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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Vaccines
• Intervention / Treatment: Biological: SPWCV+Alum 100 mcg; Biological: SPWCV+Alum 300 mcg; Biological: SPWCV+Alum 600 mcg; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98418
      • Comprehensive Clinical Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: PATH Vaccine Solutions
• Investigators: Principal Investigator: Royce Morrison, M.D., Comprehensive Clinical Development

Publications and helpful links

General Publications

• Keech CA, Morrison R, Anderson P, Tate A, Flores J, Goldblatt D, Briles D, Hural J, Malley R, Alderson MR. A Phase 1 Randomized, Placebo-controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of Inactivated Streptococcus pneumoniae Whole-cell Vaccine in Adults. Pediatr Infect Dis J. 2020 Apr;39(4):345-351. doi: 10.1097/INF.0000000000002567.
• Campo JJ, Le TQ, Pablo JV, Hung C, Teng AA, Tettelin H, Tate A, Hanage WP, Alderson MR, Liang X, Malley R, Lipsitch M, Croucher NJ. Panproteome-wide analysis of antibody responses to whole cell pneumococcal vaccination. Elife. 2018 Dec 28;7:e37015. doi: 10.7554/eLife.37015.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 7, 2012
• First Submitted That Met QC Criteria: February 22, 2012
• First Posted (Estimate): February 23, 2012

Study Record Updates

• Last Update Posted (Estimate): June 5, 2014
• Last Update Submitted That Met QC Criteria: May 6, 2014
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia; Pneumonia, Pneumococcal; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Aluminum sulfate
• Other Study ID Numbers: VAC 002