Vaccinia Vaccination (ACAM2000®) of Plasma Donors for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)
Phase: PHASE4
Conditions: Smallpox Vaccine Adverse Reaction
Sponsor: Emergent BioSolutions

Protocol Number VA-008 
Version 2.6 2020-Jun-05 
 
Emergent BioSolutions  
Confidential and Proprietary 
Page 1 of 66 
 
 
 
Clinical Study Protocol 
Vaccinia Vaccination (ACAM2000®) of Plasma Donors for the Production of 
Vaccinia Immune Globulin Intravenous (VIGIV) 
VA-008 
Version 2.6 2020-Jun-05 
 
 
 
 
 
 
  
 
 
CONFIDENTIAL 
This document is a confidential communication of the Sponsor. Acceptance of this document 
constitutes an agreement by the recipient that no unpublished information contained within will be 
published or disclosed without prior written approval, except that this document may be disclosed to 
the appropriate Ethics Committee and Regulatory Authority under the condition that they keep it 
confidential. 
 
Number: CLIN040102  Version: 1.0                    Effective Date: 08 Jun 2020
Reference Copy
This copy of the document was retrieved from the system by 

Protocol Number VA-008 
Version 2.6 2020-Jun-05 
 
 
Emergent BioSolutions 
Confidential and Proprietary 
Page 61 of 66 
 
• 
Study subjects’ condition upon completion, or withdrawal from, the study. 
• 
All communications with the IRB responsible for the study. 
• 
Drug accountability records. 
• 
Any other records as required by the Sponsor/designate, the IRB or the regulatory authority(ies). 
The Principal Investigator must arrange for the retention of the subject identification codes for at least 
two years following the submission of the clinical study report to the FDA (as per 21CFR312.57). 
Subject files and other source data must be securely stored and kept for the maximum time permitted 
by the hospital, institution or private practice but not less than 25 years after completion or 
termination of the study. Archival data may be held on microfiche or electronic record, provided that 
a backup exists and that hard copy can be obtained from it if required. If source documents are to be 
destroyed as per hospital or local regulatory policy, the investigator is requested to contact the 
sponsor. 
Records from the study that identify the subject will be confidential except that they may be given to 
and inspected by the sponsor of the study (or designate(s)), the IRB, the FDA, other government 
agencies as appropriate, and will not otherwise be released except as required by law. All information 
provided to the investigator by the sponsor is to be considered confidential unless otherwise stated. 
10.5 
Data Forms 
Detailed specifications for data management will be written in a Data Management Plan (DMP) that 
will be finalized before data collection is initiated. The DMP is a living document that will be updated 
throughout the life of the study, as needed, to ensure the accuracy and quality of the database. 
Security processes will be in place to ensure the safety of all systems and data. Every effort will be 
made to ensure that data are kept secure so that they can only be accessed by authorized staff. 
Study sites will record data collected in this clinical study into electronic Case Report Forms (eCRF) 
within the study Electronic Data Capture (EDC) system. The investigator is responsible for the 
accuracy of the data entered into the eCRFs and will be required to electronically sign the forms to 
indicate agreement with the recorded data. 
10.6 
Monitoring 
At the time the study is initiated, monitors from the sponsor/Contract Research Organization (CRO) 
will thoroughly review the protocol and eCRFs with the investigators and their staff, and assure their 
knowledge of the principles of GCP. During the study, the monitors will be available to discuss by 
telephone, e-mail, or in person (during site visits), questions regarding adverse reactions, removal of 
subjects from the study, conduct of the study and other clinical study matters, including delegation of 
study activities to suitably trained site personnel. Monitors from the sponsor/CRO will visit at the 
initiation of the study, during the study and at the completion of the study. At the time of each 
monitoring visit, and during remote monitoring of the data, the monitors will check the eCRFs of the 
Number: CLIN040102  Version: 1.0                    Effective Date: 08 Jun 2020
Reference Copy
This copy of the document was retrieved from the system by 

