COVID-19 DiseasePhase 1NCT04830800

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

A Phase 1 study testing COVIVAC and Phosphate-buffered saline in people with COVID-19 Disease and SARS Pneumonia, run by Institute of Vaccines and Medical Biologicals, Vietnam at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19 Disease, SARS Pneumonia, Pneumonia, Viral
What is being tested?: COVIVAC and Phosphate-buffered saline
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteVietnam
Study dates: 10 Mar 2021to 31 Oct 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.
Note: receipt of any COVID-19 vaccine that is licensed or granted Emergency Use Authorization in Vietnam during the course of study participation is not exclusionary if administered after Visit 5.
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

Show all 22Show fewer

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
Abnormality in screening laboratory test deemed exclusionary by the PI in consultation with the Sponsor
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.
Administration of any long-acting immune-modifying drugs (e.g., infliximab or rituximab) or the chronic administration (defined as more than 14 days) of immunosuppressants within six months prior to first study injection, or planned administration during the study period (includes systemic corticosteroids at doses equivalent to ≥ 0.5 mg/kg/day of prednisone; the use of topical steroids including inhaled and intranasal steroids is permitted).
History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding. (e.g, thalassemia, coagulation factor deficiencies).
Recent history (within the past year) or signs of alcohol or substance abuse.
Any medical, psychiatric or behavior condition that in the opinion of the PI may interfere with the study objectives, pose a risk to the subject, or prevent the subject from completing the study follow-up.
Employee of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or site.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

Hanoi Medical University
Hanoi, 10000

Other trials in Vietnam

About this study

Official title: A Phase 1/2 Randomized, Placebo-controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of COVIVAC Vaccine Produced by IVAC in Adults Aged 18-60 Years in Vietnam

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)

Read the detailed description

This prospective, single-center, randomized, placebo-controlled, observer-blind Phase 1/2 study includes two separate parts.

An interim analysis of Phase 1 data conducted after the last subject last visit for V6 (D57) will serve as the basis for decisions about down selection and advancing to Part 2 of the study (Phase 2). Down selection and advancement to Part 2 (Phase 2) will be based on the following parameters:

Post-dose 2 immunogenicity results at the aggregate treatment level
A threshold immune response at Visit 5 (D43) will be required: the observed seroresponse rate in a treatment group (defined as the percentage of subjects with at least a 4-fold rise from baseline in 80% neutralizing antibody titers) will need to be ≥52% at the LL of the 95% CI for that treatment (vaccine formulation) to be considered for advancement to Phase 2.
Post-dose 1 and post dose 2 safety results including all solicited and unsolicited adverse events, serious adverse events, and clinical laboratory results.

The following process will be followed for the decision about down selection and advancing to Part 2 (Phase 2):

The DSMB will review the unblinded safety data and provide a recommendation to the Sponsor on whether the safety profile is acceptable for advancing a formulation to Phase 2.
The Sponsor will review the DSMB recommendation in conjunction with the immunogenicity data and select two formulations to advance to Phase 2.
If multiple formulations achieve the threshold immune response (as well as have an adequate safety and tolerability profile per the DSMB), the Sponsor will select two formulations to advance to Phase 2 based on consideration of such factors as the relative functional immunogenicity of these formulations, opportunity for dose sparing, and opportunity to limit cost and possible supply constraints associated with use of the CpG adjuvant.
The selection and recommendation to advance to Phase 2 along with the interim report will be jointly reviewed by NIHE's IRB and MoH prior to Phase 2 enrollment.

