A Study to Evaluate Safety and Immunogenicity of DelNS1-nCoV-RBD LAIV for COVID-19

NCT04809389 | Unknown Phase 1

• 1 other identifier: CTC2038
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the safety and immunogenicity profile of of a novel nasal spray investigational vaccine, which is a potential prophylactic vaccine for current pandemic disease COVID-19.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• The cumulative incidence of reactogenicity for all the subjects received at least 1 dose of investigational medicinal product (IMP), regardless of whether the subject withdrew early, delayed/missed the second dose or received any antipyretic.

  Reactogenicity: Occurrence of solicited local events (nasal irritation, sneezing, nasal congestion, cough, sore throat, change in smell, change in taste, change in vision and eye pain) and solicited systemic events (fever, headache, malaise, myalgia, joint pain, nausea, vomiting, diarrhea, abdominal pain, chills and sweating)

  For a 14-day period after each vaccination

Secondary Outcomes (1)

• The seroconversion rate for serum RBD-specific binding antibodies for all the subjects received 2 doses of IMP, excluding subjects who missed the second dose, received any COVID-19 vaccine other than the IMPs or had a post-dose COVID-19 infection.

  At 28 days after the second vaccination

Study Arms (2)

Test Product

EXPERIMENTAL

DelNS1-nCoV-RBD LAIV at 1×107 EID50 and 1×107.7 EID50, 2 doses 4 weeks apart, intranasal administration

Biological: DelNS1-nCoV-RBD LAIV

Reference Product

PLACEBO COMPARATOR

Matching placebo, 2 doses 4 weeks apart, intranasal administration

Biological: Matching placebo

Interventions

DelNS1-nCoV-RBD LAIV BIOLOGICAL

Genetically engineered live attenuated influenza virus to express the receptor binding domain of SARS-CoV-2's spike protein for triggering human body's immune responses against SARS-CoV-2

Test Product

Matching placebo BIOLOGICAL

0.9% NaCl solution

Reference Product

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed Consent: The subject (or the subject's legally acceptable representative, if applicable) must be capable of giving written informed consent and, prior to the commencement of any study-specific procedure, must sign an ICF indicating the consent on the subject's voluntary participation in the study and compliance with the requirements and restrictions listed on the ICF.
• Gender and Age: Male or female, at the age of ≥ 18 and ≤ 55 on the day of signing the ICF.
• Body Weight and BMI: Body weight ≥ 50 kg and BMI ≥ 18.5 kg/m2 and \< 25 kg/m2 at screening and baseline.
• Medical Conditions or Diagnoses: Existence of all of the following medical conditions or diagnoses:
• Generally in good health with no clinically significant abnormality, as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests at screening and baseline;
• Normal vital signs at screening and baseline, as defined by:
• Body (tympanic) temperature ≤ 37.5oC;
• Resting pulse rate ≥ 50 and ≤ 100 bpm; and
• DBP ≥ 50 and ≤ 90 mmHg and SBP ≥ 90 and ≤ 140 mmHg.
• Contraception: Willingness and agreement to undertake measures to avoid pregnancy of the subject or the subject's sexual partner(s) as detailed below:
• A female subject who is a woman of childbearing potential (WOCBP) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from at least 30 days prior to the first vaccination until 60 days after the second vaccination;
• A male subject (i) who is sexually active with a WOCBP (except who is permanently sterile by bilateral orchiectomy or vasectomy) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from the first vaccination until 60 days after the second vaccination; and (ii) must be willing and agree to refrain from sperm donation during the aforesaid period.
• Breastfeeding: A female subject must be willing and agree to avoid engagement in breastfeeding at any time from the first vaccination until 60 days after the second vaccination.
• Blood Donation: Willingness and agreement to avoid blood donation from screening to the end of the period of participation in this study.

