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

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ClinicalTrials.gov Identifier: NCT01603875
Recruitment Status : Completed
First Posted : May 23, 2012
Results First Posted : February 25, 2014
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):
Jaruboot Angsanakul, MD, Queen Saovabha Memorial Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Efficacy of the New CPRV
Intervention Biological: New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).
Enrollment 105
Recruitment Details 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  
Arm/Group Title 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
Hide Arm/Group Description 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 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 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
Period Title: Overall Study
Started 35 35 35
Completed 28 27 26
Not Completed 7 8 9
Reason Not Completed
Preexisting rabies antibody             3             4             3
Lost to Follow-up             4             3             6
Protocol Violation             0             1             0
Arm/Group Title 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
Hide Arm/Group Description 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 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 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 of all reporting groups
Overall Number of Baseline Participants 28 27 26 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 27 participants 26 participants 81 participants
18.96  (1.138) 20.04  (5.633) 18.92  (0.744) 19.31  (3.345)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 26 participants 81 participants
Female
22
  78.6%
18
  66.7%
19
  73.1%
59
  72.8%
Male
6
  21.4%
9
  33.3%
7
  26.9%
22
  27.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 28 participants 27 participants 26 participants 81 participants
28 27 26 81
1.Primary Outcome
Title Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
Hide Description Blood samples will be drawn on day 0(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.
Time Frame on day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:
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
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
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
Overall Number of Participants Analyzed 31 31 32
Geometric Mean (Full Range)
Unit of Measure: International unit per ml
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
2.Primary Outcome
Title Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
Hide Description Blood samples will be drawn on day 28(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.
Time Frame on day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:
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
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
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
Overall Number of Participants Analyzed 31 31 32
Geometric Mean (Full Range)
Unit of Measure: International unit per ml
2.67
(0.57 to 11.81)
4.23
(0.46 to 19.03)
1.83
(0.16 to 17.45)
3.Primary Outcome
Title Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
Hide Description Blood samples will be drawn on day 42(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.
Time Frame on day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:
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
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
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
Overall Number of Participants Analyzed 31 31 32
Geometric Mean (Full Range)
Unit of Measure: International unit per ml
11.49
(2.38 to 51.54)
14.23
(1.83 to 64.00)
5.02
(0.59 to 26.91)
4.Primary Outcome
Title Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
Hide Description Blood samples will be drawn on day 360(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.
Time Frame on day 360
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:
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
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
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
Overall Number of Participants Analyzed 28 27 26
Geometric Mean (Full Range)
Unit of Measure: International unit per ml
0.55
(0.16 to 1.83)
0.64
(0.13 to 3.67)
0.28
(0.07 to 1.19)
5.Primary Outcome
Title Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
Hide Description Blood samples will be drawn on day 374(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.
Time Frame on day 374
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:
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
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
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
Overall Number of Participants Analyzed 28 27 26
Geometric Mean (Full Range)
Unit of Measure: International unit per ml
29.16
(7.66 to 112.40)
45.99
(4.36 to 693.38)
11.93
(3.22 to 66.83)
6.Secondary Outcome
Title Side Effects of the Vaccines. These Include Pain, Swelling, Redness, Myalgia, Rash, Fever. Serious Adverse Events Will Also be Recorded.
Hide Description

There are five injections, on day 0, 7, 28, 360 and 363.

The side effects will be record in number and percentage.

Time Frame up to 7 days after each injection
Outcome Measure Data Not Reported
Time Frame 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Adverse Event Reporting Description Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
 
Arm/Group Title 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
Hide Arm/Group Description 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 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 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
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      0/35 (0.00%)      0/35 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/35 (100.00%)      35/35 (100.00%)      35/35 (100.00%)    
General disorders       
fever   8/35 (22.86%)  2/35 (5.71%)  4/35 (11.43%) 
Injury, poisoning and procedural complications       
pain   28/35 (80.00%)  149 27/35 (77.14%)  147 15/35 (42.86%)  148
Skin and subcutaneous tissue disorders       
pruritus   5/35 (14.29%)  7 6/35 (17.14%)  8 16/35 (45.71%)  38
erythema   4/35 (11.43%)  1/35 (2.86%)  26/35 (74.29%) 
induration   2/35 (5.71%)  1/35 (2.86%)  26/35 (74.29%) 
Indicates events were collected by systematic assessment
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
Responsible Party: Jaruboot Angsanakul, MD, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT01603875     History of Changes
Other Study ID Numbers: RC5506
First Submitted: May 16, 2012
First Posted: May 23, 2012
Results First Submitted: January 3, 2014
Results First Posted: February 25, 2014
Last Update Posted: February 25, 2014