NCT00053482

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
357

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

3 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
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
7.4 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

3 months

First QC Date

January 30, 2003

Results QC Date

January 3, 2011

Last Update Submit

March 14, 2024

Conditions

Smallpox

Keywords

Smallpox vaccinesDryvax®OrthopoxvirusVaccinia virusACAM2000

Outcome Measures

Primary Outcomes (3)

  • 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

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

    Day 30 post-vaccination

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

    Days 0 to 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

  • 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

  • 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

  • +2 more other outcomes

Study Arms (5)

Group 1: ACAM2000

EXPERIMENTAL

Participants will receive dose 1 of the ACAM2000 smallpox vaccine

Biological: ACAM2000 Smallpox Vaccine

Group 2: ACAM2000

EXPERIMENTAL

Participants will receive dose 2 of the ACAM2000 smallpox vaccine

Biological: ACAM2000 Smallpox Vaccine

Group 3: ACAM2000

EXPERIMENTAL

Participants will receive dose 3 of the ACAM2000 smallpox vaccine

Biological: ACAM2000 Smallpox Vaccine

Group 4: ACAM2000

EXPERIMENTAL

Participants will receive dose 4 of the ACAM2000 smallpox vaccine

Biological: ACAM2000 Smallpox Vaccine

Group 5: Dryvax®

ACTIVE COMPARATOR

Participants will receive dose 1 of Dryvax® smallpox vaccine.

Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®

Interventions

ACAM2000 Smallpox VaccineBIOLOGICAL

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

Group 1: ACAM2000Group 2: ACAM2000Group 3: ACAM2000Group 4: ACAM2000
Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®BIOLOGICAL

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

Also known as: Dryvax®
Group 5: Dryvax®

Eligibility Criteria

Age28 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

PRA International

Lenexa, Kansas, 66219, United States

Location

Bio-Kinetic Clinical Applications

Springfield, Missouri, 65802, United States

Location

Memorial Hospital of Rhode Island Division of Infectious Diseases

Pawtucket, Rhode Island, 02860, United States

Location

MeSH Terms

Conditions

SmallpoxVaccinia

Interventions

ACAM2000DryVax vaccineSmallpox 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

April 1, 2003

Study Completion

October 1, 2003

Last Updated

March 18, 2024

Results First Posted

February 11, 2011

Record last verified: 2024-03

Locations

US(3)