Trial Outcomes & Findings for Immune Response in Adults to PrEP and Simulated Booster PEP With a New CPRV (NCT NCT01603875)
NCT ID: NCT01603875
Last Updated: 2014-02-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
on day 0
Results posted on
2014-02-25
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
35
|
|
Overall Study
COMPLETED
|
28
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
9
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|
|
Overall Study
Preexisting rabies antibody
|
3
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
6
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
Baseline Characteristics
Immune Response in Adults to PrEP and Simulated Booster PEP With a New CPRV
Baseline characteristics by cohort
| Measure |
PrEP and Simulated PEP With PVRV by Intramuscular Route
n=28 Participants
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
n=27 Participants
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
n=26 Participants
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
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
18.96 years
STANDARD_DEVIATION 1.138 • n=99 Participants
|
20.04 years
STANDARD_DEVIATION 5.633 • n=107 Participants
|
18.92 years
STANDARD_DEVIATION 0.744 • n=206 Participants
|
19.31 years
STANDARD_DEVIATION 3.345 • n=7 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Region of Enrollment
Thailand
|
28 participants
n=99 Participants
|
27 participants
n=107 Participants
|
26 participants
n=206 Participants
|
81 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: on day 0Blood 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.
Outcome measures
| Measure |
PrEP and Simulated PEP With PVRV by Intramuscular Route
n=31 Participants
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
n=31 Participants
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
n=32 Participants
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
|
|---|---|---|---|
|
Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
|
0 International unit per ml
Interval 0.0 to 0.0
|
0 International unit per ml
Interval 0.0 to 0.0
|
0 International unit per ml
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: on day 28Blood 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.
Outcome measures
| Measure |
PrEP and Simulated PEP With PVRV by Intramuscular Route
n=31 Participants
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
n=31 Participants
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
n=32 Participants
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
|
|---|---|---|---|
|
Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
|
2.67 International unit per ml
Interval 0.57 to 11.81
|
4.23 International unit per ml
Interval 0.46 to 19.03
|
1.83 International unit per ml
Interval 0.16 to 17.45
|
PRIMARY outcome
Timeframe: on day 42Blood 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.
Outcome measures
| Measure |
PrEP and Simulated PEP With PVRV by Intramuscular Route
n=31 Participants
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
n=31 Participants
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
n=32 Participants
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
|
|---|---|---|---|
|
Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
|
11.49 International unit per ml
Interval 2.38 to 51.54
|
14.23 International unit per ml
Interval 1.83 to 64.0
|
5.02 International unit per ml
Interval 0.59 to 26.91
|
PRIMARY outcome
Timeframe: on day 360Blood 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.
Outcome measures
| Measure |
PrEP and Simulated PEP With PVRV by Intramuscular Route
n=28 Participants
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
n=27 Participants
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
n=26 Participants
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
|
|---|---|---|---|
|
Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
|
0.55 International unit per ml
Interval 0.16 to 1.83
|
0.64 International unit per ml
Interval 0.13 to 3.67
|
0.28 International unit per ml
Interval 0.07 to 1.19
|
PRIMARY outcome
Timeframe: on day 374Blood 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.
Outcome measures
| Measure |
PrEP and Simulated PEP With PVRV by Intramuscular Route
n=28 Participants
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
n=27 Participants
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
n=26 Participants
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
|
|---|---|---|---|
|
Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
|
29.16 International unit per ml
Interval 7.66 to 112.4
|
45.99 International unit per ml
Interval 4.36 to 693.38
|
11.93 International unit per ml
Interval 3.22 to 66.83
|
SECONDARY outcome
Timeframe: up to 7 days after each injectionThere are five injections, on day 0, 7, 28, 360 and 363. The side effects will be record in number and percentage.
Outcome measures
Outcome data not reported
Adverse Events
PrEP and Simulated PEP With PVRV by Intramuscular Route
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
PrEP and Simulated PEP With New CPRV by Intramuscular Route
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
PrEP and Simulated PEP With New CPRV by Intradermal Route
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PrEP and Simulated PEP With PVRV by Intramuscular Route
n=35 participants at risk
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
n=35 participants at risk
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
n=35 participants at risk
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
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
pain
|
80.0%
28/35 • Number of events 149 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
77.1%
27/35 • Number of events 147 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
42.9%
15/35 • Number of events 148 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
14.3%
5/35 • Number of events 7 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
17.1%
6/35 • Number of events 8 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
45.7%
16/35 • Number of events 38 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
|
Skin and subcutaneous tissue disorders
erythema
|
11.4%
4/35 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
2.9%
1/35 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
74.3%
26/35 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
|
Skin and subcutaneous tissue disorders
induration
|
5.7%
2/35 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
2.9%
1/35 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
74.3%
26/35 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
|
General disorders
fever
|
22.9%
8/35 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
5.7%
2/35 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
11.4%
4/35 • 42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
|
Additional Information
Dr. Terapong Tantawichien
Queen Saovabha Memorial Institute
Phone: 66225201614
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place