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Covid-19Phase 1/2NCT04764422

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

A Phase 1/2 study testing Normal Saline and NDV-HXP-S vaccine in people with Covid-19 and SARS Pneumonia, run by Mahidol University at 1 site in Thailand.

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 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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Covid-19, SARS Pneumonia, Pneumonia, Viral
What is being tested?
Normal Saline and NDV-HXP-S vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
455 participants
Where
1 siteThailand
Study dates
20 Mar 2021to 12 Sep 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Phase 1 Only:
  • 1. 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.
  • History of administration of any non-study vaccine within 28 days prior to administration of study vaccine or planned vaccination during the course of study participation Note: receipt of any COVID-19 vaccine that is licensed or granted Emergency Use Authorization in Thailand 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
Show all 24Show fewer
  • 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.
  • Abnormality in screening laboratory test deemed exclusionary 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
  • 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.
  • Note: specific exclusion criteria (e.g., ≥Grade 2 acute illness, or abnormal vital sign deemed clinically relevant by the PI) will be reassessed at both vaccination visits. Any subject who cannot be vaccinated due to an acute abnormality assessed at a vaccination visit (Visit 1 or Visit 3) may return once the acute issue has resolved, if deemed appropriate by the PI. A minimum of 48 hours must have passed after a documented fever before a subject can be vaccinated. This safety requirement will not be deemed a protocol deviation should the visit fall outside the vaccination window; however, it will be encouraged to maintain the vaccination window whenever possible in these situations. Clinical laboratory test results and vital signs used to determine subject eligibility will be those obtained at screening. These tests may be repeated once if deemed appropriate by the investigator and determined to be due to a transient condition that has resolved. In addition, a test may also be repeated for test results determined to be spurious by the investigator (e.g., following improper specimen collection). The last measurement will be taken as the baseline for purposes of analysis.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

    Bangkok, 10400

Other trials in Thailand

About this study

Official title: A Phase 1/2 Randomized, Placebo-controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand

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.

Read the detailed description

This study (GPO NDV-HXP-S) will be conducted in 2 phases. Phase 1 will evaluate the 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). NDV-HXP-S or placebo (0.9% normal saline for injection) will administer IM according to a repeat vaccination schedule (given 28 days apart). In addition, as exploratory objectives, a total of 36 subjects will be randomly selected (1:1:1 ratio) from placebo and two high-dose groups i.e., NDV-HXP-S 10 µg and NDV-HXP-S 3 µg + CpG 1018, to provide additional blood at V1, V5 and V7 for assessment of T-cell-mediated immunity (CMI). 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.

In the Phase 2 study, 250 subjects aged 18-75 years will be randomized (1:2:2) to placebo (0.9% normal saline for injection), or one of two selected formulations of NDV HXP S being evaluated in Phase 1 will be enrolled to Phase 2 study. Twelve subjects in each of the three Phase 2 groups (distributed among the two age strata) will be randomized to provide additional blood at V1, V5 and V7 for assessment of T-cell-mediated immunity (CMI).

Unblinding will be done as per specific SOP provided by Sponsor. The PI will be expected to provide a rationale for the necessity of unblinding, based on the expectation that knowledge of the subject's treatment assignment will have a meaningful impact on the subject's medical care in the short term. If a subject's treatment assignment is unblinded, the subject will remain in the study and continue with protocol-defined study visits and procedures, unless there is another reason for subject discontinuation.

Scheduled unblinding regarding safety concern during severe COVID-19 situation:

The elderly subjects (60-75 years) who received placebo will be unblinded and discontinued as soon as COVID-19 vaccine (AstraZeneca) become available from Sponsor. If unblinding is occurred before complete enrollment of 75 elderly subjects, the randomization assignment will be skipped in placebo arm. Therefore, no further subjects will be randomly assigned to receive placebo after unblinding.

Being tested
Normal Saline, NDV-HXP-S 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
Medical subject headings
COVID-19, Pneumonia, Viral

