Pneumococcal Vaccines
Conditions
Brief summary
The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine (SPWCV) given with alum is safe and well tolerated by healthy adults.
Interventions
OTHERPlacebo
3 cohorts of normal saline injection
BIOLOGICALSPWCV+Alum 100 mcg
3 injections 28 days apart
BIOLOGICALSPWCV+Alum 600 mcg
3 injections 28 days apart
BIOLOGICALSPWCV+Alum 300 mcg
3 injections 28 days apart
Sponsors
PATH Vaccine Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
, Healthy adults: * If female, not breastfeeding, not pregnant, not planning pregnancy during study period), and willing to consistently use an adequate method of contraception and have repeated pregnancy tests. * In good health with normal laboratory results * Willing to comply with study restrictions, study schedule, and can be reliably contacted
Exclusion criteria
* Currently consumes alcohol in excess of 2 drinks per day for men or 1 drink per day for women. * current use or likely requirement for medications with potential for liver injury or effect immune system * History of event or condition such as anaphylaxis, severe allergic reactions, serious reactions to any vaccines, or other events that might increase risk of reaction to an investigational disease * History of diabetes, cancer, autoimmune or immunosuppressive disease or chronic such as HIV, Hepatitis B or C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unsolicited Adverse Event Reports | within 1 week (0-7 days) following each vaccinations | Safety and Tolerability assessed by cohort and product received measured by: •Number of unsolicited AEs within four weeks after each vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG | 28, 56 and 84 days following initial vaccination | • Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 SPWCV+Alum 100 mcg each individual receiving 3 vaccinations of same dose 28 days apart | 10 |
| 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 | 12 |
| Cohort 2 SPWCV+Alum 300 mcg each individual receiving 3 vaccinations of same dose 28 days apart | 10 |
| Cohort 3 SPWCV+Alum 600 mcg each individual receiving 3 vaccinations of same dose 28 days apart | 10 |
| Total | 42 |
Baseline characteristics
| Characteristic | Cohort 1 SPWCV+Alum 100 mcg | Normal Saline Injection | Cohort 2 SPWCV+Alum 300 mcg | Cohort 3 SPWCV+Alum 600 mcg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 28.9 years | 28.5 years | 25.2 years | 29.9 years | 28.1 years |
| Region of Enrollment United States | 10 participants | 12 participants | 10 participants | 10 participants | 42 participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 4 Participants | 7 Participants | 22 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 6 Participants | 3 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 10 | 6 / 12 | 5 / 10 | 6 / 10 |
| serious Total, serious adverse events | 1 / 10 | 0 / 12 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Unsolicited Adverse Event Reports
Safety and Tolerability assessed by cohort and product received measured by: •Number of unsolicited AEs within four weeks after each vaccination
Time frame: within 1 week (0-7 days) following each vaccinations
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 SPWCV+Alum 100 mcg | Unsolicited Adverse Event Reports | 7 participants |
| Normal Saline Injection | Unsolicited Adverse Event Reports | 6 participants |
| Cohort 2 SPWCV+Alum 300 mcg | Unsolicited Adverse Event Reports | 5 participants |
| Cohort 3 SPWVC+Alum 600 mcg | Unsolicited Adverse Event Reports | 6 participants |
Secondary
Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG
• Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84.
Time frame: 28, 56 and 84 days following initial vaccination
Population: only subjects with both baseline and day 84 samples were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 SPWCV+Alum 100 mcg | Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG | 0 participants |
| Normal Saline Injection | Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG | 0 participants |
| Cohort 2 SPWCV+Alum 300 mcg | Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG | 0 participants |
| Cohort 3 SPWVC+Alum 600 mcg | Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG | 1 participants |