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COVID-19 PreventionPhase 2/3NCT04640233

Clinical Trial to Assess Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Сov-2) Infection

A Phase 2/3 study testing Gam-COVID-Vac in people with COVID-19 Prevention, run by Dr. Reddy's Laboratories Limited at 23 sites in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Prevention
What is being tested?
Gam-COVID-Vac
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,600 participants
Where
23 sitesIndia
Study dates
30 Nov 2020to Sep 2021
Phase
Phase 2/3
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Written informed consent of a subject to participate in the trial
  • Males and females aged 18+ years
  • Negative human immunodeficiency virus (HIV 1 \& 2) and hepatitis B and C test results
  • Negative immunoglobulin M (IgM) and immunoglobulin G (IgG) SARS-CoV-2 antibodies through enzyme immunoassay test result
  • Negative COVID-2019 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit (72 hours prior to Visit 1 [Day 1])
  • No COVID-2019 in the medical history
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  • History of no contact with COVID-2019 persons within at least 14 days before the enrolment (according to subjects)
  • Consent for using effective methods of contraception during the entire trial 1
  • Negative urine pregnancy test at the screening visit (for child-bearing age women)
  • No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history
  • No acute infectious and/or respiratory diseases within at least 14 days before the enrolment.

Who cannot join

  • Any vaccination/immunization within 30 days before the enrolment
  • Steroids (except hormonal contraceptives) and immunoglobulins or other blood products therapy not finished 30 days before the enrolment
  • Immunosuppressors therapy finished within 3 months before the enrolment
  • Pregnancy or breast-feeding
  • Acute coronary syndrome or stroke suffered less than one year before the enrolment
  • Tuberculosis, chronic systemic infections
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  • Drug allergy (anaphylactic shock, Quincke edema, polymorphic exudative eczema, atopy, serum disease),hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study product components, acute exacerbation of allergic diseases on the enrolment day
  • Subjects who are on drugs that could have potential drug interactions with adenovirus vaccine
  • Medical history of malignancy
  • Donated blood or plasma (450+ mL) within 2 months before the enrolment
  • Splenectomy in the medical history
  • Neutropenia (absolute neutrophil count less than 1,000 mm3), agranulocytosis, significant blood loss,severe anaemia (haemoglobin less than 80 g/L), immunodeficiency including autoimmune disorders in the medical history within 6 months before the enrolment
  • Active form of a disease caused by the HIV and hepatitis B or C
  • Anorexia, protein deficiency of any origin
  • Tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the IMP or placebo administration
  • Alcohol or drug addiction in the medical history.
  • Participation in any other interventional clinical trial within 1 month prior to the Screening
  • Any other medical condition that would limit the participation of the subject as per Investigator discretion
  • Study centre staff or other employees directly involved in the trial and their families
  • Subjects contraindicated for vaccination

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

India23 sites

  • S N Medical College

    Agra

  • KLE Prabhakar Kore Hospital

    Belagavi

  • MGM Medical College and Hospital

    Chhatrapati Sambhajinagar

  • Apollo Hospital

    Delhi

  • Batra Hospital

    Delhi

  • HIMSR with CHRD-SAS

    Delhi

  • ESIC Medical College & Hospital

    Faridabad

  • AIG hospital

    Hyderabad

  • Maharaja Agrasen Superspecialty Hospital

    Jaipur

  • GSVM Medical College

    Kanpur

  • Peerless Hospital

    Kolkata

  • Atharva Hospital

    Lucknow

  • St. George's Hospital

    Mumbai

  • JSS Hospital

    Mysore

  • INCLEN trust and Gurunanak Hospital

    Palwal

  • PIMS

    Puducherry

  • BJ Sassoon Hospital

    Pune

  • KEM Hospital

    Pune

  • Noble Hospital Private Limited

    Pune

  • BAPS hospital

    Sūrat

  • Rhythm Heart Institute

    Vadodara

  • Sumandeep Vidyapeeth

    Vadodara

  • Christian Medical College

    Vellore

Other trials in India

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects.

Read the detailed description

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects.

In phase II trial, 100 subjects of immunogenicity group will be enrolled in 3:1 (Test:Placebo) ratio. These 100 subjects will be assessed for safety and immunogenicity outcomes till Day 28 post the first dose of investigational medicinal product (IMP)/placebo administration and will continue with study assessments till Day 180. Safety and immunogenicity data collected till Day 28 will be submitted to the regulatory authority for recommendation to proceed with Phase III recruitment.

In Phase III trial, 1500 subjects will be enrolled and randomized in the ratio of 3:1 (Gam-COVID--Vac : Placebo).

