Table 1.
Studies evaluating immunogenicity of 13-valent conjugate pneumococcal vaccine (PCV13) in adults.
| Study Name | Design | PPV23 Naïve | Age group | Duration of follow up | PCV13 (N)1 | PPV23 (N)1 | PLB (N) | Immunogenicity2 |
|---|---|---|---|---|---|---|---|---|
| Jackson 2013a [26] | R, DB | Y | 50-64 years | 4 years | Baseline for 60-64 yrs: N=417 (411) At 1 year for 50-59 yrs: N=406 |
Baseline for 60-64 yrs: N=414 (407) | - | In 60-64 yrs: PCV13 arm had a statistically significantly higher OPA titers in 9/13 serotypes (1,4,6A,6B,7F,9V,18C,19A,23F) compared to PPV23. In 50-59 yrs: PCV13 arm had a statistically significantly higher OPA titers in 9/13 serotypes (1,4,5,6A,6B,7F,9V,14,19A) compared to G2. |
| Jackson 2013b [27] | R, DB | N | ≥70 years | 1 year | 431 | 448 | - | PCV13 arm had a statistically significantly higher OPA titers in 11/13 serotypes (1,4,5,6A,6B,7F,9V,18C,19A,19F,23F) compared to PPV23. |
| Greenberg 2014 [29] | R, DB | Y | 60-64 years | 1 year | 482 | 238 | - | PCV13 arm had a statistically significantly higher OPA titers in 11/13 serotypes (1,4,5,6A,6B,7F,9V,18C,19A,19F,23F) compared to PPV23. |
| Juergens 2014 [30] | R | N | ≥65 years | 2 years | Baseline for PCV13 with AlPO4: N=309 (307) Baseline for PCV13 without AlPO4: N=305 (302) |
Baseline: 301 (300) | PCV13 (with AlPO4) arm had a statistically significantly higher OPA titers and IgG GMCs in 11/13 serotypes (1,3,4,5,6A,6B,9V,18C, 19A,19F,23F) compared to PPV23. PCV13 (without AlPO4): had a statistically significantly higher IgG GMCs in 1/13 serotypes (7F) compared to PCV13 (with ALPO4). |
|
| Shiramoto 2015 [31] | R, DB | Y | ≥65 years | 4 months | 382 | 382 | - | PCV13 arm had a statistically significantly higher OPA titers in 13/13 serotypes. |
| van Deursen 2017 [32] | R, DB | Y | ≥65 years | 2 years | 1006 | - | 1005 | PCV13 arm had a statistically significantly higher OPA titers in 13/13 serotypes. At 12 months, PCV13 arm had a statistically significantly reached GMFR (OPA titers) in 9/13 serotypes (4,6A,6B, 7F, 14, 18C, 19A,19F, 23F). At 24 months, PCV13 arm had a statistically significantly reached GMFR (OPA titers) in 6/13 serotypes (4,6A,6B, 18C, 19A, 23F). |
Abbreviations: PCV13 - 13 valent conjugate pneumococcal vaccine; PPV23 - 23 valent pneumococcal polysaccharide vaccine; PLB- Placebo
1
N is for all randomized subjects and those included in the immunogenicity analyses are included in brackets if they differed from original.
2
All OPA GMT ratios are reported at 1 month after vaccination