Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand

NCT04764422 | Completed Phase 1 DMC

• 1 other identifier: GPO NDV-HXP-S
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted in 2 phases. Phase 1 designed to evaluate safety, tolerability and immunogenicity COVID-19 vaccine (NDV-HXP-S) administered at different doses levels (1, 3, and 10 µg) without adjuvant, and at two different dose levels (1 and 3 µg) with the adjuvant CpG 1018 among healthy adults, (age 18-59 years) (210 subjects). Subjects will receive 2 doses of assigned investigational product (IP) on D1 and D29 (V1 and V3), and be assessed in clinic for safety and reactogenicity at 7 days after each vaccination (day 1 as day vaccination). An interim analysis of Phase 1 data will be conducted as the basis for decisions about advancement to Phase 2 of the study and about treatment group down selection. Phase 2 (250 subjects) will include approximately one-third subjects with age 60-75 years.

Conditions

Covid-19; SARS Pneumonia; Pneumonia, Viral; Covid-19 Vaccine

Keywords

COVID-19; COVID-19 VACCINE; ADULT; THAILAND; GPO; The Government Pharmaceutical Organization; SAFETY; TOLERABILITY; IMMUNOGENICITY; NDV-HXP-S Vaccine; CpG1018; SARS-CoV-2

Outcome Measures

Primary Outcomes (15)

• Frequency of solicited reportable local adverse event after first vaccination

  Frequency of solicited reportable local adverse events (pain or tenderness, erythema, swelling or induration) of first vaccination

  Day 1 up to Day 7 after first vaccination

• Frequency of solicited reportable local adverse event after second vaccination

  Frequency of solicited reportable local adverse events (pain or tenderness, erythema, swelling or induration) of second vaccination

  Day 1 up to Day 7 after second vaccination

• Frequency of solicited reportable systemic adverse event after first vaccination

  Frequency of solicited reportable systemic adverse events (fever, headache,fatigue or malaise, myalgia, arthralgia,nausea or vomitting) of first vaccination

  Day 1 up to Day 7 after first vaccination

• Frequency of solicited reportable systemic adverse event after second vaccination

  Frequency of solicited reportable systemic adverse events (fever, headache,fatigue or malaise, myalgia, arthralgia,nausea or vomitting) of second vaccination

  Day 1 up to Day 7 after second vaccination

• Measurement of hemoglobin changed from baseline at 7 days after first and second vaccination

  Measurement of hemoglobin (g/dl) changed from baseline at 7 days after first and second vaccination

  Day 8, Day 36

• Measurement of white blood cells changed from baseline at 7 days after first and second vaccination

  Measurement of white blood cells (10\^3 cells/ul) changed from baseline at 7 days after first and second vaccination

  Day 8, Day 36

• Measurement of platelet count changed from baseline at 7 days after first and second vaccination

  Measurement of platelet count (10\^3 cells/ul) changed from baseline at 7 days after first and second vaccination

  Day 8, Day 36

• Measurement of creatinine changed from baseline at 7 days after first and second vaccination

  Measurement of creatinine (mg/dl) changed from baseline at 7 days after first and second vaccination

  Day 8, Day 36

• Measurement of AST changed from baseline at 7 days after first and second vaccination

  Measurement of AST (U/L) changed from baseline at 7 days after first and second vaccination

  Day 8, Day 36

• Measurement of ALT change from baseline at 7 days after first and second vaccination

  Measurement of ALT (U/L) change from baseline at 7 days after first and second vaccination

  Day 8, Day 36

• Measurement of total bilirubin changed from baseline at 7 days after first and second vaccination

  Measurement of total bilirubin (mg/dl) change from baseline at 7 days after first and second vaccination

  Day 8, Day 36

• Frequency of all unsolicited AEs

  Frequency of all unsolicited AEs

  Day 1 up to Day 56

• Frequency of SAEs

  Frequency of SAEs throughout the entire study period

  Day 1 up to Day 365

• Frequency of medically-attended adverse event (MAAEs)

  Frequency of medically-attended adverse event (MAAEs) throughout the entire study period

