Boosting Immune Responses Following Fractional-Dose Inactivated Poliovirus Vaccine: A Randomized, Controlled Trial.
J Infect Dis
; 215(2): 175-182, 2017 Jan 15.
Article
em En
| MEDLINE
| ID: mdl-28073858
ABSTRACT
BACKGROUND:
Fractional-dose administration of inactivated poliovirus vaccine (fIPV) could increase IPV affordability and stretch limited supplies. We assessed immune responses following fIPV administered intradermally, compared with full-dose IPV administered intramuscularly, among adults with a history of oral poliovirus vaccine (OPV) receipt.METHODS:
We conducted a randomized, controlled noninferiority trial in Cuba. fIPV or IPV were administered on days 0 and 28; serum was collected on days 0, 7, 28, and 56 for analysis by a neutralization assay. The primary end point was seroconversion or a ≥4-fold rise in antibody titer. The noninferiority limit was 10%. The secondary end point was safety, assessed by the number and intensity of adverse reactions.RESULTS:
A total of 503 of 534 enrolled participants (94.2%) completed all study requirements. Twenty-eight days after the first dose, 94.8%, 98.0%, and 98.0% of fIPV recipients had an immune response to poliovirus types 1, 2, and 3, respectively, compared with 98.1% (P = .06), 98.0% (P = 1.00), and 99.2% (P = .45) in the IPV arm. Noninferiority was achieved on days 7, 28, and 56 for all serotypes. No serious adverse events were reported.CONCLUSION:
fIPV induced similar boosting immune responses, compared with full-dose IPV. This suggests that fIPV would be an effective strategy to boost population immunity in an outbreak situation. CLINICAL TRIALS REGISTRATION ACTRN12615000305527.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Poliomielite
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Vacina Antipólio de Vírus Inativado
/
Imunização Secundária
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
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Humans
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Male
País/Região como assunto:
Caribe
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Cuba
Idioma:
En
Revista:
J Infect Dis
Ano de publicação:
2017
Tipo de documento:
Article