Tuberculosis Clinical Trial
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
Verified date | December 2013 |
Source | PATH |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Africa: Medicines Control Council |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 96 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 50 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
South Africa | SATVI, University of Cape Town | Cape Town |
Lead Sponsor | Collaborator |
---|---|
PATH | University of Cape Town, World Health Organization |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Diameter of skin bleb | immediately post-vaccination | No | |
Other | Fluid leakage on skin at injection site | immediately post-vaccination | No | |
Primary | Injection site adverse events (day of injection) | Following BCG vaccination, each participant will be observed for at least 30 minutes for any signs or symptoms of local or systemic intolerance. | 30 minutes | Yes |
Primary | 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 | Yes |
Primary | 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 | Yes |
Primary | Short term whole blood intracellular cytokine staining assay for BCG-specific CD4 (cluster of differentiation 4) and CD8 (cluster of differentiation 8) T-cells | 10 weeks post-vaccination | No | |
Primary | Short term whole blood intracellular cytokine staining assay for BCG-specific CD4 and CD8 T-cells | 14 weeks post-vaccination | No | |
Primary | Long term 6 day whole blood proliferation assay for BCG-specific CD4 and CD8 T-cells | 10 weeks post-vaccination | No | |
Primary | Long term 6 day whole blood proliferation assay for BCG-specific CD4 and CD8 T-cells | 14 weeks post-vaccination | No | |
Secondary | Ex vivo Ki67 assay and absolute cell counts to detect BCG-specific immune response | 10 weeks post vaccination | No | |
Secondary | Ex vivo Ki67 assay and absolute cell counts to detect BCG-specific immune response | 14 weeks post vaccination | No | |
Secondary | Ribonucleic acid (RNA) isolation and preservation from whole blood | 10 weeks post vaccination | No | |
Secondary | RNA isolation and preservation from whole blood | 14 weeks post vaccination | No | |
Secondary | PBMC (peripheral blood mononuclear cell) isolation and cryopreservation for later analysis | 10 weeks post vaccination | No | |
Secondary | PBMC isolation and cryopreservation for later analysis | 14 weeks post vaccination | No |
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