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

• Sponsor: Emergent BioSolutions (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01158157
• Collaborator: Centers for Disease Control and Prevention (U.S. Fed)
• Enrollment: 25
• Location: 1
• Arm: 1
• Actual Duration (Months): 17.1
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).

Condition or Disease	Intervention/Treatment	Phase
Smallpox Vaccine Adverse Reaction	Biological: ACAM2000	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Vaccinia Vaccine (ACAM2000) for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)
• Actual Study Start Date: Sep 13, 2010
• Actual Primary Completion Date: Feb 14, 2012
• Actual Study Completion Date: Feb 14, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Vaccination This study was a single arm study. All eligible subjects received ACAM2000.	Biological: ACAM2000; Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.

Outcome Measures

Primary Outcome Measures

1. Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration [Days 0 to 90 post-vaccination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Signed written informed consent.

• Age 18 - 65 years.

• Normal and healthy as determined by medical history, physical exam, vital signs and clinical laboratory tests at screening visit.

• Subject must meet all required subject suitability criteria that pertain to normal Source Plasma donors.

• Subject must have been previously immunized for smallpox, at ≥1 year prior to commencement of screening assessments for the VA-006 trial, and vaccination history must be confirmed by oral or written history AND the presence of a visible pathognomonic smallpox vaccination scar.

• Female subjects of childbearing potential must use at least one of the following means of birth control documented by a physician's letter:

• Surgical sterilization

• Hormonal (oral/injectable/implant) for at least 30 days prior to vaccination

• Intrauterine device (IUD) inserted at least 7 days prior to vaccination.

• Female subjects who are not using one of the methods of birth control listed above must be documented as postmenopausal, which is defined as not having a menstrual period for longer than 12 months and having a serum follicle-stimulating hormone (FSH) level ≥ 40 mIU/mL.

Exclusion Criteria:

• History of severe adverse event(s) from previous participation in the VA-001 or VA-005 trials or any other smallpox vaccination program/study.

• Subject, household contact, or other close/intimate contact:

• with eczema, history of eczema, exfoliative skin conditions, wounds, burns, or other skin conditions at the Investigator's discretion.

• with a history of immunodeficiencies (see section 7.1.2 of the protocol).

• who received radiotherapy or chemotherapy, adrenocorticotropic hormone (ACTH), corticosteroids, or immunosuppressive drugs.

• with eye disease treated with topical steroids.

• with known or suspected disorders of immunoglobulin synthesis.

• with leukemia, lymphomas of any type, melanoma, or other malignant neoplasms affecting the bone marrow or lymphatic systems.

• with a history of adverse reactions to smallpox (vaccinia) vaccine.

• has recently been diagnosed with cancer and who will be undergoing chemotherapy or radiation therapy during the vaccination healing time.

• is a transplant recipient (except for corneal transplant).

• is pregnant, planning pregnancy or breast feeding (female subjects must have negative serum pregnancy test at screening and negative urine pregnancy test prior to vaccination).

• Household or other close/intimate contact(s) under the age of 12 months.

• History of allergies to latex, phenol, any of the antibiotics listed in the vaccine content, or any other component of ACAM2000 or its diluent

• Severely or morbidly obese or higher obesity classification (BMI ≥ 35).

• Subjects with abnormal EKG and/or cardiac Troponin levels at screening.

• Subjects with cancer or kidney disease (except kidney stones).

• Subject has 3 or more of the following risk factors:

• High blood pressure diagnosed by a doctor

• High blood cholesterol diagnosed by a doctor

• Diabetes or high blood sugar diagnosed by a doctor

• A first degree relative (for example, mother, father, brother, sister) who had a heart condition before the age of 50

• Currently smokes cigarettes

• Cardiovascular disease or heart condition diagnosed by a doctor at any time in the past, with or without symptoms, including:

• Arrhythmia

• Syncope

• Previous myocardial infarction

• Angina

• Coronary artery disease

• Congestive heart failure

• Cardiomyopathy

• Stroke or transient ischemic attack

• Chest pain or shortness of breath with activity (such as walking up stairs)

• Other heart conditions being treated by a physician.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cangene Plasma Resources, Mid-Florida	Altamonte Springs	Florida	United States	32701

Sponsors and Collaborators

• Emergent BioSolutions
• Centers for Disease Control and Prevention

Investigators

• Principal Investigator: Ronald Brown, MD, Cangene Plasma Resources, Mid-Florida

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• World Health Organization. Declaration of global eradication of smallpox. Wkly. Epidemiol. Rec., 55:145-152, 1980.
• Centers for Disease Control and Prevention (CDC). Public Health Service recommendations on smallpox vaccination. MMWR, 20:339, 1971.
• CDC. Recommendation of the Immunization Practices Advisory Committee (ACIP). Smallpox vaccination of hospital and health personnel. MMWR, 25:9, 1976.
• CDC. Smallpox vaccine no longer available for civilians-United States. MMWR, 32:387, 1983.
• CDC. Vaccinia (smallpox) vaccine recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR, 40:1-10, 1991.

Publications

• Russell PK. Vaccines in civilian defense against bioterrorism. Emerg Infect Dis. 1999 Jul-Aug;5(4):531-3.

• Responsible Party: Emergent BioSolutions
• ClinicalTrials.gov Identifier: NCT01158157
• Other Study ID Numbers: VA-006
• First Posted: Jul 8, 2010
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vaccinia; Smallpox

Study Results

Participant Flow

Arm/Group Title	Vaccination
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
COMPLETED	25
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Vaccination
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 Participants	25
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	25 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	4 16%
Male	21 84%
Region of Enrollment (participants) [Number]
United States	25 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47 (9.1)

Outcome Measures

1. Primary Outcome

Title	Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration
Time Frame	Days 0 to 90 post-vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACAM200 Vaccination Dose
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.
Measure Participants	25
Vaccination complications	52 208%
Headache	8 32%
injection site scab	4 16%

Adverse Events

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
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 (%)	# Events
Total	0/25 (0%)
Serious Adverse Events
	ACAM200 Vaccination Dose
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Other (Not Including Serious) Adverse Events
	ACAM200 Vaccination Dose
	Affected / at Risk (%)	# Events
Total	15/25 (60%)
General disorders
Injection site scab	1/25 (4%)	1
Injury, poisoning and procedural complications
Vaccination complication	13/25 (52%)	14
Nervous system disorders
Headache	2/25 (8%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.