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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00053508
Other study ID # H-300-002
Secondary ID
Status Terminated
Phase Phase 2
First received January 30, 2003
Last updated January 17, 2014
Start date September 2002
Est. completion date September 2003

Study information

Verified date January 2014
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.


Description:

In addition to assessment of safety parameters, the objective of this study is to determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine. Specifically, the objectives of this study are to:

1. Compare the safety and tolerability of three dose levels of ACAM1000 and a standard dose of Dryvax® in healthy adults 18-29 years of age and naïve to smallpox vaccine. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis.

2. Determine the immunogenicity of three dose levels of ACAM1000 and a standard dose of Dryvax® in healthy adults 18-29 years of age by comparing: (a)the proportion of subjects at each dose level who develop a major cutaneous reaction; (b)the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between Baseline and Day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on Day 30.

3. Determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine.


Recruitment information / eligibility

Status Terminated
Enrollment 274
Est. completion date September 2003
Est. primary completion date March 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 29 Years
Eligibility Inclusion criteria:

- in good general health.

- not pregnant and using effective birth control

- agreed to participate in entire study and comply with protocol requirements.

Exclusion criteria:

- military service prior to 1989.

- no previous smallpox vaccination.

- no contact with with children 1 year of age or younger

- immunodeficiency individuals or close contacts who are immunodeficient

- past history or current renal disease

- diagnosis or past history of eczema

- known allergy or past allergic reactions to latex gloves or to some antibiotics (neomycin, streptomycin, chlortetracycline, and polymyxin B).

- known allergy or past allergic to blood products.

- known allergy or past allergic reaction to cidofovir or sulfa-containing drugs.

- transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit.

- serology positive for HIV, hepatitis B or hepatitis C.

- current diagnosis or history within six months of drug or alcohol abuse disorders, psychiatric illness.

- inoculation with any other live vaccine within 30 days of Day 0 or participation in another drug or vaccine trial within 30 days of Day 0.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
ACAM1000
Group 1 dose: 1.4 x 10-8th PFU/ml (350,000 PFU) Group 2 dose: 2.8 x 10-7th PFU/ml (70,000 PFU) Group 3 dose: 5.6 x 10-6th PFU/ml (14,000 PFU)
vaccinia virus (calf lymph) smallpox vaccine: Dryvax
group 4 dose: 1.6 x 10-8th PFU/ml (250,000 PFU)

Locations

Country Name City State
United States Radiant Research Cincinnati Ohio
United States Orlando Clinical Research Center Orlando Florida
United States Mayo Vaccine Research Group Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of subjects in each treatment group who develop a major cutaneous reaction on Day 7, Day 10, and/or Day 15. Day 7, Day 10, and/or Day 15 No
Secondary 1.The comparison of treatment groups for the proportion of subjects developing a >fourfold rise in neutralizing antibodies. 2. neutralizing antibody response. 3. geometric mean neutralizing titer on day 31 will be compared between treatment groups. days 0 and 30, day 31 No
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