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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 November 2012
• Main ID: NCT01537185
• Date of registration: 07/02/2012
• Primary sponsor: PATH Vaccine Solutions
• Public title: Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
• Scientific 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
• Date of first enrolment: February 2012
• Target sample size: 42
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01537185
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Royce Morrison, M.D.
• Affiliation: Comprehensive Clinical Development

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pneumococcal Vaccines

Intervention(s)

Biological: SPWCV + alum

Other: normal saline injection

Primary Outcome(s)

Safety [Time Frame: within 1 week (0-7 days) following each vaccinations]

Secondary Outcome(s)

immunogenicity [Time Frame: 28, 56 and 84 days following initial vaccination]

Secondary ID(s)

VAC 002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors