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

Pneumococcal Vaccines Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537185
• Other study ID #: VAC 002
• Status: Completed
• Phase: Phase 1
• First received: February 7, 2012
• Last updated: May 6, 2014
• Start date: February 2012
• Est. completion date: April 2013

Study information

• Verified date: February 2012
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pneumococcal Vaccines

Intervention

Other:
• Placebo
3 cohorts of normal saline injection

Biological:
• SPWCV+Alum 100 mcg
3 injections 28 days apart
• SPWCV+Alum 600 mcg
3 injections 28 days apart
• SPWCV+Alum 300 mcg
3 injections 28 days apart

Locations

Country	Name	City	State
United States	Comprehensive Clinical Development	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
PATH Vaccine Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG	• Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84.	28, 56 and 84 days following initial vaccination	No