Immune Response in Adults to PrEP and Simulated Booster PEP With a New CPRV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jaruboot Angsanakul, MD, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier:
NCT01603875
First received: May 16, 2012
Last updated: January 3, 2014
Last verified: January 2014
Results First Received: January 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Efficacy of the New CPRV
Intervention: Biological: New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).

  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
We recruited 66 subjects from Faculty of Veterinarian, Chulalongkorn University. The recruitment held between June 25, 2012 and July 2, 2012. Others 39 subjects was recruited from Faculty of Veterinarian, Mahanakorn University of Technology.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PrEP and Simulated PEP With PVRV by Intramuscular Route New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
PrEP and Simulated PEP With New CPRV by Intramuscular Route New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
PrEP and Simulated PEP With New CPRV by Intradermal Route New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention

Participant Flow:   Overall Study
    PrEP and Simulated PEP With PVRV by Intramuscular Route     PrEP and Simulated PEP With New CPRV by Intramuscular Route     PrEP and Simulated PEP With New CPRV by Intradermal Route  
STARTED     35     35     35  
COMPLETED     28     27     26  
NOT COMPLETED     7     8     9  
Preexisting rabies antibody                 3                 4                 3  
Lost to Follow-up                 4                 3                 6  
Protocol Violation                 0                 1                 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
PrEP and Simulated PEP With PVRV by Intramuscular Route New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
PrEP and Simulated PEP With New CPRV by Intramuscular Route New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
PrEP and Simulated PEP With New CPRV by Intradermal Route New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
Total Total of all reporting groups

Baseline Measures
    PrEP and Simulated PEP With PVRV by Intramuscular Route     PrEP and Simulated PEP With New CPRV by Intramuscular Route     PrEP and Simulated PEP With New CPRV by Intradermal Route     Total  
Number of Participants  
[units: participants]
  28     27     26     81  
Age  
[units: years]
Mean ± Standard Deviation
  18.96  ± 1.138     20.04  ± 5.633     18.92  ± 0.744     19.31  ± 3.345  
Gender  
[units: participants]
       
Female     22     18     19     59  
Male     6     9     7     22  
Region of Enrollment  
[units: participants]
       
Thailand     28     27     26     81  



  Outcome Measures
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1.  Primary:   Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)   [ Time Frame: on day 0 ]

2.  Primary:   Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)   [ Time Frame: on day 28 ]

3.  Primary:   Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)   [ Time Frame: on day 42 ]

4.  Primary:   Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)   [ Time Frame: on day 360 ]

5.  Primary:   Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)   [ Time Frame: on day 374 ]

6.  Secondary:   Side Effects of the Vaccines. These Include Pain, Swelling, Redness, Myalgia, Rash, Fever. Serious Adverse Events Will Also be Recorded.   [ Time Frame: up to 7 days after each injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Terapong Tantawichien
Organization: Queen Saovabha Memorial Institute
phone: 66225201614 ext 125
e-mail: terapong_tantawichien@hotmail.com


No publications provided


Responsible Party: Jaruboot Angsanakul, MD, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT01603875     History of Changes
Other Study ID Numbers: RC5506
Study First Received: May 16, 2012
Results First Received: January 3, 2014
Last Updated: January 3, 2014
Health Authority: Thailand: Food and Drug Administration