Conditions: COVID-19 Disease, SARS Pneumonia, Pneumonia, Viral, COVID-19 Vaccine
Being tested: COVIVAC, Phosphate-buffered saline
Keywords: COVID-19, COVIVAC, COVID-19 disease, SARS-CoV-2, COVID-19 vaccine
Medical subject headings: Pneumonia, Viral, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COVIVACBiological
COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
Phosphate-buffered salineBiological
Phosphate buffer solution (pH 7.2), manufactured by IVAC

Study groups in NCT04830800
Study group	Role	What they receive
COVIVAC 1mcg	Experimental	1mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. Receives: Biological: COVIVAC
COVIVAC 3mcg	Experimental	3mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. Receives: Biological: COVIVAC
COVIVAC 10mcg	Experimental	10mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. Receives: 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. Receives: Biological: COVIVAC
Placebo	Placebo comparator	Phosphate buffered saline (pH 7.2) for intramuscular injection administered as two doses (0.5mL each) 28 days apart. Receives: Biological: Phosphate-buffered saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Solicited Adverse Events
Percentage of participants with solicited local and systemic adverse events (AEs)
Measured: During the first 7 days after each vaccination
Clinical Safety Tests
Percentage of participants with clinically significant hematological and biochemical abnormalities
Measured: At 7 days post each vaccination
Unsolicited Adverse Events
Number of participants with any unsolicited adverse event
Measured: During the first 28 days after each vaccination
Serious Adverse Event
Number of participants with serious adverse events (SAEs)
Measured: Throughout the Study Period (until Day 197)
Medical Attended Adverse Events
Number of participants with medically-attended AEs (MAAEs)
Measured: 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)
Measured: Throughout the Study Period (until Day 197)

Secondary outcomes (6)

GMT of 50% Neutralizing Antibody (NT50)
50% neutralizing antibody (NT50) geometric mean titer (GMT) against SARS-CoV-2 pseudovirus
Measured: GMT of NT50 at 28 days after first vaccination, at 14 days and 6 months after the second vaccination
Geometric Mean Fold Rise (GMFR)
Geometric mean fold rise (GMFR) (from baseline) in NT50 against SARS-CoV-2 pseudovirus
Measured: GMFR at 28 days after first vaccination, at 14 days and 6 months after the second vaccination
Seroresponse in NT50
Percentage of subjects with NT50 seroresponse against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline
Measured: Seroresponse at 28 days after first vaccination, at 14 days and 6 months after the second vaccination
Anti-S IgG GMC
Immunogenicity outcome measurement
Measured: 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 (from baseline) in anti-S IgG GMC
Measured: GMFR at 28 days after the first vaccination, 14 days and 6 months after the second vaccination
Seroresponse in Anti-S IgG Concentration
Percentage of subjects with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline
Measured: Seroresponse at 28 days after the first vaccination, 14 days and 6 months after the second vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 202131 Oct 2021

First posted5 Apr 2021
Study start10 Mar 2021
Primary completion6 Jun 2021
Study completion31 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19 DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04830800
Sponsor's protocol ID: COVIVAC-0102 (phase 1)
Status last verified: Jan 2025
First submitted: 12 Mar 2021
Last updated: 13 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There should be an agreement and approval by IRB before sharing IDP

Publications

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.
PubMed 35577631

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Randomized, Placebo-controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of COVIVAC Vaccine Produced by IVAC in Adults Aged 18-60 Years in Vietnam
ClinicalTrials.gov ID: NCT04830800
Acronym / sponsor ID: COVIVAC-0102 (phase 1)
Conditions: COVID-19 Disease, SARS Pneumonia, Pneumonia, Viral, COVID-19 Vaccine
Keywords: COVID-19, COVIVAC, COVID-19 disease, SARS-CoV-2, COVID-19 vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Institute of Vaccines and Medical Biologicals, VietnamIndustry (pharma, biotech, devices)
Collaborators: National Institute of Hygiene and Epidemiology, Vietnam, Hanoi Medical University
Study start: 10 Mar 2021 (actual)
Primary completion: 6 Jun 2021 (actual)
Study completion: 31 Oct 2021 (actual)
First posted: 5 Apr 2021 (actual)
Results: Posted 13 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This prospective, single-center, randomized, placebo-controlled, observer-blind Phase 1/2 study includes two separate parts.

Detailed description

This prospective, single-center, randomized, placebo-controlled, observer-blind Phase 1/2 study includes two separate parts.

