COVID-19Phase 3NCT04780035

Study of the Tolerability, Safety, Immunogenicity and Preventive Efficacy of the EpiVacCorona Vaccine for the Prevention of COVID-19

A Phase 3 study testing EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) in people with COVID-19, run by Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" at 8 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of the clinical study is to evaluate the tolerability, safety, immunogenicity and prophylactic efficacy of the EpiVacCorona vaccine in volunteers aged 18 and above. 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
What is being tested?: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,000 participants
Where: 8 sitesRussia
Study dates: 27 Nov 2020to 20 Dec 2021
Phase: Phase 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

Availability of a signed and dated informed consent of the volunteer to participate in a clinical trial, prior to any of the study procedures.
Volunteers (men and women) above the age of 18 years with stable indicators of basic vital functions.
Ability to attend all scheduled visits and all planned procedures and examinations.
Consent of volunteers to use effective contraceptive methods throughout the study, including the observation period for possible post-vaccination reactions.

Who cannot join

History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) or another coronavirus infection (HCoV-229E, HCOV-OC43, HCoV-NL63, HCoV-HKU1).
History of exposure to confirmed or suspected cases of SARS-CoV-2 infection within 1 month prior to randomization.
Positive for IgM or IgG to SARS-CoV-2 as detected during screening.
Positive PCR test for SARS-CoV-2 as detected during screening.
Clinically and laboratory (according to PCR data) confirmed disease caused by SARS-CoV-2 coronavirus, at the moment or in the past.
Serious post-vaccination reaction (body temperature above 40 °C , hyperemia or edema greater than 8 cm in diameter) or complication (collapse or shock-like state that developed within 48 hours after vaccination; convulsions, with or without of a febrile state) to a previous vaccination in the past.

Show all 35Show fewer

Aggravated allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, history of serum disease, history of hypersensitivity or allergic reactions to the administration of any vaccines, any known allergic reactions to vaccine components, etc.).
Hypersensitivity to any component of the product, allergy to vaccine components.
History of vaccination with any vaccine within one month prior to randomization.
Previous vaccination with rabies vaccines less than 2 months prior to randomization, or planned vaccination with rabies vaccines within 1 month after immunization with the vaccine under study.
Pregnancy or breastfeeding.
The military.
Persons in custody in detention facilities and those serving sentences in correctional facilities.
Children under the age of 18.
History of any acute respiratory illness less than 3 months prior to randomization.
Acute infectious or non-infectious diseases, exacerbation of chronic diseases less than 4 weeks prior to randomization.
History of tuberculosis (pulmonary and extrapulmonary), cancer, autoimmune diseases, skin diseases.
Long-term use (more than 14 days) of immunosuppressants, systemic glucocorticosteroids or immunomodulatory drugs within 6 months prior to randomization.
Use of immunoglobulin drugs or blood products within 3 months prior to randomization.
Chronic diseases of the cardiovascular, bronchopulmonary, endocrine systems, gastrointestinal tract, liver, kidneys, blood, disease of the endocrine system in the exacerbation phase or that in the decompensation phase in the past or as detected during laboratory and imaging examination.
History of surgery within 6 months prior to randomization.
Participation in other clinical trials less than 3 months prior to randomization.
Persons with alcohol or drug abuse (medications or narcotics). Use of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, or 200 ml of wine or 50 ml of alcohol) or history of alcoholism, narcomania or drug (medication) abuse.
Mental illness or neurasthenia.
Positive test for HIV, viral hepatitis B and C, or syphilis.
Premenopausal women (last menstrual period ≤ 1 year prior to signing the informed consent) who are not surgically sterile and women who have reproductive potential but do not use or plan to use approved birth control products throughout the study nor they agree to a urine pregnancy test while participating in the study.
Serious concomitant diseases or pathological conditions not listed above, which, according to the investigator's opinion, could complicate the assessment of the study results, including any pathological deviations from the age norms and laboratory norms of blood and urine parameters, clinically significant in the investigator's opinion.
And:
The investigator's decision to exclude the volunteer for the benefit of the volunteer.
False inclusion (violation of inclusion or non-inclusion criteria) or the appearance of non-inclusion criteria during the study.
The decision of the investigator or the Sponsor to exclude the volunteer from the study due to a clinically significant deviation from the protocol/violation of the protocol.
Any undesirable phenomenon requiring the appointment of drugs not authorized by the protocol of this study.
Volunteer's desire to complete the study early for any reason.
Volunteer's failure to show up for a scheduled visit without the warning the investigator or loss of communication with the volunteer.
Positive urine drug test and / or alcohol breath test during the visit.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Russia8 sites

