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Trial record 3 of 8 for:    acam2000 | Smallpox | Phase 3

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01158157
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : March 26, 2019
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Emergent BioSolutions

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Smallpox Vaccine Adverse Reaction
Intervention Biological: ACAM2000
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vaccination
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 25 [1]
Completed 25
Not Completed 0
[1]
61 subjects screened; 25 subjects were vaccinated; 36 subjects were not eligible.
Arm/Group Title Vaccination
Hide Arm/Group Description

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 Number of Baseline Participants 25
Hide Baseline Analysis Population Description
A total of 61 subjects were screened for VA-006 study; 25 subjects satisfied the eligibility criteria and were percutaneously administered ACAM2000 vaccine, while 36 subjects were not eligible for the study and were not administered ACAM2000.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
4
  16.0%
Male
21
  84.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
Age  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
47  (9.1)
1.Primary Outcome
Title Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration
Hide Description [Not Specified]
Time Frame Days 0 to 90 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Post-vaccination adverse events were assessed in the safety population.
Arm/Group Title ACAM200 Vaccination Dose
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Participants received a single percutaneous administration of a droplet (2.5 μL) of the ACAM2000 smallpox vaccine using a bifurcated needle on Day 0.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: percentage of participants
Vaccination complications 52
Headache 8
injection site scab 4
Time Frame 1 year, 6 months
Adverse Event Reporting Description 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.
 
Arm/Group Title ACAM200 Vaccination Dose
Hide Arm/Group Description Participants received a single percutaneous administration of a droplet (2.5 μL) of the ACAM2000 smallpox vaccine using a bifurcated needle on Day 0.
All-Cause Mortality
ACAM200 Vaccination Dose
Affected / at Risk (%)
Total   0/25 (0.00%)    
Hide Serious Adverse Events
ACAM200 Vaccination Dose
Affected / at Risk (%) # Events
Total   0/25 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ACAM200 Vaccination Dose
Affected / at Risk (%) # Events
Total   15/25 (60.00%)    
General disorders   
Injection site scab   1/25 (4.00%)  1
Injury, poisoning and procedural complications   
Vaccination complication   13/25 (52.00%)  14
Nervous system disorders   
Headache   2/25 (8.00%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christine Hall, Ph.D. Director Clinical
Organization: Cangene Corporation
Phone: 204-275-4248
EMail: chall@ebsi.com
Layout table for additonal information
Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT01158157    
Other Study ID Numbers: VA-006
First Submitted: July 5, 2010
First Posted: July 8, 2010
Results First Submitted: June 7, 2017
Results First Posted: March 26, 2019
Last Update Posted: March 18, 2020