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| ID | Type | Description | Link |
|---|---|---|---|
| CDC Task Order 0957-045 | Other Grant/Funding Number | Centers for Disease Control |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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The purpose of this study is to give seniors different doses of a new pneumococcal vaccine called PCV7 to evaluate the safety of the vaccine and compare the immune response to find out which amount gives the best immune response. The PCV7 vaccine is currently licensed by the FDA for use in infants and toddlers only.
The purpose of this prospective randomized study is to assess the safety, post-vaccination antibody response, and memory response to a subsequent polysaccharide challenge of varying doses of PCV7 compared with the standard dose of PPV23 in immunocompetent adults 70-79 years of age who were previously vaccinated with PPV23 at age 65 years or above and at least 5 years previously. The study will be conducted among a total of 220 persons recruited from GHC and the Seattle VAMC. Participants will be randomized into one of 5 study groups with 44 participants per group. The antigen content of PCV7 will be varied by administration of different volumes of the licensed pediatric formulation of that vaccine. Four groups will receive one of four volumes (0.1 mL, 0.5 mL, 1.0 mL, 2.0 mL) of the licensed pediatric formulation of PCV7 followed 12 months later by administration of a challenge 0.1 mL dose of PPV23 to assess the induction of immunologic memory. The comparison group will receive the standard 0.5 mL dose of PPV23 following 12 months later by administration of a 0.1 mL dose of PPV23.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1mL Pneumococcal Conjugate Vaccine | Experimental | Participants in this group were randomized at enrollment to receive 0.1mL PCV7, Prevnar® at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later. |
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| 0.5mL Pneumococcal Conjugate Vaccine | Experimental | Participants in this group were randomized at enrollment to receive 0.5mL PCV7, Prevnar® at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later. |
|
| 1.0mL Pneumococcal Conjugate Vaccine | Experimental | Participants in this group were randomized at enrollment to receive 1.0mL PCV7, Prevnar® at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later. |
|
| 2.0mL Pneumococcal Conjugate Vaccine | Experimental | Participants in this group were randomized at enrollment to receive 2.0mL PCV7, Prevnar® at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later. |
|
| 0.5mL Pneumococcal Polysacc Vaccine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCV7, Prevnar® | Biological | Randomized to receive 0.1mL, 0.5mL, 1.0mL or 2.0mL at the enrollment visit, followed by 0.1mL PPV23 12 months later. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the immunologic response to varying doses of 7-valent pneumococcal conjugate vaccine (PCV7) among older adults. | Pre/post enrollment vaccination, and pre/post 1 year challenge vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety to varying doses of 7-valent pneumococcal conjugate vaccine (PCV7) among older adults. | During the 13 month study period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa A Jackson, MD, MPH | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Group Health Research Institute | Seattle | Washington | 98101 | United States | ||
| VA Puget Sound Health Care System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17391816 | Result | Jackson LA, Neuzil KM, Nahm MH, Whitney CG, Yu O, Nelson JC, Starkovich PT, Dunstan M, Carste B, Shay DK, Baggs J, Carlone GM. Immunogenicity of varying dosages of 7-valent pneumococcal polysaccharide-protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2007 May 16;25(20):4029-37. doi: 10.1016/j.vaccine.2007.02.062. Epub 2007 Mar 12. | |
| 15882530 |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
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| Experimental |
Participants in this group were randomized at enrollment to receive 0.5mL Pneumovax 23 at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later. |
|
| Pneumovax 23 | Biological | Randomized to receive 0.5mL at the enrollment visit, followed by 0.1mL PPV23 12 months later. |
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| Seattle |
| Washington |
| 98108 |
| United States |
| Result |
| Jackson LA, Neuzil KM, Whitney CG, Starkovich P, Dunstan M, Yu O, Nelson JC, Feikin DR, Shay DK, Baggs J, Carste B, Nahm MH, Carlone G. Safety of varying dosages of 7-valent pneumococcal protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2005 May 25;23(28):3697-703. doi: 10.1016/j.vaccine.2005.02.017. |
| D013290 |
| Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |