Trial Outcomes & Findings for Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults (NCT NCT01537185)
NCT ID: NCT01537185
Last Updated: 2014-06-05
Results Overview
Safety and Tolerability assessed by cohort and product received measured by: •Number of unsolicited AEs within four weeks after each vaccination
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
within 1 week (0-7 days) following each vaccinations
Results posted on
2014-06-05
Participant Flow
Participant milestones
| Measure |
Cohort 1 SPWCV+Alum 100 mcg
each individual receiving 3 vaccinations of same dose 28 days apart
|
Normal Saline Injection
placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection
|
Cohort 2 SPWCV+Alum 300 mcg
each individual receiving 3 vaccinations of the same dose 28 days apart
|
Cohort 3 SPWVC+Alum 600 mcg
each individual receiving 3 vaccinations of the same dose 28 days apart
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
10
|
10
|
|
Overall Study
COMPLETED
|
7
|
6
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
Baseline characteristics by cohort
| Measure |
Cohort 1 SPWCV+Alum 100 mcg
n=10 Participants
each individual receiving 3 vaccinations of same dose 28 days apart
|
Normal Saline Injection
n=12 Participants
placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection
|
Cohort 2 SPWCV+Alum 300 mcg
n=10 Participants
each individual receiving 3 vaccinations of same dose 28 days apart
|
Cohort 3 SPWCV+Alum 600 mcg
n=10 Participants
each individual receiving 3 vaccinations of same dose 28 days apart
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
28.9 years
n=5 Participants
|
28.5 years
n=7 Participants
|
25.2 years
n=5 Participants
|
29.9 years
n=4 Participants
|
28.1 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
42 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: within 1 week (0-7 days) following each vaccinationsSafety and Tolerability assessed by cohort and product received measured by: •Number of unsolicited AEs within four weeks after each vaccination
Outcome measures
| Measure |
Cohort 3 SPWVC+Alum 600 mcg
n=10 Participants
each individual receiving 3 vaccinations of same dose 28 days apart
|
Cohort 1 SPWCV+Alum 100 mcg
n=10 Participants
each individual receiving 3 vaccinations of same dose 28 days apart
|
Normal Saline Injection
n=12 Participants
placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection
|
Cohort 2 SPWCV+Alum 300 mcg
n=10 Participants
each individual receiving 3 vaccinations of the same dose 28 days apart
|
|---|---|---|---|---|
|
Unsolicited Adverse Event Reports
|
6 participants
|
7 participants
|
6 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 28, 56 and 84 days following initial vaccinationPopulation: only subjects with both baseline and day 84 samples were included in the analysis.
• Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84.
Outcome measures
| Measure |
Cohort 3 SPWVC+Alum 600 mcg
n=9 Participants
each individual receiving 3 vaccinations of same dose 28 days apart
|
Cohort 1 SPWCV+Alum 100 mcg
n=9 Participants
each individual receiving 3 vaccinations of same dose 28 days apart
|
Normal Saline Injection
n=9 Participants
placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection
|
Cohort 2 SPWCV+Alum 300 mcg
n=5 Participants
each individual receiving 3 vaccinations of the same dose 28 days apart
|
|---|---|---|---|---|
|
Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Cohort 1 SPWCV+Alum 100 mcg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Normal Saline Injection
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2 SPWCV+Alum 300 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3 SPWCV+Alum 600 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 SPWCV+Alum 100 mcg
n=10 participants at risk
each individual receiving 3 vaccinations of same dose 28 days apart
|
Normal Saline Injection
n=12 participants at risk
placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection
|
Cohort 2 SPWCV+Alum 300 mcg
n=10 participants at risk
each individual receiving 3 vaccinations of same dose 28 days apart
|
Cohort 3 SPWCV+Alum 600 mcg
n=10 participants at risk
each individual receiving 3 vaccinations of same dose 28 days apart
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
ruptured ectopic pregnancy with hemorrhage
|
10.0%
1/10 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/10
|
Other adverse events
| Measure |
Cohort 1 SPWCV+Alum 100 mcg
n=10 participants at risk
each individual receiving 3 vaccinations of same dose 28 days apart
|
Normal Saline Injection
n=12 participants at risk
placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection
|
Cohort 2 SPWCV+Alum 300 mcg
n=10 participants at risk
each individual receiving 3 vaccinations of same dose 28 days apart
|
Cohort 3 SPWCV+Alum 600 mcg
n=10 participants at risk
each individual receiving 3 vaccinations of same dose 28 days apart
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
neutropenia
|
10.0%
1/10
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
diarrhea
|
10.0%
1/10
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
0.00%
0/10
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
toothache
|
0.00%
0/10
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Infections and infestations
pharyngitis
|
0.00%
0/10
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/10
|
|
Infections and infestations
upper respiratory tract infection
|
10.0%
1/10
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Infections and infestations
viral infection
|
0.00%
0/10
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Infections and infestations
viral upper respiratory tract infection
|
10.0%
1/10
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
foot fracture
|
0.00%
0/10
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
laceration
|
10.0%
1/10
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
ligament sprain
|
10.0%
1/10
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
lip injury
|
0.00%
0/10
|
0.00%
0/12
|
0.00%
0/10
|
10.0%
1/10
|
|
Injury, poisoning and procedural complications
wound
|
10.0%
1/10
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Investigations
alanine aminotransferase increased
|
0.00%
0/10
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/10
|
|
Investigations
haemoglobin decreased
|
0.00%
0/10
|
16.7%
2/12
|
10.0%
1/10
|
20.0%
2/10
|
|
Investigations
platelet count decreased
|
10.0%
1/10
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
hyperglycemia
|
10.0%
1/10
|
16.7%
2/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Nervous system disorders
headache
|
0.00%
0/10
|
0.00%
0/12
|
0.00%
0/10
|
20.0%
2/10
|
|
Reproductive system and breast disorders
dysfunctional uterine bleeding
|
0.00%
0/10
|
0.00%
0/12
|
0.00%
0/10
|
10.0%
1/10
|
|
Reproductive system and breast disorders
dysmenorrhoea
|
0.00%
0/10
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
10.0%
1/10
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis allergic
|
10.0%
1/10
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
10.0%
1/10
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
0.00%
0/10
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
alopecia
|
0.00%
0/10
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
ecchymosis
|
10.0%
1/10
|
0.00%
0/12
|
0.00%
0/10
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
night sweats
|
0.00%
0/10
|
0.00%
0/12
|
0.00%
0/10
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
skin ulcer
|
0.00%
0/10
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/10
|
|
Surgical and medical procedures
Endodontic Procedure
|
0.00%
0/10
|
0.00%
0/12
|
0.00%
0/10
|
10.0%
1/10
|
|
General disorders
injection site pain
|
0.00%
0/10
|
0.00%
0/12
|
20.0%
2/10
|
10.0%
1/10
|
|
General disorders
irritability
|
0.00%
0/10
|
0.00%
0/12
|
0.00%
0/10
|
10.0%
1/10
|
|
Infections and infestations
tooth abscess
|
0.00%
0/10
|
0.00%
0/12
|
0.00%
0/10
|
10.0%
1/10
|
|
Injury, poisoning and procedural complications
sunburn
|
0.00%
0/10
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/10
|
|
Investigations
aspartate aminotransferase increased
|
0.00%
0/10
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/10
|
Additional Information
Dr. Royce Morrison
Comprehensive Clinical Development Northwest
Phone: 206 285 3500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60