NCT01537185

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 5, 2014

Completed
Last Updated

June 5, 2014

Status Verified

February 1, 2012

Enrollment Period

8 months

First QC Date

February 7, 2012

Results QC Date

March 28, 2014

Last Update Submit

May 6, 2014

Conditions

Pneumococcal Vaccines

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG

    28, 56 and 84 days following initial vaccination

Study Arms (4)

Cohort 1 SPWCV+Alum 100 mcg

EXPERIMENTAL

each individual receiving 3 vaccinations of same dose 28 days apart

Biological: SPWCV+Alum 100 mcg

Cohort 2 SPWCV+Alum 300 mcg

EXPERIMENTAL

each individual receiving 3 vaccinations of same dose 28 days apart

Biological: SPWCV+Alum 300 mcg

Cohort 3 SPWCV+Alum 600 mcg

EXPERIMENTAL

each individual receiving 3 vaccinations of same dose 28 days apart

Biological: SPWCV+Alum 600 mcg

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

Other: Placebo

Interventions

PlaceboOTHER

3 cohorts of normal saline injection

Normal Saline Injection
SPWCV+Alum 100 mcgBIOLOGICAL

3 injections 28 days apart

Cohort 1 SPWCV+Alum 100 mcg
SPWCV+Alum 600 mcgBIOLOGICAL

3 injections 28 days apart

Cohort 3 SPWCV+Alum 600 mcg
SPWCV+Alum 300 mcgBIOLOGICAL

3 injections 28 days apart

Cohort 2 SPWCV+Alum 300 mcg

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Clinical Development

Tacoma, Washington, 98418, United States

Location

Related Publications (2)

  • 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.

    PMID: 31895881DERIVED

  • 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.

    PMID: 30592459DERIVED

Results Point of Contact

Title
Dr. Royce Morrison
Organization
Comprehensive Clinical Development Northwest
ckeech@path.org
206 285 3500

Study Officials

  • Royce Morrison, M.D.

    Comprehensive Clinical Development

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 23, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2012

Study Completion

April 1, 2013

Last Updated

June 5, 2014

Results First Posted

June 5, 2014

Record last verified: 2012-02

Locations

US(1)