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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742364
• Other study ID #: HS 645
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: December 30, 2013
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Device:
• Bioject ID Pen

• Needle and syringe

Locations

Country	Name	City	State
South Africa	SATVI, University of Cape Town	Cape Town

Sponsors (3)

Lead Sponsor	Collaborator
PATH	University of Cape Town, World Health Organization

Country where clinical trial is conducted

South Africa, 

Outcome

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