Study of an Investigational Pneumococcal Vaccine in Healthy Adult Volunteers

This study was designed to evaluate the safety, tolerability, and immunogenicity of three doses of an investigational pneumococcal vaccine in healthy adult volunteers.

Primary Objective:

• To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections; Pneumococcal Pneumonia
• Intervention / Treatment: Biological: Pneumococcal Vaccine

Detailed Description

Each volunteer participant will receive two injections with one of three vaccine doses, administered on Day 0 and Day 30, in a dose-ascending manner, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each injection.

• Study Type: Interventional
• Enrollment (Actual): 63
• 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: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 18 to 50 years on the day of inclusion
• Healthy, as determined by medical history and clinical examination
• Informed consent obtained
• Able to attend all scheduled visits and to comply with all trial procedures
• For a woman, inability to bear a child or negative urine pregnancy test at each vaccination visit
• For a woman of child-bearing potential: use of two medically acceptable, effective methods of contraception (oral contraceptive, intrauterine device, diaphragm, spermicide, or condom) or abstinence throughout the study participation starting at least 30 days prior to the first vaccination up to at least 30 days after the last vaccination.

Exclusion Criteria:

• Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system) that could interfere with trial conduct or and/or raise a safety concern
• For a woman, breast-feeding
• Participation in another clinical trial in the 30 days preceding the first trial vaccination
• Planned participation in another clinical trial during the present trial period
• Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
• Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
• Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
• Blood or blood-derived products received in the past 3 months
• Any vaccination in the 30 days preceding the first trial vaccination
• Vaccination planned in the 30 days following any trial vaccination
• Known Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity
• Known thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
• Febrile illness (≥ 38.0°C [or 100.4°F]) within 72 hours of inclusion/vaccination
• Previous vaccination in the preceding 5 years against pneumococcal disease with another vaccine
• History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years
• Subject at high risk of pneumococcal infection during the trial
• Subjects living in a household with children < 5 years of age
• Antibiotic usage or upper or lower respiratory tract infection within one week before any blood draw for immunogenicity (Visits 1, 3, and 5).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pneumococcal Vaccine Dose 1 (Low dose); Participants will receive 2 injections of Dose 1 investigational Pneumococcal vaccine (Low dose) on Day 0 and Day 30, respectively.	Biological: Pneumococcal Vaccine; 0.5 mL, intramuscular
Experimental: Pneumococcal Vaccine Dose 2 (Middle dose); Participants will receive 2 injections of the investigational Pneumococcal vaccine (Middle dose) on Day 0 and Day 30, respectively.	Biological: Pneumococcal Vaccine; 0.5 mL, intramuscular
Experimental: Pneumococcal Vaccine Dose 3 (High dose); Participants will receive 2 injections of the investigational Pneumococcal vaccine (High dose) on Day 0 and Day 30, respectively.	Biological: Pneumococcal Vaccine; 0.5 mL, intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of 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	Day 0 up to Day 60 post vaccination

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Seiberling M, Bologa M, Brookes R, Ochs M, Go K, Neveu D, Kamtchoua T, Lashley P, Yuan T, Gurunathan S. Safety and immunogenicity of a pneumococcal histidine triad protein D vaccine candidate in adults. Vaccine. 2012 Dec 14;30(52):7455-60. doi: 10.1016/j.vaccine.2012.10.080. Epub 2012 Nov 3.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): August 1, 2007

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 Vaccines; Pneumococcal Infections; pneumococcal protein
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia, Pneumococcal; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: PPR01