Covid19Phase 4NCT04952402

SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine

A Phase 4 study testing Study-provided Moderna mRNA-1273 COVID-19 vaccine, Community-provided Moderna mRNA-1273 COVID-19 Vaccine and Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine in people with Covid19 and SARS-CoV2 Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate the safety and efficacy of mRNA COVID-19 vaccines in: People with prior COVID-19 (SARS-CoV-2 infection) who were in the ACTIV-2/A5401 study. And People who have never had COVID-19 (SARS-CoV-2 infection). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Covid19, SARS-CoV2 Infection
What is being tested?: Study-provided Moderna mRNA-1273 COVID-19 vaccine, Community-provided Moderna mRNA-1273 COVID-19 Vaccine and Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 6 sitesUnited States
Study dates: 9 Jul 2021to 10 Jan 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

For all participants: Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures.
For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Receipt of all selected investigational therapy or active comparator/placebo for that therapy at selected sites.
For participants who are in, or who have completed, the ACTIV-2/A5401 trial and receive study-provided Moderna mRNA-1273 COVID-19 vaccine: Receipt of the last dose of investigational therapy or active comparator/placebo for that therapy ≥30 days and ≤240 days prior to study entry.
For participants who are in, or who have completed, the ACTIV-2/A5401 trial and have received or will be receiving community-provided mRNA-based COVID-19 vaccine: Receipt of the last dose of investigational therapy or active comparator/placebo for that therapy ≥30 and ≤240 days prior to receipt or planned receipt of the first dose of community-provided vaccine.

Who cannot join

For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Self-report of prior receipt of a non-mRNA-based COVID-19 vaccine.
For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Self-report of receipt of the first dose of an mRNA-based COVID-19 vaccine 140 days or more before A5404 enrollment.
For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Self-report of a second SARS-CoV-2 infection after the infection that qualified the participant for ACTIV-2/A5401.
For non-A5401/ACTIV-2 participants: Self-report of receipt of any prior COVID-19 vaccine.
For non-A5401/ACTIV-2 participants: Known prior history of any SARS-CoV-2-positive test (e.g., PCR test, Nucleic Acid Amplification Test (NAAT), antigen test, serology test).
For participants who receive study-provided Moderna mRNA-1273 COVID-19 vaccine: Known allergy to any component of the Moderna COVID-19 vaccine.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
Boston, Massachusetts, 02115
Chapel Hill CRS (Site ID: 3201)
Chapel Hill, North Carolina, 27599
Rush University CRS (Site ID: 2702)
Chicago, Illinois, 60612
UCLA CARE Center CRS
Los Angeles, California, 90035-4709
UCSD Antiviral Research Center CRS
San Diego, California, 92103
University of Washington AIDS CRS
Seattle, Washington, 98104-9929

Other trials in United States

About this study

The purpose of this study is to evaluate the safety and efficacy of mRNA COVID-19 vaccines in:

People with prior COVID-19 (SARS-CoV-2 infection) who were in the ACTIV-2/A5401 study.

And

People who have never had COVID-19 (SARS-CoV-2 infection).

Read the detailed description

A5404 is a phase IV, open-label study. The objective of A5404 is to evaluate how prior investigational therapy for COVID-19 versus comparator (placebo or active comparator) affects vaccine response. The safety of mRNA COVID-19 vaccines is also explored.

Eligible A5404 participants include: Participants of ACTIV-2/A5401 at selected sites who received an investigational therapy or its comparator; and persons without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-A5401 participants). In line with our protocol, for outcome measures related to neutralizing antibodies and adverse events, we further break down the ACTIV-2/A5401 participants into two exposure groups: those who received an active therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV, BMS 096414+BMS 986413 subcutaneous) and those who received Camostat Oral or Placebo.

Participants of ACTIV-2/A5401 received study-provided standard dosing of the Moderna mRNA-1273 vaccine, or a community-provided mRNA-based COVID-19 vaccine (e.g., Moderna or Pfizer). Participants in ACTIV-2/A5401 received their mRNA-based COVID-19 vaccine 60-240 days after receiving their last dose of a select ACTIV-2/A5401 investigational therapy, or its comparator. Participants without prior COVID-19 received study-provided standard dosing of the Moderna mRNA-1273 vaccine.

The study closed early to accrual on February 25, 2022 due to slow enrollment. Clarification Memo #1 (dated January 11, 2023) reflects decisions to discontinue follow up at study Day 365 instead of following participants to Day 730 after the first dose of vaccine and to reallocate some secondary outcome measures to exploratory outcome measures.

Conditions: Covid19, SARS-CoV2 Infection
Being tested: Study-provided Moderna mRNA-1273 COVID-19 vaccine, Community-provided Moderna mRNA-1273 COVID-19 Vaccine, Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 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.

Study-provided Moderna mRNA-1273 COVID-19 vaccineBiological
Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).
Community-provided Moderna mRNA-1273 COVID-19 VaccineBiological
Participants received a two-dose series.
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 VaccineBiological
Participants received a two-dose series.

