Clinical trial NCT00053508: Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Official title: The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM1000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination A Phase 2, Randomized, Double-Blind, Dose-Response Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Smallpox
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2003-01-31
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of subjects in each treatment group who develop a major cutaneous reaction on Day 7, Day 10, and/or Day 15.
timeFrame: Day 7, Day 10, and/or Day 15
Secondary outcomes:
measure: 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.
timeFrame: days 0 and 30, day 31
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Rochester
country: United States
facility: Mayo Vaccine Research Group
state: Minnesota
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Director
role: STUDY_DIRECTOR
References: