Study of Two Investigational Pneumococcal Vaccines in Healthy Adults

• ClinicalTrials.gov Identifier: NCT01444339
• Recruitment Status: Completed
• First Posted: September 30, 2011
• Last Update Posted: September 30, 2011
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Pneumococcal Infections; Streptococcus Pneumoniae Infections; Pneumococcal Pneumonia	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	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 131 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: February 2010
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: September 2010

Arms and Interventions

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 Name: Tris buffered saline

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Switzerland

Allschwil, Switzerland

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Medical Director; Sanofi Pasteur Ltd.

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT01444339
• Other Study ID Numbers: PPR05
• First Posted: September 30, 2011
• Last Update Posted: September 30, 2011
• Last Verified: September 2011

Keywords provided by Sanofi:

Pneumococcal Infections; Streptococcus Pneumoniae Infections; Pneumococcal Vaccine

Additional relevant MeSH terms:

Infection; Communicable Diseases; Pneumococcal Infections; Pneumonia, Pneumococcal; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Pneumonia, Bacterial; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine; Immunologic Factors; Physiological Effects of Drugs