A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC (Phase 1)

NCT04830800 | Completed Phase 1 Results DMC

• 1 other identifier: COVIVAC-0102 (phase 1)
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-center, randomized, placebo-controlled, observer-blind Phase 1/2 study includes two separate parts. Part 1 is a first-in-human, Phase 1 study designed to evaluate the safety, tolerability and immunogenicity of the COVIVAC vaccine at three different dose levels (1, 3, and 10 µg) without adjuvant, and at one dose level (1 µg) with the adjuvant CpG 1018, in a total of 120 subjects aged 18-59 years. (Part 2 will be registered in a separate record)

Conditions

COVID-19 Disease; SARS Pneumonia; Pneumonia, Viral; COVID-19 Vaccine

Keywords

COVID-19; COVIVAC; COVID-19 disease; SARS-CoV-2; COVID-19 vaccine

Outcome Measures

Primary Outcomes (6)

• Solicited Adverse Events

  Percentage of participants with solicited local and systemic adverse events (AEs)

  During the first 7 days after each vaccination

• Clinical Safety Tests

  Percentage of participants with clinically significant hematological and biochemical abnormalities

  At 7 days post each vaccination

• Unsolicited Adverse Events

  Number of participants with any unsolicited adverse event

  During the first 28 days after each vaccination

• Serious Adverse Event

  Number of participants with serious adverse events (SAEs)

  Throughout the Study Period (until Day 197)

• Medical Attended Adverse Events

  Number of participants with medically-attended AEs (MAAEs)

  Throughout the Study Period (until Day 197)

• Adverse Event of Special Interest

  Number of participants with adverse events of special interest (AESI) , including AESI relevant to COVID-19, and potential immune-mediated medical conditions (PIMMC)

  Throughout the Study Period (until Day 197)

Secondary Outcomes (6)

• GMT of 50% Neutralizing Antibody (NT50)

  GMT of NT50 at 28 days after first vaccination, at 14 days and 6 months after the second vaccination

• Geometric Mean Fold Rise (GMFR)

  GMFR at 28 days after first vaccination, at 14 days and 6 months after the second vaccination

• Seroresponse in NT50

  Seroresponse at 28 days after first vaccination, at 14 days and 6 months after the second vaccination

• Anti-S IgG GMC

  GMC of Anti-S IgG at 28 days after the first vaccination, at 14 days and 6 months after the second vaccination

• GMFR in Anti-S IgG GMC

  GMFR at 28 days after the first vaccination, 14 days and 6 months after the second vaccination

Study Arms (5)

COVIVAC 1mcg

EXPERIMENTAL

1mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.

Biological: COVIVAC

COVIVAC 3mcg

EXPERIMENTAL

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

Biological: COVIVAC

COVIVAC 10mcg

EXPERIMENTAL

10mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.

Biological: COVIVAC

COVIVAC 1mcg + CpG1018 1.5mg

EXPERIMENTAL

1mcg + CpG1018 IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.

Biological: COVIVAC

Placebo

PLACEBO COMPARATOR

Phosphate buffered saline (pH 7.2) for intramuscular injection administered as two doses (0.5mL each) 28 days apart.

Biological: Phosphate-buffered saline

Interventions

COVIVAC BIOLOGICAL

COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19

COVIVAC 10mcg; COVIVAC 1mcg; COVIVAC 1mcg + CpG1018 1.5mg; COVIVAC 3mcg

Phosphate-buffered saline BIOLOGICAL

Phosphate buffer solution (pH 7.2), manufactured by IVAC

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Phase 1 Only:
• Adult 18 through 59 years of age inclusive at the time of randomization.
• 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.
• 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 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
• 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)
• 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
• Hanoi Medical University: collaborator

Study Sites (1)

Hanoi Medical University

Hanoi, 10000, Vietnam

Location

Related Publications (1)

• Duc Dang A, Dinh Vu T, Hai Vu H, Thanh Ta V, Thi Van Pham A, Thi Ngoc Dang M, Van Le B, Huu Duong T, Van Nguyen D, Lawpoolsri S, Chinwangso P, McLellan JS, Hsieh CL, Garcia-Sastre A, Palese P, Sun W, Martinez JL, Gonzalez-Dominguez I, Slamanig S, Manuel Carreno J, Tcheou J, Krammer F, Raskin A, Minh Vu H, Cong Tran T, Mai Nguyen H, Mercer LD, Raghunandan R, Lal M, White JA, Hjorth R, Innis BL, Scharf R. Safety and immunogenicity of an egg-based inactivated Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Interim results of a randomized, placebo-controlled, phase 1/2 trial in Vietnam. Vaccine. 2022 Jun 9;40(26):3621-3632. doi: 10.1016/j.vaccine.2022.04.078. Epub 2022 May 14.

  PMID: 35577631 DERIVED

MeSH Terms

Conditions

Pneumonia, Viral; COVID-19

Interventions

COVI-VAC

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

thangtran@path.org

84-913301883

Publication Agreements

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

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: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In Phase 1 is dose escalation design, eligible participants will be randomized to received study vaccine or placebo from low dose to higher dose and later to the formulation with CpG adjuvant.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: April 5, 2021
• Study Start: March 10, 2021
• Primary Completion: June 6, 2021
• Study Completion: October 31, 2021
• Last Updated: February 13, 2025
• Results First Posted: February 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)