Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

Smallpox Clinical Trial

Official title:

The Effect of Dose on Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00053482
• Other study ID #: H-400-003
• Status: Completed
• Phase: Phase 2
• Start date: January 2003
• Est. completion date: October 2003

Study information

• Verified date: March 2024
• Source: Emergent BioSolutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.

Description:

Specifically, the objectives of this study are to:

1. Compare the safety and tolerability of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age and previously vaccinated to smallpox. 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 four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age by comparing:

1. the proportion of subjects at each dose level who develop a major cutaneous reaction

2. 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 ACAM2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age, with a history of smallpox vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: October 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Years and older

Eligibility

Inclusion criteria:

• have a history of previous smallpox vaccination greater than 10 years previous to the date of screening and presence of a vaccination scar.

• females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children.

• agree to be available for the entire study and agree to comply with all requirements.

exclusion criteria:

• children 1 year of age or younger in the household or be in close contact

• smallpox vaccination within ten years

• known or suspected Human immunodeficient virus (HIV) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above.

• renal disease

• current or past history of eczema or a household member or direct contact who has eczema.

• known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin B

• known allergy or past allergic reaction to blood products.

• known allergy to cidofovir or sulfa-containing drugs.

• history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or Stevens-Johnson syndrome.

• transfusion of blood or treatment with any blood product.

• current or history of drug or alcohol abuse

• innoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.

Related Conditions & MeSH terms

• Smallpox

Intervention

Biological:
• ACAM2000 Smallpox Vaccine
Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml
• Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®
Group 5 dose: 1.0x10-8th PFU/ml

Locations

Country	Name	City	State
United States	PRA International	Lenexa	Kansas
United States	Memorial Hospital of Rhode Island Division of Infectious Diseases	Pawtucket	Rhode Island
United States	Bio-Kinetic Clinical Applications	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Emergent BioSolutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine		Days 0 to 30 post-vaccination
Other	Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine		Days 0 (Baseline) and 15 post-vaccination
Other	Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine		Days 0 (Baseline) and 15 post-vaccination
Other	Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine		Days 0 (Baseline) and 15 post-vaccination
Other	Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine		Days 0 (Baseline) and 15 post-vaccination
Primary	The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine	The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)	Day 30 post-vaccination
Primary	Participants With = 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.		Day 30 post-vaccination
Primary	Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine		Days 0 to 30 post-vaccination