Trial Outcomes & Findings for Comparative Study of Bacille Calmette Guerin (BCG) Delivery Via Disposable Syringe Jet Injector and Needle & Syringe (NCT NCT01742364)

Last Updated: 2017-02-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

96 participants

Primary outcome timeframe

14 weeks

Results posted on

2017-02-08

Participant Flow

Infants: 131 consents obtained; 50 screening failures, no participation refusals, and 66 enrolled at birth. 15 infants were consented, screened, and eligible for participation but were not enrolled because the enrollment target had been reached. Adults: 95 consents obtained; 63 screening failures, 2 participation refusals, and 30 enrolled.

Participant milestones

Participant milestones
Measure	INFANTS: Bioject Intradermal (ID) Pen Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	INFANTS: Needle and Syringe Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe	ADULTS: Bioject Intradermal (ID) Pen Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	ADULTS: Needle and Syringe Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe
Overall Study STARTED	33	33	15	15
Overall Study COMPLETED	33	33	15	15
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INFANTS: Bioject Intradermal (ID) Pen n=33 Participants Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	INFANTS: Needle and Syringe n=33 Participants Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe	ADULTS: Bioject Intradermal (ID) Pen n=15 Participants Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	ADULTS: Needle and Syringe n=15 Participants Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe	Total n=96 Participants Total of all reporting groups
Age, Categorical <=18 years	33 Participants n=5 Participants	33 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	66 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	30 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Gender Female	18 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	10 Participants n=4 Participants	57 Participants n=21 Participants
Gender Male	15 Participants n=5 Participants	17 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	39 Participants n=21 Participants

PRIMARY outcome

Timeframe: 14 weeks

Outcome measures

Outcome measures
Measure	INFANTS: Bioject Intradermal (ID) Pen n=33 Participants Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	INFANTS: Needle and Syringe n=33 Participants Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe	ADULTS: Bioject Intradermal (ID) Pen n=15 Participants Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	ADULTS: Needle and Syringe n=15 Participants Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe
Injection Site Adverse Events (Following Injection)	138 Adverse events	141 Adverse events	126 Adverse events	146 Adverse events

PRIMARY outcome

Timeframe: 14 weeks

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.

Outcome measures

Outcome measures
Measure	INFANTS: Bioject Intradermal (ID) Pen n=33 Participants Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	INFANTS: Needle and Syringe n=33 Participants Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe	ADULTS: Bioject Intradermal (ID) Pen n=15 Participants Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	ADULTS: Needle and Syringe n=15 Participants Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe
Systemic Adverse Events	20 Adverse events	20 Adverse events	18 Adverse events	27 Adverse events

PRIMARY outcome

Timeframe: 10 weeks post-vaccination

Population: Due to failed phlebotomy on 5 infants, results were not available for 2 participants in the Bioject ID Pen arm and for 3 participants in the Needle and syringe arm. Immunogenicity was not measured for adults in the study.

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.

Outcome measures

Outcome measures
Measure	INFANTS: Bioject Intradermal (ID) Pen n=31 Participants Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	INFANTS: Needle and Syringe n=30 Participants Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe	ADULTS: Bioject Intradermal (ID) Pen Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	ADULTS: Needle and Syringe Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe
Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 (Cluster of Differentiation 4) T-cells	0.664 percentage responding to cytokines Interval 0.41 to 1.16	0.485 percentage responding to cytokines Interval 0.308 to 0.842	—	—

PRIMARY outcome

Timeframe: 14 weeks post-vaccination

Outcome measures

Outcome measures
Measure	INFANTS: Bioject Intradermal (ID) Pen n=31 Participants Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	INFANTS: Needle and Syringe n=30 Participants Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe	ADULTS: Bioject Intradermal (ID) Pen Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	ADULTS: Needle and Syringe Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe
Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 T-cells	0.386 percentage responding to cytokines Interval 0.242 to 0.637	0.325 percentage responding to cytokines Interval 0.227 to 0.427	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately post-vaccination

