Safety, Tolerability and Immunogenicity of Recombinant COVID-19 Vaccine Betuvax-CoV-2

NCT05270954 | Unknown Phase 1 DMC

• 1 other identifier: Betuvax-CoV-2.2021.CT1-2.RUS
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 3

Brief Summary

Randomized, double-blind, multicenter parallel-group clinical study of safety, tolerability and immunogenicity of the Betuvax-CoV-2 vaccine. The aim of this study is to investigate the safety, tolerability and immunogenicity of the Betuvax-CoV-2 Recombinant vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus, suspension for intramuscular administration, 10 μg/ml and 40 μg/ml (Ltd. Institute of New Medical Technologies, Russia) in healthy adult volunteers, aged 18 to 60 (inclusive).

Conditions

COVID-19

Keywords

SARS-CoV-2; coronavirus; recombinant vaccine; virus-like vaccine; betulin

Outcome Measures

Primary Outcomes (6)

• Total specific anti-SARS-CoV-2 antibodies

  The proportion of the volunteers with an increased level of the total specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)

  21 days after the second administration of the study drug/placebo

• Total specific anti-SARS-CoV-2 antibodies

  The proportion of the volunteers with an increased level of the total specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)

  90±5 days after the first administration of the study drug/placebo

• Neutralizing anti-SARS-CoV-2 antibodies

  The proportion of the volunteers tested positive for the presence of neutralizing anti-SARS-CoV-2 antibodies (SARS-CoV-2 Surrogate Virus Neutralization Test)

  21 days after the second administration of the study drug/placebo

• Neutralizing anti-SARS-CoV-2 antibodies

  The proportion of the volunteers tested positive for the presence of neutralizing anti-SARS-CoV-2 antibodies (SARS-CoV-2 Surrogate Virus Neutralization Test)

  90±5 days after the first administration of the study drug/placebo

• Adverse events

  The proportion of the volunteers with any adverse events

  Within 50 days of the first dose of the study drug/placebo

• Severe adverse events

  The proportion of the volunteers with severe adverse events

  Within 50 days of the first dose of the study drug/placebo

Secondary Outcomes (50)

• Total specific anti-SARS-CoV-2 antibodies

  180±5 days after the first administration of the study drug/placebo

• IgG-specific anti-SARS-CoV-2 antibodies

  21 days after the second administration of the study drug/placebo

• IgG-specific anti-SARS-CoV-2 antibodies

  90±5 days after the first dose of the study drug/placebo

• IgG-specific anti-SARS-CoV-2 antibodies

  180±5 days after the first dose of the study drug/placebo

• IgM-specific anti-SARS-CoV-2 antibodies

  21 days after the second administration of the study drug/placebo

Study Arms (5)

Group 1 (Phase 1)

ACTIVE COMPARATOR

All volunteers randomized to Group 1 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 5 μg, twice, within a 28-day period.

Biological: Betuvax-CoV-2

Group 2 (Phase 1)

ACTIVE COMPARATOR

All volunteers randomized to Group 2 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 20 μg, twice, within a 28-day period.

Biological: Betuvax-CoV-2

Group 3 (Phase 2)

ACTIVE COMPARATOR

All volunteers randomized to Group 3 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 5 μg, twice, within a 28-day period.

Biological: Betuvax-CoV-2

Group 4 (Phase 2)

ACTIVE COMPARATOR

All volunteers randomized to Group 4 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 20 μg, twice, within a 28-day period.

Biological: Betuvax-CoV-2

Group 5 (Phase 2)

PLACEBO COMPARATOR

Volunteers randomized to Group 5 will be administered a placebo reference drug (0.9% aqueous sodium chloride solution), twice, within a 28-day period.

