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Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S.
Sadoff, Jerald; Gray, Glenda; Vandebosch, An; Cárdenas, Vicky; Shukarev, Georgi; Grinsztejn, Beatriz; Goepfert, Paul A; Truyers, Carla; Van Dromme, Ilse; Spiessens, Bart; Vingerhoets, Johan; Custers, Jerome; Scheper, Gert; Robb, Merlin L; Treanor, John; Ryser, Martin F; Barouch, Dan H; Swann, Edith; Marovich, Mary A; Neuzil, Kathleen M; Corey, Lawrence; Stoddard, Jeffrey; Hardt, Karin; Ruiz-Guiñazú, Javier; Le Gars, Mathieu; Schuitemaker, Hanneke; Van Hoof, Johan; Struyf, Frank; Douoguih, Macaya.
Afiliação
  • Sadoff J; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Gray G; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Vandebosch A; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Cárdenas V; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Shukarev G; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Grinsztejn B; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Goepfert PA; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Truyers C; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Van Dromme I; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Spiessens B; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Vingerhoets J; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Custers J; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Scheper G; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Robb ML; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Treanor J; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Ryser MF; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Barouch DH; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Swann E; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Marovich MA; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Neuzil KM; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Corey L; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Stoddard J; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Hardt K; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Ruiz-Guiñazú J; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Le Gars M; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Schuitemaker H; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Van Hoof J; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Struyf F; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
  • Douoguih M; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J
N Engl J Med ; 386(9): 847-860, 2022 03 03.
Article em En | MEDLINE | ID: mdl-35139271
ABSTRACT

BACKGROUND:

The Ad26.COV2.S vaccine was highly effective against severe-critical coronavirus disease 2019 (Covid-19), hospitalization, and death in the primary phase 3 efficacy analysis.

METHODS:

We conducted the final analysis in the double-blind phase of our multinational, randomized, placebo-controlled trial, in which adults were assigned in a 11 ratio to receive single-dose Ad26.COV2.S (5×1010 viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe-critical Covid-19 with onset at least 14 days after administration and at least 28 days after administration in the per-protocol population. Safety and key secondary and exploratory end points were also assessed.

RESULTS:

Median follow-up in this analysis was 4 months; 8940 participants had at least 6 months of follow-up. In the per-protocol population (39,185 participants), vaccine efficacy against moderate to severe-critical Covid-19 at least 14 days after administration was 56.3% (95% confidence interval [CI], 51.3 to 60.8; 484 cases in the vaccine group vs. 1067 in the placebo group); at least 28 days after administration, vaccine efficacy was 52.9% (95% CI, 47.1 to 58.1; 433 cases in the vaccine group vs. 883 in the placebo group). Efficacy in the United States, primarily against the reference strain (B.1.D614G) and the B.1.1.7 (alpha) variant, was 69.7% (95% CI, 60.7 to 76.9); efficacy was reduced elsewhere against the P.1 (gamma), C.37 (lambda), and B.1.621 (mu) variants. Efficacy was 74.6% (95% CI, 64.7 to 82.1) against severe-critical Covid-19 (with only 4 severe-critical cases caused by the B.1.617.2 [delta] variant), 75.6% (95% CI, 54.3 to 88.0) against Covid-19 leading to medical intervention (including hospitalization), and 82.8% (95% CI, 40.5 to 96.8) against Covid-19-related death, with protection lasting 6 months or longer. Efficacy against any severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was 41.7% (95% CI, 36.3 to 46.7). Ad26.COV2.S was associated with mainly mild-to-moderate adverse events, and no new safety concerns were identified.

CONCLUSIONS:

A single dose of Ad26.COV2.S provided 52.9% protection against moderate to severe-critical Covid-19. Protection varied according to variant; higher protection was observed against severe Covid-19, medical intervention, and death than against other end points and lasted for 6 months or longer. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722.).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: COVID-19 / Eficácia de Vacinas / Ad26COVS1 Tipo de estudo: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adolescent / Adult / Humans / Middle aged Idioma: En Revista: N Engl J Med Ano de publicação: 2022 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: COVID-19 / Eficácia de Vacinas / Ad26COVS1 Tipo de estudo: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adolescent / Adult / Humans / Middle aged Idioma: En Revista: N Engl J Med Ano de publicação: 2022 Tipo de documento: Article