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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 SPWCV+Alum 100 mcg | Experimental | each individual receiving 3 vaccinations of same dose 28 days apart |
|
| Cohort 2 SPWCV+Alum 300 mcg | Experimental | each individual receiving 3 vaccinations of same dose 28 days apart |
|
| Cohort 3 SPWCV+Alum 600 mcg | Experimental | each individual receiving 3 vaccinations of same dose 28 days apart |
|
| Normal Saline Injection | Placebo Comparator | placebo group within each cohort receive 3 injections of normal saline 28 days apart normal saline injection: 3 cohorts of normal saline injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | 3 cohorts of normal saline injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 1 week (0-7 days) following each vaccinations |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28, 56 and 84 days following initial vaccination |
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Inclusion Criteria, Healthy adults:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Royce Morrison, M.D. | Comprehensive Clinical Development | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Clinical Development | Tacoma | Washington | 98418 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31895881 | Derived | Keech CA, Morrison R, Anderson P, Tate A, Flores J, Goldblatt D, Briles D, Hural J, Malley R, Alderson MR. A Phase 1 Randomized, Placebo-controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of Inactivated Streptococcus pneumoniae Whole-cell Vaccine in Adults. Pediatr Infect Dis J. 2020 Apr;39(4):345-351. doi: 10.1097/INF.0000000000002567. | |
| 30592459 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 SPWCV+Alum 100 mcg | each individual receiving 3 vaccinations of same dose 28 days apart |
| FG001 | 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 |
| FG002 | Cohort 2 SPWCV+Alum 300 mcg | each individual receiving 3 vaccinations of the same dose 28 days apart |
| FG003 | Cohort 3 SPWVC+Alum 600 mcg | each individual receiving 3 vaccinations of the same dose 28 days apart |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 SPWCV+Alum 100 mcg | each individual receiving 3 vaccinations of same dose 28 days apart |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | within 1 week (0-7 days) following each vaccinations |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 SPWCV+Alum 100 mcg | each individual receiving 3 vaccinations of same dose 28 days apart |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ruptured ectopic pregnancy with hemorrhage | Reproductive system and breast disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutropenia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Royce Morrison | Comprehensive Clinical Development Northwest | 206 285 3500 | ckeech@path.org |
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| SPWCV+Alum 100 mcg |
| Biological |
3 injections 28 days apart |
|
| SPWCV+Alum 600 mcg | Biological | 3 injections 28 days apart |
|
| SPWCV+Alum 300 mcg | Biological | 3 injections 28 days apart |
|
| Campo JJ, Le TQ, Pablo JV, Hung C, Teng AA, Tettelin H, Tate A, Hanage WP, Alderson MR, Liang X, Malley R, Lipsitch M, Croucher NJ. Panproteome-wide analysis of antibody responses to whole cell pneumococcal vaccination. Elife. 2018 Dec 28;7:e37015. doi: 10.7554/eLife.37015. |
| BG002 | Cohort 2 SPWCV+Alum 300 mcg | each individual receiving 3 vaccinations of same dose 28 days apart |
| BG003 | Cohort 3 SPWCV+Alum 600 mcg | each individual receiving 3 vaccinations of same dose 28 days apart |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cohort 2 SPWCV+Alum 300 mcg |
each individual receiving 3 vaccinations of the same dose 28 days apart |
| OG003 | Cohort 3 SPWVC+Alum 600 mcg | each individual receiving 3 vaccinations of the same dose 28 days apart |
|
|
| 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. | only subjects with both baseline and day 84 samples were included in the analysis. | Posted | Number | participants | 28, 56 and 84 days following initial vaccination |
|
|
|
| 1 |
| 10 |
| 7 |
| 10 |
| EG001 | 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 | 0 | 12 | 6 | 12 |
| EG002 | Cohort 2 SPWCV+Alum 300 mcg | each individual receiving 3 vaccinations of same dose 28 days apart | 0 | 10 | 5 | 10 |
| EG003 | Cohort 3 SPWCV+Alum 600 mcg | each individual receiving 3 vaccinations of same dose 28 days apart | 0 | 10 | 6 | 10 |
| diarrhea | Gastrointestinal disorders |
|
| gastroesophageal reflux disease | Gastrointestinal disorders |
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| toothache | Gastrointestinal disorders |
|
| pharyngitis | Infections and infestations |
|
| upper respiratory tract infection | Infections and infestations |
|
| viral infection | Infections and infestations |
|
| viral upper respiratory tract infection | Infections and infestations |
|
| foot fracture | Injury, poisoning and procedural complications |
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| laceration | Injury, poisoning and procedural complications |
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| ligament sprain | Injury, poisoning and procedural complications |
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| lip injury | Injury, poisoning and procedural complications |
|
| wound | Injury, poisoning and procedural complications |
|
| alanine aminotransferase increased | Investigations |
|
| haemoglobin decreased | Investigations |
|
| platelet count decreased | Investigations |
|
| hyperglycemia | Metabolism and nutrition disorders |
|
| headache | Nervous system disorders |
|
| dysfunctional uterine bleeding | Reproductive system and breast disorders |
|
| dysmenorrhoea | Reproductive system and breast disorders |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders |
|
| rhinitis allergic | Respiratory, thoracic and mediastinal disorders |
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| sinus congestion | Respiratory, thoracic and mediastinal disorders |
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| wheezing | Respiratory, thoracic and mediastinal disorders |
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| alopecia | Skin and subcutaneous tissue disorders |
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| ecchymosis | Skin and subcutaneous tissue disorders |
|
| night sweats | Skin and subcutaneous tissue disorders |
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| skin ulcer | Skin and subcutaneous tissue disorders |
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| Endodontic Procedure | Surgical and medical procedures |
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| injection site pain | General disorders |
|
| irritability | General disorders |
|
| tooth abscess | Infections and infestations |
|
| sunburn | Injury, poisoning and procedural complications |
|
| aspartate aminotransferase increased | Investigations |
|
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