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COMPLETEDPHASE1/PHASE2

Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime-Boost Regimen for the Prevention of COVID-19

A Phase I/II Single-Blinded Randomized Safety and Immunogenicity Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime Boost Regimen for the Prevention of COVID 19

NCT04684446•R-Pharm

View on ClinicalTrials.gov

Summary

The objective is to evaluate the safety and immunogenicity of AZD1222 given in combination with (either before or after) rAd26-S, for the prevention of COVID 19 in adults ≥ 18 years of age.

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Adults ≥ 18 years of age at the time of signing the informed consent
•2. Overtly healthy as determined by medical evaluation, or
•\- Medically stable such that, according to the judgment of the investigator, hospitalisation within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up.
•o A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment
•3. Able to understand and comply with study requirements/procedures based on the assessment of the investigator
•4. Reproduction:
•Female participants
•1. Women of childbearing potential must:
•* Have a negative pregnancy test on the day of screening and on Day 1
•* Use one highly effective form of birth control for at least 28 days prior to Day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study vaccine. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly.
+5 more criteria

Exclusion Criteria

•Medical Conditions
•1. Known past laboratory-confirmed SARS-CoV-2 infection.
•2. Positive SARS-CoV-2 RT PCR test at screening.
•3. Seropositivity to SARS-CoV-2 at screening.
•4. Significant infection or other illness, including fever \> 37.8°C on the day prior to or on the day of randomization 5. Thrombocytopenia ≥ Grade 2 (i.e. \< 100 000/mm\^3) 6. Clinically significant neutropenia (as determined by the investigator). 7. Clinically significant anaemia (as determined by the investigator) 8. Any confirmed or suspected immunosuppressive or immunodeficient state; including human immunodeficiency virus (HIV) infection; asplenia; recurrent severe infections and use of chronic immunosuppressant medication (within the past 6 months(≥ 20 mg/day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days within 30 days prior to vaccination), except topical/inhaled steroids or short-term oral steroids ( course lasting ≤ 14 days).
•9\. History of allergy to any component of the vaccine 10. Any history of anaphylaxis or angioedema. 11. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and uterine cervical carcinoma in situ).
•12\. History of serious psychiatric condition likely to affect participation in the study.
•13\. Bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
•14 Suspected or known current alcohol or drug dependency. 15 History of Guillan-Barré syndrome or any other demyelinating condition. 16 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.
•17 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).
+10 more criteria

Locations (4)

OJSC Clinical and Diagnostic Center Euromedservice

Moscow, Russia

LLC PiterClinica

Saint Petersburg, Russia

Federal State Budgetary Educational Institution of Higher Education " First Saint Petersburg State Medical University named after Academician I. P. Pavlov" of the Ministry of Healthcare of the Russian Federation

Saint Petersburg, Russia

Federal State Budget Institution "Scientific and Research Institute of Flu n.a. A.A. Smorodintseva" of Ministry of Health of Russian Federation

Saint Petersburg, Russia

Key Dates

Start Date

September 15, 2021

Primary Completion Date

November 26, 2021

Completion Date

March 29, 2022

Last Updated

June 3, 2022

Enrollment

100

ACTUAL participants

Conditions

COVID-19

Interventions

AZD1222

BIOLOGICAL

rAd26-S

BIOLOGICAL

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

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RECRUITINGPHASE1

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

NCT07221162

COVID-19

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime-Boost Regimen for the Prevention of COVID-19

Inclusion Criteria

Exclusion Criteria

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

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