Back to resultsPhase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
Primary Purpose
Pneumococcal Vaccines
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
SPWCV+Alum 100 mcg
SPWCV+Alum 600 mcg
SPWCV+Alum 300 mcg
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Vaccines
Eligibility Criteria
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
Sites / Locations
- Comprehensive Clinical Development
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Cohort 1 SPWCV+Alum 100 mcg
Cohort 2 SPWCV+Alum 300 mcg
Cohort 3 SPWCV+Alum 600 mcg
Normal Saline Injection
Arm Description
each individual receiving 3 vaccinations of same dose 28 days apart
each individual receiving 3 vaccinations of same dose 28 days apart
each individual receiving 3 vaccinations of same dose 28 days apart
placebo group within each cohort receive 3 injections of normal saline 28 days apart normal saline injection: 3 cohorts of normal saline injection
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01537185
Brief Title
Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
Official Title
A Phase 1 Randomized, Double-Blind, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (SPWCV+Alum) in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PATH Vaccine Solutions
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Vaccines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 SPWCV+Alum 100 mcg
Arm Type
Experimental
Arm Description
each individual receiving 3 vaccinations of same dose 28 days apart
Arm Title
Cohort 2 SPWCV+Alum 300 mcg
Arm Type
Experimental
Arm Description
each individual receiving 3 vaccinations of same dose 28 days apart
Arm Title
Cohort 3 SPWCV+Alum 600 mcg
Arm Type
Experimental
Arm Description
each individual receiving 3 vaccinations of same dose 28 days apart
Arm Title
Normal Saline Injection
Arm Type
Placebo Comparator
Arm Description
placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
3 cohorts of normal saline injection
Intervention Type
Biological
Intervention Name(s)
SPWCV+Alum 100 mcg
Intervention Description
3 injections 28 days apart
Intervention Type
Biological
Intervention Name(s)
SPWCV+Alum 600 mcg
Intervention Description
3 injections 28 days apart
Intervention Type
Biological
Intervention Name(s)
SPWCV+Alum 300 mcg
Intervention Description
3 injections 28 days apart
Primary Outcome Measure Information:
Title
Unsolicited Adverse Event Reports
Description
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
Secondary Outcome Measure Information:
Title
Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG
Description
• 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Royce Morrison, M.D.
Organizational Affiliation
Comprehensive Clinical Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Clinical Development
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98418
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31895881
Citation
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.
Results Reference
derived
PubMed Identifier
30592459
Citation
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.
Results Reference
derived
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Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
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