Federal State Autonomous Educational Institution of Higher Education - Immanuel Kant Baltic University (short name: FSAEIHE- I. Kant Baltic Federal University)
Kaliningrad, 236016
State Autonomous Healthcare Institution - Clinical City Hospital # 7 of Kazan (short name: SAHI CCH # 7)
Kazan', 420103
State Budgetary Healthcare Institution of the Moscow region - Krasnogorsk City Hospital # 1 (short name: SBHI MR KCH # 1)
Krasnogorsk, Moscow Oblast, 143408
Federal State Budgetary Institution - N.I. Pirogov National Medical and Surgical Center, Ministry of Health of the Russian Federation (short name: FSBI - N.I. Pirogov NMSC, Ministry of Health of the Russian Federation)
Moscow, 105203
Federal State Budgetary Research Institution - Academician B.V. Petrovsky Russian Research Center for Surgery (short name: FSBRI - Academician B.V. Petrovsky RRCS)
Moscow, 119991
Research Center: Federal State Budgetary Institution - Central Clinical Hospital with Polyclinic, Administrative Office of the President of the Russian Federation (short name: FSBI Central Clinical Hospital with Polyclinic)
Moscow, 121359
State Budgetary Healthcare Institution of the Moscow region - M.F. Vladimirsky Moscow Regional Research Clinical Institute (short name: M.F. Vladimirsky SBHI MRRCI)
Moscow, 129110
State Budgetary Educational Institution of Higher Professional Education - Tyumen State Medical University, Ministry of Health of the Russian Federation (short name: SBEIHPE - Tyumen State Medical University, Ministry of Health of Russian Federation)
Tyumen, 625023

Other trials in Russia

About this study

Official title: Multicenter Double-blind Placebo-controlled Comparative Randomized Study of the Tolerability, Safety, Immunogenicity and Prophylactic Efficacy of the EpiVacCorona Peptide Antigen-based Vaccine for the Prevention of COVID-19, With the Participation of 3000 Volunteers Aged 18 Years and Above (Phase III-IV)

The objective of the clinical study is to evaluate the tolerability, safety, immunogenicity and prophylactic efficacy of the EpiVacCorona vaccine in volunteers aged 18 and above.

The study tasks are to:

evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly;
evaluate the tolerability of the EpiVacCorona vaccine when administered twice intramuscularly;
identify any adverse events to the administration of the EpiVacCorona vaccine;
investigate the humoral immune response following two doses of the EpiVacCorona vaccine;
investigate the cell-mediated immune response following two doses of the EpiVacCorona vaccine;
evaluate the prophylactic efficacy of the EpiVacCorona vaccine when administered twice intramuscularly.

Read the detailed description

The study will screen a maximum of 4,929 volunteers of both sexes aged 18 and above, of which 3,000 volunteers who meet the inclusion criteria and do not have the exclusion criteria will be randomized:

2,250 volunteers who will be vaccinated with the EpiVacCorona vaccine, twice intramuscularly at a dose of 0.5 ml;
750 volunteers who will be vaccinated with a placebo, twice intramuscularly at a dose of 0.5 ml.

If volunteers drop out of the study, they will not be replaced. All volunteers will be followed up by an investigator physician for 6 months following the first vaccination in order to identify possible late adverse events. In case the volunteer has any late reactions, he/she will be invited to the clinic to correct his/her condition.

