Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study in Adults to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, Given in Combination With rAd26-S, Recombinant Adenovirus Type 26 Component of Gam-COVID-Vac Vaccine, for the Prevention of COVID-19.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04686773
Recruitment Status : Not yet recruiting
First Posted : December 29, 2020
Last Update Posted : January 14, 2021
Sponsor:
Collaborators:
AstraZeneca
Russian Direct Investment Fund
The Gamaleya National Center of Epidemiology & Microbiology
Information provided by (Responsible Party):
R-Pharm

Brief Summary:
The primary objective of this study is to describe the safety and tolerability of one IM dose of AZD1222 followed by one IM dose of rAd26-S in adults ≥ 18 years of age

Condition or disease Intervention/treatment Phase
COVID-19 Biological: AZD1222 Biological: rAd26-S Phase 2

Detailed Description:

This is a prospective, multicenter, open-label clinical study, designed to provide data on the heterologous prime-boost use of AZD1222 and rAd26-S, to be administered one after the other.

All participants will be healthy adults ≥ 18 years of age. They will receive 1 intramuscular (IM) injection of 5×10^10 viral particles (vp) (nominal) of AZD1222 on Day 1 followed by rAd26-S 1×10^11 viral particles (vp) (nominal) on Day 29 of the study.

All participants will remain on study for 6 months (180 days) following the first vaccination. Safety will be assessed for the duration of the study as follows:

  • Solicited adverse events (AEs; local and systemic) will be assessed for 7 days following each vaccination (ie, until Day 8 following the first administration and Day 36 following the second administration)
  • Unsolicited AEs will be recorded for 28 days following each vaccination (ie, until Day 29 following the first administration and Day 57 following the second administration)
  • Serious adverse events (SAEs) will be recorded from signing of the informed consent form through Day 180

Immunogenicity will also be assessed for the duration of the study, including serologic quantification of Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) antigen-specific antibody levels and antibody seroconversion rate, neutralizing antibody assays.

The study will allow to explore the safety and immunogenicity of two different adenovirus vector vaccines combination, thereby complementing data from other pivotal controlled vaccine trials in other countries.

This study is going to be conducted in the Republic of Azerbaijan. It is expected that approximately 100 participants will be included in the study and receive the vaccine.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Open-label Study in Adults to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, Given in Combination With rAd26-S, Recombinant Adenovirus Type 26 Component of Gam-COVID-Vac Vaccine, for the Prevention of COVID 19
Estimated Study Start Date : February 10, 2021
Estimated Primary Completion Date : April 9, 2021
Estimated Study Completion Date : September 20, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: AZD-1222

Arm Intervention/treatment
Experimental: AZD1222 5×10^10 vp + rAd26-S (1.0±0.5) х 10^11vp
Subjects will receive 1 intramuscular (IM) injection of 5×10^10 viral particles (nominal) of AZD1222 on Day 1 followed by rAd26-S 1×10^11 viral particles (nominal) on Day 29 of the study.
Biological: AZD1222

Active substance: ChAdOx1 nCoV-19, a replicant-deficient simian adenoviral vector in the amount of 5 х 10^10 particles per dose.

Solution for intramuscular injection, supplied in vials in a carton box


Biological: rAd26-S

Component I (Dose 1) - (0.5 ml per dose) contains:

Active substance: recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 10^11 particles per dose.

Solution for intramuscular injection, supplied in vials in a carton box

Other Name: Gam-COVID-Vac combined vector vaccine




Primary Outcome Measures :
  1. Incidence of Serious Adverse Events (SAEs) post first dose until the study end [ Time Frame: from Day 1 until Day 180 ]
    Incidence of Serious Adverse Events (SAEs) post first dose until the study end


Secondary Outcome Measures :
  1. Incidence of unsolicited Adverse Events (AEs) for 28 days post each dose [ Time Frame: from Day 1 to Day 28 and from Day 29 to Day 57 ]
    Incidence of unsolicited AEs for 28 days post each dose

  2. Incidence of local and systemic solicited AEs for 7 days post each dose [ Time Frame: from Day 1 to Day 8 and From Day 29 to Day 36 ]
    Incidence of local and systemic solicited AEs for 7 days post each dose

