NCT00053495

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
353

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

February 11, 2011

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

January 30, 2003

Results QC Date

January 3, 2011

Last Update Submit

March 14, 2024

Conditions

Smallpox

Keywords

Smallpox

Outcome Measures

Primary Outcomes (3)

  • Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine

    The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity.

    Days 0 to 30 post-vaccination

  • Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.

    Day 30 post-vaccination

  • Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.

    Day 30 post-vaccination

Other Outcomes (5)

  • Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.

    Days 0 to 30 post-vaccination

  • Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine

    Days 0 (baseline) and 15 post-vaccination

  • 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

  • +2 more other outcomes

Study Arms (5)

Group 1: ACAM2000 Dose 1

EXPERIMENTAL

Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units (PFU)/mL on Day 0.

Biological: Vaccinia virus: ACAM2000 smallpox vaccine

Group 2: ACAM2000 Dose 2

EXPERIMENTAL

Participants will receive a single dose of ACAM2000 smallpox vaccine, 2.0x10-8th plaque-forming units/mL on Day 0.

Biological: Vaccinia virus: ACAM2000 smallpox vaccine

Group 3: ACAM2000 Dose 3

EXPERIMENTAL

Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0

Biological: Vaccinia virus: ACAM2000 smallpox vaccine

Group 4: ACAM2000 Dose 4

EXPERIMENTAL

Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0

Biological: Vaccinia virus: ACAM2000 smallpox vaccine

Group 5: Dryvax® Vaccine

ACTIVE COMPARATOR

Participants will receive a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0

Biological: vaccinia virus (calf lymph): Dryvax

Interventions

Vaccinia virus: ACAM2000 smallpox vaccineBIOLOGICAL

Group 1 dose: 1.0x10-8th PFU/ml Group 2 dose: 2.0x10-8th PFU/ml Group 3 dose: 1.0x10-7th PFU/ml Group 4 dose: 5.0x10-6th PFU/ml

Group 1: ACAM2000 Dose 1Group 2: ACAM2000 Dose 2Group 3: ACAM2000 Dose 3Group 4: ACAM2000 Dose 4
vaccinia virus (calf lymph): DryvaxBIOLOGICAL

Group 5 dose: 1.0x10-8th PFU/ml

Also known as: Dryvax®
Group 5: Dryvax® Vaccine

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • military service prior to 1989.
  • history of previous smallpox vaccination.
  • children 1 year of age or younger in the household or be in close contact
  • smallpox vaccination within ten years
  • known or suspected human immunodeficiency 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
  • inoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Orlando Clinical Research Center

Orlando, Florida, 32806, United States

Location

PRA International

Lenexa, Kansas, 66219, United States

Location

Bio-Kinetic Clinical Applications

Springfield, Missouri, 65802, United States

Location

Memorial Hospital of Rhode IslandDivision of Infectious Diseases

Pawtucket, Rhode Island, 02860, United States

Location

MeSH Terms

Conditions

Smallpox

Interventions

Smallpox Vaccine

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Eddie Darton, Medical Director
Organization
Emergent BioSolutions
dartone@ebsi.com
240-631-3688

Study Officials

  • Medical Director

    Emergent BioSolutions

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2003

First Posted

January 31, 2003

Study Start

January 1, 2003

Primary Completion

June 1, 2003

Study Completion

November 1, 2003

Last Updated

March 18, 2024

Results First Posted

February 11, 2011

Record last verified: 2024-03

Locations

US(4)