An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 Vaccinees

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00686582
• Date of registration: 27/05/2008
• Primary sponsor: Bavarian Nordic
• Public title: An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 Vaccinees
• Scientific title: An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 Vaccinees
• Date of first enrolment: August 2008
• Target sample size: 304
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00686582
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

Groups 1 and 2 (first consenting 75 subjects in each group to be vaccinated)

- Male and female subjects having participated in Group 1 or 2 of the study POX-MVA-005
who completed the trial according to protocol.

- Women of childbearing potential must have a negative serum pregnancy test at
screening and a negative urine or serum pregnancy test within 24 hours prior to
vaccination.

- Women of childbearing potential must have used an acceptable method of contraception
for 30 days prior to the vaccination, must agree to use an acceptable method of
contraception during the study, and must not become pregnant for at least 28 days
after the vaccination. A woman is considered of childbearing potential unless
post-menopausal or surgically sterilized. (Acceptable contraception methods are
restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices
or licensed hormonal products.)

- Read, signed and dated informed consent document after being advised of the risks and
benefits of the study in a language understood by the subject signed, and prior to
performance of any study specific procedure.

- Troponin I within normal institutional limits.

- White blood cells = 2,500/mm3 and <= 11,000/mm3.

- Absolute neutrophil count within normal limits.

- Negative urine glucose by dipstick or urinalysis.

- Hemoglobin within the laboratory reference ranges (unless the investigator considers
the deviation to be not clinically significant).

- Platelets 100 - 440/nL.

- Adequate renal function defined as:

1. Serum creatinine without clinically significant findings.

2. Urine protein <= 30 mg/dL or none or trace proteinuria (by urinalysis or dip
stick).

- Adequate hepatic function defined as:

1. Total bilirubin <= 1.5 x upper limit of normal (ULN) in the absence of other
evidence of significant liver disease (healthy subjects without clinical
disease; Morbus Meulengracht can be included).

2. AST (SGOT), ALT (SGPT), alkaline phosphatase without clinically significant
findings.

- Electrocardiogram (ECG) without clinically relevant abnormal findings (e.g. any kind
of atrioventricular or intraventricular conditions or blocks such as complete left or
right bundle branch block, AV node block, QTc or PR prolongation, premature atrial
contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two
premature ventricular contractions (PVC) in a row, ST elevation consistent with
ischemia).

Group 4 (all subjects) and Groups 1 and 2 (subjects N > 75): blood draw only

- Male and female subjects having participated in the study POX-MVA-005 who completed
the trial according to protocol.

- Read, signed and dated informed consent document after being advised of the risks and
benefits of the blood draw in a language understood by the subject signed, and prior
to performance of the blood draw.

Exclusion Criteria:

Groups 1 and 2 (first consenting 75 subjects in each group to be vaccinated)

- Participation in another study with a smallpox vaccine after the POX-MVA-005 study.

- Pregnant or breast-feeding women.

- Uncontrolled serious infection i.e. not responding to antimicrobial therapy.

- History of any serious medical condition, which in the opinion of the investigator
would compromise the safety of the subject.

- History of or active autoimmune disease. Persons with vitiligo or thyroid disease
taking thyroid replacement are not excluded.

- Known or suspected impairment of immunologic function including, but not limited to,
clinically significant liver disease; diabetes mellitus; moderate to severe kidney
impairment.

- History of malignancy, other than squamous cell or basal cell skin cancer, unless
there has been surgical excision that is considered to have achieved cure. Subjects
with history of skin cancer must not be vaccinated at the previous site of cancer.

- History or clinical manifestation of clinically significant and severe hematological,
renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal
disorders.

- Clinically significant mental disorder not adequately controlled by medical
treatment.

- Any condition which might interfere with study objectives or would limit the
subject's ability to complete the study or to be compliant in the opinion of the
investigator.

- History of coronary heart disease, myocardial infarction, angina, congestive heart
failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood
pressure, or any other heart condition under the care of a doctor.

- History of an immediate family member (father, mother, brother, or sister) who died
due to ischemic heart disease before age 50 years.

- Twenty percent or greater risk of developing a myocardial infarction or coronary
death within the next 10 years using the National Cholesterol Education Program's
risk assessment tool.
(http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof).

- History of intravenous drug abuse.

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine, e.g. tris (hydroxymethyl)-amino methane, chicken embryo fibroblast
proteins, aminoglycosides (gentamycin).

- History of any anaphylactic shock or severe allergic reaction requiring immediate
treatment.

- Having received any vaccinations or planned vaccinations with a live vaccine within
30 days prior or after study vaccination.

- Having received any vaccinations or planned vaccinations with a killed vaccine within
14 days prior or after study vaccination.

- Chronic administration (defined as more than 14 days) of > 5 mg prednisone (or
equivalent) per day or any other immune-modifying drugs during a period starting from
three months prior to administration of the vaccine and ending at study conclusion
(Visit 4).

- Post organ transplant subjects whether or not receiving chronic immunosuppressive
therapy.

- Administration or planned administration of immunoglobulins and/or any blood products
during a period starting from 3 months prior to administration of the vaccine and
ending at study conclusion.

- Use of any investigational or non-registered drug or vaccine other than the study
vaccine within 30 days preceding administration of the study vaccine, or planned
administration of such a drug during the study period.




Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Smallpox

Intervention(s)

Biological: IMVAMUNE

Procedure: Blood Draw Only

Primary Outcome(s)

Percentage of subjects with appearance (initially seronegative subjects) or increase (compared to baseline by pre-existing titers) of antibody titers in a vaccinia-specific IgG ELISA derived from individual peak responses. [Time Frame: 7 months]

Secondary ID(s)

DMID 08-0018

EudraCT-No.2007-006297-28

POX-MVA-023

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Allergy and Infectious Disease (NIAID)