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NCT04830800

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

Completed Phase 1 Results posted Last updated 13 February 2025
What this trial tests

Phase 1 trial testing COVIVAC in COVID-19 Disease in 120 participants. Completed in 31 October 2021.

Timeline
10 March 2021
Primary endpoint
6 June 2021
31 October 2021

Quick facts

Lead sponsorInstitute of Vaccines and Medical Biologicals, Vietnam
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment120
Start date10 March 2021
Primary completion6 June 2021
Estimated completion31 October 2021
Sites1 location across Vietnam

Drugs / interventions tested

Conditions studied

Sponsor

Institute of Vaccines and Medical Biologicals, Vietnam

Who can join

Adults 18 to 60, any sex, with COVID-19 Disease or SARS Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Solicited Adverse Events Primary · During the first 7 days after each vaccination

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

GroupValue95% CI
COVIVAC 1 mcg88.068.8 – 97.5
COVIVAC 3 mcg68.046.5 – 85.1
COVIVAC 10 mcg88.068.8 – 97.5
COVIVAC 1mcg + CpG80.059.3 – 93.2
Placebo70.045.7 – 88.1
Clinical Safety Tests Primary · At 7 days post each vaccination

Percentage of participants with clinically significant hematological and biochemical abnormalities

GroupValue95% CI
COVIVAC 1 mcg0
COVIVAC 3 mcg0
COVIVAC 10 mcg0
COVIVAC 1mcg + CpG0
Placebo0
Unsolicited Adverse Events Primary · During the first 28 days after each vaccination

Number of participants with any unsolicited adverse event

GroupValue95% CI
COVIVAC 1 mcg44.024.4 – 65.1
COVIVAC 3 mcg32.014.9 – 53.5
COVIVAC 10 mcg48.027.8 – 68.7
COVIVAC 1mcg + CpG52.031.3 – 72.2
Placebo45.023.1 – 68.5
Serious Adverse Event Primary · Throughout the Study Period (until Day 197)

Number of participants with serious adverse events (SAEs)

GroupValue95% CI
COVIVAC 1 mcg0.00.0 – 13.7
COVIVAC 3 mcg0.00.0 – 13.7
COVIVAC 10 mcg0.00.0 – 13.7
COVIVAC 1mcg + CpG4.00.1 – 20.4
Placebo5.00.1 – 24.9
Medical Attended Adverse Events Primary · Throughout the Study Period (until Day 197)

Number of participants with medically-attended AEs (MAAEs)

GroupValue95% CI
COVIVAC 1 mcg3
COVIVAC 3 mcg3
COVIVAC 10 mcg2
COVIVAC 1mcg + CpG2
Placebo0
Adverse Event of Special Interest Primary · 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)

GroupValue95% CI
COVIVAC 1 mcg0
COVIVAC 3 mcg0
COVIVAC 10 mcg0
COVIVAC 1mcg + CpG0
Placebo0
GMT of 50% Neutralizing Antibody (NT50) Secondary · GMT of NT50 at 28 days after first vaccination, at 14 days and 6 months after the second vaccination

50% neutralizing antibody (NT50) geometric mean titer (GMT) against SARS-CoV-2 pseudovirus

GMT of NT50 at 28 days after first vaccination
GroupValue95% CI
COVIVAC 1 mcg10.676.98 – 16.31
COVIVAC 3 mcg8.486.63 – 10.85
COVIVAC 10 mcg23.5014.91 – 37.02
COVIVAC 1mcg + CpG9.356.29 – 13.89
Placebo5.00NA – NA
GMT of NT50 at 14 days after second vaccination
GroupValue95% CI
COVIVAC 1 mcg104.9669.29 – 159.00
COVIVAC 3 mcg170.24119.11 – 243.32
COVIVAC 10 mcg460.87284.49 – 746.58
COVIVAC 1mcg + CpG268.32175.99 – 409.07
Placebo5.00NA – NA
GMT of NT50 at 6 months after second vaccination
GroupValue95% CI
COVIVAC 1 mcg230.7275.92 – 701.16
COVIVAC 3 mcg607.00254.44 – 1448.11
COVIVAC 10 mcg556.25237.39 – 1303.36
COVIVAC 1mcg + CpG452.35182.87 – 1118.91
Placebo20.2711.54 – 35.58
Geometric Mean Fold Rise (GMFR) Secondary · GMFR at 28 days after first vaccination, at 14 days and 6 months after the second vaccination

Geometric mean fold rise (GMFR) (from baseline) in NT50 against SARS-CoV-2 pseudovirus

