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DOI 10.1016/j.vaccine.2020.03.045

Медицинская библиотека · Vaccine · 2020

Short-term immunogenicity and safety of hepatitis-A and varicella vaccines in HIV-exposed uninfected and HIV-unexposed South African children.

Mutsaerts Eleonora A M L, Nunes Marta C, Bhikha Sutika, Ikulinda Benit T, Jose Lisa, Koen Anthonet, Moultrie Andrew, Grobbee Diederick E, Klipstein-Grobusch Kerstin, Weinberg Adriana, Madhi Shabir A

Клиническое исследование IV фазыСтатьяПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

BACKGROUND

HIV-exposed uninfected (HEU) children have increased risk of infectious morbidity during early childhood. We evaluated the short-term immunogenicity and safety of single dose inactivated hepatitis-A virus (HAV) vaccine and live attenuated varicella zoster virus (VZV) vaccine in South African children.

METHODS

195 HIV-unexposed and 64 HEU children received either one dose of HAV or VZV vaccine at 18 months of age. Blood samples were tested for hepatitis-A or VZV antibodies before and one month after vaccination by chemiluminescent microparticle immunoassay and enzyme-linked immunosorbent assay, respectively. All children were evaluated for solicited adverse events (AEs).

RESULTS

One-month post-vaccination, a similar percentage of HIV-unexposed (91.8%) and HEU (82.9%) children were seropositive for hepatitis-A (p = 0.144). VZV antibody geometric mean fold-rise was also similar in HIV-unexposed (5.6; 95%CI: 4.6-6.7) and HEU children (5.1; 95%CI: 3.7-7.2); however, only 44% HIV-unexposed and HEU seroconverted (titers > 50 mIU/ml). AEs occurred with similar frequency and severity between groups, except for more systemic AEs after VZV vaccination in HEU than HIV-unexposed children.

CONCLUSIONS

Single dose HAV and VZV vaccine was similarly immunogenic in HIV-unexposed and HEU children. We did not identify differences in short-term humoral immunity after administration of either a live attenuated or inactivated vaccine. Seroconversion rates after a single dose of VZV vaccine were, however, lower compared to reports from previous studies (85-89%).

CLINICAL TRIALS REGISTRATION: NCT03330171.

Для цитирования: Mutsaerts Eleonora A M L, Nunes Marta C, Bhikha Sutika, Ikulinda Benit T, Jose Lisa, Koen Anthonet, Moultrie Andrew, Grobbee Diederick E, Klipstein-Grobusch Kerstin, Weinberg Adriana, Madhi Shabir A. Short-term immunogenicity and safety of hepatitis-A and varicella vaccines in HIV-exposed uninfected and HIV-unexposed South African children.. Vaccine. 2020. DOI: 10.1016/j.vaccine.2020.03.045.

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