You may not qualify if:

• Medical History: History of any of the following diseases or conditions:
• COVID-19;
• SARS;
• Any significant respiratory diseases (e.g. COPD, asthma);
• Any significant cardiovascular disease (e.g. angina, cardiac arrhythmias);
• Blood dyscrasias or any significant disorder of coagulation;
• Any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis);
• Any chronic infection (e.g. hepatitis B, hepatitis C and HIV);
• Any malignant neoplastic disease;
• Encephalopathy, neuropathy or unstable central nervous system (CNS) pathology;
• Any psychiatric disorder, psychotic disorder, major affective disorder or suicidal ideation;
• Any immunodeficiency or autoimmune disease;
• Any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance, which requires hospitalization or emergency medical care;
• Any hypersensitivity to (especially anaphylactic reactions) to eggs, egg proteins or gentamicin sulfate;
• Any chronic rhinitis, nasal septal defect, cleft palate, nasal polyps or other nasal abnormality that might affect vaccine administration;

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

HKU Phase 1 Clinical Trials Centre

Hong Kong, Hong Kong

Location

Related Publications (5)

• Mossler C, Groiss F, Wolzt M, Wolschek M, Seipelt J, Muster T. Phase I/II trial of a replication-deficient trivalent influenza virus vaccine lacking NS1. Vaccine. 2013 Dec 16;31(52):6194-200. doi: 10.1016/j.vaccine.2013.10.061. Epub 2013 Oct 30.

  PMID: 24183981 BACKGROUND

• Surichan S, Wirachwong P, Supachaturas W, Utid K, Theerasurakarn S, Langsanam P, Lakornrach P, Nitisaporn L, Chansikkakorn C, Vangkanonta W, Kaweepornpoj R, Poopipatpol K, Thirapakpoomanunt S, Srichainak S, Artavatkun W, Chokevivat V, Wibulpolprasert S. Development of influenza vaccine production capacity by the Government Pharmaceutical Organization of Thailand: addressing the threat of an influenza pandemic. Vaccine. 2011 Jul 1;29 Suppl 1:A29-33. doi: 10.1016/j.vaccine.2011.04.120.

  PMID: 21684425 BACKGROUND

• Wacheck V, Egorov A, Groiss F, Pfeiffer A, Fuereder T, Hoeflmayer D, Kundi M, Popow-Kraupp T, Redlberger-Fritz M, Mueller CA, Cinatl J, Michaelis M, Geiler J, Bergmann M, Romanova J, Roethl E, Morokutti A, Wolschek M, Ferko B, Seipelt J, Dick-Gudenus R, Muster T. A novel type of influenza vaccine: safety and immunogenicity of replication-deficient influenza virus created by deletion of the interferon antagonist NS1. J Infect Dis. 2010 Feb 1;201(3):354-62. doi: 10.1086/649428.

  PMID: 20039806 BACKGROUND

• Wang P, Zheng M, Lau SY, Chen P, Mok BW, Liu S, Liu H, Huang X, Cremin CJ, Song W, Chen Y, Wong YC, Huang H, To KK, Chen Z, Xia N, Yuen KY, Chen H. Generation of DelNS1 Influenza Viruses: a Strategy for Optimizing Live Attenuated Influenza Vaccines. mBio. 2019 Sep 17;10(5):e02180-19. doi: 10.1128/mBio.02180-19.

  PMID: 31530680 BACKGROUND

• Zheng M, Wang P, Song W, Lau SY, Liu S, Huang X, Mok BW, Liu YC, Chen Y, Yuen KY, Chen H. An A14U Substitution in the 3' Noncoding Region of the M Segment of Viral RNA Supports Replication of Influenza Virus with an NS1 Deletion by Modulating Alternative Splicing of M Segment mRNAs. J Virol. 2015 Oct;89(20):10273-85. doi: 10.1128/JVI.00919-15. Epub 2015 Jul 29.

  PMID: 26223635 BACKGROUND

Related Links

• Accessed on 07 January 2021
• Accessed on 07 January 2021
• Accessed on 07 January 2021
• Accessed on 28 December 2020

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ivan Fan-ngai Hung

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 22, 2021
• Study Start: March 29, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)