Drug: Placebo

Interventions

Betuvax-CoV-2 BIOLOGICAL

Vaccine: Betuvax-CoV-2 intramuscular injection solution (0.5 ml)

Group 1 (Phase 1); Group 2 (Phase 1); Group 3 (Phase 2); Group 4 (Phase 2)

Placebo DRUG

Placebo: a 0.9% NaCl intramuscular injection solution (0.5 ml)

Also known as: 0.9% NaCl

Group 5 (Phase 2)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 60 years of age.
• Verified healthy condition according to the data of standard clinical, laboratory and instrumental examination methods.
• For women being in an active reproductive period: Consent to adhere to appropriate methods of contraception during the entire period of the participation in the study and for 1 month after the completion of the participation in the study (appropriate methods of contraception include abstinence from sexual intercourse or any two of the following methods: an intrauterine device (intrauterine device without release and with a release of a local hormonal drug), diaphragm, spermicides, cervical caps, oral contraceptives, contraceptive sponge and/or condom); for men: Consent to adhere to appropriate dual barrier methods of contraception during the entire period of the participation in the study and 1 month after completion of the participation in the study.
• Body mass index (BMI): 18.5≤ BMI≤30 kg/m2.
• Negative breath alcohol test.
• Negative laboratory blood tests for HIV, syphilis and hepatitis B and C.
• Ability and willingness to attend all scheduled visits and undergo all procedures and examinations planned by the Protocol.
• Signed and dated Informed Consent to participate in the study.

You may not qualify if:

• Contact with COVID-19 patients during 14 days before the start of the study.
• PCR SARS-CoV-2 positive test.
• Titer of the total specific anti-SARS-CoV-2 antibodies (ELISA) more than 1:10.
• Drug allergies, hereditary angioedema.
• Hypersensitivity to any component of the vaccine or any excipients of Betuvax-CoV-2 or allergy to the components of the vaccine.
• Intolerance to any of the components or any excipients of the vaccine Betuvax-CoV-2.
• Allergic reaction to previous immunizations.
• Serious post-vaccination reactions/complications associated with previous immunizations.
• For women of childbearing potential - lactation period, pregnancy or suspicion of it, early postpartum period.
• Women in the premenopausal period (last menstrual period \<1 year prior to signing informed consent) who are not surgically sterile and women who have childbearing potential but do not use or plan to use appropriate methods of contraception throughout the study and do not agree to perform a urine pregnancy test while participating in a study.
• Men who serve in the military by conscription.
• Individuals in custody in pre-trial detention centers and those serving sentences in places of deprivation of liberty.
• Children under 18 years of age.
• Chronic diseases (including oncological and autoimmune), diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as the gastrointestinal tract, liver, kidneys, blood, central nervous system; surgical interventions on the gastrointestinal tract (with the exception of appendectomy).
• Active tuberculosis at the time of screening (based on history and physical examination).

Sponsors & Collaborators

• Artgen Biotech: lead
• Betuvax LLC: collaborator
• CEG BIO LLC: collaborator

Study Sites (3)

Center of professional medicine

Perm, 614000, Russia

Location

"Eco-Safety" R&D center

Saint Petersburg, 196143, Russia

Location

Department of Vaccinology, Smorodintsev Research Institute of Influenza of the Ministry of Health of the Russian Federation

Saint Petersburg, 197376, Russia

Location

Related Publications (1)

• Kudriavtsev AV, Vakhrusheva AV, Kryuchkov NA, Frolova ME, Blagodatskikh KA, Ivanishin TV, Djonovic M, Romanovskaya-Romanko EA, Kovalenko AN, Lioznov DA, Zubkova TG, Teplykh SV, Oseshnyuk RA, Stukova MA, Isaev AA, Krasilnikov IV. Safety and Immunogenicity of Betuvax-CoV-2, an RBD-Fc-Based SARS-CoV-2 Recombinant Vaccine: Preliminary Results of the First-in-Human, Randomized, Double-Blind, Placebo-Controlled Phase I/II Clinical Trial. Vaccines (Basel). 2023 Feb 1;11(2):326. doi: 10.3390/vaccines11020326.

  PMID: 36851204 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The Phase 1 is Open Label; The Phase 2 is double-blind.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 8, 2022
• Study Start: October 14, 2021
• Primary Completion: April 25, 2022
• Study Completion: July 24, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

RU (3)