  Day 1 up to Day 365

• Frequency of AESI

  Frequency of AESI throughout the entire study period, including AESI relevant to COVID-19, and potential immune-mediated medical conditions (PIMMC) presented as number and percentage

  Day 1 up to Day 365

Secondary Outcomes (7)

• GMT Neutralizing antibody titer 50 changed from baseline after vaccination

  Day 29, Day 43, Day 197, Day 365

• GMT Neutralizing antibody titer 80 changed from baseline after vaccination

  Day 29, Day 43, Day 197, Day 365

• NT50 seroresponses changed from baseline after vaccination

  Day 29, Day 43, Day 197, Day 365

• NT80 seroresponses changed from baseline after vaccination

  Day 29, Day 43, Day 197, Day 365

• GMT Anti-S IgG after vaccination

  Day 29, Day 43, Day 197, Day 365

Other Outcomes (3)

• S protein-specific T cells response changed from baseline after vaccination

  Day 43, Day 197

• Anti-NDV HN GMT changed from baseline after vaccination

  Day 29, Day 43, Day 197, Day 365

• Anti-NDV HN IgG GMT changed from baseline after vaccination

  Day 29, Day 43, Day 197, Day 365

Study Arms (6)

Placebo

PLACEBO COMPARATOR

0.9% Normal Saline for injection

Biological: Normal Saline

NDV-HXP-S 1 µg

ACTIVE COMPARATOR

35 subjects age 18-59 will receive NDV-HXP-S 1 µg study vacine administered 0.5 mL IM

Biological: NDV-HXP-S vaccine

NDV-HXP-S 3 µg

ACTIVE COMPARATOR

35 subjects age 18-59 will receive NDV-HXP-S 3 µg study vacine administered 0.5 mL IM

Biological: NDV-HXP-S vaccine

NDV-HXP-S 10 µg

ACTIVE COMPARATOR

35 subjects age 18-59 will receive NDV-HXP-S 10 µg study vacine administered 0.5 mL IM

Biological: NDV-HXP-S vaccine

NDV-HXP-S 1 µg + CpG1018 1.5 mg

ACTIVE COMPARATOR

35 subjects age 18-59 will receive NDV-HXP-S 1 µg + CpG1018 1.5 mg study vacine administered 0.5 mL IM

Biological: NDV-HXP-S vaccine

NDV-HXP-S 3 µg + CpG1018 1.5 mg

ACTIVE COMPARATOR

35 subjects age 18-59 will receive NDV-HXP-S 3 µg + CpG1018 1.5 mg study vacine administered 0.5 mL IM

Biological: NDV-HXP-S vaccine

Interventions

Normal Saline BIOLOGICAL

0.9% normal saline for injection

Placebo

NDV-HXP-S vaccine BIOLOGICAL

Vaccine NDV-HXP-S, manufactured by GPO with or without adjuvant CpG1018.

NDV-HXP-S 1 µg; NDV-HXP-S 1 µg + CpG1018 1.5 mg; NDV-HXP-S 10 µg; NDV-HXP-S 3 µg; NDV-HXP-S 3 µg + CpG1018 1.5 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase 1 Only:
• Adult 18 through 59 years of age, inclusive, at screening
• Healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator.
• Phase 2 Only:
• Adult 18 through 75 years of age, inclusive, at screening.
• Having no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator.
• Both Phase 1 and Phase 2:
• Has provided written informed consent prior to performance of any study-specific procedure.
• Has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at screening.
• Resides in study site area and is able and willing to adhere to all protocol visits and procedures.
• If a woman is of childbearing potential, must not be breastfeeding or be pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to receipt of the first dose of IP), must plan to avoid pregnancy for at least 28 days after the last dose of IP, and be willing to use an adequate method of contraception consistently and have a repeated pregnancy test prior to the second (last) dose of IP.