Conditions: COVID-19
Being tested: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19), Placebo (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections)
Keywords: EpiVacCorona vaccine
Medical subject headings: COVID-19

What participants receive

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

EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)Biological
The EpiVacCorona vaccine is intended to prevent COVID-19. The vaccine relies on chemically synthesized peptide antigens of SARS-CoV-2 proteins conjugated to a carrier protein and adsorbed on an aluminum-containing adjuvant (aluminum hydroxide).
The vaccine induces the specific immunity against the SARS-CoV-2 coronavirus following two intramuscular injections spaced 21 to 28 days apart.
The EpiVacCorona vaccine contributes to the development of protective immunity against SARS-CoV-2 coronavirus following two intramuscular administrations given 21 to 28 days apart.
Placebo (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections)Other
The use of placebo: intramuscularly twice, given 21 to 28 days apart at a dose of 0.5 ml

Study groups in NCT04780035
Study group	Role	What they receive
Group "Vaccine"	Experimental	2,250 volunteers who will be vaccinated with the EpiVacCorona vaccine, twice intramuscularly at a dose of 0.5 ml. Receives: Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)
"Control Group"	Placebo comparator	750 volunteers who will be vaccinated with a placebo, twice intramuscularly at a dose of 0.5 ml. Receives: Other: Placebo (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections)

What is being measured

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

The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, within 6 months post vaccination versus a placebo
The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, in combination with one or more of the following symptoms: fever or chills; cough; shortness of breath or labored breathing; fatigue; muscle pain; headache; loss of taste or smell; sore throat; a stuffy nose or runny nose; nausea or vomiting; diarrhea, within 6 months post vaccination versus a placebo
Measured: within 6 months after the first vaccination
The prophylactic efficacy of the vaccine
The prophylactic efficacy of the vaccine under study is ≥50% compared to a placebo, with the lower limit of the confidence interval of the point estimate for the primary efficacy variable > 30%
Measured: 9 months after the first vaccination

Secondary outcomes (5)

The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies
The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies in ELISA is more than 4 times greater 21 to 28 days following the second vaccination
Measured: 21-28 days after the second vaccination
The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers
The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA is more than 4 times greater 21 to 28 days following the second vaccination
Measured: 21-28 days after the second vaccination
The frequency of severe cases of COVID-19 following a single / double vaccination
The frequency of severe cases of COVID-19 following a single / double vaccination (including hospitalization, transfer to an intensive care unit, death, etc.)
Measured: through the whole study, an average of 9 months
Duration of disease
Duration of illness in case of COVID-19 disease
Measured: through the whole study, an average of 9 months
The incidence of asymptomatic COVID-19 following a single / double vaccination
The incidence of asymptomatic COVID-19 following a single / double vaccination (to assess the effectiveness of vaccination in preventing SARS-CoV-2 infection)
Measured: through the whole study, an average of 9 months

Timeline

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

27 Nov 202020 Dec 2021

First posted3 Mar 2021
Study start27 Nov 2020
Primary completion31 Aug 2021
Study completion20 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 3,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04780035
Sponsor's protocol ID: COV/pept-03/20
Status last verified: Mar 2022
First submitted: 25 Feb 2021
Last updated: 16 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Double-blind Placebo-controlled Comparative Randomized Study of the Tolerability, Safety, Immunogenicity and Prophylactic Efficacy of the EpiVacCorona Peptide Antigen-based Vaccine for the Prevention of COVID-19, With the Participation of 3000 Volunteers Aged 18 Years and Above (Phase III-IV)
ClinicalTrials.gov ID: NCT04780035
Acronym / sponsor ID: COV/pept-03/20
Conditions: COVID-19
Keywords: EpiVacCorona vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,000 participants (actual)
Lead sponsor: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"Other government
Study start: 27 Nov 2020 (actual)
Primary completion: 31 Aug 2021 (actual)
Study completion: 20 Dec 2021 (actual)
First posted: 3 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of the clinical study is to evaluate the tolerability, safety, immunogenicity and prophylactic efficacy of the EpiVacCorona vaccine in volunteers aged 18 and above.

The study tasks are to:

evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly;
evaluate the tolerability of the EpiVacCorona vaccine when administered twice intramuscularly;
identify any adverse events to the administration of the EpiVacCorona vaccine;
investigate the humoral immune response following two doses of the EpiVacCorona vaccine;
investigate the cell-mediated immune response following two doses of the EpiVacCorona vaccine;
evaluate the prophylactic efficacy of the EpiVacCorona vaccine when administered twice intramuscularly.

