Table 1.
Demographic and baseline features of participants included in the analysis evaluating the immunogenicity of a 7-valent pneumococcal conjugate vaccine (PCV) following each of three doses.
| Variable | Overall | HUUa | HEUb | ART+c | ART−d | Group-5e |
|---|---|---|---|---|---|---|
| Total number of subjects enrolled | 565 | 119 | 124 | 205 | 104 | 13 |
| Male sex (%) | 266 (47.1) | 66 (55.5) | 67 (54.0) | 87 (42.4) | 40 (38.5) | 6 (46.2) |
| Total Race: Black African (%) | 515 (91.2) | 90 (75.6) | 116 (93.5) | 196 (95.6) | 101 (97.1) | 12 (92.3) |
| Mixed ancestry (%) | 50 (8.8) | 29 (24.4) | 8 (6.5) | 9 (4.4) | 3 (2.9) | 1 (7.8) |
| Mean age (standard deviation; SD) at time of immunogenicity analysis/vaccine administration in weeks (n = number of observation per cell) | ||||||
| Pre-vaccine/PCV dose-1f | 7.36 (1.16) | 7.03 (1.03) | 7.36 (0.99) | 7.53 (1.24) | 7.28 (1.15) | 8.35 (1.56) |
| Post dose-1/PCV dose-2 | 11.45 (1.24) | 11.1 (1.12) | 11.48 (1.01) | 11.61 (1.34) | 11.4 (1.27) | 12.7 (1.84) |
| Post dose-2/PCV dose-3 | 15.53 (1.33) | 15.17 (1.21) | 15.58 (1.07) | 15.68 (1.49) | 15.47 (1.3) | 16.59 (1.65) |
| Post dose-3g | 19.51 (1.29) | 19.18 (1.24) | 19.53 (1.03) | 19.59 (1.32) | 19.65 (1.49) | 20.73 (1.65) |
| HIV-1 Viral load at baseline- copies/ml (range) |
750,000 (395,500–>750,000) | 750,000 (436,500–>750,000) | 750,000 (>750,000) | |||
| Pre-vaccination median CD4+ lymphocyte Count (IQR)h |
2058 (1619–2058) | 2058 (1588–2058) | 1613 (1161–1613) | |||
| Pre-vaccination mean CD4+ lymphocyte % (SD) |
35.66 (8.39) | 36.91 (9.37) | 21.75 (5.84) | |||
| One-month post dose-3 median CD4+ lymphocyte count at (IQR)i |
2212 (1695–2212) | 1845 (1110–1845) | 1957 (798.5–1957) | |||
| One-month post dose-3 mean CD4+ % (SD)i |
40.65 (9.35) | 30.1 (8.89) | 28.09 (9.66) | |||
| Median days (range) to ART initiation relative to PCV1 |
Not undertaken | 0 (−4 to 0) | 40 (7.0 to −71.0)j | 0 days | ||
HUU: HIV non-infected children born to HIV non-infected mothers.
HEU: HIV-uninfected born to HIV-infected mothers.
ART+: HIV-infected children with CD4+ ≥ 25% at enrolment randomized to initiate ART immediately.
ART−: HIV-infected children with CD4+ ≥25% at enrolment randomized to deferred anti-retroviral treatment (ART) arm.
Group-5: HIV infected children with CD4+ cell count <25% started on antiretroviral treatment (ART) at time of first dose of PCV-7.
Blood draw was undertaken just prior to and on the same day of PCV vaccination where applicable.
Includes subjects who received all PCV doses within protocol-defined window periods and available immunogenicity data within 3–6 weeks after 3rd dose of PCV-7.
IQR: interquartile range.
Involve 171, 77 and 8 observations in ART+, ART− and Group-5 children, respectively.
13 (16.8%) of 77 HIV+/ART− children had been initiated on ART at the time of the immunogenicity analysis.