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. Author manuscript; available in PMC: 2010 Jan 11.
Published in final edited form as: J Infect Dis. 2009 Mar 1;199(5):711–716. doi: 10.1086/596558

Table 1. Clinical and virologic responses to 1 or 2 107.0-TCID50 doses of H9N2 reassortant influenza vaccine (A chicken/Hong Kong/G9/97 × A/Ann Arbor/6/60 ca).

Category Total
Participants,
no.		 participants
infecteda, %		 Detection of virus in NW
By culture
 By rRT-PCR
Participants,
%		 Duration,b
mean (SD),
days		 Peak titer,
mean (SD), log10
TCID50/mLc 		Participants,
%		 Duration,b
mean (SD),
days		 Participants with illness,d %
Fever URI LRI Cough OM SI HA
H9N2 seropositivee
 Dose 1 9 11 0 0 ≤0.6 22 1.0 (0.0) 0 0 0 0 0 11 33
 Dose 2 3 67 0 0 ≤0.6 33 1.0 0 0 0 0 0 33 33
H9N2 seronegativee
 Dose 1 41 39 5 1.0 (0.0) 1.0 (0.4)* 37 1.1 (0.2) 2 10 0 2 0 7 24
 Dose 2 24 75 0 0 ≤0.6 8 1.5 (0.7) 0 0 0 0 0 0 13

NOTE. HA, headache; LRI, lower-respiratory-tract illness; NW, nasal wash; OM, otitis media; rRT-PCR, real-time reverse-transcriptase polymerase chain reaction; SI, systemic illness (defined as chills and/or myalgias in more than 1 muscle group); URI, upper respiratory tract illness (rhinorrhea).

a

Infection after immunization with the H9N2 G9/AA ca reassortant vaccine was defined as (1) shedding of vaccine virus detected by culture and/or (2) shedding of vaccine virus detected by rRT-PCR, at any time after study day 1 and/or (3) ≥4-fold increase in serum HI or in either neutralizing or H9 IgG antibodies. Participants whose NW specimens were positive by rRT-PCR on study day 1 only but who did not have evidence of infection were not considered to be infected, because this occurred frequently and we could not exclude the possibility that input virus was being detected.

b

For those individuals whose NW specimens were positive for vaccine virus.

c

Culture-negative specimens were assigned a titer of 100.6 TCID50/mL.

d

Following dose 1, 1 H9-seronegative participant (2%) had conjunctivitis. Following dose 2, 1 H9-seronegative participant (4%) had an episode of epistaxis.

e

Individuals were considered (on study day 0) to be H9N2 seropositive if their titers of serum HI to the vaccine virus were >1:8 and were considered to be H9N2 seronegative if their titers were ≤1:8. A total of 9 H9N2-seropositive and 41 H9N2-seronegative individuals received dose 1 of vaccine; of these, 3 H9N2-seropositive and 24 H9N2-seronegative individuals received dose 2 of vaccine.