Trial Outcomes & Findings for VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV (NCT NCT01158157)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

25 participants

Primary outcome timeframe

Days 0 to 90 post-vaccination

Results posted on

2024-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	Vaccination This study was a single arm study. All eligible subjects received ACAM2000. ACAM2000: Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaccination n=25 Participants This study was a single arm study. All eligible subjects received ACAM2000. ACAM2000: Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants
Age	47 years STANDARD_DEVIATION 9.1 • n=5 Participants

PRIMARY outcome

Timeframe: Days 0 to 90 post-vaccination

Population: Post-vaccination adverse events were assessed in the safety population.

Outcome measures

Outcome measures
Measure	ACAM200 Vaccination Dose n=25 Participants Participants received a single percutaneous administration of a droplet (2.5 μL) of the ACAM2000 smallpox vaccine using a bifurcated needle on Day 0.
Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration Vaccination complications	52 percentage of participants
Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration Headache	8 percentage of participants
Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration injection site scab	4 percentage of participants

Adverse Events

ACAM200 Vaccination Dose

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ACAM200 Vaccination Dose n=25 participants at risk Participants received a single percutaneous administration of a droplet (2.5 μL) of the ACAM2000 smallpox vaccine using a bifurcated needle on Day 0.
General disorders Injection site scab	4.0% 1/25 • Number of events 1 • 1 year, 6 months AE: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Injury, poisoning and procedural complications Vaccination complication	52.0% 13/25 • Number of events 14 • 1 year, 6 months AE: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Nervous system disorders Headache	8.0% 2/25 • Number of events 2 • 1 year, 6 months AE: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Additional Information

Christine Hall, Ph.D. Director Clinical

Cangene Corporation

Phone: 204-275-4248

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place