You may not qualify if:

• Phase 1 Only:
• \. A positive serologic test for SARS-CoV-2 IgG test.
• Both Phase 1 and Phase 2:
• Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation.
• Previous receipt of investigational vaccine for SARS or MERS, or any investigational or licensed vaccine that may have an impact on interpretation of the trial results
• History of hypersensitivity reaction to any prior vaccination or known hypersensitivity to any component of the study vaccine
• History of egg or chicken allergy
• History of angioedema
• History of anaphylaxis
• Acute illness (moderate or severe) and/or fever (body temperature measured orally ≥38°C)
• Any abnormal vital sign deemed clinically relevant by the PI.
• A positive serologic test for SARS-CoV-2 IgM test, human immunodeficiency virus (HIV 1/2 Ab), hepatitis B (HBsAg) or hepatitis C (HCV Ab)
• History of laboratory-confirmed COVID-19 (RT-PCR positive to SAR-CoV-2)
• History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ
• Any confirmed or suspected immunosuppressive or immunodeficient state

Sponsors & Collaborators

• Mahidol University: lead
• The Government Pharmaceutical Organization: collaborator

Study Sites (1)

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, 10400, Thailand

Location

Related Publications (2)

• Pitisuttithum P, Luvira V, Lawpoolsri S, Muangnoicharoen S, Kamolratanakul S, Sivakorn C, Narakorn P, Surichan S, Prangpratanporn S, Puksuriwong S, Lamola S, Mercer LD, Raghunandan R, Sun W, Liu Y, Carreno JM, Scharf R, Phumratanaprapin W, Amanat F, Gagnon L, Hsieh CL, Kaweepornpoj R, Khan S, Lal M, McCroskery S, McLellan J, Mena I, Meseck M, Phonrat B, Sabmee Y, Singchareon R, Slamanig S, Suthepakul N, Tcheou J, Thantamnu N, Theerasurakarn S, Tran S, Vilasmongkolchai T, White JA, Bhardwaj N, Garcia-Sastre A, Palese P, Krammer F, Poopipatpol K, Wirachwong P, Hjorth R, Innis BL. 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. EClinicalMedicine. 2022 Mar 8;45:101323. doi: 10.1016/j.eclinm.2022.101323. eCollection 2022 Mar.

  PMID: 35284808 DERIVED

• Pitisuttithum P, Luvira V, Lawpoolsri S, Muangnoicharoen S, Kamolratanakul S, Sivakorn C, Narakorn P, Surichan S, Prangpratanporn S, Puksuriwong S, Lamola S, Mercer LD, Raghunandan R, Sun W, Liu Y, Carreno JM, Scharf R, Phumratanaprapin W, Amanat F, Gagnon L, Hsieh CL, Kaweepornpoj R, Khan S, Lal M, McCroskery S, McLellan J, Mena I, Meseck M, Phonrat B, Sabmee Y, Singchareon R, Slamanig S, Suthepakul N, Tcheou J, Thantamnu N, Theerasurakarn S, Tran S, Vilasmongkolchai T, White JA, Garcia-Sastre A, Palese P, Krammer F, Poopipatpol K, Wirachwong P, Hjorth R, Innis BL. Safety and Immunogenicity of an Inactivated Recombinant Newcastle Disease Virus Vaccine Expressing SARS-CoV-2 Spike: Interim Results of a Randomised, Placebo-Controlled, Phase 1/2 Trial. medRxiv [Preprint]. 2021 Sep 22:2021.09.17.21263758. doi: 10.1101/2021.09.17.21263758.

  PMID: 34580673 DERIVED

MeSH Terms

Conditions

COVID-19; Pneumonia, Viral

Interventions

Saline Solution; NDV-HXP-S COVID-19 vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Punnee Pitisutthithum

  Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Unblinded study staff, including the site pharmacist, will be responsible for preparing study products (in accordance with the randomly determined assignment), administering the study vaccine, and handling all drug accountability procedures. These personnel will not participate in the other aspects of the clinical trial, to help ensure the integrity of the blind at the site. Unblinded staff will retrieve a subject's randomization assignment after being informed by the PI or designee that a subject is eligible for randomization. They will prepare the 0.5 ml dose of study product based on the subject's randomization
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 21, 2021
• Study Start: March 20, 2021
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2 years after vaccine marketing
• Access Criteria: as document attach when completed study in NCT clinicaltrials.gov

Locations

TH (1)