Study groups in NCT04952402
Study group	Role	What they receive
Cohort: ACTIV-2/A5401	Experimental	Participants of the ACTIV-2/A5401 randomized trial who received a select investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV, BMS 096414+BMS 986413 subcutaneous, Camostat Oral) or its corresponding comparator (Placebo). Receives: Biological: Study-provided Moderna mRNA-1273 COVID-19 vaccine; Biological: Community-provided Moderna mRNA-1273 COVID-19 Vaccine; Biological: Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine
Cohort: COVID-19 Naïve	Experimental	Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants). Receives: Biological: Study-provided Moderna mRNA-1273 COVID-19 vaccine

What is being measured

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

Neutralizing Antibody (NAb) Level
NAb level was measured by using both 50% neutralizing dilution titers (ND50) and 80% neutralizing titers (ND80). A higher NAb level corresponds to a stronger immune response. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000. We carry forward the Day 56 NAb measurement if the Day 140 measurement is not reported.
Measured: Measured 140 days after the first dose of the vaccine

Secondary outcomes (5)

Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine
Relative change is defined as the ratio of post-vaccine NAb level/pre-vaccine NAb level. A ratio greater than one indicates an increase of NAb response. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000.
Measured: Measured before the first dose of the vaccine, and 56 days after the first dose of the vaccine
Proportion of Participants With New Grade 3 or Higher AE, or SAE, or AE Leading to Change or Discontinuation in Vaccine Receipt
An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. A serious adverse event (SAE) is defined as any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above.
Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1).
Measured: From first dose of the vaccine through 140 days after the first dose of the vaccine
Number of Participants With Grade 1 or Higher Allergic Reaction
Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1).
Measured: From first dose of the vaccine through 56 days after the first dose of the vaccine
Proportion of Participants With Grade 2 or Higher Injection Site Reaction
Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1).
Measured: From first dose of the vaccine through 56 days after the first dose of the vaccine
Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine by Received Vaccine
Relative change is defined as the ratio of post-vaccine NAb level/pre-vaccine NAb level by received vaccine, i.e., Moderna mRNA-1273 versus Pfizer-BioNTech BNT162b2. A ratio greater than one indicates an increase of NAb response for those on Moderna mRNA-1273 versus Pfizer-BioNTech BNT162b2. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000.
Measured: Measured before the first dose of the vaccine, and 56 days after the first dose of the vaccine

Timeline

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

9 Jul 202110 Jan 2023

First posted7 Jul 2021
Study start9 Jul 2021
Primary completion28 Feb 2022
Study completion10 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
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 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04952402
Sponsor's protocol ID: A5404
Status last verified: May 2023
First submitted: 28 Jun 2021
Last updated: 24 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie results in the publication, after deidentification.

Publications

Smith DM, Weir IR, Ramirez S, Coelho CH, Manne-Goehler J, Aziz M, Benson CA, Wu X, Hyer R, Dhillon PK, Faraji F, Bloom N, Myers A, Ramezani-Rad P, Lopez PG, Parikh UM, Heaps AL, Javan AC, Bender Ignacio RA, Li JZ, Greninger AL, Daar ES, Wohl DA, Crotty S, Sieg SF, Chew KW. Impact of COVID-19 Monoclonal Antibody Therapy on Subsequent Vaccine-Elicited SARS-CoV-2 Immune Responses. J Infect Dis. 2026 Aug 3;234(1):e18-e28. doi: 10.1093/infdis/jiag091.
PubMed 41700320

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?

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Study at a glance

From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine
ClinicalTrials.gov ID: NCT04952402
Acronym / sponsor ID: A5404
Conditions: Covid19, SARS-CoV2 Infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 9 Jul 2021 (actual)
Primary completion: 28 Feb 2022 (actual)
Study completion: 10 Jan 2023 (actual)
First posted: 7 Jul 2021 (actual)
Results: Posted 19 May 2023

Clinical summary

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

The purpose of this study is to evaluate the safety and efficacy of mRNA COVID-19 vaccines in:

People with prior COVID-19 (SARS-CoV-2 infection) who were in the ACTIV-2/A5401 study.

And

People who have never had COVID-19 (SARS-CoV-2 infection).

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort: ACTIV-2/A5401	Experimental	Biological: Study-provided Moderna mRNA-1273 COVID-19 vaccine, Biological: Community-provided Moderna mRNA-1273 COVID-19 Vaccine, Biological: Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 VaccineParticipants of the ACTIV-2/A5401 randomized trial who received a select investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV, BMS 096414+BMS 986413 subcutaneous, Camostat Oral) or its corresponding comparator (Placebo).
Cohort: COVID-19 Naïve	Experimental	Biological: Study-provided Moderna mRNA-1273 COVID-19 vaccineParticipants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants).

Who may qualify

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

Key inclusion criteria (4 listed)

For all participants: Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures.
For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Receipt of all selected investigational therapy or active comparator/placebo for that therapy at selected sites.
For participants who are in, or who have completed, the ACTIV-2/A5401 trial and receive study-provided Moderna mRNA-1273 COVID-19 vaccine: Receipt of the last dose of investigational therapy or active comparator/placebo for that therapy ≥30 days and ≤240 days prior to study entry.
For participants who are in, or who have completed, the ACTIV-2/A5401 trial and have received or will be receiving community-provided mRNA-based COVID-19 vaccine: Receipt of the last dose of investigational therapy or active comparator/placebo for that therapy ≥30 and ≤240 days prior to receipt or planned receipt of the first dose of community-provided vaccine.