Each subject will participate in this adaptive study phase II/III clinical trial for 180±14 days after the first dose of the IMP/placebo and will have one screening visit and seven on-site visits during the trial period. The IMP/placebo will be administered intramuscularly during vaccination Visits 1 and 3 (Day 1 and Day 21±2). The observation Visits 2, 4, 5, 6, and 7 will be made on Day 19±2, Day 28±2, Day 42±2, Day 90±7, and Day 180±14, respectively. During the observation visits, vital indicators will be assessed in all subjects and changes in the subjects' condition and well being compared to the previous visit will be recorded. The schedule of examination procedures is mentioned in the Schedule of Event tables.

Additionally, the subjects will be able to have remote consultations with the study physician through the weekly telephonic follow-up.

Blood samples will be taken from immunogenicity group of phase II (all 100) and phase III (284 out of 1500) trials during the following visits to assess the immunogenicity parameters.

Being tested
Gam-COVID-Vac, Placebo
Keywords
Sputnik, Gamaleya

What participants receive

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

  • Gam-COVID-VacBiological

    Vaccine for intramuscular injection

  • PlaceboOther

    Placebo comparator

Study groups in NCT04640233
Study groupRoleWhat they receive
Primary GroupExperimentalGam-COVID-Vac combined vector vaccine, 0.5 ml/dose + 0.5 ml/dose prime-boost immunization on day 1 (component I rAd26-S) and on day 21 (component II rAd5-S)
Receives: Biological: Gam-COVID-Vac
Control GroupPlacebo comparatorPlacebo, 0.5 ml/dose + 0.5 ml/dose immunization on days 1 and 21
Receives: Other: Placebo

What is being measured

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

  1. Adverse Events

    For Phase II study - - Incidence \& severity of adverse events (AEs) after first dose of IMP/Placebo

    For Phase III study -

    • Incidence of related serious adverse events (SAEs) following vaccination during the study

    Measured: For Phase II study - at Day 28; For Phase III study - till day 180 after first dose

  2. Immunogenicity

    For Phase II study -

    • Seroconversion rate of SARS-CoV-2 glycoprotein-specific antibodies in immunogenicity group

    Measured: For Phase II study - Day 28 after first dose

  3. Immunogenicity

    For Phase III study - Geometric mean titre ratio of SARS-CoV-2 glycoprotein-specific antibodies between IMP and placebo in immunogenicity group

    Measured: For Phase III study - Day 42 after first dose

Secondary outcomes (7)

  1. Adverse Events

    Incidence and severity of adverse events after injecting the first dose of the IMP/placebo

    Incidence of SAE following vaccination

    Measured: Baseline to Day 180

  2. Immunogenicity assessment

    Seroconversion rate of SARS-CoV-2 glycoprotein-specific antibodies in immunogenicity group

    Seroconversion rate of SARS-CoV-2 virus-neutralizing antibodies in immunogenicity group

    Measured: Baseline, Day 21, Day 28, Day 42, Day 90, and Day 180

  3. Immunogenicity assessment

    Geometric mean virus-neutralizing antibodies titre in immunogenicity group

    Measured: Baseline, Day 21, Day 28, Day 42, Day 90, and Day 180

  4. Immunogenicity assessment

    Interferon gamma concentration in T-cells after restimulation with the SARS-CoV-2 glycoprotein in cell mediated immunogenicity group

    Measured: Baseline, Day 28, Day 42, Day 90 and Day 180

  5. Immunogenicity assessment

    The number of proliferating cluster of differentiation 4 (CD4) cell and cluster of differentiation 8 (CD8) cells in response to mitogen stimulation in cell mediated immunogenicity group

    Measured: Baseline, Day 28, Day 42, Day 90 and Day 180

  6. Percentage of subjects with mild, moderate, severe coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose of the vaccine/placebo

    Comparing percentage of subjects developing COVID-19 disease between Gam-COVID-Vac combined vector vaccine and placebo based on severity course

    Measured: Baseline to Day 180

  7. Incidence of coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose in trial subjects

    Comparing incidence of COVID-19 disease between Gam-COVID-Vac combined vector vaccine and placebo

    Measured: Baseline to Day 180

Timeline

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

  1. First posted23 Nov 2020
  2. Study start30 Nov 2020
  3. Primary completionAug 2021 (estimated)
  4. Study completionSep 2021 (estimated)

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04640233
Sponsor's protocol ID
RDI-GCV-001
Other IDs
CTRI/2020/11/029234
Status last verified
May 2021
First submitted
17 Nov 2020
Last updated
2 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Gam-COVID-Vac in people with COVID-19 Prevention, run by Dr. Reddy's Laboratories Limited at 23 sites in India.

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 20 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in India. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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?

Adverse Events (time frame: For Phase II study - at Day 28; For Phase III study - till day 180 after first dose). The study lists 3 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 NCT04640233.

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 2 Jun 2021.

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