Clinical trial NCT01444339: Study of Two Investigational Pneumococcal Vaccines in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumococcal Infections
Streptococcus Pneumoniae Infections
Pneumococcal Pneumonia
Keywords: Pneumococcal Infections
Streptococcus Pneumoniae Infections
Pneumococcal Vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number and percentage of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
timeFrame: 30 days post-vaccination
Secondary outcomes:
measure: Immunogenicity of Investigational Pneumococcal vaccines after 2 vaccinations
timeFrame: Days 0 and 30 post-vaccination
Other outcomes:
Locations:
city: Allschwil
country: Switzerland
Study officials:
affiliation: Sanofi Pasteur Ltd.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.