NDV-HXP-S Vaccine Clinical Trial (COVIVAC)

NCT05940194 | Completed Phase 2 Results DMC

• 1 other identifier: COVIVAC-0102 (Phase 2)
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-center, randomized, placebo-controlled (phase 1) and active-controlled (phase 2), observer-blind Phase 1/2 study includes two separate parts. After completing the phase 1 interim analysis, 2 doses (3mcg and 6mcg) were selected for phase 2. In Part 2 of this combined Phase 1/2 study, 374 adults aged 18-75 years will be randomized (1:1:1) to AZD1222, or COVIVAC 3 µg being evaluated in Phase 1 or the intermediate dose of COVIVAC 6 µg being selected after consideration of phase 1 results.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants With Local and Systemic Solicited AEs by Severity During the First 7 Days After Each Vaccination.

  * Local solicited AEs: Pain or tenderness, Swelling or induration, Erythema * Systemic solicited AEs: Fever (defined as oral temperature ≥ 38°C), Headache, Fatigue or malaise, Myalgia, Arthralgia, Nausea or vomiting * Severity grading: Mild = Causes no or minimal interference with normal daily activities; intervention not indicated; Moderate =Interferes with but does not prevent normal daily activities; intervention indicated; Severe = Prevents normal daily activities; intervention or hospitalization indicated.

  7 days after each vaccination

• Percentage of Participants With Unsolicited AEs by Severity and Relatedness During the First 28 Days After Each Vaccination

  * An unsolicited adverse event is any AE reported spontaneously by the subject, observed by the study staff during study visits or those identified during review of medical records or source documents. Solicited AEs with an onset after the seven-day solicitation period will be considered unsolicited AEs * Severity grading: Mild = Causes no or minimal interference with normal daily activities; intervention not indicated; Moderate =Interferes with but does not prevent normal daily activities; intervention indicated; Severe = Prevents normal daily activities; intervention or hospitalization indicated.

  28 days after each vaccination

• Percentage of Participants With SAEs Severity and Relatedness Throughout the Entire Study Period

  A SAE is a specific AE that: * Results in death. * Is life-threatening.\* * Requires inpatient hospitalization or prolongation of an existing hospitalization.\*\* * Results in a persistent or significant disability or incapacity.\*\*\* * Results in a congenital anomaly or birth defect.

  From the first vaccination until Day 197

• Percentage of Participants With AE of Special Interest by Severity and Relatedness Throughout the Entire Study Period

  AEs of Special interest which are AEs relevant to COVID-19 and potential immune-mediated medical conditions (PIMMC) occurred throughout the entire study period

  From first vaccination to Day 197

• NT50 GMT at 14 Days and 6 Months After Second Vaccination

  NT50 GMT against SARS-CoV-2 pseudovirus in subjects who are anti-S IgG seronegative at baseline

  14 days and 6 months after second vaccination

• GMFR in NT50 at 14 Days and 6 Months After Second Vaccination

  GMFR in NT50 against SARS-CoV-2 pseudovirus measured at 14 days and 6 months after second vaccination to the baseline

  14 days and 6 months after second vaccination

• Percentage of Subjects With Seroresponse in NT50 at 14 Days and 6 Months After Second Vaccination

  Seroresponses against SARS-CoV-2 pseudovirus as defined by a ≥ 4-fold increase from baseline

  14 days and 6 months after second vaccination

Secondary Outcomes (3)

• IgG GMC at 14 Days and 6 Months After Second Vaccination

  14 days and 6 months after the second vaccination

• GMFR in Anti-S IgG GMC at 14 Days and 6 Months After Second Vaccination

  14 days and 6 months after the second vaccination

• Percentage of Subjects With Seroresponses in Anti-S IgG Concentration at 14 Days and 6 Months After Second Vaccination

  14 days and 6 months after the second vaccination

Other Outcomes (2)

• IFN-gamma

  14 days and 6 months after the second vaccination

• IL5

  14 days and 6 months after second vaccination

Study Arms (3)

COVIVAC 3 mcg

EXPERIMENTAL

3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.

Biological: COVIVAC vaccine

COVIVAC 6 mcg

EXPERIMENTAL

6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.

Biological: COVIVAC vaccine

AZD1222

ACTIVE COMPARATOR

AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.

Biological: COVIVAC vaccine

Interventions

COVIVAC vaccine BIOLOGICAL

For prevention Covid-19

AZD1222; COVIVAC 3 mcg; COVIVAC 6 mcg

Eligibility Criteria

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

You may qualify if:

• Adult ≥ 18 years old inclusive at the time of randomization.
• 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.
• 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 age, must not be breastfeeding or be pregnant (based on a negative urine pregnancy test at screening and 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:

• 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.
• History of administration of any non-study vaccine within 28 days prior to administration of study vaccine or planned vaccination within 3 months after enrolment.
• 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 (≥ grade 2)
• 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 hepatitis B (HBsAg) or hepatitis C (HCV Ab) (phase 1 only)
• History of confirmed HIV
• History of laboratory-confirmed COVID-19
• History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ
• Any confirmed or suspected immunosuppressive or immunodeficient state
• Administration of immunoglobulin or any blood product within 90 days prior to first study injection or planned administration during the study period.

Sponsors & Collaborators

• Institute of Vaccines and Medical Biologicals, Vietnam: lead
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator
• Center for Disease Control of Thai Binh Province, Vietnam: collaborator

Study Sites (1)

District Health Center of Vu Thu District

Thái Bình, Thai Binh, 414900, Vietnam

Location

Related Publications (1)

• Thiem VD, Anh DD, Ha VH, Van Thom N, Thang TC, Mateus J, Carreno JM, Raghunandan R, Huong NM, Mercer LD, Flores J, Escarrega EA, Raskin A, Thai DH, Van Be L, Sette A, Innis BL, Krammer F, Weiskopf D. Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: A randomised, comparator-controlled, phase 2 trial. Vaccine. 2025 Jan 12;44:126542. doi: 10.1016/j.vaccine.2024.126542. Epub 2024 Nov 29.

  PMID: 39615342 DERIVED

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

Results Point of Contact

• Title: Dr. Thang Tran Cong, Medical office
• Organization: PATH

thangtran@path.org

+84913301883

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2023
• First Posted: July 11, 2023
• Study Start: August 11, 2021
• Primary Completion: October 18, 2021
• Study Completion: March 11, 2022
• Last Updated: January 15, 2025
• Results First Posted: January 15, 2025

Record last verified: 2024-06

Locations

VN (1)