Safety and immunogenicity of a parenterally administered rotavirus VP8 subunit vaccine in healthy adults.
Vaccine
; 33(31): 3766-72, 2015 Jul 17.
Article
de En
| MEDLINE
| ID: mdl-26065919
ABSTRACT
BACKGROUND:
The P2-VP8 subunit vaccine for the prevention of rotavirus gastroenteritis is comprised of a truncated VP8 subunit protein from the rotavirus Wa strain (G1[P8]) fused to the tetanus toxin P2 epitope, and adsorbed on aluminum hydroxide for intramuscular administration.METHODS:
Three groups of 16 adults were randomized to receive three injections of P2-VP8 (12) or placebo (4) at doses of 10, 30 or 60 µg of vaccine. IgG and IgA antibodies to P2-VP8 were assessed by ELISA in serum and lymphocyte supernatant (ALS). Serum samples were tested for neutralizing antibodies to homologous and heterologous strains of rotavirus.RESULTS:
The vaccine was well-tolerated. All vaccine recipients demonstrated significant IgA responses and all but one demonstrated IgG responses; in the 60 µg cohort, geometric mean titers (GMTs) rose 70- and 80-fold for IgA and IgG, respectively. Homologous neutralizing antibody responses were observed in about half of participants in all three dose cohorts; in the 60 µg cohort, GMTs against Wa rose from 128 to 992. Neutralizing antibody responses were robust to P[8] strains, moderate to P[4] strains and negligible to P[6] strains. ALS IgA responses were dose dependent.CONCLUSIONS:
The P2-VP8 subunit vaccine was well tolerated and evoked promising immune responses. CLINICAL TRIALS REGISTRATION NCT01764256.Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Infections à rotavirus
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Protéines de liaison à l'ARN
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Protéines virales non structurales
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Vaccins anti-rotavirus
/
Gastroentérite
Type d'étude:
Clinical_trials
Limites:
Adolescent
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Adult
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Female
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Humans
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Male
/
Middle aged
Langue:
En
Journal:
Vaccine
Année:
2015
Type de document:
Article