PMID- 32307279 OWN - NLM STAT- MEDLINE DCOM- 20210413 LR - 20210413 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 38 IP - 22 DP - 2020 May 8 TI - Short-term immunogenicity and safety of hepatitis-A and varicella vaccines in HIV-exposed uninfected and HIV-unexposed South African children. PG - 3862-3868 LID - S0264-410X(20)30433-3 [pii] LID - 10.1016/j.vaccine.2020.03.045 [doi] AB - 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. CI - Copyright (c) 2020 Elsevier Ltd. All rights reserved. FAU - Mutsaerts, Eleonora A M L AU - Mutsaerts EAML AD - Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands. Electronic address: mutsaertse@rmpru.co.za. FAU - Nunes, Marta C AU - Nunes MC AD - Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. FAU - Bhikha, Sutika AU - Bhikha S AD - Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. FAU - Ikulinda, Benit T AU - Ikulinda BT AD - Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. FAU - Jose, Lisa AU - Jose L AD - Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. FAU - Koen, Anthonet AU - Koen A AD - Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. FAU - Moultrie, Andrew AU - Moultrie A AD - Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. FAU - Grobbee, Diederick E AU - Grobbee DE AD - Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands. FAU - Klipstein-Grobusch, Kerstin AU - Klipstein-Grobusch K AD - Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands; Division of Epidemiology and Biostatistics, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. FAU - Weinberg, Adriana AU - Weinberg A AD - Department of Pediatrics, Medicine and Pathology, Anschutz Medical Center University of Colorado Denver, Aurora, CO, USA. FAU - Madhi, Shabir A AU - Madhi SA AD - Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. LA - eng SI - ClinicalTrials.gov/NCT03330171 PT - Clinical Trial, Phase IV PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20200416 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Viral) RN - 0 (Chickenpox Vaccine) RN - 0 (Hepatitis A Vaccines) RN - 0 (Vaccines, Attenuated) SB - IM MH - Antibodies, Viral/*blood MH - Chickenpox Vaccine/adverse effects/*immunology MH - Child MH - Child, Preschool MH - *HIV Seronegativity MH - Hepatitis A Vaccines/adverse effects/*immunology MH - Herpesvirus 3, Human/immunology MH - Humans MH - *Immunogenicity, Vaccine MH - South Africa MH - Vaccines, Attenuated/adverse effects/immunology OTO - NOTNLM OT - Chickenpox vaccine OT - HIV exposure OT - Hepatitis A vaccines OT - Hepatitis A virus OT - Immunogenicity OT - Varicella zoster virus COIS- Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Weinberg receives research grants from Merck and GSK. Moneys go to the University of Colorado. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2020/04/21 06:00 MHDA- 2021/04/14 06:00 CRDT- 2020/04/21 06:00 PHST- 2019/12/02 00:00 [received] PHST- 2020/03/18 00:00 [revised] PHST- 2020/03/24 00:00 [accepted] PHST- 2020/04/21 06:00 [pubmed] PHST- 2021/04/14 06:00 [medline] PHST- 2020/04/21 06:00 [entrez] AID - S0264-410X(20)30433-3 [pii] AID - 10.1016/j.vaccine.2020.03.045 [doi] PST - ppublish SO - Vaccine. 2020 May 8;38(22):3862-3868. doi: 10.1016/j.vaccine.2020.03.045. Epub 2020 Apr 16.