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For both vaccines, the antibody titers were significantly higher after the third dose compared to the first two doses.
For each RTS,S vaccine formulation, reactogenicity seen after the first two doses in the three vaccine schedule groups was similar.
Of the RSV FTM- protein and of the H5 hemagglutinin, 40 µg were used for the first two doses and 20 µg for the following four doses.
The first two doses will be given at the hospital (Psychiatric Center Glostrup).
Accelerated or rapid schedules, used in emergency situations, are based mainly on reduced intervals between the first two doses.
The first two doses were administered on consecutive days, and the following six doses given every other day.
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No DLTs occurred at the first two dose levels (1.0/60 and 1.0/75 mg m−2).
Between the first two dose groups the risk increases linearly and is flat between the second and the fifth.
In the absence of dose-limiting toxicities, only three patients were to be treated at the first two dose levels.
Twenty-nine patients completed vaccination and 72-week study follow-up (Fig. 1).> Safety evaluation in the first two dose groups has been reported [ 24].
An additional dose (2.8 mg) was to be evaluated after at least three patients in the 2.1 mg cohort had been assessed for toxicity over 12 weeks of treatment, provided MTD was not reached at the first two dose levels.
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