, including symptoms of lethargy, disrupted feeding patterns, fever, lymphadenopathy, rash, or any other physical abnormalities will be monitored for up to fourteen weeks following vaccination.

  14 weeks

• Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 (Cluster of Differentiation 4) T-cells

  BCG-specific immunogenicity was tested in infants only, since they are the target study population and BCG immunogenicity in adults is known to be different from that in infants. Utilizing a whole-blood intracellular cytokine staining (ICS) assay, we analyzed cytokine co-expression patterns by BCG-specific CD4 and CD8 T-cells. Briefly, 0.5 ml heparinized whole blood was incubated for 12 hours with BCG, no antigen or phytohemagglutinin (PHA) in the presence of anti-CD28 and anti-CD49d, with the last 5 hours including Brefeldin A prior to treating with BD FACS™ Lysing Solution and cryopreservation. Cells were batch-thawed, permeabilized with BD Perm/Wash™ buffer, and stained with fluorescent antibodies. At least 120,000 CD3+CD4+ T-cells were acquired for the no-antigen and BCG samples on a BD™ LSR II flow cytometer.

  10 weeks post-vaccination

• Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 T-cells

  BCG-specific immunogenicity was tested in infants only, since they are the target study population and BCG immunogenicity in adults is known to be different from that in infants. Utilizing a whole-blood intracellular cytokine staining (ICS) assay, we analyzed cytokine co-expression patterns by BCG-specific CD4 and CD8 T-cells. Briefly, 0.5 ml heparinized whole blood was incubated for 12 hours with BCG, no antigen or phytohemagglutinin (PHA) in the presence of anti-CD28 and anti-CD49d, with the last 5 hours including Brefeldin A prior to treating with BD FACS™ Lysing Solution and cryopreservation. Cells were batch-thawed, permeabilized with BD Perm/Wash™ buffer, and stained with fluorescent antibodies. At least 120,000 CD3+CD4+ T-cells were acquired for the no-antigen and BCG samples on a BD™ LSR II flow cytometer.

  14 weeks post-vaccination

Other Outcomes (2)

• Diameter of Skin Bleb

  Immediately post-vaccination

• Fluid Leakage on Skin at Injection Site

  Immediately post-vaccination

Study Arms (2)

Bioject Intradermal (ID) Pen

EXPERIMENTAL

Intradermal administration of BCG vaccine via the Bioject ID Pen.

Device: Bioject ID Pen

Needle and syringe

ACTIVE COMPARATOR

Intradermal administration of BCG vaccine via needle and syringe.

Device: Needle and syringe

Interventions

Bioject ID Pen DEVICE

Participants in this arm will receive a standard dose of BCG via the Bioject ID needle-free jet injector device (investigational administration technique).

Also known as: Disposable Syringe Jet Injector, DSJI, Jet Injector, ID Pen

Bioject Intradermal (ID) Pen

Needle and syringe DEVICE

Participants in this arm will receive a standard dose of BCG via syringe and needle by the Mantoux technique (standard of care administration technique).

Needle and syringe

Eligibility Criteria

• Age: Up to 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female, age 18 to 50 years.
• Written informed consent, including permission for access to medical records and an HIV test.
• Available for study follow up and display a willingness and capacity to comply to study procedures.
• In good general health, as assessed by medical history and a focused physical examination.
• HIV test (rapid test, ELISA \[enzyme-linked immunosorbent assay\], or PCR \[polymerase chain reaction\]) negative.
• Quantiferon®-TB Gold (Cellestis) test for latent TB infection negative within 2 weeks of enrolment.
• BCG vaccination at birth as confirmed by history or the presence of a BCG scar.
• In the case of female participants, a negative urine or serum pregnancy test at enrolment, and not pregnant or lactating. Evidence of contraception is not required since BCG is not contra-indicated in pregnancy.

You may not qualify if:

• A history or evidence of a significant or chronic medical condition or disease.
• Skin condition, bruising or birth mark at the intended injection site.
• History of previous active tuberculosis (TB) disease or current active TB disease.
• History of a household contact with active TB disease who has received less than 2 months treatment.
• Neonate Stage
• Male or female neonates within 48 hours of birth.
• Written informed consent, including permission to access medical records and results of antenatal HIV tests.
• Infant participants and their caregivers available for study follow-up and display the willingness and capacity to comply with study procedures.
• Neonates must be in good general health as assessed by medical history during pregnancy and delivery, and focused physical examination.
• Birth weight more than or equal to 2500 grams.
• Apgar score at 5 minutes more than or equal to 7.
• A maternal HIV test result (rapid test, ELISA or PCR) taken during pregnancy must be available, documented and negative.
• Participant must not have received BCG vaccination prior to enrolment.
• Significant antenatal or intrapartum complications that may affect the health of the neonate.
• Skin condition, bruising or birth mark at the intended injection site.

Sponsors & Collaborators

• PATH: lead
• World Health Organization: collaborator
• University of Cape Town: collaborator

Study Sites (1)

SATVI, University of Cape Town

Cape Town, 7925, South Africa

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Needles; Syringes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Courtney Jarrahian
• Organization: PATH

cjarrahian@path.org

206-285-3500

Study Officials

• Hennie Geldenhuys

  South African Tuberculosis Vaccine Initiative

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 5, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 8, 2017
• Results First Posted: February 8, 2017

Record last verified: 2013-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)