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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01537185
First Posted: February 23, 2012
Last Update Posted: June 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PATH ( PATH Vaccine Solutions )
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ( PATH Vaccine Solutions ):

Primary Outcome Measures:
  • Unsolicited Adverse Event Reports [ Time Frame: 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 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 ]
    • 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: PATH Vaccine Solutions
ClinicalTrials.gov Identifier: NCT01537185     History of Changes
Other Study ID Numbers: VAC 002
First Submitted: February 7, 2012
First Posted: February 23, 2012
Results First Submitted: March 28, 2014
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014
Last Verified: February 2012

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Aluminum sulfate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs