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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]

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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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:
unchecked 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.
unchecked 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.


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