Table 1. Safety Assessment and Virologic Response to 2 Doses of H6N1 Teal HK 97/AA ca Vaccine.
Subjects | No. of Subjects | % infecteda | Virus Detection by Culture in Nasal Wash | Virus Detection by rRT-PCR in Nasal Wash | Symptoms Reported No. with Indicated Illness | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No. Shedding Virusb | Peak Titer mean log10 TCID50/mlc | No. pos. on Day 1 | No. pos. after Day 1 | Duration of shedding mean daysd | Fever | URI | LRI | Ha | Reactogenicity evente | |||
First Dose | 22 | 32 | 0 | 20.6 | 8 | 2f | 1.3 | 0 | 3 | 0 | 6 | 7 |
Second Dose | 18 | 28 | 0 | 20.6 | 6 | 2g | 1.7 | 0 | 5h | 1 | 3 | 6 |
Abbreviations used are as follows: No.=Number, pos.=positive, Ha=headache; URI= Upper respiratory illness (includes rhinorrhea, nasal congestion, cough, pharyngitis) LRI= Lower respiratory illness (includes pneumonia, wheezing, rhonchi)
Infection is defined as shedding of vaccine virus and/or a four fold or greater rise in serum HI antibody titer, serum neutralizing antibody titer, or in serum H6 HA IgG or IgA titer.
Number shedding virus are those participants who had virus recoverable by culture.
Viral titers are expressed as log10 TCID50/ml. Peak titers of 0.6 log10 TCID50/ml were assigned to culture-negative samples.
Mean duration calculated for participants who were rRT-PCR positive.
Reactogenicity events are defined as fever, nasal congestion, rhinorrhea, pharyngitis, cough, otitis media, pneumonia, headache, myalgia, chills, conjunctivitis, wheezing, rhonchi and epistaxis. Transient abnormalities in blood pressure, pulse and respiratory rate are not included here, nor are adverse events that were thought to be unrelated or not likely to be related.
2 participants had virus detected by rRT-PCR days 1 and 2.
1 participant had virus detected by rRT-PCR days 1 and 2, the other on days 1 and 4.
Parainfluenza virus type 3 was detected in nasal washes from 2 participants, and rhinovirus was detected in nasal washes from 1 participant