What participants receive

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

  • Normal SalineBiological

    0.9% normal saline for injection

  • NDV-HXP-S vaccineBiological

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

Study groups in NCT04764422
Study groupRoleWhat they receive
PlaceboPlacebo comparator0.9% Normal Saline for injection
Receives: Biological: Normal Saline
NDV-HXP-S 1 µgActive comparator35 subjects age 18-59 will receive NDV-HXP-S 1 µg study vacine administered 0.5 mL IM
Receives: Biological: NDV-HXP-S vaccine
NDV-HXP-S 3 µgActive comparator35 subjects age 18-59 will receive NDV-HXP-S 3 µg study vacine administered 0.5 mL IM
Receives: Biological: NDV-HXP-S vaccine
NDV-HXP-S 10 µgActive comparator35 subjects age 18-59 will receive NDV-HXP-S 10 µg study vacine administered 0.5 mL IM
Receives: Biological: NDV-HXP-S vaccine
NDV-HXP-S 1 µg + CpG1018 1.5 mgActive comparator35 subjects age 18-59 will receive NDV-HXP-S 1 µg + CpG1018 1.5 mg study vacine administered 0.5 mL IM
Receives: Biological: NDV-HXP-S vaccine
NDV-HXP-S 3 µg + CpG1018 1.5 mgActive comparator35 subjects age 18-59 will receive NDV-HXP-S 3 µg + CpG1018 1.5 mg study vacine administered 0.5 mL IM
Receives: Biological: NDV-HXP-S vaccine

What is being measured

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

  1. 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

    Measured: Day 1 up to Day 7 after first vaccination

  2. 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

    Measured: Day 1 up to Day 7 after second vaccination

  3. 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

    Measured: Day 1 up to Day 7 after first vaccination

  4. 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

    Measured: Day 1 up to Day 7 after second vaccination

  5. 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

    Measured: Day 8, Day 36

  6. 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

    Measured: Day 8, Day 36

  7. 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

    Measured: Day 8, Day 36

  8. 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

    Measured: Day 8, Day 36

  9. 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

    Measured: Day 8, Day 36

  10. 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

    Measured: Day 8, Day 36

  11. 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

    Measured: Day 8, Day 36

  12. Frequency of all unsolicited AEs

    Frequency of all unsolicited AEs

    Measured: Day 1 up to Day 56

  13. Frequency of SAEs

    Frequency of SAEs throughout the entire study period

    Measured: Day 1 up to Day 365

  14. Frequency of medically-attended adverse event (MAAEs)

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

    Measured: Day 1 up to Day 365

  15. 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

    Measured: Day 1 up to Day 365

Secondary outcomes (7)

  1. GMT Neutralizing antibody titer 50 changed from baseline after vaccination

    GMT Neutralizing antibody titer 50 changed from baseline after vaccination

    Measured: Day 29, Day 43, Day 197, Day 365

  2. GMT Neutralizing antibody titer 80 changed from baseline after vaccination

    GMT Neutralizing antibody titer 80 changed from baseline after vaccination

    Measured: Day 29, Day 43, Day 197, Day 365

  3. NT50 seroresponses changed from baseline after vaccination

    Frequency of subjects with NT50 seroresponses against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline after vaccination

    Measured: Day 29, Day 43, Day 197, Day 365

  4. NT80 seroresponses changed from baseline after vaccination

    Frequency of subjects with NT80 seroresponses against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline after vaccination

    Measured: Day 29, Day 43, Day 197, Day 365

  5. GMT Anti-S IgG after vaccination

    GMT Anti-S IgG after vaccination in subjects who are anti-S IgG seronegative at baseline

    Measured: Day 29, Day 43, Day 197, Day 365

  6. GMFR changed from baseline in anti-S IgG GMT after vaccination

    GMFR changed from baseline in anti-S IgG GMT after vaccination

    Measured: Day 29, Day 43, Day 197, Day 365

  7. Anti-S IgG Seroresponses changed from baseline after vaccination

    Frequency 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 after vaccination

    Measured: Day 29, Day 43, Day 197, Day 365

Timeline

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

  1. First posted21 Feb 2021
  2. Study start20 Mar 2021
  3. Primary completion12 Sep 2022
  4. Study completion12 Sep 2022

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
455 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04764422
Sponsor's protocol ID
GPO NDV-HXP-S
Status last verified
Nov 2022
First submitted
8 Feb 2021
Last updated
15 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: data or left over specimen will be shared for future study ONLY subject who consent allow using their data/specimens. Sharing will be done without personnel identification

Publications

  • 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.

    PubMed 35284808

  • 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.

    PubMed 34580673

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Normal Saline and NDV-HXP-S vaccine in people with Covid-19 and SARS Pneumonia, run by Mahidol University at 1 site in Thailand.

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 11 inclusion and 24 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 15 Nov 2022. 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 Thailand. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Frequency of solicited reportable local adverse event after first vaccination (time frame: Day 1 up to Day 7 after first vaccination). The study lists 15 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 NCT04764422, which also lists 2 linked publications.

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 15 Nov 2022.

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