Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PATH ( PATH Vaccine Solutions )
ClinicalTrials.gov Identifier:
NCT01537185
First received: February 7, 2012
Last updated: May 6, 2014
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Pneumococcal Vaccines
Other: Placebo
Biological: SPWCV+Alum 100 mcg
Biological: SPWCV+Alum 600 mcg
Biological: SPWCV+Alum 300 mcg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • Unsolicited Adverse Event Reports [ Time Frame: within 1 week (0-7 days) following each vaccinations ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 28, 56 and 84 days following initial vaccination ] [ Designated as safety issue: No ]
    • Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84.


Enrollment: 42
Study Start Date: February 2012
Study Completion Date: April 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 SPWCV+Alum 100 mcg
each individual receiving 3 vaccinations of same dose 28 days apart
Biological: SPWCV+Alum 100 mcg
3 injections 28 days apart
Experimental: Cohort 2 SPWCV+Alum 300 mcg
each individual receiving 3 vaccinations of same dose 28 days apart
Biological: SPWCV+Alum 300 mcg
3 injections 28 days apart
Experimental: Cohort 3 SPWCV+Alum 600 mcg
each individual receiving 3 vaccinations of same dose 28 days apart
Biological: SPWCV+Alum 600 mcg
3 injections 28 days apart
Placebo Comparator: 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

Other: Placebo
3 cohorts of normal saline injection

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537185

Locations
United States, Washington
Comprehensive Clinical Development
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
PATH Vaccine Solutions
Investigators
Principal Investigator: Royce Morrison, M.D. Comprehensive Clinical Development
  More Information

No publications provided

Responsible Party: PATH ( PATH Vaccine Solutions )
ClinicalTrials.gov Identifier: NCT01537185     History of Changes
Other Study ID Numbers: VAC 002
Study First Received: February 7, 2012
Results First Received: March 28, 2014
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014