Safety and Immunogenicity of an Inactivated Recombinant Newcastle Disease Virus Vaccine Expressing SARS-CoV-2 Spike: A Randomised, Comparator-Controlled, Phase 2 Trial

Publication date: Nov 30, 2023

Abstract: Production of affordable coronavirus disease 2019 (COVID-19) vaccines in low- and lower-middle-income countries is needed. NDV-HXP-S is an inactivated egg-based recombinant Newcastle disease virus vaccine expressing the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A public sector manufacturer in Vietnam assessed the immunogenicity of NDV-HXP-S (COVIVAC) relative to an authorized vaccine. This phase 2 stage of a randomised, observer-blind, controlled, phase 1/2 trial was conducted at three community health centers in Thai Binh Province, Vietnam. Healthy males and non-pregnant females, 18 years of age and older, were eligible. Participants were randomised by age (18-59, [≥] 60 years) to receive one of three treatments by intramuscular injection twice, 28 days apart: COVIVAC at 3 g or 6 g, or AstraZeneca COVID-19 vaccine VAXZEVRIA. Participants and personnel assessing outcomes were masked to treatment. The main outcome was the induction of 50% neutralising antibody titers against vaccine-homologous pseudotyped virus 14 days (day 43) and 6 months (day 197) after the second vaccination by age group. The primary immunogenicity and safety analyses included all participants who received one dose of the vaccine. ClinicalTrials.gov NCT05940194. During August 10-23, 2021, 737 individuals were screened, and 374 were randomised (124-125 per group); all received dose one, and three missed dose two. On day 43, the geometric mean fold rise of 50% neutralising antibody titers for subjects age 18-59 years was 31.20 (COVIVAC 3 g N=82, 95% CI 25.14-38.74), 35.80 (COVIVAC 6 g ; N=83, 95% CI 29.03-44.15), 18.85 (VAXZEVRIA; N=82, 95% CI 15.10-23.54), and for subjects age [≥] 60 years was 37.27 (COVIVAC 3 g ; N=42, 95% CI 27.43-50.63), 50.10 (COVIVAC 6 g ; N=40, 95% CI 35.46-70.76), 16.11 (VAXZEVRIA; N=40, 95% CI 11.73-22.13). Among subjects seronegative for anti-S IgG at baseline, the day 43 geometric mean titer ratio of neutralising antibody (COVIVC 6 g/VAXZEVRIA) was 1.77 (95% CI 1.30-2.40) for subjects age 18-59 years and 3.24 (95% CI 1.98-5.32) for subjects age [≥] 60 years. On day 197, the age-specific ratios were 1.11 (95% CI 0.51-2.43) and 2.32 (0.69-7.85). Vaccines were well tolerated; reactogenicity was predominantly mild and transient. The percentage of subjects with unsolicited adverse events (AEs) during 28 days after vaccinations was similar among treatments (COVIVAC 3 g 29.0%, COVIVAC 6 g 23.2%, VAXZEVRIA 31.2%); no vaccine-related AE was reported. Considering that induction of neutralising antibodies against SARS-CoV-2 has been correlated with the efficacy of COVID-19 vaccines, including VAXZEVRIA, our results suggest that vaccination with COVIVAC may afford clinical benefit matching or exceeding that of the VAXZEVRIA vaccine.

Concepts Keywords
75n93019c00065 Antibody
Affordable Cov
Baker Covid
Cancer Covivac
Vietnam Dose
Medrxiv
Neutralising
Preprint
Sars
Specific
Spike
Subjects
Vaccine
Vaccines
Vaxzevria

Semantics

Type Source Name
disease VO Newcastle disease virus vaccine
disease IDO production
disease MESH coronavirus disease 2019
disease VO NDV-HXP-S
disease VO Severe acute respiratory syndrome coronavirus 2
disease VO CoviVac
disease VO vaccine
disease VO injection
disease VO COVID-19 vaccine
disease VO vaccination
disease VO dose
disease VO titer
disease VO USA
disease IDO cell
drug DRUGBANK 3 6-Dihydroxy-Xanthene-9-Propionic Acid
disease VO population
disease MESH infection
disease VO vaccine efficacy
disease VO influenza vaccines
drug DRUGBANK Proline
drug DRUGBANK Etoperidone
disease IDO history
disease IDO immunodeficiency
disease VO vaccine dose
disease VO protocol
drug DRUGBANK Aspartame
disease MESH Influenza
disease IDO blood
drug DRUGBANK Nitrogen
disease MESH erythema
disease MESH arthralgia
disease MESH causality
disease IDO assay
disease VO Canada
disease VO organization
disease VO antibody titer
disease IDO facility
drug DRUGBANK Methylergometrine
drug DRUGBANK Formaldehyde
disease IDO adaptive immune response
drug DRUGBANK Dimethyl sulfoxide
disease MESH infectious diseases
disease VO vaccination frequency
disease MESH emergency
disease VO adverse event
disease VO report
disease IDO symptom
disease MESH intestinal obstruction
disease MESH sialadenitis
disease MESH leukemia
disease MESH colon cancer
disease MESH gastric cancer
pathway KEGG Gastric cancer
disease VO vaccinated
disease VO frequency
disease IDO site
disease VO Corbevax
disease VO VLA2001
disease VO immunization
disease VO Viruses
disease VO effectiveness
drug DRUGBANK Methionine
disease VO viable
drug DRUGBANK Stanolone
disease VO Eae
disease VO company
drug DRUGBANK Nitrazepam
disease VO immunized
drug DRUGBANK Deoxythymidine

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