PMID- 26241950 OWN - NLM STAT- MEDLINE DCOM- 20160606 LR - 20150908 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 33 IP - 38 DP - 2015 Sep 11 TI - Safety, immunogenicity and shedding of LAIV4 in HIV-infected and uninfected children. PG - 4790-7 LID - S0264-410X(15)01060-9 [pii] LID - 10.1016/j.vaccine.2015.07.082 [doi] AB - OBJECTIVES: HIV-infected children have poor responses to inactivated influenza vaccines. Live vaccines (LAIVs) are highly efficacious in children, but they are not used in HIV-infected children du e to limited information. We investigated the safety, immunogenicity and viral shedding of LAIV4 in HIV-infected compared with uninfected children. DESIGN: Forty-six HIV-infected and 56 uninfected children 2 to 25 years old, who had been previously vaccinated against influenza, consented to receive a single dose of LAIV4. All grade adverse events (AEs) were recorded in the first month post-vaccination and serious AEs (SAEs) throughout the influenza season. Nasopharyngeal swabs for influenza PCR and IgA ELISA and blood for hemagglutination inhibition antibody (HAI) measurements were collected at entry, 2-5, 7-10 and 21-28 days post-vaccination. RESULTS: The HIV-infected subjects had median CD4+ cells of 649 cells/muL and plasma HIV RNA of 20 copies/mL. AEs were similar in the two groups. There were no vaccine-related SAEs. Shedding of >/=1 vaccine virus was detected in 67% HIV-infected and 50% uninfected participants (p=0.14). HAI titers did not appreciably change, but mucosal IgA antibodies significantly increased post-vaccination in both groups. High baseline HAI and IgA antibody concentrations were associated with decreased viral shedding in controls, but not in HIV-infected subjects. Similar proportions of HIV-infected vaccinees and controls reported influenza-like illnesses (12% and 6%) throughout the season. CONCLUSIONS: LAIV4 was equally safe and immunogenic and caused similar viral shedding in HIV-infected and uninfected children. A correlate of protection against vaccine viral shedding was not identified in HIV-infected participants, although both circulating and mucosal antibodies correlated with protection in controls. CI - Copyright (c) 2015 Elsevier Ltd. All rights reserved. FAU - Curtis, Donna AU - Curtis D AD - University of Colorado Denver, 12700 E 19th Avenue, Room 11126, Aurora, CO 80045, USA. FAU - Ning, Mariangeli F AU - Ning MF AD - University of Colorado Denver, 12700 E 19th Avenue, Room 11126, Aurora, CO 80045, USA. FAU - Armon, Carl AU - Armon C AD - Children's Hospital Colorado, 13123 E 16th Avenue, B055, Aurora, CO 80045, USA. FAU - Li, Shaobing AU - Li S AD - University of Colorado Denver, 12700 E 19th Avenue, Room 11126, Aurora, CO 80045, USA. FAU - Weinberg, Adriana AU - Weinberg A AD - University of Colorado Denver, 12700 E 19th Avenue, Room 11126, Aurora, CO 80045, USA. Electronic address: Adriana.Weinberg@ucdenver.edu. LA - eng GR - UL1 TR001082/TR/NCATS NIH HHS/United States PT - Clinical Study PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20150801 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Immunoglobulin A) RN - 0 (Influenza Vaccines) RN - 0 (Vaccines, Attenuated) SB - IM MH - Adolescent MH - Adult MH - Child MH - Child, Preschool MH - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology MH - Enzyme-Linked Immunosorbent Assay MH - Female MH - HIV Infections/complications/*immunology MH - Hemagglutination Inhibition Tests MH - Humans MH - Immunoglobulin A/analysis MH - Influenza Vaccines/administration & dosage/*adverse effects/*immunology MH - Influenza, Human/*prevention & control MH - Male MH - Nasopharynx/virology MH - Orthomyxoviridae/*isolation & purification MH - Polymerase Chain Reaction MH - Vaccines, Attenuated/administration & dosage/adverse effects/immunology MH - *Virus Shedding MH - Young Adult OTO - NOTNLM OT - Children OT - HIV OT - Immunogenicity OT - Influenza infection OT - Influenza vaccine OT - LAIV4 OT - Safety EDAT- 2015/08/05 06:00 MHDA- 2016/06/09 06:00 CRDT- 2015/08/05 06:00 PHST- 2015/03/03 00:00 [received] PHST- 2015/07/25 00:00 [accepted] PHST- 2015/08/05 06:00 [entrez] PHST- 2015/08/05 06:00 [pubmed] PHST- 2016/06/09 06:00 [medline] AID - S0264-410X(15)01060-9 [pii] AID - 10.1016/j.vaccine.2015.07.082 [doi] PST - ppublish SO - Vaccine. 2015 Sep 11;33(38):4790-7. doi: 10.1016/j.vaccine.2015.07.082. Epub 2015 Aug 1.