Attenuated influenza A vaccine (Alice) in an adult population: vaccine-related illness, serum and nasal antibody production, and intrafamily transmission.

Ninety-five healthy adults, ages 18 to 56 years, received two intranasal doses, 2 weeks apart, of a live, attenuated, influenza type A (H3N2) vaccine (an inhibitor-resistant recombinant strain of A/England/42/72 named "Alice"). Ninety-two persons were given placebos similarly. Ninety-three percent of 68 subjects with initial serum hemagglutination-inhibition (HI) titers of greater than or equal to 1:40 to influenza A (H3N2) had a fourfold or greater antibody increase in postvaccination sera. Forty-four percent of 27 subjects with an initial HI titer of greater than or equal to 1:80 had similar increases. Overall, 77% of vaccinees had fourfold or greater antibody titer increases. Vaccinees had geometric mean serum HI titers (GMT) of 1:26, 1:123, and 1:166 at 0, 14, and 30 days, respectively. The GMTs for placebos were 1:21, 1:22, and 1:21. Thirty-five vaccinees were examined for both serum and nasal antibody; 89% had significant increases in one or both. Nasal antibody response was directly related to the level of initial serum HI titer in that 83% of 12 persons with prevaccination HI titers of 1:80 greater than or equal to 1:80 showed significant nasal antibody rises, whereas only 61% of the remaining 23 subjects with prevaccination HI titers of less than or equal to 1:40 did so. The number and severity of clinical signs and symptoms reported by vaccinees and placebos did not differ significantly. The greatest differences noted between groups were for nasal congestion on days 0 to 6 (8.3%) and rhinitis on days 14 to 20 (5.9%). Four vaccinees shed Alice after primary vaccination, but viral titers were low (10 to 100 tissue culture-infective doses/ml). One member in each of 15 cohabiting male-female couples received Alice while the other received a placebo; one of the placebo members had significant increases in serum and nasal antibody, indicating a possible transmission.

RCT Entities:   Population Interventions Outcomes