Trial Outcomes & Findings for Multisite Controlled Trial of Cocaine Vaccine (NCT NCT00969878)
NCT ID: NCT00969878
Last Updated: 2017-03-15
Results Overview
Number of patients having at least 2 weeks of cocaine-free urines between weeks 9-16 after vaccination with five doses of TA-CD 400 µg compared to placebo
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
300 participants
Primary outcome timeframe
Over 8 weeks ( Study Weeks 9 to 16 inclusive)
Results posted on
2017-03-15
Participant Flow
Participant milestones
| Measure |
Placebo Injection
TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).
Placebo Injection: On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor.
|
TA-CD Vaccination
TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).
TA-CD Vaccination: On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor.
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
152
|
|
Overall Study
COMPLETED
|
118
|
126
|
|
Overall Study
NOT COMPLETED
|
30
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multisite Controlled Trial of Cocaine Vaccine
Baseline characteristics by cohort
| Measure |
Placebo Injection
n=148 Participants
TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).
Placebo Injection: On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor.
|
TA-CD Vaccination
n=152 Participants
TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).
TA-CD Vaccination: On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
148 Participants
n=93 Participants
|
152 Participants
n=4 Participants
|
300 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=93 Participants
|
114 Participants
n=4 Participants
|
228 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
148 participants
n=93 Participants
|
152 participants
n=4 Participants
|
300 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Over 8 weeks ( Study Weeks 9 to 16 inclusive)Number of patients having at least 2 weeks of cocaine-free urines between weeks 9-16 after vaccination with five doses of TA-CD 400 µg compared to placebo
Outcome measures
| Measure |
Placebo Injection
n=148 Participants
A saline injection to mimic the active medication is administered to the Placebo group.
|
TA-CD Vaccination
n=152 Participants
The group randomized to receive the active medication, received the actual TA-CD vaccination at preset intervals as specified in the approved protocol.
|
|---|---|---|
|
Cocaine Abstinence During Weeks 9 to 16 Inclusive
|
21 participants
|
30 participants
|
SECONDARY outcome
Timeframe: During the 18 weeks study period.Peak antibody levels after five vaccinations with TA-CD, which occurred at week 16.
Outcome measures
| Measure |
Placebo Injection
n=118 Participants
A saline injection to mimic the active medication is administered to the Placebo group.
|
TA-CD Vaccination
n=126 Participants
The group randomized to receive the active medication, received the actual TA-CD vaccination at preset intervals as specified in the approved protocol.
|
|---|---|---|
|
•The Immunogenicity of TA-CD;
|
0 micrograms/ml
Interval 0.0 to 0.0
|
59 micrograms/ml
Interval 0.0 to 186.0
|
Adverse Events
Placebo Injection
Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths
TA-CD Vaccination
Serious events: 14 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Injection
n=148 participants at risk
Subjects randomized to the placebo group were injected with a saline solution on the same schedule as those in the active medication group.
|
TA-CD Vaccination
n=152 participants at risk
Subjects randomized to the active medication group were injected with the active TA-CD at preset intervals per protocol specifications.
|
|---|---|---|
|
Psychiatric disorders
Depression with suicidality
|
4.1%
6/148 • Number of events 6 • 6 months
|
3.3%
5/152 • Number of events 5 • 6 months
|
|
General disorders
Other hospitalizations
|
6.1%
9/148 • Number of events 9 • 6 months
|
5.9%
9/152 • Number of events 9 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place