  3. Incidence of Adverse events of special interest (AESIs) post first dose until study end [ Time Frame: from Day 1 to Day 180 ]
    Incidence of AESIs post first dose until study end (Day 180)

  4. assessment of time course of antibody to Spike protein of one IM dose of AZD1222 followed by one IM dose of rAd26-S [ Time Frame: On Day 1 and on Day 29 ]
    assessment of time course of antibody to Spike protein of one IM dose of AZD1222 followed by one IM dose of rAd26-S

  5. Determination of anti-SARS-CoV-2 neutralising antibody levels in serum following one IM dose of AZD1222 followed by one IM dose of rAd26-S [ Time Frame: On Day 1 and on day 29 ]
    Determination of anti-SARS-CoV-2 neutralising antibody levels in serum following one IM dose of AZD1222 followed by one IM dose of rAd26-S

  6. Proportion of participants who have a post treatment seroresponse [ Time Frame: from Day 1 (before dose) to Day 28 and from Day 29 (before dose) to Day 57 ]
    Proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titers from day of dosing baseline value to 28 days post each dose) as measured by SARS-CoV-2 antibodies to Spike protein



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Agree to sign the study informed consent form (ICF) before performing any study-specific procedure
  • Healthy or medically stable, when, in the opinion of the investigator, no hospitalization is expected during the study period, and the participant is likely to be able to take part in the study until the end of the observation period specified in the protocol.

    • A stable medical condition is defined as a disease that did not require significant changes in therapy or hospitalization 3 months before inclusion.
  • The ability to understand and comply with the protocol requirements in the investigator's opinion
  • Female participants

    1. For female participants of childbearing potential the following is required:

      • A negative pregnancy test result on the day of screening and on Day 1.
      • use appropriate contraception through 28 days before Day 1 and through 60 days following administration of the second dose
    2. Female participants have the childbearing potential if they do not meet any of the following criteria:

      • Surgical sterilization (including bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or
      • Postmenopause
      • For women under the age of 50, postmenopause is defined as having two of the following criteria:
  • Amenorrhea ≥ 12 months before the first dose, with no alternative cause, after discontinuation of exogenous sex hormone therapy, and
  • Level of follicle-stimulating hormone in the postmenopausal range

Exclusion Criteria:

  • History of allergic reactions or allergy to any component of the vaccines
  • Positive SARS-CoV-2 Reverse Transcription Polymerase Chain Reaction (PCR) test at screening
  • Seropositivity to SARS-CoV-2 at screening (IgG test).
  • Known past laboratory-confirmed SARS-CoV-2 infection.
  • Significant infection or other illness, acute infectious and non-infectious diseases, exacerbation of chronic diseases
  • Positive HIV, hepatitis B, hepatitis C, and syphilis test results
  • Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; HIV; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤14 days).
  • History of primary malignant tumor in history
  • Bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture)
  • Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed).
  • History of Guillain-Barré syndrome or any other demyelinating condition.
  • Any other significant disease, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study or impair interpretation of the study data.
  • Prior or planned receipt of an investigational vaccine or product intended to treat or prevent SARS-CoV-2 or COVID-19 infection. Note: Registered therapy options are permitted for study participants hospitalized with COVID-19.
  • Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the planned administration of the vaccine candidate
  • Participation in the planning and / or conduct of the study (applies to the Sponsor's staff and / or the Investigational site staff).
  • For female subjects only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
  • Investigator's opinion that the participant should not participate in the study because of questionable incompliance to the procedures, limitations and study requirements.
  • Previous participation in other clinical trials less than 3 months prior to inclusion in this clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686773


Locations
Layout table for location information
Azerbaijan
Baki Saglamic Merkezi
Baku, Azerbaijan
Sponsors and Collaborators
R-Pharm
AstraZeneca
Russian Direct Investment Fund
The Gamaleya National Center of Epidemiology & Microbiology
Investigators
Layout table for investigator information
Study Director: Mikhail Samsonov Chief Medical Officer, R-Pharm
Layout table for additonal information
Responsible Party: R-Pharm
ClinicalTrials.gov Identifier: NCT04686773    
Other Study ID Numbers: AZD1222 - rAd26-S
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by R-Pharm:
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
2019-nCoV
2019 novel coronavirus
Respiratory disease
lung disease
COVID-19
coronavirus
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs