Study of Two Investigational Pneumococcal Vaccines in Healthy Adults

This study is designed to evaluate the safety, tolerability, and immunogenicity of two investigational pneumococcal vaccines at three dose levels in healthy adults.

Primary Objective:

- To evaluate the safety and tolerability of two investigational pneumococcal vaccines.

Observational Objective:

- To evaluate the immunogenicity of the investigational pneumococcal vaccines.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections; Streptococcus Pneumoniae Infections; Pneumococcal Pneumonia
• Intervention / Treatment: Biological: Pneumococcal Vaccine Formulation 1; Biological: Pneumococcal Vaccine Formulation 2; Biological: Pneumococcal Vaccine Formulation 3; Biological: Pneumococcal Vaccine Formulation 4; Biological: Pneumococcal Vaccine Formulation 5; Biological: Placebo

Detailed Description

An initial cohort of 6 participants will receive a single dose of one of two investigational pneumococcal vaccines. After safety evaluation of that cohort, additional cohorts will receive 2 injections 30 days apart of same investigational pneumococcal vaccine at same or increased dose level. All participants will be monitored for safety for 30 days after each vaccination.

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Allschwil, Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 18 to 50 years on the day of inclusion
• Informed consent form has been signed and dated
• Able to attend all scheduled visits and comply with all trial procedures
• Subject is healthy, as determined by medical history and physical examination
• For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to first vaccination until 4 weeks after the last vaccination.

Exclusion Criteria:

• Known pregnancy or positive serum/urine pregnancy test
• Currently breastfeeding a child
• Chronic illness, that in the opinion of the investigator, is at a stage that could interfere with trial conduct or completion
• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
• Planned participation in another clinical trial during the present trial period
• Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Known systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine(s) or to a vaccine containing any of the same substances
• Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
• Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
• Planned receipt of any vaccine in the 4 weeks following the trial vaccination
• Known seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
• Laboratory confirmed / self-reported thrombocytopenia contraindicating intramuscular vaccination
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Identified as a study site employee who is involved in the protocol and may have direct access to trial-related data
• Previous vaccination against pneumococcal disease (in the previous 5 years)
• History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years
• At high risk for pneumococcal infection during the trial
• Living in a household with children < 5 years of age.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pneumococcal Vaccine Formulation 1; Participants will receive an injection of pneumococcal vaccine (Formulation 1, 1 middle dose) on Day 0 and Day 30, respectively.	Biological: Pneumococcal Vaccine Formulation 1; 0.5 mL, intramuscular (1 middle dose)
Experimental: Pneumococcal Vaccine Formulation 2; Participants will receive an injection of Pneumococcal vaccine (Formulation 2, 2 low doses) on Day 0 and Day 30, respectively.	Biological: Pneumococcal Vaccine Formulation 2; 0.5 mL, intramuscular (2 low doses)
Experimental: Pneumococcal Vaccine Formulation 3; Participants will receive an injection of pneumococcal vaccine (Formulation 3, 2 middle doses) on Day 0 and Day 30, respectively.	Biological: Pneumococcal Vaccine Formulation 3; 0.5 mL, intramuscular (2 middle doses)
Experimental: Pneumococcal Vaccine Formulation 4; Participants will receive an injection of pneumococcal vaccine (Formulation 4, 2 middle doses) on Day 0 and Day 30, respectively.	Biological: Pneumococcal Vaccine Formulation 4; 0.5 mL, intramuscular (2 middle doses)
Experimental: Pneumococcal Vaccine Formulation 5; Participants will receive an injection of pneumococcal vaccine (Formulation 5, 2 high doses) on Day 0 and Day 30, respectively.	Biological: Pneumococcal Vaccine Formulation 5; 0.5 mL, intramuscular (2 high doses)
Placebo Comparator: Pooled placebo Group; Participants will receive an injection of a placebo on Day 0 and Day 30, respectively.	Biological: Placebo; 0.5 mL, intramuscular; Other Names: Tris buffered saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and percentage of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial	Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia	30 days post-vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of Investigational Pneumococcal vaccines after 2 vaccinations	Evaluation of immune responses to antigen component of the investigational vaccine by enzyme linked immunosorbent assay (ELISA).	Days 0 and 30 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Medical Director, Sanofi Pasteur Ltd.

Publications and helpful links

General Publications

• Bologa M, Kamtchoua T, Hopfer R, Sheng X, Hicks B, Bixler G, Hou V, Pehlic V, Yuan T, Gurunathan S. Safety and immunogenicity of pneumococcal protein vaccine candidates: monovalent choline-binding protein A (PcpA) vaccine and bivalent PcpA-pneumococcal histidine triad protein D vaccine. Vaccine. 2012 Dec 14;30(52):7461-8. doi: 10.1016/j.vaccine.2012.10.076. Epub 2012 Nov 2.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: September 28, 2011
• First Submitted That Met QC Criteria: September 29, 2011
• First Posted (Estimate): September 30, 2011

Study Record Updates

• Last Update Posted (Estimate): September 30, 2011
• Last Update Submitted That Met QC Criteria: September 29, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Pneumococcal Infections; Streptococcus Pneumoniae Infections; Pneumococcal Vaccine
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Infections; Communicable Diseases; Pneumococcal Infections; Pneumonia; Pneumonia, Pneumococcal; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: PPR05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No