Post-dose 2 immunogenicity results at the aggregate treatment level
A threshold immune response at Visit 5 (D43) will be required: the observed seroresponse rate in a treatment group (defined as the percentage of subjects with at least a 4-fold rise from baseline in 80% neutralizing antibody titers) will need to be ≥52% at the LL of the 95% CI for that treatment (vaccine formulation) to be considered for advancement to Phase 2.
Post-dose 1 and post dose 2 safety results including all solicited and unsolicited adverse events, serious adverse events, and clinical laboratory results.

The following process will be followed for the decision about down selection and advancing to Part 2 (Phase 2):

The DSMB will review the unblinded safety data and provide a recommendation to the Sponsor on whether the safety profile is acceptable for advancing a formulation to Phase 2.
The Sponsor will review the DSMB recommendation in conjunction with the immunogenicity data and select two formulations to advance to Phase 2.
If multiple formulations achieve the threshold immune response (as well as have an adequate safety and tolerability profile per the DSMB), the Sponsor will select two formulations to advance to Phase 2 based on consideration of such factors as the relative functional immunogenicity of these formulations, opportunity for dose sparing, and opportunity to limit cost and possible supply constraints associated with use of the CpG adjuvant.
The selection and recommendation to advance to Phase 2 along with the interim report will be jointly reviewed by NIHE's IRB and MoH prior to Phase 2 enrollment.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5
Model description: 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.

Arm	Type	Receives
COVIVAC 1mcg	Experimental	Biological: COVIVAC1mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC 3mcg	Experimental	Biological: COVIVAC3mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC 10mcg	Experimental	Biological: COVIVAC10mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC 1mcg + CpG1018 1.5mg	Experimental	Biological: COVIVAC1mcg + CpG1018 IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
Placebo	Placebo comparator	Biological: Phosphate-buffered salinePhosphate buffered saline (pH 7.2) for intramuscular injection administered as two doses (0.5mL each) 28 days apart.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (22 listed)

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.
Note: receipt of any COVID-19 vaccine that is licensed or granted Emergency Use Authorization in Vietnam during the course of study participation is not exclusionary if administered after Visit 5.
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
COVIVACCOVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19	Biological	COVIVAC 10mcg, COVIVAC 1mcg, COVIVAC 1mcg + CpG1018 1.5mg, COVIVAC 3mcg
Phosphate-buffered salinePhosphate buffer solution (pH 7.2), manufactured by IVAC	Biological	Placebo

Primary outcome

Solicited Adverse Events
Time frame: During the first 7 days after each vaccination
Percentage of participants with solicited local and systemic adverse events (AEs)
Clinical Safety Tests
Time frame: At 7 days post each vaccination
Percentage of participants with clinically significant hematological and biochemical abnormalities
Unsolicited Adverse Events
Time frame: During the first 28 days after each vaccination
Number of participants with any unsolicited adverse event
Serious Adverse Event
Time frame: Throughout the Study Period (until Day 197)
Number of participants with serious adverse events (SAEs)
Medical Attended Adverse Events
Time frame: Throughout the Study Period (until Day 197)
Number of participants with medically-attended AEs (MAAEs)
Adverse Event of Special Interest
Time frame: Throughout the Study Period (until Day 197)
Number of participants with adverse events of special interest (AESI) , including AESI relevant to COVID-19, and potential immune-mediated medical conditions (PIMMC)

6 secondary outcomes

GMT of 50% Neutralizing Antibody (NT50)
Time frame: GMT of NT50 at 28 days after first vaccination, at 14 days and 6 months after the second vaccination
Geometric Mean Fold Rise (GMFR)
Time frame: GMFR at 28 days after first vaccination, at 14 days and 6 months after the second vaccination
Seroresponse in NT50
Time frame: Seroresponse at 28 days after first vaccination, at 14 days and 6 months after the second vaccination
Anti-S IgG GMC
Time frame: 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
Time frame: GMFR at 28 days after the first vaccination, 14 days and 6 months after the second vaccination
Seroresponse in Anti-S IgG Concentration
Time frame: Seroresponse at 28 days after the first vaccination, 14 days and 6 months after the second vaccination

Results and safety

Results posted to the registry on 13 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COVIVAC 1mcg	25	23
COVIVAC 3mcg	25	24
COVIVAC 10mcg	25	25
COVIVAC 1mcg + CpG1018 1.5mg	25	24
Placebo	20	20

Primary outcome: Solicited Adverse Events

Time frame: During the first 7 days after each vaccination. Number (95% Confidence Interval). Unit: percent of participants

Measure	COVIVAC 1 mcg n = 25	COVIVAC 3 mcg n = 25	COVIVAC 10 mcg n = 25	COVIVAC 1mcg + CpG n = 25	Placebo n = 20
Value	88.0 (68.8 to 97.5)	68.0 (46.5 to 85.1)	88.0 (68.8 to 97.5)	80.0 (59.3 to 93.2)	70.0 (45.7 to 88.1)

Population analysed: All participants receiving at least one dose of study vaccine/placebo will be included in the safety analysis population.

Primary outcome: Clinical Safety Tests

Time frame: At 7 days post each vaccination. Number. Unit: percent of participants

Measure	COVIVAC 1 mcg n = 25	COVIVAC 3 mcg n = 25	COVIVAC 10 mcg n = 25	COVIVAC 1mcg + CpG n = 25	Placebo n = 20
Value	0	0	0	0	0

Population analysed: All participants receiving at least one dose of study vaccine/placebo will be included in the safety analysis population

Primary outcome: Unsolicited Adverse Events

Time frame: During the first 28 days after each vaccination. Number (95% Confidence Interval). Unit: percent of participants

Measure	COVIVAC 1 mcg n = 25	COVIVAC 3 mcg n = 25	COVIVAC 10 mcg n = 25	COVIVAC 1mcg + CpG n = 25	Placebo n = 20
Value	44.0 (24.4 to 65.1)	32.0 (14.9 to 53.5)	48.0 (27.8 to 68.7)	52.0 (31.3 to 72.2)	45.0 (23.1 to 68.5)

Population analysed: All participants receiving at least one dose of study vaccine/placebo will be included in the safety analysis population

Primary outcome: Serious Adverse Event

Time frame: Throughout the Study Period (until Day 197). Number (95% Confidence Interval). Unit: percent of participants

Measure	COVIVAC 1 mcg n = 25	COVIVAC 3 mcg n = 25	COVIVAC 10 mcg n = 25	COVIVAC 1mcg + CpG n = 25	Placebo n = 20
Value	0.0 (0.0 to 13.7)	0.0 (0.0 to 13.7)	0.0 (0.0 to 13.7)	4.0 (0.1 to 20.4)	5.0 (0.1 to 24.9)

Population analysed: There are 116 subject attended the follow-up visit day 197 (23 subjects in 1mcg arm, 24 subjects in 3mcg arm, 25 subjects in 10mcg arm, 24 subjects in 1mcg + CpG arm, and 20 subjects in placebo arm)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COVIVAC 1 mcg	0 of 25 (0%)	4 of 25 (16%)	0 of 25
COVIVAC 3 mcg	0 of 25 (0%)	3 of 25 (12%)	0 of 25
COVIVAC 10 mcg	0 of 25 (0%)	0 of 25 (0%)	0 of 25
COVIVAC 1mcg + CpG	1 of 25 (4%)	2 of 25 (8%)	0 of 25
Placebo	1 of 20 (5%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35577631Duc 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.
Individual participant dataSharing planned: No. There should be an agreement and approval by IRB before sharing IDP

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing COVIVAC and Phosphate-buffered saline in people with COVID-19 Disease and SARS Pneumonia, run by Institute of Vaccines and Medical Biologicals, Vietnam at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Solicited Adverse Events (time frame: During the first 7 days after each vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04830800, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.