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Group B streptococcus vaccination in pregnant women with or without HIV in Africa: a non-randomised phase 2, open-label, multicentre trial.

Heyderman RS, Madhi SA, French N, Cutland C, Ngwira B, Kayambo D, Mboizi R, Koen A, Jose L, Olugbosi M, Wittke F, Slobod K, Dull PM - Lancet Infect Dis (2016)

Bottom Line: We aimed to compare safety and immunogenicity of trivalent glycoconjugate GBS vaccine in pregnant women with and without HIV in Malawi and South Africa.The primary outcomes were safety in mothers and infants and the amount of placental transfer of GBS serotype-specific antibodies from mothers to their infants.The vaccine was less immunogenic in women infected with HIV than it was in those not infected, irrespective of CD4 cell count, resulting in lower levels of serotype-specific maternal antibody transferred to infants, which could reduce vaccine protection against invasive GBS disease.

View Article: PubMed Central - PubMed

Affiliation: Malawi Liverpool Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi; Division of Infection and Immunity, University College London, London, UK. Electronic address: r.heyderman@ucl.ac.uk.

No MeSH data available.


Related in: MedlinePlus

Study profileMost participants who did not complete the study were from the Malawi site, with the exception of the two women who relocated: one woman in the high CD4 cell count group who was lost to follow-up after delivery and one infant in the high CD4 cell count group who died between birth and day 42.
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fig1: Study profileMost participants who did not complete the study were from the Malawi site, with the exception of the two women who relocated: one woman in the high CD4 cell count group who was lost to follow-up after delivery and one infant in the high CD4 cell count group who died between birth and day 42.

Mentions: Of 398 women screened across two sites in Malawi and South Africa, 270 women and their infants were enrolled in the study between Sept 26, 2011, and Dec 4, 2012: 90 without HIV (45 from each country), 89 with HIV and high CD4 cell counts (44 from Malawi and 45 from South Africa), and 91 with HIV and low CD4 cell counts (46 from Malawi and 45 from South Africa; figure). 254 (94%) women completed the study across the three groups; seven were lost to follow-up, six withdrew consent, one died, and two relocated away from the study area. 256 (96%) of 266 infants enrolled completed the study across the groups. 270 mothers were enrolled in the study but only 260 remained in the study at delivery, five of whom had twins, resulting in 265 livebirths. One mother died during labour and had a stillbirth that was included in the enrolled infants (n=266). Reasons for withdrawal were death or stillbirth (n=8), and loss to follow-up (n=2).


Group B streptococcus vaccination in pregnant women with or without HIV in Africa: a non-randomised phase 2, open-label, multicentre trial.

Heyderman RS, Madhi SA, French N, Cutland C, Ngwira B, Kayambo D, Mboizi R, Koen A, Jose L, Olugbosi M, Wittke F, Slobod K, Dull PM - Lancet Infect Dis (2016)

Study profileMost participants who did not complete the study were from the Malawi site, with the exception of the two women who relocated: one woman in the high CD4 cell count group who was lost to follow-up after delivery and one infant in the high CD4 cell count group who died between birth and day 42.
© Copyright Policy - CC BY
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4835545&req=5

fig1: Study profileMost participants who did not complete the study were from the Malawi site, with the exception of the two women who relocated: one woman in the high CD4 cell count group who was lost to follow-up after delivery and one infant in the high CD4 cell count group who died between birth and day 42.
Mentions: Of 398 women screened across two sites in Malawi and South Africa, 270 women and their infants were enrolled in the study between Sept 26, 2011, and Dec 4, 2012: 90 without HIV (45 from each country), 89 with HIV and high CD4 cell counts (44 from Malawi and 45 from South Africa), and 91 with HIV and low CD4 cell counts (46 from Malawi and 45 from South Africa; figure). 254 (94%) women completed the study across the three groups; seven were lost to follow-up, six withdrew consent, one died, and two relocated away from the study area. 256 (96%) of 266 infants enrolled completed the study across the groups. 270 mothers were enrolled in the study but only 260 remained in the study at delivery, five of whom had twins, resulting in 265 livebirths. One mother died during labour and had a stillbirth that was included in the enrolled infants (n=266). Reasons for withdrawal were death or stillbirth (n=8), and loss to follow-up (n=2).

Bottom Line: We aimed to compare safety and immunogenicity of trivalent glycoconjugate GBS vaccine in pregnant women with and without HIV in Malawi and South Africa.The primary outcomes were safety in mothers and infants and the amount of placental transfer of GBS serotype-specific antibodies from mothers to their infants.The vaccine was less immunogenic in women infected with HIV than it was in those not infected, irrespective of CD4 cell count, resulting in lower levels of serotype-specific maternal antibody transferred to infants, which could reduce vaccine protection against invasive GBS disease.

View Article: PubMed Central - PubMed

Affiliation: Malawi Liverpool Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi; Division of Infection and Immunity, University College London, London, UK. Electronic address: r.heyderman@ucl.ac.uk.

No MeSH data available.


Related in: MedlinePlus