GMFR at 28 after first vaccination
GroupValue95% CI
COVIVAC 1 mcg2.061.37 – 3.11
COVIVAC 3 mcg1.701.33 – 2.17
COVIVAC 10 mcg4.913.15 – 7.66
COVIVAC 1mcg + CpG1.871.26 – 2.78
Placebo1.00NA – NA
GMFR at 14 days after first vaccination
GroupValue95% CI
COVIVAC 1 mcg22.5013.74 – 30.60
COVIVAC 3 mcg34.0523.82 – 48.66
COVIVAC 10 mcg84.7551.76 – 138.77
COVIVAC 1mcg + CpG53.6635.20 – 81.81
Placebo1.00NA – NA
GMFR at 6 months after second vaccination
GroupValue95% CI
COVIVAC 1 mcg49.5317.04 – 143.93
COVIVAC 3 mcg121.4050.89 – 289.62
COVIVAC 10 mcg103.2745.14 – 263.28
COVIVAC 1mcg + CpG90.4736.57 – 223.78
Placebo4.422.68 – 7.28
Seroresponse in NT50 Secondary · Seroresponse at 28 days after first vaccination, at 14 days and 6 months after the second vaccination

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

Seroresponse at 28 days after first vaccination
GroupValue95% CI
COVIVAC 1 mcg13.02.8 – 33.6
COVIVAC 3 mcg0.00.0 – 13.7
COVIVAC 10 mcg40.021.1 – 61.3
COVIVAC 1mcg + CpG8.01.0 – 26.0
Placebo0.00.0 – 16.8
Seroresponse at 14 days after second vaccination
GroupValue95% CI
COVIVAC 1 mcg84.063.9 – 95.5
COVIVAC 3 mcg96.079.6 – 99.9
COVIVAC 10 mcg96.079.6 – 99.9
COVIVAC 1mcg + CpG96.079.6 – 99.9
Placebo0.00.0 – 16.8
Seroresponse at 6 months after second vaccination
GroupValue95% CI
COVIVAC 1 mcg68.245.1 – 86.1
COVIVAC 3 mcg87.567.6 – 97.3
COVIVAC 10 mcg87.567.6 – 97.3
COVIVAC 1mcg + CpG81.859.7 – 94.8
Placebo26.39.1 – 51.2
Anti-S IgG GMC Secondary · GMC of Anti-S IgG at 28 days after the first vaccination, at 14 days and 6 months after the second vaccination

Immunogenicity outcome measurement

GMC of Anti-S IgG at 28 days after first vaccination
GroupValue95% CI
COVIVAC 1 mcg9.896.28 – 15.57
COVIVAC 3 mcg15.3511.33 – 20.81
COVIVAC 10 mcg29.3319.26 – 44.66
COVIVAC 1mcg + CpG6.404.64 – 8.83
Placebo3.15NA – NA
GMC of Anti-S IgG at 14 days after second vaccination
GroupValue95% CI
COVIVAC 1 mcg122.5487.06 – 172.48
COVIVAC 3 mcg173.38128.12 – 234.61
COVIVAC 10 mcg446.50302.60 – 658.83
COVIVAC 1mcg + CpG206.51152.89 – 278.93
Placebo3.15NA – NA
GMC of Anti-S IgG at 6 months after second vaccination
GroupValue95% CI
COVIVAC 1 mcg242.54129.73 – 909.71
COVIVAC 3 mcg469.36178.31 – 1235.52
COVIVAC 10 mcg515.41228.33 – 1163.46
COVIVAC 1mcg + CpG350.79137.91 – 892.26
Placebo85.9833.22 – 222.51
GMFR in Anti-S IgG GMC Secondary · GMFR at 28 days after the first vaccination, 14 days and 6 months after the second vaccination

GMFR (from baseline) in anti-S IgG GMC

GMFR at 28 days after first vaccination
GroupValue95% CI
COVIVAC 1 mcg3.001.93 – 4.68
COVIVAC 3 mcg4.873.59 – 6.61
COVIVAC 10 mcg9.146.10 – 13.69
COVIVAC 1mcg + CpG2.031.47 – 2.80
Placebo1.000.99 – 1.01
GMFR at 14 days after second vaccination
GroupValue95% CI
COVIVAC 1 mcg34.6523.11 – 51.93
COVIVAC 3 mcg55.0240.66 – 74.46
COVIVAC 10 mcg124.1178.20 – 196.99
COVIVAC 1mcg + CpG65.5448.52 – 88.52
Placebo0.980.94 – 1.02
GMFR at 6 months after second vaccination
GroupValue95% CI
COVIVAC 1 mcg103.1340.49 – 262.73
COVIVAC 3 mcg148.9556.59 – 392.10
COVIVAC 10 mcg147.6065.92 – 330.50
COVIVAC 1mcg + CpG111.3343.77 – 283.16
Placebo30.6113.60 – 68.88
Seroresponse in Anti-S IgG Concentration Secondary · Seroresponse at 28 days after the first vaccination, 14 days and 6 months after the second vaccination

