Systems Biology of 23-valent Pneumococcal Polysaccharide Vaccine (PNEUMOVAX®23) in the Young and Elderly
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Purpose
Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population.
In this trial, the investigators will study the immunologic differences of the FDA approved licensed pneumococcal vaccine between a younger and an older group. Twenty two healthy volunteers between the age of 25-40 and forty four healthy volunteers above the age of 65 will be enrolled in the study. Each participant in the study will be given one pneumococcal shot. Blood work will be obtained prior to vaccination, one day, three days, seven days, fourteen days, as well as one month and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.
| Condition | Intervention |
|---|---|
|
Pneumococcal Infection |
Biological: PNEUMOVAX |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Systems Biology of PNEUMOVAX®23 in the Young and Elderly |
- Number of participants with innate immunity signatures that correlate with the quality of antibodies after PNEUMOVAX [ Time Frame: 2 years ] [ Designated as safety issue: No ]The primary outcomes will identify the number of participants with innate immunity signatures in the young and older groups that correlate with the quality of antibodies produced after PNEUMOVAX
- Number of participants with specific B cell responses that correlate with the innate immune signatures after PNEUMOVAX [ Time Frame: 2 years ] [ Designated as safety issue: No ]The secondary outcomes will identify the number of participants with a positive B cell response to PNEUMOVAX particulary looking at the antibody repertoire, quantity of antibodies and plasmablasts
| Estimated Enrollment: | 66 |
| Study Start Date: | June 2013 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Older Group
Participants above the age of 65 years
|
Biological: PNEUMOVAX
Give 1 dose of PNEUMOVAX to all participants
Other Name: 23-valent polysaccharide pneumococcal vaccine
|
|
Experimental: Younger Group
Participants between the ages of 25-40 years
|
Biological: PNEUMOVAX
Give 1 dose of PNEUMOVAX to all participants
Other Name: 23-valent polysaccharide pneumococcal vaccine
|
Detailed Description:
RATIONALE: 23-valent pneumococcal polysaccharide vaccine (PPV23) is known to induce diminished functional antibody responses and lower protection in the elderly. We hypothesize that this is due to intrinsic defects in subjects' innate immune responses to pneumococcal polysaccharides, which translates into sub-optimal functional adaptive immune responses. Therefore, early innate immune responses to vaccination should correlate with, and predict the immunogenicity of PPV23 in the young and elderly.
STUDY DESIGN: Single center, open label study in which adult healthy volunteers will be vaccinated with PPV23. Blood samples will be collected on Days D0 (at enrollment) and D1, D3, D7, D14, D30 and D180 post vaccination to study innate and adaptive immune responses.
Even though PPV23 is considered safe, volunteers will be asked to report any local or systemic AEs from Day 0 (vaccination) to Day 7 in memory aids. Reactogenicity events will also be evaluated by injection site examination on visits at D0, D1, D3 and D7. Also volunteers are asked to report any local or systemic AEs for 30 days post vaccination and any SAEs for 180 days post vaccination. Volunteers are also asked to report local and systemic AEs developing the day of a blood draw.
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Able to understand and give informed consent.
- Immunocompetent subjects aged 25-40 years, or community dwelling subjects >65 years of age with or without prior pneumococcal infection.
Exclusion Criteria:
- Prior vaccination with more than 1 dose of pneumococcal vaccine or 1 dose of PPV23 less than 5 years prior
Receipt of immune products
- Subjects received blood products within 3 months*.
- Subjects received of any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry*.
- Subjects received of any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry*.
Presence of co-morbidities or immunosuppressive states such as:
- Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease**, severe liver disease, cerebrospinal fluid leaks, severe kidney disease, auto immune diseases, severe gastrointestinal diseases and uncontrolled hypertension.
- Alcohol, drug abuse or psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
- Impaired immune function or chronic infections including, but not limited, to HIV; hepatitis B or C; organ transplant; cancer; current and/or expected receipt of chemotherapy, radiation therapy or any other immunosuppressive therapy (i.e., more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days*, nasal and topical steroids are allowed); functional or anatomic asplenia and congenital immunodeficiency.
Conditions that could affect the safety of the volunteers such as:
- Severe reactions to prior vaccinations.
- Any allergy to any component of the vaccines (phenol…).
- History of Guillain-Barré syndrome.
- History of bleeding disorders.
- Volunteers with any acute illness* including (but not limited to) fever > 100.4 F (> 38 C) at the time of vaccination.
- Volunteers with social conditions or occupational conditions or any condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
- Pregnant or breast feeding or women expected to conceive within 30 days after vaccination
Contacts and Locations| Contact: Nadine Rouphael, MD | 4046861000 ext 16509 | nroupha@emory.edu |
| Contact: Aneesh Mehta, MD | 4046861000 ext 16927 | aneesh.mehta@emory.edu |
| United States, Georgia | |
| Hope Clinic of the Emory Vaccine Center | Not yet recruiting |
| Decatur, Georgia, United States, 30030 | |
| Contact: Mary Bower, RN 404-712-1370 mbbower@emory.edu | |
| Principal Investigator: Nadine Rouphael, MD | |
| Principal Investigator: Aneesh Mehta, MD | |
| Sub-Investigator: Mark Mulligan, MD | |
| Sub-Investigator: Srilatha Edugupanti, MD | |
| Sub-Investigator: Keith Klugman, MD | |
| Principal Investigator: | Nadine Rouphael, MD | Emory University |
More Information
No publications provided
| Responsible Party: | Nadine Rouphael, MD, Emory University |
| ClinicalTrials.gov Identifier: | NCT01307449 History of Changes |
| Other Study ID Numbers: | VAX003, U19AI090023 |
| Study First Received: | March 1, 2011 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Emory University:
|
pneumococcal vaccine immune responses |
Additional relevant MeSH terms:
|
Pneumococcal Infections Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 16, 2013