Fig 1.
CONSORT diagram for VRC 703 clinical trial.
Each group was stratified by age: younger adults (18–50 years) and older adults (51–70 years for IM or 51–64 for ID). All subjects who received at least one vaccination (n = 316) were analyzed for safety and reactogenicity. All subjects who completed the vaccination schedule (n = 299) were also analyzed for immunogenicity.
Table 1.
Vaccine regimens and intervals of each group.
Table 2.
Influenza strains included in the vaccines.
Table 3.
Baseline demographics of participants.
Table 4.
Summary of solicited local reactogenicity after prime and boost vaccination.
Fig 2.
Magnitude and frequency of antibody responses at three weeks after IIV3 administration for DNA-IIV3 prime-boost, IIV3 prime, or concurrent DNA/IIV3 prime.
The antibody responses were measured for the (A) ID route and (B) IM route by hemagglutination inhibition assay (HAI) and are displayed by group geometric mean titers (GMT) or group seroconversion rates for all 2012/13 vaccine strains, with error bars indicating the 95% CI. Comparisons were made between vaccine regimens for each route. Displayed p values for seroconversion rates were calculated based on Fisher’s Exact test, while GMT comparisons were based on pairwise T-test.
Fig 3.
Vaccine regimen comparison of magnitude and frequency of antibody response at 3 weeks post boost.
The GMT and seroconversion rates are shown for antibody responses measured by HAI for all 2012/13 and 2013/14 vaccine strains for the (A) ID route and (B) IM route, with error bars indicating the 95% CI. Comparisons were made between vaccine regimens for each route. Displayed p values for seroconversion rates were calculated based on Fisher’s Exact test, while GMT comparisons were based on pairwise T-test.
Fig 4.
Magnitude and frequency of antibody response at 3 weeks post boost in older adults.
The GMT and seroconversion rates are shown for antibody responses measured by HAI for all 2012/13 and 2013/14 vaccine strains in older adults following (A) ID route and (B) IM route, with error bars indicating the 95% CI. Comparisons were made between vaccine regimens for each route. Displayed p values for seroconversion rates were calculated based on Fisher’s Exact test, while GMT comparisons were based on pairwise T-test.