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

Seroresponse at 28 days after first vaccination
GroupValue95% CI
COVIVAC 1 mcg44.235.1 – 53.5
COVIVAC 3 mcg44.024.4 – 65.1
COVIVAC 10 mcg64.042.5 – 82.0
COVIVAC 1mcg + CpG84.063.9 – 95.5
Placebo0.00.0 – 16.8
Seroresponse at 14 days after second vaccination
GroupValue95% CI
COVIVAC 1 mcg82.574.5 – 88.8
COVIVAC 3 mcg96.076.9 – 99.9
COVIVAC 10 mcg100.086.3 – 100.0
COVIVAC 1mcg + CpG100.086.3 – 100.0
Placebo0.00.0 – 16.8
Seroresponse at 6 months after second vaccination
GroupValue95% CI
COVIVAC 1 mcg82.661.2 – 95.0
COVIVAC 3 mcg87.567.6 – 97.3
COVIVAC 10 mcg10085.8 – 100.0
COVIVAC 1mcg + CpG90.970.8 – 98.9
Placebo89.566.9 – 98.7

Adverse events — posted to ClinicalTrials.gov

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. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

COVIVAC 1 mcg
Serious: 0/25 (0%)
Deaths: 0/25
COVIVAC 3 mcg
Serious: 0/25 (0%)
Deaths: 0/25
COVIVAC 10 mcg
Serious: 0/25 (0%)
Deaths: 0/25
COVIVAC 1mcg + CpG
Serious: 1/25 (4%)
Deaths: 0/25
Placebo
Serious: 1/20 (5%)
Deaths: 0/20

Serious adverse events (2 terms)

ReactionSystemCOVIVAC 1 mcgCOVIVAC 3 mcgCOVIVAC 10 mcgCOVIVAC 1mcg + CpGPlacebo
AdnexitisReproductive system and breast disorders—————
COMPLICATED WOUND AT LEFT HANDInjury, poisoning and procedural complications—————
Other adverse events (1 terms — click to expand)

ReactionSystemCOVIVAC 1 mcgCOVIVAC 3 mcgCOVIVAC 10 mcgCOVIVAC 1mcg + CpGPlacebo
Oropharyngeal painRespiratory, thoracic and mediastinal disorders—————

Most-reported serious reactions: Adnexitis, COMPLICATED WOUND AT LEFT HAND.

Data from ClinicalTrials.gov NCT04830800 adverse events section.

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Efficacy and safety of COVID-19 vaccines.
    Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
  2. A Newcastle disease virus expressing a stabilized spike protein of SARS-CoV-2 induces protective immune responses.
    Sun W, Liu Y, Amanat F, González-Domínguez I, et al · · 2021 · cited 92× · PMID 34707161 · DOI 10.1038/s41467-021-26499-y
  3. 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.
    Pitisuttithum P, Luvira V, Lawpoolsri S, Muangnoicharoen S, et al · · 2022 · cited 50× · PMID 35284808 · DOI 10.1016/j.eclinm.2022.101323
  4. Safety and Immunogenicity of a Newcastle Disease Virus Vector-Based SARS-CoV-2 Vaccine Candidate, AVX/COVID-12-HEXAPRO (Patria), in Pigs.
    Lara-Puente JH, Carreño JM, Sun W, Suárez-Martínez A, et al · · 2021 · cited 42× · PMID 34544278 · DOI 10.1128/mbio.01908-21
  5. A Narrative Review of COVID-19 Vaccines.
    Eroglu B, Nuwarda RF, Ramzan I, Kayser V. · · 2021 · cited 38× · PMID 35062723 · DOI 10.3390/vaccines10010062
  6. 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.
    Duc Dang A, Dinh Vu T, Hai Vu H, Thanh Ta V, et al · · 2022 · cited 34× · PMID 35577631 · DOI 10.1016/j.vaccine.2022.04.078
  7. Interim safety and immunogenicity results from an NDV-based COVID-19 vaccine phase I trial in Mexico.
    Ponce-de-León S, Torres M, Soto-Ramírez LE, Calva JJ, et al · · 2023 · cited 32× · PMID 37164959 · DOI 10.1038/s41541-023-00662-6
  8. Safety and Immunogenicity Analysis of a Newcastle Disease Virus (NDV-HXP-S) Expressing the Spike Protein of SARS-CoV-2 in Sprague Dawley Rats.
    Tcheou J, Raskin A, Singh G, Kawabata H, et al · · 2021 · cited 28× · PMID 34868082 · DOI 10.3389/fimmu.2021.791764

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