Detailed description

2,250 volunteers who will be vaccinated with the EpiVacCorona vaccine, twice intramuscularly at a dose of 0.5 ml;
750 volunteers who will be vaccinated with a placebo, twice intramuscularly at a dose of 0.5 ml.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group "Vaccine"	Experimental	Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)2,250 volunteers who will be vaccinated with the EpiVacCorona vaccine, twice intramuscularly at a dose of 0.5 ml.
"Control Group"	Placebo comparator	Other: Placebo (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections)750 volunteers who will be vaccinated with a placebo, twice intramuscularly at a dose of 0.5 ml.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Availability of a signed and dated informed consent of the volunteer to participate in a clinical trial, prior to any of the study procedures.
Volunteers (men and women) above the age of 18 years with stable indicators of basic vital functions.
Ability to attend all scheduled visits and all planned procedures and examinations.
Consent of volunteers to use effective contraceptive methods throughout the study, including the observation period for possible post-vaccination reactions.

Key exclusion criteria (35 listed)

History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) or another coronavirus infection (HCoV-229E, HCOV-OC43, HCoV-NL63, HCoV-HKU1).
History of exposure to confirmed or suspected cases of SARS-CoV-2 infection within 1 month prior to randomization.
Positive for IgM or IgG to SARS-CoV-2 as detected during screening.
Positive PCR test for SARS-CoV-2 as detected during screening.
Clinically and laboratory (according to PCR data) confirmed disease caused by SARS-CoV-2 coronavirus, at the moment or in the past.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)The EpiVacCorona vaccine is intended to prevent COVID-19. The vaccine relies on chemically synthesized peptide antigens of SARS-CoV-2 proteins conjugated to a carrier protein and adsorbed on an aluminum-containing adjuvant (aluminum hydroxide). The vaccine induces the specific immunity against the SARS-CoV-2 coronavirus following two intramuscular injections spaced 21 to 28 days apart. The EpiVacCorona vaccine contributes to the development of protective immunity against SARS-CoV-2 coronavirus following two intramuscular administrations given 21 to 28 days apart.	Biological	Group "Vaccine"
Placebo (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections)The use of placebo: intramuscularly twice, given 21 to 28 days apart at a dose of 0.5 ml	Other	"Control Group"

Primary outcome

The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, within 6 months post vaccination versus a placebo
Time frame: within 6 months after the first vaccination
The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, in combination with one or more of the following symptoms: fever or chills; cough; shortness of breath or labored breathing; fatigue; muscle pain; headache; loss of taste or smell; sore throat; a stuffy nose or runny nose; nausea or vomiting; diarrhea, within 6 months post vaccination versus a placebo
The prophylactic efficacy of the vaccine
Time frame: 9 months after the first vaccination
The prophylactic efficacy of the vaccine under study is ≥50% compared to a placebo, with the lower limit of the confidence interval of the point estimate for the primary efficacy variable > 30%

5 secondary outcomes

The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies
Time frame: 21-28 days after the second vaccination
The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers
Time frame: 21-28 days after the second vaccination
The frequency of severe cases of COVID-19 following a single / double vaccination
Time frame: through the whole study, an average of 9 months
Duration of disease
Time frame: through the whole study, an average of 9 months
The incidence of asymptomatic COVID-19 following a single / double vaccination
Time frame: through the whole study, an average of 9 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
Individual participant dataSharing planned: No

Related trials for COVID-19

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rinat A. Maksyutov, PhD study director

Federal Budgetary Research Institution - State Research Center of Virology and Biotechnology "Vector", Federal Service for Surveillance on Consumer Rights Protection and Human Well-being

Nikita V. Lomakin principal investigator

Federal State Budgetary Institution - Central Clinical Hospital with Polyclinic, Administrative Office of the President of the Russian Federation

Vitaly G. Gusarov principal investigator

Federal State Budgetary Institution - N.I. Pirogov National Medical and Surgical Center, Ministry of Health of the Russian Federation

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 35 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: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Russia. 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, within 6 months post vaccination versus a placebo (time frame: within 6 months after the first vaccination). The study lists 2 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 NCT04780035.

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 16 Mar 2022.