Outcome measures

Outcome measures
Measure	INFANTS: Bioject Intradermal (ID) Pen n=33 Participants Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	INFANTS: Needle and Syringe n=33 Participants Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe	ADULTS: Bioject Intradermal (ID) Pen n=15 Participants Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	ADULTS: Needle and Syringe n=15 Participants Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe
Diameter of Skin Bleb No wheal	0 participants	12 participants	0 participants	0 participants
Diameter of Skin Bleb Wheal > 0 mm	33 participants	21 participants	15 participants	15 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately post-vaccination

Population: For adults, the skin fluid deposition was estimated and categorized by the vaccinator (e.g., no wetness, damp skin, flow on skin, spray in air); for infants, volume was measured objectively and categorized by the filter paper technique (units in µl).

Outcome measures

Outcome measures
Measure	INFANTS: Bioject Intradermal (ID) Pen n=33 Participants Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	INFANTS: Needle and Syringe n=33 Participants Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe	ADULTS: Bioject Intradermal (ID) Pen n=15 Participants Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	ADULTS: Needle and Syringe n=15 Participants Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe
Fluid Leakage on Skin at Injection Site Damp skin	0 participants	0 participants	15 participants	8 participants
Fluid Leakage on Skin at Injection Site ≤ 2.5 µl	5 participants	28 participants	0 participants	0 participants
Fluid Leakage on Skin at Injection Site > 2.5 µl to ≤ 5 µl	12 participants	2 participants	0 participants	0 participants
Fluid Leakage on Skin at Injection Site > 5 µl to ≤ 10 µl	14 participants	1 participants	0 participants	0 participants
Fluid Leakage on Skin at Injection Site > 10 µl to ≤ 20 µl	2 participants	2 participants	0 participants	0 participants
Fluid Leakage on Skin at Injection Site > 20 µl	0 participants	0 participants	0 participants	0 participants
Fluid Leakage on Skin at Injection Site No wetness	0 participants	0 participants	0 participants	7 participants
Fluid Leakage on Skin at Injection Site Flow on skin	0 participants	0 participants	0 participants	0 participants
Fluid Leakage on Skin at Injection Site Spray in air	0 participants	0 participants	0 participants	0 participants

Adverse Events

INFANTS: Bioject Intradermal (ID) Pen

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

INFANTS: Needle and Syringe

Serious events: 4 serious events

Other events: 27 other events

Deaths: 0 deaths

ADULTS: Bioject Intradermal (ID) Pen

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

ADULTS: Needle and Syringe

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	INFANTS: Bioject Intradermal (ID) Pen n=33 participants at risk Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	INFANTS: Needle and Syringe n=33 participants at risk Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe	ADULTS: Bioject Intradermal (ID) Pen n=15 participants at risk Intradermal administration of BCG vaccine via the Bioject ID Pen. Bioject ID Pen	ADULTS: Needle and Syringe n=15 participants at risk Intradermal administration of BCG vaccine via needle and syringe. Needle and syringe
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/33 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.	6.1% 2/33 • Number of events 2 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.	0.00% 0/15 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.	0.00% 0/15 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.
Respiratory, thoracic and mediastinal disorders Viral pneumonia	3.0% 1/33 • Number of events 1 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.	0.00% 0/33 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.	0.00% 0/15 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.	0.00% 0/15 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.
Endocrine disorders Neonatal jaundice	0.00% 0/33 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.	3.0% 1/33 • Number of events 1 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.	0.00% 0/15 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.	0.00% 0/15 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.
Endocrine disorders Urinary tract infection	0.00% 0/33 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.	3.0% 1/33 • Number of events 1 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.	0.00% 0/15 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.	0.00% 0/15 • 14 weeks for infants, 12 weeks for adults Infants attended study visits 4, 10, and 14 weeks after vaccination, and parents were contacted by telephone 1, 7, and 14 days after vaccination. Adults were seen 1, 2, 4, and 12 weeks after vaccination.

Other adverse events

Additional Information

Courtney Jarrahian

PATH

Phone: 206-285-3500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60