N/A
N=96
Comparative Study of Bacille Calmette Guerin (BCG) Delivery Via Disposable Syringe Jet Injector and Needle & Syringe
Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT01742364 ↗Enrolled (actual)
96
Serious AEs
5.2%
Results posted
Feb 2017
Primary outcome: Primary: Injection Site Adverse Events (Following Injection) — 138; 141; 126; 146 Adverse events — p=0.475
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bioject ID Pen (Device); Needle and syringe (Device)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Injection Site Adverse Events (Following Injection) |
138; 141; 126; 146 | 0.475 |
| PRIMARY Systemic Adverse Events |
20; 20; 18; 27 | — |
| PRIMARY Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 (Cluster of Differentiation 4) T-cells |
0.664; 0.485 | 0.205 |
| PRIMARY Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 T-cells |
0.386; 0.325 | 0.325 |
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. 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.
Eligibility Criteria
Adult stage
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
- Maternal HIV test (rapid test, ELISA or PCR) not performed antenatally, HIV test results not available, or HIV test result known positive.
- Maternal history of current active TB, or other household contact with known active TB disease who has received less than 2 months of treatment.
Data sourced from ClinicalTrials.gov (NCT01742364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.