{Reference Type}: Journal Article
{Title}: Immunogenicity, reactogenicity, and safety of a second booster with BNT162b2 or full-dose mRNA-1273: A randomized VACCELERATE trial in adults aged ≥75 years (EU-COVAT-1-AGED Part B).
{Author}: Stemler J;Yeghiazaryan L;Stephan C;Mohn KG;Carcas-Sansuan AJ;Rodriguez ER;Moltó J;Mitxeltorena IV;Welte T;Zablockienė B;Akova M;Bethe U;Heringer S;Salmanton-García J;Jeck J;Tischmann L;Zarrouk M;Cüppers A;Biehl LM;Grothe J;Mellinghoff SC;Nacov JA;Neuhann JM;Sprute R;Frías-Iniesta J;Negi R;Gaillard C;Saini G;León AG;Mallon PWG;Lammens C;Hotterbeekx A;Loens K;Malhotra-Kumar S;Goossens H;Kumar-Singh S;König F;Posch M;Koehler P;Cornely OA; ;
{Journal}: Int J Infect Dis
{Volume}: 146
{Issue}: 0
{Year}: 2024 Sep 9
{Factor}: 12.074
{DOI}: 10.1016/j.ijid.2024.107161
{Abstract}: <B>OBJECTIVE: </B>To assess the safety and immunogenicity of a fourth vaccination (second booster) in individuals aged ≥75 years.<BR><B>METHODS: </B>Participants were randomized to BNT162b2 (Comirnaty, 30 µg) or messenger RNA (mRNA)-1273 (Spikevax, 100 µg). The primary end point was the rate of two-fold antibody titer increase 14 days after vaccination, targeting the receptor binding domain (RBD) region of wild-type SARS-CoV-2. The secondary end points included changes in neutralizing activity against wild-type and 25 variants. Safety was assessed by monitoring solicited adverse events (AEs) for 7 days.<BR><B>RESULTS: </B>A total of 269 participants (mean age 81 years, mRNA-1273 n = 135/BNT162b2 n = 134) were included. Two-fold anti-RBD immunoglobulin (Ig) G titer increase was achieved by 101 of 129 (78%) and 116 of 133 (87%) subjects in the BNT162b2 and the mRNA-1273 group, respectively (P = 0.054). A second booster of mRNA-1273 provided higher anti-RBD IgG geometric mean titer: 21.326 IU/mL (95% confidence interval: 18.235-24.940) vs BNT162b2: 15.181 IU/mL (95% confidence interval: 13.172-17.497). A higher neutralizing activity was noted for the mRNA-1273 group. The most frequent AE was pain at the injection site (51% in mRNA-1273 and 48% in BNT162b2). Participants in the mRNA-1273 group had less vaccine-related AEs (30% vs 39%).<BR><B>CONCLUSIONS: </B>A second booster of either BNT162b2 or mRNA-1273 provided substantial IgG increase. Full-dose mRNA-1273 provided higher IgG levels and neutralizing capacity against SARS-CoV-2, with similar safety profile for subjects of advanced age.