학술논문
Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Interim results of a randomised, placebo-controlled, phase 1 trial
Document Type
article
Author
Punnee Pitisuttithum; Viravarn Luvira; Saranath Lawpoolsri; Sant Muangnoicharoen; Supitcha Kamolratanakul; Chaisith Sivakorn; Piengthong Narakorn; Somchaiya Surichan; Sumalee Prangpratanporn; Suttida Puksuriwong; Steven Lamola; Laina D. Mercer; Rama Raghunandan; Weina Sun; Yonghong Liu; Juan Manuel Carreño; Rami Scharf; Weerapong Phumratanaprapin; Fatima Amanat; Luc Gagnon; Ching-Lin Hsieh; Ruangchai Kaweepornpoj; Sarwat Khan; Manjari Lal; Stephen McCroskery; Jason McLellan; Ignacio Mena; Marcia Meseck; Benjaluck Phonrat; Yupa Sabmee; Ratsamikorn Singchareon; Stefan Slamanig; Nava Suthepakul; Johnstone Tcheou; Narumon Thantamnu; Sompone Theerasurakarn; Steven Tran; Thanakrit Vilasmongkolchai; Jessica A White; Nina Bhardwaj; Adolfo Garcia-Sastre; Peter Palese; Florian Krammer; Kittisak Poopipatpol; Ponthip Wirachwong; Richard Hjorth; Bruce L Innis
Source
EClinicalMedicine, Vol 45, Iss , Pp 101323- (2022)
Subject
Language
English
ISSN
2589-5370
Abstract
Summary: Background: Production of affordable coronavirus disease 2019 (COVID-19) vaccines in low- and middle-income countries is needed. NDV-HXP-S is an inactivated egg-based recombinant Newcastle disease virus vaccine expressing the spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It's being developed by public sector manufacturers in Thailand, Vietnam, and Brazil; herein are initial results from Thailand. Methods: This phase 1 stage of a randomised, dose-escalation, observer-blind, placebo-controlled, phase 1/2 trial was conducted at the Vaccine Trial Centre, Mahidol University (Bangkok). Healthy males and non-pregnant females, aged 18–59 years and negative for SARS-CoV-2 antibodies, were eligible. Participants were randomised to receive one of six treatments by intramuscular injection twice, 28 days apart: 1 µg, 1 µg+CpG1018 (a toll-like receptor 9 agonist), 3 µg, 3 µg+CpG1018, 10 µg, or placebo. Participants and personnel assessing outcomes were masked to treatment. The primary outcomes were solicited and spontaneously reported adverse events (AEs) during 7 and 28 days after each vaccination, respectively. Secondary outcomes were immunogenicity measures (anti-S IgG and pseudotyped virus neutralisation). An interim analysis assessed safety at day 57 in treatment-exposed individuals and immunogenicity through day 43 per protocol. ClinicalTrials.gov (NCT04764422). Findings: Between March 20 and April 23, 2021, 377 individuals were screened and 210 were enroled (35 per group); all received dose one; five missed dose two. The most common solicited AEs among vaccinees, all predominantly mild, were injection site pain (