Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT00053495

First received: January 30, 2003

Last updated: May 7, 2012

Last verified: May 2012

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: Vaccinia virus: ACAM2000 smallpox vaccine Biological: vaccinia virus (calf lymph): Dryvax

Participant Flow

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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 10 January 2003 to 14 April 2003 in 4 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 353 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, 2.0x10^8th 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	101	101	51	49
COMPLETED	51	101	101	51	49
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

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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, 2.0x10^8th 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
Total	Total of all reporting groups

Baseline Measures

	ACAM2000 Dose 1	ACAM2000 Dose 2	ACAM2000 Dose 3	ACAM2000 Dose 4	Dryvax® Vaccine	Total
Number of Participants [units: participants]	51	101	101	51	49	353
Age [units: participants]
<=18 years	0	0	0	0	0	0
Between 18 and 65 years	51	101	101	51	49	353
>=65 years	0	0	0	0	0	0
Age [units: Years] Mean ± Standard Deviation	23 ± 2.4	22 ± 3.1	22 ± 3.2	22 ± 3.0	22 ± 3.1	22 ± 3
Gender [units: participants]
Female	18	36	34	14	13	115
Male	33	65	67	37	36	238
Region of Enrollment [units: participants]
United States	51	101	101	51	49	353

Outcome Measures

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1. 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 ]

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2. Primary:

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

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3. 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 ]

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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 ]

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5. Other Pre-specified:

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

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6. 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 6

7. Other Pre-specified:

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

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8. Other Pre-specified:

Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. [ Time Frame: Days 0 (baseline) and 15 post-vaccination ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:	Sanofi
ClinicalTrials.gov Identifier:	NCT00053495 History of Changes
Other Study ID Numbers:	H-400-005
Study First Received:	January 30, 2003
Results First Received:	January 3, 2011
Last Updated:	May 7, 2012
Health Authority:	United States: Food and Drug Administration

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