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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Program for Appropriate Technology in Health ( PATH Vaccine Solutions )
ClinicalTrials.gov Identifier:
NCT01537185
First received: February 7, 2012
Last updated: October 30, 2012
Last verified: February 2012
History of Changes
  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: normal saline injection
Biological: SPWCV + alum
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
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:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Program for Appropriate Technology in Health:

Primary Outcome Measures:
  • Safety [ 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 vaccine-related SAEs
    • Proportion of subjects AEs leading to discontinuation of product or study
    • Proportion of subjects with >= Grade 2 local reactogenicity events
    • Average duration of local reactogenicity
    • Proportion of subjects with Grade 2 or greater systemic reactogenicity
    • Average duration of systemic reactogenicity
    • Number of unsolicited AEs within four weeks after each vaccination
    • Maximum severity per volunteer
    • Proportion of AEs related to vaccine


Secondary Outcome Measures:
  • immunogenicity [ 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.


Estimated Enrollment: 42
Study Start Date: February 2012
Estimated Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPWCV + alum
3 dose cohorts, with each individual receiving 3 vaccinations of same dose 28 days apart
 Biological: SPWCV + alum
3 dose cohorts of 100, 300 and 600 micrograms for 3 injections 28 days apart
Placebo Comparator: normal saline injection
placebo group within each cohort receive 3 injections of normal saline 28 days apart
 Other: normal saline injection
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
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: Program for Appropriate Technology in Health ( PATH Vaccine Solutions )
ClinicalTrials.gov Identifier: NCT01537185     History of Changes
Other Study ID Numbers: VAC 002
Study First Received: February 7, 2012
Last Updated: October 30, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013