Single and two-dose typhoid conjugate vaccine safety and immunogenicity in HIV-exposed uninfected and HIV-unexposed uninfected Malawian children.

Autor:	Nampota-Nkomba N; Blantyre Malaria Project, Kamuzu University of Health Sciences, Blantyre, Malawi.; Graduate Program in Life Sciences, University of Maryland School of Medicine, Baltimore, MD, USA., Nyirenda OM; Blantyre Malaria Project, Kamuzu University of Health Sciences, Blantyre, Malawi., Mapemba V; Blantyre Malaria Project, Kamuzu University of Health Sciences, Blantyre, Malawi., Masonga R; Blantyre Malaria Project, Kamuzu University of Health Sciences, Blantyre, Malawi., Patel PD; Malawi-Liverpool-Wellcome Program, Kamuzu University of Health Sciences, Blantyre, Malawi., Misiri T; Malawi-Liverpool-Wellcome Program, Kamuzu University of Health Sciences, Blantyre, Malawi., Mwakiseghile F; Malawi-Liverpool-Wellcome Program, Kamuzu University of Health Sciences, Blantyre, Malawi., Wachepa R; Malawi-Liverpool-Wellcome Program, Kamuzu University of Health Sciences, Blantyre, Malawi., Ndaferankhande JM; Malawi-Liverpool-Wellcome Program, Kamuzu University of Health Sciences, Blantyre, Malawi., Lipenga B; Malawi-Liverpool-Wellcome Program, Kamuzu University of Health Sciences, Blantyre, Malawi., Patel P; Malawi-Liverpool-Wellcome Program, Kamuzu University of Health Sciences, Blantyre, Malawi., Banda H; Malawi-Liverpool-Wellcome Program, Kamuzu University of Health Sciences, Blantyre, Malawi., Oshinsky J; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA., Pasetti MF; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA., Heyderman RS; Malawi-Liverpool-Wellcome Program, Kamuzu University of Health Sciences, Blantyre, Malawi.; Department of Infection, Division of Infectious Diseases, University College London, London, UK., Jamka LP; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA., Hosangadi D; Graduate Program in Life Sciences, University of Maryland School of Medicine, Baltimore, MD, USA., Datta S; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA., Gordon MA; Malawi-Liverpool-Wellcome Program, Kamuzu University of Health Sciences, Blantyre, Malawi.; Malawi-Liverpool-Wellcome Program, University of Liverpool, Liverpool, UK., Neuzil KM; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.; Fogarty International Center, National Institute of Health, Bethesda, MD, USA., Laurens MB; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Jazyk:	angličtina
Zdroj:	Human vaccines & immunotherapeutics [Hum Vaccin Immunother] 2024 Dec 31; Vol. 20 (1), pp. 2384760. Date of Electronic Publication: 2024 Sep 12.
DOI:	10.1080/21645515.2024.2384760
Abstrakt:	Vaccine safety and immunogenicity data in human immunodeficiency virus (HIV)-exposed uninfected (HEU) children are important for decision-making in HIV and typhoid co-endemic countries. In an open-label study, we recruited Malawian HEU and HIV unexposed uninfected (HUU) infants aged 9 - 11 months. HEU participants were randomized to receive Vi-tetanus toxoid conjugate vaccine (Vi-TT) at 9 months, Vi-TT at 15 months, or Vi-TT at 9 and 15 months. HUU participants received Vi-TT at 9 and 15 months. Safety outcomes included solicited and unsolicited adverse events (AE) and serious AEs (SAEs) within 7 days, 28 days, and 6 months of vaccination, respectively. Serum was collected before and at day 28 after each vaccination to measure anti-Vi IgG antibodies by enzyme-linked immunosorbent assay (ELISA). Cohort 1 (66 participants) enrollment began 02 December 2019, and follow-up was terminated before completion due to the COVID-19 pandemic. Cohort 2 (100 participants) enrollment began 25 March 2020. Solicited AEs were mostly mild, with no significant differences between HEU and HUU participants or one- and two-dose groups. All six SAEs were unrelated to vaccination. Anti-Vi geometric mean titers (GMT) increased significantly from 4.1 to 4.6 ELISA units (EU)/mL at baseline to 2572.0 - 4117.6 EU/mL on day 28 post-vaccination, and similarly between HEU and HUU participants for both one- and two-dose schedules. All participants seroconverted (>4-fold increase in GMT) by the final study visit. Our findings of comparable safety and immunogenicity of Vi-TT in HUU and HEU children support country introductions with single-dose Vi-TT in HIV-endemic countries.
Databáze:	MEDLINE
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