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The aim was to determine whether the immunogenicity of an investigational hepatitis B vaccine (spHB) is at least as high as that of a licensed control vaccine, Engerix B®, and to evaluate its safety before inclusion in new pediatric combination vaccines. Two randomized, controlled, blind-observer, Phase 3 trials were performed: one in Argentina (344 participants aged 10–15 years, 10 μg HBsAg/dose) and one in Uruguay (344 participants aged 16–45 years, 20 μg HBsAg/dose). Both vaccines were given in a 0, 1, 6 month schedule to all participants with a baseline anti-Hep B antibody titer <0.6 mIU/mL. Antibody titers were measured pre-dose 1, 1 month after dose 2, pre-dose 3, and 1 month after dose 3. Statistical non-inferiority analyses were performed on seroprotection rates (SP) post-dose 3 (% with anti-Hep B titers ≥10 mIU/mL; delta non-inferiority limit of −10%). In both studies, SP for the spHB vaccine was 100% and the spHB vaccine was non-inferior in terms of SP to the licensed control vaccine. GMTs post-dose 3 were approximately 1.8- and 4.1-fold higher for spHB in the 10–15 year and 16–45 year age groups, respectively. Reactogenicity was low for each vaccine, after each dose. This highly immunogenic hepatitis B candidate vaccine was selected for further investigation as a component of new pediatric combination vaccines. 相似文献
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Leonidas JC; Berdon WE; Valderrama E; Neveling U; Schuval S; Weiss SJ; Hilfer C; Godine L 《Radiology》1996,198(2):377
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JC Sitek† M Loeb‡ JR Ronnevig¶ 《Journal of the European Academy of Dermatology and Venereology》2007,21(7):891-896
BACKGROUND: Since 1997, a number of trials have shown promising results in treating generalized vitiligo with narrowband ultraviolet B (UVB) both in adults and children. However, there is little knowledge concerning the duration and permanency of the treatment-induced repigmentation. OBJECTIVE: Our main objective was to perform a follow-up trial of successfully treated patients receiving narrowband UVB for generalized vitiligo. METHODS: We have investigated to what degree the treatment-induced repigmentation remains stable for up to 2 years post-treatment. We performed an initial open trial including 31 patients with generalized vitiligo. They received narrowband UVB thrice weekly for up to 12 months. Patients experiencing > 75% repigmentation were defined responders and were included in the follow-up trial. Responders were followed every 6 months for up to 2 years after cessation of treatment. We observed the pigmentation status and registered any changes indicating loss of pigmentation and relapse. RESULTS: Eleven of the 31 treated patients were included in the follow-up trial. Six patients had relapse and five patients had stable response 24 months after cessation of treatment. Four out of six relapses were within 6 months post-treatment. CONCLUSION: In our study population of 31 patients with generalized vitiligo, five patients (16%) experienced > 75% stable repigmentation 2 years after cessation of a treatment programme of up to 1 years narrowband UVB therapy. 相似文献
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Ongoing pregnancies after intracytoplasmic injection using cryopreserved testicular spermatozoa 总被引:4,自引:2,他引:2
Perraguin-Jayot S; Audebert A; Emperaire JC; Parneix I 《Human reproduction (Oxford, England)》1997,12(12):2706-2709
We report two clinical pregnancies occurring after intracytoplasmic sperm
injection (ICSI) using cryopreserved spermatozoa obtained from testicular
biopsy, made in two different infertility situations in our clinic. The
first patient showed a secretory azoospermia associated with elevated serum
follicular stimulating hormone (FSH) level and spermiogenesis maturation
arrest. The second patient was affected by azoospermia resulting from
bilateral epididymal obstruction. Spermatozoa present in the wet
preparation of testicular biopsy made on the day of scrotal exploration
were cryopreserved within the testicular tissue for both men.
Intracytoplasmic injections were performed at a later date, using
spermatozoa prepared from frozen-thawed tissues. In each case, three
embryos were obtained and transferred in utero. The transfers resulted in a
twin pregnancy for the first case, and in a singleton pregnancy for the
second. Living foetuses were seen in the ultrasound scan at the 7th week
and both pregnancies are proceeding to date beyond 30 weeks without
complications.
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