Safety, immunogenicity and shedding of LAIV4 in HIV-infected and uninfected children.

Abstract

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/μL 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.

• Authors: Donna Curtis, Mariangeli F Ning, Carl Armon, Shaobing Li, Adriana Weinberg
• Journal: Vaccine (Vaccine) Vol. 33 Issue 38 Pg. 4790-7 (Sep 11 2015) ISSN: 1873-2518 [Electronic] Netherlands
• PMID: 26241950 (Publication Type: Clinical Study, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 Elsevier Ltd. All rights reserved.

Chemical References

• Immunoglobulin A
• Influenza Vaccines
• Vaccines, Attenuated

Topics

• Adolescent
• Adult
• Child
• Child, Preschool
• Drug-Related Side Effects and Adverse Reactions (epidemiology, pathology)
• Enzyme-Linked Immunosorbent Assay
• Female
• HIV Infections (complications, immunology)
• Hemagglutination Inhibition Tests
• Humans
• Immunoglobulin A (analysis)
• Influenza Vaccines (administration & dosage, adverse effects, immunology)
• Influenza, Human (prevention & control)
• Male
• Nasopharynx (virology)
• Orthomyxoviridae (isolation & purification)
• Polymerase Chain Reaction
• Vaccines, Attenuated (administration & dosage, adverse effects, immunology)
• Virus Shedding
• Young Adult