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OpenTrials
Completed

NCT Number: NCT01537185

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

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.

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Key information

Conditions

Pneumococcal Vaccines

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Comprehensive Clinical Development

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

3 cohorts of normal saline injection

SPWCV+Alum 100 mcg

Biological

3 injections 28 days apart

SPWCV+Alum 600 mcg

Biological

3 injections 28 days apart

SPWCV+Alum 300 mcg

Biological

3 injections 28 days apart

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

PATH Vaccine Solutions

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Feb 23, 2012
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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