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Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19.
Sadoff, Jerald; Gray, Glenda; Vandebosch, An; Cárdenas, Vicky; Shukarev, Georgi; Grinsztejn, Beatriz; Goepfert, Paul A; Truyers, Carla; Fennema, Hein; Spiessens, Bart; Offergeld, Kim; Scheper, Gert; Taylor, Kimberly L; Robb, Merlin L; Treanor, John; Barouch, Dan H; Stoddard, Jeffrey; Ryser, Martin F; Marovich, Mary A; Neuzil, Kathleen M; Corey, Lawrence; Cauwenberghs, Nancy; Tanner, Tamzin; Hardt, Karin; Ruiz-Guiñazú, Javier; Le Gars, Mathieu; Schuitemaker, Hanneke; Van Hoof, Johan; Struyf, Frank; Douoguih, Macaya.
  • Sadoff J; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Gray G; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Vandebosch A; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Cárdenas V; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Shukarev G; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Grinsztejn B; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Goepfert PA; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Truyers C; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Fennema H; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Spiessens B; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Offergeld K; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Scheper G; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Taylor KL; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Robb ML; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Treanor J; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Barouch DH; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Stoddard J; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Ryser MF; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Marovich MA; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Neuzil KM; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Corey L; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Cauwenberghs N; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Tanner T; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Hardt K; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Ruiz-Guiñazú J; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Le Gars M; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Schuitemaker H; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Van Hoof J; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Struyf F; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
  • Douoguih M; From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J
N Engl J Med ; 384(23): 2187-2201, 2021 06 10.
Article in English | MEDLINE | ID: covidwho-1196903
ABSTRACT

BACKGROUND:

The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation.

METHODS:

In an international, randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned adult participants in a 11 ratio to receive a single dose of Ad26.COV2.S (5×1010 viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe-critical coronavirus disease 2019 (Covid-19) with an onset at least 14 days and at least 28 days after administration among participants in the per-protocol population who had tested negative for SARS-CoV-2. Safety was also assessed.

RESULTS:

The per-protocol population included 19,630 SARS-CoV-2-negative participants who received Ad26.COV2.S and 19,691 who received placebo. Ad26.COV2.S protected against moderate to severe-critical Covid-19 with onset at least 14 days after administration (116 cases in the vaccine group vs. 348 in the placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 to 73.4) and at least 28 days after administration (66 vs. 193 cases; efficacy, 66.1%; adjusted 95% CI, 55.0 to 74.8). Vaccine efficacy was higher against severe-critical Covid-19 (76.7% [adjusted 95% CI, 54.6 to 89.1] for onset at ≥14 days and 85.4% [adjusted 95% CI, 54.2 to 96.9] for onset at ≥28 days). Despite 86 of 91 cases (94.5%) in South Africa with sequenced virus having the 20H/501Y.V2 variant, vaccine efficacy was 52.0% and 64.0% against moderate to severe-critical Covid-19 with onset at least 14 days and at least 28 days after administration, respectively, and efficacy against severe-critical Covid-19 was 73.1% and 81.7%, respectively. Reactogenicity was higher with Ad26.COV2.S than with placebo but was generally mild to moderate and transient. The incidence of serious adverse events was balanced between the two groups. Three deaths occurred in the vaccine group (none were Covid-19-related), and 16 in the placebo group (5 were Covid-19-related).

CONCLUSIONS:

A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe-critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunogenicity, Vaccine / COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: N Engl J Med Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunogenicity, Vaccine / COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: N Engl J Med Year: 2021 Document Type: Article