Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

This study has been completed.

Study NCT00053482 Information provided by Sanofi-Aventis

First Received on January 30, 2003. Last Updated on February 10, 2011 History of Changes

Results First Received: January 3, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Smallpox
Interventions:	Biological: ACAM2000 Smallpox Vaccine Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 07 January 2003 to 31 March 2003 in 3 medical centers in the US.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 357 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Reporting Groups

	Description
ACAM2000 Dose 1	Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
ACAM2000 Dose 2	Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
ACAM2000 Dose 3	Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
ACAM2000 Dose 4	Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
Dryvax® Vaccine	Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0

Participant Flow: Overall Study

	ACAM2000 Dose 1	ACAM2000 Dose 2	ACAM2000 Dose 3	ACAM2000 Dose 4	Dryvax® Vaccine
STARTED	51	102	102	50	52
COMPLETED	51	102	102	50	52
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
ACAM2000 Dose 1	Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
ACAM2000 Dose 2	Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
ACAM2000 Dose 3	Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
ACAM2000 Dose 4	Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
Dryvax® Vaccine	Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0

Baseline Measures

	ACAM2000 Dose 1	ACAM2000 Dose 2	ACAM2000 Dose 3	ACAM2000 Dose 4	Dryvax® Vaccine	Total
Number of Participants [units: participants]	51	102	102	50	52	357
Age [units: participants]
<=18 years	0	0	0	0	0	0
Between 18 and 65 years	51	102	102	50	52	357
>=65 years	0	0	0	0	0	0
Age [units: Years] Mean ± Standard Deviation	48 ± 9.7	48 ± 10.1	50 ± 11.7	47 ± 9.1	48 ± 9.2	48 ± 10.5
Gender [units: participants]
Female	27	57	54	18	19	175
Male	24	45	48	32	33	182
Region of Enrollment [units: participants]
United States	51	102	102	50	52	357

Outcome Measures

Show All Outcome Measures

1. Primary:

The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Day 30 post-vaccination ]

Show Outcome Measure 1

2. Primary:

Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. [ Time Frame: Day 30 post-vaccination ]

Show Outcome Measure 2

3. Primary:

Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Days 0 to 30 post-vaccination ]

Show Outcome Measure 3

4. Other Pre-specified:

Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Days 0 to 30 post-vaccination ]

Show Outcome Measure 4

5. Other Pre-specified:

Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Days 0 (Baseline) and 15 post-vaccination ]

Show Outcome Measure 5

6. Other Pre-specified:

Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Days 0 (Baseline) and 15 post-vaccination ]

Show Outcome Measure 6

7. Other Pre-specified:

Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Days 0 (Baseline) and 15 post-vaccination ]

Show Outcome Measure 7

8. Other Pre-specified:

Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [ Time Frame: Days 0 (Baseline) and 15 post-vaccination ]

Show Outcome Measure 8

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com

No publications provided

Responsible Party:	Medical Director, Sanofi pasteur Inc
ClinicalTrials.gov Identifier:	NCT00053482 History of Changes
Other Study ID Numbers:	H-400-003
Study First Received:	January 30, 2003
Results First Received:	January 3, 2011
Last Updated:	February 10, 2011
Health Authority:	United States: Food and Drug Administration