A Randomized, Double-blind, Placebo-controlled, First-in-Human Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers

The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of Ad26.ZIKV.001 at 2 dose levels, 5*10^10 viral particles (vp) and 1*10^11 vp, administered intramuscularly as single dose and as 2-dose schedules in healthy adults.

Start Date26 Nov 2017

Sponsor / Collaborator

Janssen Vaccines & Prevention BV

100 Clinical Results associated with JNJ-66684657

100 Translational Medicine associated with JNJ-66684657

100 Patents (Medical) associated with JNJ-66684657

Literatures (Medical) associated with JNJ-66684657

01 Jan 2023·Reviews in Medical Virology

Safety and immunogenicity of Zika virus vaccine: A systematic review of clinical trials

Review

Author: Molla, Md. Maruf Ahmed ; Yeasmin, Mahmuda ; Saif‐Ur‐Rahman, K. M. ; Masud, H. M. Abdullah Al

AbstractSeveral phase‐1 clinical trials have been performed to evaluate the safety and efficacy of candidate anti‐Zika vaccines. In this systematic review, we systematically evaluated the safety and immunogenicity of candidate vaccines, which would aid researchers in formulating an effective vaccination strategy for phase‐2 trials based on current evidence. A literature search was conducted using the electronic databases MEDLINE through Pubmed, Web of Science, and Cochrane Database for relevant studies on candidate anti‐zika vaccines. Studies on animal models were excluded from our study. Healthy individuals who were administered candidate Zika vaccines to evaluate the immune response and adverse events (AEs) compared to placebo were considered. Data were extracted, tabulated, and analysed using Microsoft Excel, while the risk of bias plots were generated using tidyverse and Robvis packages in R‐studio. A total of five phase‐1 clinical trials were included in our analysis comprising of studies on inactivated, viral vector, and DNA vaccines. Immunogenicity ranged from 10% to 100% after vaccination with the lowest seroconversion rate (10%) and geometric mean titre (GMT) (6.3; 95% confidence interval (CI):3.7–10.8) observed among recipients of single‐dose inactivated anti‐zika vaccine (ZPIV). For DNA vaccines, the seroconversion rate ranged from 60% to 100% with the highest seroconversion rate (100%) and GMT (2871; 95% CI:705.3–11688) observed among recipients of three shots of high dose GLS‐5700 vaccine. For viral vector vaccine (Ad26.ZIKV.001) seroconversion rate (100%) and GMT peaked after two shots with both low and high‐dose vaccines. In all those studies AEs were mostly local including injection site pain, erythema, and itching. The most common systemic AEs included fever, myalgia, nausea, and fatigue. In phase‐1 clinical trials, all candidate vaccines were found to be highly immunogenic and relatively safe, especially when administered in higher doses and with the help of needle‐free devices.

01 May 2021·Annals of Internal MedicineQ1 · MEDICINE

A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study of Ad26.ZIKV.001, an Ad26-Vectored Anti–Zika Virus Vaccine

Q1 · MEDICINE

Article

Author: Cox, Freek ; Abbink, Peter ; Habets, Marrit N. ; Truyers, Carla ; Cahill, Conor P. ; Leyssen, Maarten ; Barouch, Dan H. ; Modjarrad, Kayvon ; Kanjilal, Diane G. ; Williams, Kristi ; Stephenson, Kathryn E. ; Hendriks, Jenny ; Zahn, Roland C. ; Fierro, Carlos ; Heerwegh, Dirk ; Salisch, Nadine C. ; van der Fits, Leslie ; Larocca, Rafael A. ; De La Barrera, Rafael A. ; Schuitemaker, Hanneke ; Douoguih, Macaya ; van Hoof, Johan ; Liu, Jinyan ; Peter, Lauren

BACKGROUNDZika virus (ZIKV) may cause severe congenital disease after maternal-fetal transmission. No vaccine is currently available.OBJECTIVETo assess the safety and immunogenicity of Ad26.ZIKV.001, a prophylactic ZIKV vaccine candidate.DESIGNPhase 1 randomized, double-blind, placebo-controlled clinical study. (ClinicalTrials.gov: NCT03356561).SETTINGUnited States.PARTICIPANTS100 healthy adult volunteers.INTERVENTIONAd26.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.MEASUREMENTSLocal 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.RESULTSAll 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.LIMITATIONThe study was conducted in a nonendemic area, so it did not assess safety and immunogenicity in a flavivirus-exposed population.CONCLUSIONThe safety and immunogenicity profile makes Ad26.ZIKV.001 a promising candidate for further development if the need reemerges.PRIMARY FUNDING SOURCEJanssen Vaccines and Infectious Diseases.

100 Deals associated with JNJ-66684657

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03356561 (Pubmed \| Ann Intern Med) Manual	Phase 1	Zika Virus Infection	100	Ad26.ZIKV.001 (1-dose regimens)	rocjgxgzvg(qpvupwhmjz) = egrdgtnamr yoesfvjeac (ehqgppwvdx ) View more	Positive	01 May 2021
				Ad26.ZIKV.001 (2-dose regimens)	oebkxviwtp(qvgqxophfy) = sxfgcwpihy nijwikqjua (drxwbsizsq ) View more

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