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

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
University of Cape Town
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01742364
First received: November 30, 2012
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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. 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. 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.

Condition Intervention
Tuberculosis
Device: Bioject ID Pen
Device: Needle and syringe

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial in Adults and Newborns to Compare the Safety, Reactogenicity and Immunogenicity of BCG Administration Via a Disposable Syringe Jet Injector (DSJI) to BCG Administration Via Syringe and Needle

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • Injection site adverse events (day of injection) [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    Following BCG vaccination, each participant will be observed for at least 30 minutes for any signs or symptoms of local or systemic intolerance.

  • Injection site adverse events (following injection) [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Systemic adverse events [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Short term whole blood intracellular cytokine staining assay for BCG-specific CD4 (cluster of differentiation 4) and CD8 (cluster of differentiation 8) T-cells [ Time Frame: 10 weeks post-vaccination ] [ Designated as safety issue: No ]
  • Short term whole blood intracellular cytokine staining assay for BCG-specific CD4 and CD8 T-cells [ Time Frame: 14 weeks post-vaccination ] [ Designated as safety issue: No ]
  • Long term 6 day whole blood proliferation assay for BCG-specific CD4 and CD8 T-cells [ Time Frame: 10 weeks post-vaccination ] [ Designated as safety issue: No ]
  • Long term 6 day whole blood proliferation assay for BCG-specific CD4 and CD8 T-cells [ Time Frame: 14 weeks post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ex vivo Ki67 assay and absolute cell counts to detect BCG-specific immune response [ Time Frame: 10 weeks post vaccination ] [ Designated as safety issue: No ]
  • Ex vivo Ki67 assay and absolute cell counts to detect BCG-specific immune response [ Time Frame: 14 weeks post vaccination ] [ Designated as safety issue: No ]
  • Ribonucleic acid (RNA) isolation and preservation from whole blood [ Time Frame: 10 weeks post vaccination ] [ Designated as safety issue: No ]
  • RNA isolation and preservation from whole blood [ Time Frame: 14 weeks post vaccination ] [ Designated as safety issue: No ]
  • PBMC (peripheral blood mononuclear cell) isolation and cryopreservation for later analysis [ Time Frame: 10 weeks post vaccination ] [ Designated as safety issue: No ]
  • PBMC isolation and cryopreservation for later analysis [ Time Frame: 14 weeks post vaccination ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Diameter of skin bleb [ Time Frame: immediately post-vaccination ] [ Designated as safety issue: No ]
  • Fluid leakage on skin at injection site [ Time Frame: immediately post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bioject Intradermal (ID) Pen
Intradermal administration of BCG vaccine via the Bioject ID Pen.
Device: Bioject ID Pen
Other Names:
  • Disposable Syringe Jet Injector
  • DSJI
  • Jet Injector
  • ID Pen
Active Comparator: Needle and syringe
Intradermal administration of BCG vaccine via needle and syringe.
Device: Needle and syringe

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Adult stage

  • Inclusion criteria:

    1. Male or female, age 18 to 50 years.
    2. Written informed consent, including permission for access to medical records and an HIV test.
    3. Available for study follow up and display a willingness and capacity to comply to study procedures.
    4. In good general health, as assessed by medical history and a focused physical examination.
    5. HIV test (rapid test, ELISA [enzyme-linked immunosorbent assay], or PCR [polymerase chain reaction]) negative.
    6. Quantiferon®-TB Gold (Cellestis) test for latent TB infection negative within 2 weeks of enrolment.
    7. BCG vaccination at birth as confirmed by history or the presence of a BCG scar.
    8. 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.
  • Exclusion criteria:

    1. A history or evidence of a significant or chronic medical condition or disease.
    2. Skin condition, bruising or birth mark at the intended injection site.
    3. History of previous active tuberculosis (TB) disease or current active TB disease.
    4. History of a household contact with active TB disease who has received less than 2 months treatment.

Neonate Stage

  • Inclusion criteria:

    1. Male or female neonates within 48 hours of birth.
    2. Written informed consent, including permission to access medical records and results of antenatal HIV tests.
    3. Infant participants and their caregivers available for study follow-up and display the willingness and capacity to comply with study procedures.
    4. Neonates must be in good general health as assessed by medical history during pregnancy and delivery, and focused physical examination.
    5. Birth weight more than or equal to 2500 grams.
    6. Apgar score at 5 minutes more than or equal to 7.
    7. A maternal HIV test result (rapid test, ELISA or PCR) taken during pregnancy must be available, documented and negative.
  • Exclusion criteria:

    1. Participant must not have received BCG vaccination prior to enrolment.
    2. Significant antenatal or intrapartum complications that may affect the health of the neonate.
    3. Skin condition, bruising or birth mark at the intended injection site.
    4. Maternal HIV test (rapid test, ELISA or PCR) not performed antenatally, HIV test results not available, or HIV test result known positive.
    5. Maternal history of current active TB, or other household contact with known active TB disease who has received less than 2 months of treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742364

Locations
South Africa
SATVI, University of Cape Town
Cape Town, South Africa, 7925
Sponsors and Collaborators
PATH
World Health Organization
University of Cape Town
Investigators
Principal Investigator: Hennie Geldenhuys South African Tuberculosis Vaccine Initiative
  More Information

No publications provided

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01742364     History of Changes
Other Study ID Numbers: HS 645
Study First Received: November 30, 2012
Last Updated: December 30, 2013
Health Authority: South Africa: Medicines Control Council

Keywords provided by PATH:
disposable syringe jet injector (DSJI)
DSJI
BCG
tuberculosis
intradermal delivery
South Africa

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 24, 2014