Safety and immunogenicity of a monovalent 2009 influenza A/H1N1v vaccine adjuvanted with AS03A or unadjuvanted in HIV-infected adults: a randomized, controlled trial.
J Infect Dis
; 204(1): 124-34, 2011 Jul 01.
Article
em En
| MEDLINE
| ID: mdl-21628666
ABSTRACT
BACKGROUND:
Human immunodeficiency virus (HIV)-infected patients have decreased immune response to vaccines. Few data are available about pandemic flu vaccination in this population.METHODS:
We conducted a multicenter, patient-blinded, randomized trial in a cohort of HIV-infected adults. Patients received 2 injections 21 days apart of a AS03(A)-adjuvanted H1N1v vaccine containing 3.75 µg hemagglutinin (HA) or a nonadjuvanted H1N1v vaccine containing 15 µg HA to assess hemagglutination inhibition (HI) response and safety.RESULTS:
A total of 309 patients were randomized, and 306 were vaccinated. After the first vaccine dose, HI titers ≥140 were observed in 93.4% of the patients in the adjuvanted group (A group) (n = 155) and in 75.5% in the nonadjuvanted group (B group) (n = 151) (P < .001); seroconversion rates were 88.8% and 71.2%, and factor increases in geometric mean titers (GMT) of 21.9 and 15.1, respectively. After 2 injections, 98.6% of patients of the A group and 92.1% of the B group demonstrated HI titers ≥140 (P = .018); seroconversion rates were 96.5% and 87.1%, respectively, and factor increases in GMT were 45.5 and 21.2, respectively. The majority of adverse events were mild to moderate in severity; no impact on CD4+ cell count or viral load has been detected.CONCLUSIONS:
In HIV-1-infected adults, the AS03(A)-adjuvanted H1N1v vaccine yielded a higher immune response than did the nonadjuvanted one, with no impact on HIV infection.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Esqualeno
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Vacinas contra Influenza
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Infecções por HIV
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Adjuvantes Imunológicos
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Influenza Humana
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Vírus da Influenza A Subtipo H1N1
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2011
Tipo de documento:
Article