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A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study of Ad26.ZIKV.001, an Ad26-Vectored Anti-Zika Virus Vaccine.
Salisch, Nadine C; Stephenson, Kathryn E; Williams, Kristi; Cox, Freek; van der Fits, Leslie; Heerwegh, Dirk; Truyers, Carla; Habets, Marrit N; Kanjilal, Diane G; Larocca, Rafael A; Abbink, Peter; Liu, Jinyan; Peter, Lauren; Fierro, Carlos; De La Barrera, Rafael A; Modjarrad, Kayvon; Zahn, Roland C; Hendriks, Jenny; Cahill, Conor P; Leyssen, Maarten; Douoguih, Macaya; van Hoof, Johan; Schuitemaker, Hanneke; Barouch, Dan H.
  • Salisch NC; Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).
  • Stephenson KE; Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).
  • Williams K; Janssen Research and Development, Spring House, Pennsylvania (K.W.).
  • Cox F; Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).
  • van der Fits L; Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).
  • Heerwegh D; Janssen Research and Development, Beerse, Belgium (D.H., C.T.).
  • Truyers C; Janssen Research and Development, Beerse, Belgium (D.H., C.T.).
  • Habets MN; Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).
  • Kanjilal DG; Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).
  • Larocca RA; Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).
  • Abbink P; Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).
  • Liu J; Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).
  • Peter L; Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).
  • Fierro C; Johnson County Clin-Trials, Lenexa, Kansas (C.F.).
  • De La Barrera RA; Walter Reed Army Institute of Research, Silver Spring, Maryland (R.A.D., K.M.).
  • Modjarrad K; Walter Reed Army Institute of Research, Silver Spring, Maryland (R.A.D., K.M.).
  • Zahn RC; Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).
  • Hendriks J; Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).
  • Cahill CP; Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).
  • Leyssen M; Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).
  • Douoguih M; Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).
  • van Hoof J; Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).
  • Schuitemaker H; Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).
  • Barouch DH; Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).
Ann Intern Med ; 174(5): 585-594, 2021 05.
Article in English | MEDLINE | ID: covidwho-1248392
ABSTRACT

BACKGROUND:

Zika virus (ZIKV) may cause severe congenital disease after maternal-fetal transmission. No vaccine is currently available.

OBJECTIVE:

To assess the safety and immunogenicity of Ad26.ZIKV.001, a prophylactic ZIKV vaccine candidate.

DESIGN:

Phase 1 randomized, double-blind, placebo-controlled clinical study. (ClinicalTrials.gov NCT03356561).

SETTING:

United States.

PARTICIPANTS:

100 healthy adult volunteers. INTERVENTION Ad26.ZIKV.001, an adenovirus serotype 26 vector encoding ZIKV M-Env, administered in 1- or 2-dose regimens of 5 × 1010 or 1 × 1011 viral particles (vp), or placebo. MEASUREMENTS Local and systemic adverse events; neutralization titers by microneutralization assay (MN50) and T-cell responses by interferon-γ enzyme-linked immunospot and intracellular cytokine staining; and protectivity of vaccine-induced antibodies in a subset of participants through transfer in an exploratory mouse ZIKV challenge model.

RESULTS:

All regimens were well tolerated, with no safety concerns identified. In both 2-dose regimens, ZIKV neutralizing titers peaked 14 days after the second vaccination, with geometric mean MN50 titers (GMTs) of 1065.6 (95% CI, 494.9 to 2294.5) for 5 × 1010 vp and 956.6 (595.8 to 1535.8) for 1 × 1011 vp. Titers persisted for at least 1 year at a GMT of 68.7 (CI, 26.4-178.9) for 5 × 1010 vp and 87.0 (CI, 29.3 to 258.6) for 1 × 1011 vp. A 1-dose regimen of 1 × 1011 vp Ad26.ZIKV.001 induced seroconversion in all participants 56 days after the first vaccination (GMT, 103.4 [CI, 52.7 to 202.9]), with titers persisting for at least 1 year (GMT, 90.2 [CI, 38.4 to 212.2]). Env-specific cellular responses were induced. Protection against ZIKV challenge was observed after antibody transfer from participants into mice, and MN50 titers correlated with protection in this model.

LIMITATION:

The study was conducted in a nonendemic area, so it did not assess safety and immunogenicity in a flavivirus-exposed population.

CONCLUSION:

The safety and immunogenicity profile makes Ad26.ZIKV.001 a promising candidate for further development if the need reemerges. PRIMARY FUNDING SOURCE Janssen Vaccines and Infectious Diseases.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Viral Vaccines / Zika Virus Infection Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Animals / Female / Humans / Male Country/Region as subject: North America Language: English Journal: Ann Intern Med Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Viral Vaccines / Zika Virus Infection Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Animals / Female / Humans / Male Country/Region as subject: North America Language: English Journal: Ann Intern Med Year: 2021 Document Type: Article