tetano
Editor, Senior Moderator
Hum Vaccin Immunother
. 2025 Dec;21(1):2450120.
doi: 10.1080/21645515.2025.2450120. Epub 2025 Jan 27. Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial
Jelena Tica[SUP] 1 [/SUP], Veronica V Rezelj[SUP] 2 [/SUP], Benoit Baron[SUP] 3 [/SUP], Vitalija van Paassen[SUP] 3 [/SUP], Javier Zaidman[SUP] 4 [/SUP], Lee Fairlie[SUP] 5 [/SUP], Gert Scheper[SUP] 6 [/SUP], Mathieu Le Gars[SUP] 2 [/SUP], Frank Struyf[SUP] 7 [/SUP], Macaya Douoguih[SUP] 8 [/SUP], Javier Ruiz-Guiñazú[SUP] 9 [/SUP]; COV3006 study group; COV3006 Study Group Collaborators
Collaborators, Affiliations
We conducted a randomized, Phase 2 trial to assess the safety and humoral immunogenicity of reduced doses/dose volume of the standard dose of Ad26.COV2.S COVID-19 vaccine (5 × 10[SUP]10[/SUP] viral particles [vp]) in healthy adolescents aged 12-17 years. Participants were randomly assigned to receive Ad26.COV2.S at reduced dose levels of 0.625 × 10[SUP]10[/SUP] (0.5 mL), 1.25 × 10[SUP]10[/SUP] (0.5 mL) or 2.5 × 10[SUP]10[/SUP] (0.5 mL or low volume 0.25 mL) vp in a 1- or 2-dose (56-day interval) primary schedule. Adolescents who received a 1-dose primary schedule received a 2.5 × 10[SUP]10[/SUP] vp booster dose 6 months later. Safety and humoral immunogenicity were assessed up to 6 months post-last vaccination. All regimens were well tolerated, with no safety concerns identified. Local and systemic solicited AEs in adolescents were consistent with the known safety profile in adults. All 1- and 2-dose Ad26.COV2.S primary schedules elicited robust peak Spike-binding antibody responses and virus neutralizing titers against the reference strain, in participants with and without preexisting SARS-CoV-2 immunity. Immune responses were durable for at least 6 months. Spike-binding antibody responses were comparable to those elicited in young adults aged 18-25 years who received a standard dose of Ad26.COV2.S in Phase 3 efficacy studies Reduced doses/dose volume of Ad26.COV2.S had an acceptable safety profile and elicited robust humoral immune responses in adolescents aged 12-17 years. All 1- and 2-dose schedules elicited Spike-binding antibody responses that were comparable to an adult population in whom efficacy has been demonstrated using a higher vaccine dose. (clinicaltrials.gov NCT05007080).
Keywords: Ad26.COV2.S; COVID-19 vaccine; adolescent; dose-range study; immunogenicity; safety; shelf life; virus vector vaccine.
. 2025 Dec;21(1):2450120.
doi: 10.1080/21645515.2025.2450120. Epub 2025 Jan 27. Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial
Jelena Tica[SUP] 1 [/SUP], Veronica V Rezelj[SUP] 2 [/SUP], Benoit Baron[SUP] 3 [/SUP], Vitalija van Paassen[SUP] 3 [/SUP], Javier Zaidman[SUP] 4 [/SUP], Lee Fairlie[SUP] 5 [/SUP], Gert Scheper[SUP] 6 [/SUP], Mathieu Le Gars[SUP] 2 [/SUP], Frank Struyf[SUP] 7 [/SUP], Macaya Douoguih[SUP] 8 [/SUP], Javier Ruiz-Guiñazú[SUP] 9 [/SUP]; COV3006 study group; COV3006 Study Group Collaborators
Collaborators, Affiliations
- PMID: 39868766
- DOI: 10.1080/21645515.2025.2450120
We conducted a randomized, Phase 2 trial to assess the safety and humoral immunogenicity of reduced doses/dose volume of the standard dose of Ad26.COV2.S COVID-19 vaccine (5 × 10[SUP]10[/SUP] viral particles [vp]) in healthy adolescents aged 12-17 years. Participants were randomly assigned to receive Ad26.COV2.S at reduced dose levels of 0.625 × 10[SUP]10[/SUP] (0.5 mL), 1.25 × 10[SUP]10[/SUP] (0.5 mL) or 2.5 × 10[SUP]10[/SUP] (0.5 mL or low volume 0.25 mL) vp in a 1- or 2-dose (56-day interval) primary schedule. Adolescents who received a 1-dose primary schedule received a 2.5 × 10[SUP]10[/SUP] vp booster dose 6 months later. Safety and humoral immunogenicity were assessed up to 6 months post-last vaccination. All regimens were well tolerated, with no safety concerns identified. Local and systemic solicited AEs in adolescents were consistent with the known safety profile in adults. All 1- and 2-dose Ad26.COV2.S primary schedules elicited robust peak Spike-binding antibody responses and virus neutralizing titers against the reference strain, in participants with and without preexisting SARS-CoV-2 immunity. Immune responses were durable for at least 6 months. Spike-binding antibody responses were comparable to those elicited in young adults aged 18-25 years who received a standard dose of Ad26.COV2.S in Phase 3 efficacy studies Reduced doses/dose volume of Ad26.COV2.S had an acceptable safety profile and elicited robust humoral immune responses in adolescents aged 12-17 years. All 1- and 2-dose schedules elicited Spike-binding antibody responses that were comparable to an adult population in whom efficacy has been demonstrated using a higher vaccine dose. (clinicaltrials.gov NCT05007080).
Keywords: Ad26.COV2.S; COVID-19 vaccine; adolescent; dose-range study; immunogenicity; safety; shelf life; virus vector vaccine.