Open-label, Non-randomized, Non-comparative, Phase II Study of Safety and Immunogenicity of Combination of AZD1222 and rAd26-S for COVID-19 Prevention

NCT04686773 | Completed Phase 2

• 1 other identifier: CV03872092
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess safety and immunogenicity of heterologous booster vaccine containing combination of AZD1222 and rAd26-S (one of components of Gam-COVID-Vac vaccine) in adult subjects aged ≥ 18 years old to prevent COVID-19 spread.

Conditions

COVID-19

Keywords

SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; 2019-nCoV; 2019 novel coronavirus; Respiratory disease; lung disease; COVID-19; coronavirus

Outcome Measures

Primary Outcomes (1)

• Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the second vaccination.

  Antibody seroconversion rate (≥4-fold increase from baseline) to SARS CoV-2 Spike protein 29 days after the second vaccination.

  Day 57

Secondary Outcomes (9)

• Incidence of local and systemic solicited Adverse Events (AEs) for 7 days post each dose

  from Day 1 to Day 8 and From Day 29 to Day 36

• Incidence of unsolicited AEs, serious adverse events (SAEs) and AEs of special interest

  up to day 29, up to day 57

• Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the first vaccination.

  day 29

• Antibody seroconversion rate against receptor-binding domain antigen 29 days after each vaccination.

  day 29, 57

• Change from baseline Geometric mean titre (GMT) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens

  Day 1, 15, 29, 57, 180

Study Arms (1)

AZD1222 5×10^10 vp + rAd26-S (1.0±0.5) х 10^11vp

EXPERIMENTAL

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; Biological: rAd26-S

Interventions

AZD1222 BIOLOGICAL

AZD1222 (0.5 ml per dose) contains: 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 (5 mL, up to 10 doses per vial) in a carton box.

Also known as: AZ_VACCINE_COVID-19, (previously called ChAdOx1 nCoV-19)

AZD1222 5×10^10 vp + rAd26-S (1.0±0.5) х 10^11vp

rAd26-S BIOLOGICAL

Component I (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 (3 mL, 5 doses per vial) in a carton box

Also known as: Gam-COVID-Vac combined vector vaccine (Component I)

AZD1222 5×10^10 vp + rAd26-S (1.0±0.5) х 10^11vp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are:
• Overtly healthy as determined by medical examination, 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.
• (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.)
• Able to understand and comply with study requirements/procedures based on the assessment of the investigator.
• Female participants
• Women of childbearing potential must:
• Have a negative pregnancy test on the day of screening and Day 1.
• Use of a 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 (see the table below). Periodic abstinence, the rhythm method, and withdrawal are NOT acceptable methods of contraception.
• Women are considered of childbearing potential unless they meet either of the following criteria:
• Surgically sterilized (including bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or
• Postmenopausal
• For women aged \< 50 years old, postmenopause is defined as having both:
• A history ≥ 12 months amenorrhea prior to the first dosing, without an alternative cause, following cessation of exogenous sex hormone treatment and
• A follicle-stimulating hormone level in post-menopausal range. (Until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential.)

You may not qualify if:

• Known past confirmed SARS-CoV-2 infection less than 6 month prior to screening (the date of diagnosis must be confirmed by an official document).
• Positive SARS-CoV-2 Reverse transcriptase polymerase chain reaction (RT-PCR) test at screening.
• Significant infection or other illness including fever \> 37.8 °C on the day prior to or day of vaccination.
• Thrombocytopenia of grade ≥ 2 (i.e., \<100,000/ mm3)
• Clinically significant neutropenia (as determined by the investigator).
• Clinically significant anemia (as determined by the investigator).
• Any confirmed or suspected immunosuppressive or immunodeficient condition including infection caused by human immunodeficiency virus (HIV); asplenia; recurring and severe infections and administration of chronic immunosuppressive drugs within previous 6 months ( ≥ 20 mg/day of prednisone or another steroid at an equivalent dose used daily or every other day for ≥ 15 days within the 30-day period preceding immunization) except for topical/inhalation steroids or short-term oral steroids (courses ≤14 days).
• Note: enrollment of HIV-positive subjects with CD4 levels \> 500 cells/mL3 ≥12 months receiving stable antiretroviral therapy for HIV therapy is allowed.
• Note: topical use of tacrolimus is permitted unless it was used within 14 days prior to enrollment.
• History of allergic reactions to any of the product ingredients.
• History of anaphylaxis or angioedema.
• Current diagnosis of a malignant neoplasm and therapy thereof (except for basal-cell skin carcinoma or cervical cancer in situ).
• History of serious mental conditions which are expected to impair participation in this study.
• Bleeding disorders (e.g. coagulation factor deficiency, coagulopathy or impaired platelet disorders) or history of relevant hemorrhages or subcutaneous bruises after intramuscular injections or vein punctures.
• Suspected alcohol or psychoactive drug addiction or a known current addiction.

Sponsors & Collaborators

• R-Pharm: lead
• AstraZeneca: collaborator
• Russian Direct Investment Fund: collaborator
• The Gamaleya National Center of Epidemiology & Microbiology: collaborator

Study Sites (1)

Public legal entity "Baku Health Center"

Baku, Azerbaijan

Location

MeSH Terms

Conditions

COVID-19; Respiration Disorders; Lung Diseases; Coronavirus Infections

Interventions

ChAdOx1 nCoV-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines

Study Officials

• Mikhail Samsonov

  Chief Medical Officer, R-Pharm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: December 29, 2020
• Study Start: March 5, 2021
• Primary Completion: October 30, 2021
• Study Completion: March 18, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-06

Locations

AZ (1)