Protocol Number VA-008 
Version 2.6 2020-Jun-05 
 
 
Emergent BioSolutions 
Confidential and Proprietary 
Page 62 of 66 
 
subjects to ensure that all items have been completed, that the data are accurate and obtained in the 
manner specified in the protocol and that data recorded in the eCRFs for the study agree with medical 
records at the site. The monitors will also check for general protocol and regulatory compliance by 
subjects and site personnel to ensure adherence to the Common Rule and ICH GCP. 
Site monitoring visits will be performed remotely  instead  of in-person monitoring visits until travel 
restrictions due to COVID-19 are eased as agreed upon with the CRO. 
Safety will be monitored using a risk-based monitoring approach. Data will be monitored as part of a 
medical monitoring plan. A Data and Safety Monitoring Board (DSMB) will be established to ensure 
the safety of subjects participating in this study according to the DSMB charter.  
10.7 
Quality Control and Quality Assurance 
Emergent Quality Assurance department (or authorized representatives) may conduct onsite audits of 
all aspects of the clinical study prior to, during the study, or after the study has been completed. The 
clinical study may also be inspected by regulatory authorities or the IRB to verify that the study is 
being or has been conducted in accordance with protocol requirements, GCP, as well as the applicable 
regulatory requirements. 
10.8 
Publication Policy 
Data arising from this study are the sole property of the sponsor of the study, Emergent. The sponsor 
must provide written, prior agreement to any publication based, in whole or in part, on data from this 
study. All proposed abstracts, manuscripts or presentations from the study must be provided to 
Emergent for review at least 60 days prior to submission for publication/presentation. Any 
information identified by Emergent as confidential must be deleted prior to submission. 
The Publication Policy applicable to this protocol is the one agreed upon and described in the Clinical 
Study Agreement between Emergent and the Principal Investigator. 
11 REFERENCES 
1. 
CDC. Vaccinia (smallpox) vaccine recommendations of the Immunization Practices Advisory 
Committee (ACIP). MMWR, 40:1-10, 1991. 
2. 
World Health Organization. Declaration of global eradication of smallpox. Wkly. Epidemiol. 
Rec., 55:145-152, 1980. 
3. 
CDC. Public Health Service recommendations on smallpox vaccination. MMWR, 20:339, 1971. 
4. 
CDC. Recommendation of the Immunization Practices Advisory Committee (ACIP). Smallpox 
vaccination of hospital and health personnel. MMWR, 25:9, 1976. 
5. 
CDC. Smallpox vaccine no longer available for civilians—United States. MMWR, 32:387, 1983. 
Number: CLIN040102  Version: 1.0                    Effective Date: 08 Jun 2020
Reference Copy
This copy of the document was retrieved from the system by 

Protocol Number VA-008 
Version 2.6 2020-Jun-05 
 
 
Emergent BioSolutions 
Confidential and Proprietary 
Page 63 of 66 
 
6. 
Russell, PK, Vaccines in civilian defense against bioterrorism. Emerg. Infect. Diseases, 5(4): 531-
533, 1999. 
7. 
CDC. Smallpox Vaccination and Adverse Events Training Module. Available at: 
http://emergency.cdc.gov/training/smallpoxvaccine/reactions/default.htm. 
8. 
CDC. Surveillance Guidelines for Smallpox Vaccine (vaccinia) Adverse Reactions. Available at: 
https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5501a1.htm.  
Number: CLIN040102  Version: 1.0                    Effective Date: 08 Jun 2020
Reference Copy
This copy of the document was retrieved from the system by 

Protocol Number VA-008 
Version 2.6 2020-Jun-05 
 
 
Emergent BioSolutions 
Confidential and Proprietary 
Page 64 of 66 
 
APPENDIX I 
CARE OF VACCINATION SITE 
Following vaccination, a small bump will develop at the site of vaccination. This bump may become 
a pus-filled blister, which subsequently dries to form a scab. Blister formation may not occur in 
subjects being revaccinated. Following primary vaccination, the vaccination site scab separates 14-21 
days after vaccination, leaving a typical scar. Following revaccination however, the progression of the 
lesion at the site of vaccination may be shorter. 
The main objectives in caring for a smallpox vaccination site are to avoid spread of the virus from the 
vaccination site to another area of the vaccinee’s body (such as the eye) to avoid spread to another 
person, and to keep the area clean and dry. Each study subject who is revaccinated should be 
instructed to take the following steps to avoid spread of the virus: 
• 
It is extremely important that thorough hand washing with soap and water or >60% alcohol-based 
hand-rub solution be performed after any direct contact with the vaccination site, or with 
materials that have come in contact with the vaccination site (bandages, etc.), to prevent self-
inoculation of the virus to other areas of the body. Thorough hand washing with soap and water 
or >60% alcohol-based hand-rub solution is the most important measure to prevent transmission 
of vaccinia virus to another person or to another part of the body, after any direct contact with the 
vaccination site or the bandages that have come in contact with the vaccination site. 
• 
A supply of porous bandages, waterproof bandages, and labelled zip-locking bags will be 
provided. 
• 
The vaccination site must be completely covered with a porous bandage at all times until the scab 
has separated on its own and the underlying skin has healed. The porous bandage must be 
changed frequently (i.e., every 1-2 days) to prevent maceration (softening) of the vaccination site 
secondary to fluid build-up. An occlusive (air-tight) cover should NOT be used except for 
bathing. 
• 
The vaccinee must wear a shirt with sleeves that cover the vaccination site as an extra precaution 
to prevent spread of the vaccinia virus. This is particularly important in situations of close 
physical contact. 
• 
The vaccination site must be kept dry. Before bathing or showering, the vaccination site and scab 
must be covered with a waterproof bandage. The waterproof bandage can be applied over the 
porous bandage. The vaccination site must not be scrubbed. After bathing, the waterproof 
bandage must be removed. 
• 
Salves or ointments must not be applied to the vaccination site. 
• 
Do not touch, squeeze, prick, or pick at the vaccination site or the scab. Allow the site to blister, 
allow the blister to turn into a scab, and allow the scab to fall off naturally. 
• 
Do not touch the vaccination site, scab or soiled bandage and subsequently touch other parts of 
the body, particularly the eyes, anal and genital areas, that are susceptible to accidental (auto-) 
inoculation. 
Number: CLIN040102  Version: 1.0                    Effective Date: 08 Jun 2020
Reference Copy
This copy of the document was retrieved from the system by 

Protocol Number VA-008 
Version 2.6 2020-Jun-05 
 
 
Emergent BioSolutions 
Confidential and Proprietary 
Page 65 of 66 
 
• 
Do not throw any used dressings, or bandages away into your toilet or trash. Collect all used 
bandages, dressings and the vaccination site scab (once it has separated and fallen off naturally) 
and place them in the sealed plastic waste bags provided by the study site. Wash hands 
afterwards. Return these bags to the donor center at each visit for proper disposal. 
• 
To prevent transmission to other persons, physical contact of objects that have come into contact 
with the vaccination site or scab (e.g., soiled bandages, clothing, and fingers) must be avoided. 
• 
Wash separately clothing, towels, bedding or other items that may have come in direct contact 
with the vaccination site, scab, or drainage from the site, using hot water with detergent and/or 
bleach. Wash hands afterwards. 
• 
Avoid touching the side of the bandage that touched your vaccination site. 
• 
Wash hands well after changing the dressing or touching the vaccination site, using soap and 
water or >60% alcohol-based hand-rub solution. 
• 
Avoid contact with anyone at risk of complications of smallpox vaccination until the vaccination 
site scab has fallen off naturally. 
Number: CLIN040102  Version: 1.0                    Effective Date: 08 Jun 2020
Reference Copy
This copy of the document was retrieved from the system by 

Protocol Number VA-008 
Version 2.6 2020-Jun-05 
 
 
Emergent BioSolutions 
Confidential and Proprietary 
Page 66 of 66 
 
APPENDIX II 
ALGORITHM FOR PERICARDITIS AND MYOCARDITIS 
EVALUATION POST-ACAM2000 VACCINATION  
If unable to visit the site in person, subjects with potential clinical symptoms are referred to the ER. 
 
Number: CLIN040102  Version: 1.0                    Effective Date: 08 Jun 2020
Reference Copy
This copy of the document was retrieved from the system by