Key exclusion criteria (6 listed)

For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Self-report of prior receipt of a non-mRNA-based COVID-19 vaccine.
For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Self-report of receipt of the first dose of an mRNA-based COVID-19 vaccine 140 days or more before A5404 enrollment.
For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Self-report of a second SARS-CoV-2 infection after the infection that qualified the participant for ACTIV-2/A5401.
For non-A5401/ACTIV-2 participants: Self-report of receipt of any prior COVID-19 vaccine.
For non-A5401/ACTIV-2 participants: Known prior history of any SARS-CoV-2-positive test (e.g., PCR test, Nucleic Acid Amplification Test (NAAT), antigen test, serology test).

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
Study-provided Moderna mRNA-1273 COVID-19 vaccineParticipants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).	Biological	Cohort: ACTIV-2/A5401, Cohort: COVID-19 Naïve
Community-provided Moderna mRNA-1273 COVID-19 VaccineParticipants received a two-dose series.	Biological	Cohort: ACTIV-2/A5401
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 VaccineParticipants received a two-dose series.	Biological	Cohort: ACTIV-2/A5401

Primary outcome

Neutralizing Antibody (NAb) Level
Time frame: Measured 140 days after the first dose of the vaccine
NAb level was measured by using both 50% neutralizing dilution titers (ND50) and 80% neutralizing titers (ND80). A higher NAb level corresponds to a stronger immune response. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000. We carry forward the Day 56 NAb measurement if the Day 140 measurement is not reported.

5 secondary outcomes

Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine
Time frame: Measured before the first dose of the vaccine, and 56 days after the first dose of the vaccine
Proportion of Participants With New Grade 3 or Higher AE, or SAE, or AE Leading to Change or Discontinuation in Vaccine Receipt
Time frame: From first dose of the vaccine through 140 days after the first dose of the vaccine
Number of Participants With Grade 1 or Higher Allergic Reaction
Time frame: From first dose of the vaccine through 56 days after the first dose of the vaccine
Proportion of Participants With Grade 2 or Higher Injection Site Reaction
Time frame: From first dose of the vaccine through 56 days after the first dose of the vaccine
Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine by Received Vaccine
Time frame: Measured before the first dose of the vaccine, and 56 days after the first dose of the vaccine

Results and safety

Results posted to the registry on 19 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort: ACTIV-2/A5401	18	17
Cohort: COVID-19 Naïve	25	21

Primary outcome: Neutralizing Antibody (NAb) Level

Time frame: Measured 140 days after the first dose of the vaccine. Geometric mean (95% Confidence Interval). Unit: titer

Measure	ACTIV-2/A5401 Investigational Therapy Except Camostat n = 8	ACTIV-2/A5401 Placebo or Camostat n = 10	COVID-19 Naïve n = 24
50% neutralizing dilution titers (ND50)	2242.47 (688.55 to 7303.29)	2695.21 (1005.71 to 7222.88)	2196.74 (970.88 to 4970.42)
80% neutralizing dilution titers (ND80)	888.80 (222.60 to 3548.78)	972.43 (358.67 to 2636.46)	794.90 (364.34 to 1734.27)

Population analysed: The analysis population includes all participants who received at least the first dose of an mRNA-based COVID-19 vaccine and who provided a specimen sample at either Day 56 or Day 140 (One COVID-19 naïve participant who was not able to provide specimen at any study visits was excluded).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From study entry through 1 year after receiving the first dose of vaccine.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACTIV-2/A5401 Investigational Therapy Except Camostat	0 of 8 (0%)	2 of 8 (25%)	0 of 8
ACTIV-2/A5401 Placebo or Camostat	0 of 10 (0%)	8 of 10 (80%)	0 of 10
COVID-19 Naïve	0 of 25 (0%)	7 of 25 (28%)	0 of 25

Limitations and caveats (from the sponsor): The study closed early to accrual due to difficulty enrolling participants. Therefore the sample size is very small and precision is limited.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41700320Smith DM, Weir IR, Ramirez S, Coelho CH, Manne-Goehler J, Aziz M, Benson CA, Wu X, Hyer R, Dhillon PK, Faraji F, Bloom N, Myers A, Ramezani-Rad P, Lopez PG, Parikh UM, Heaps AL, Javan AC, Bender Ignacio RA, Li JZ, Greninger AL, Daar ES, Wohl DA, Crotty S, Sieg SF, Chew KW. Impact of COVID-19 Monoclonal Antibody Therapy on Subsequent Vaccine-Elicited SARS-CoV-2 Immune Responses. J Infect Dis. 2026 Aug 3;234(1):e18-e28. doi: 10.1093/infdis/jiag091.
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017.Link provided by the sponsor.
Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.

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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.

David Smith, MD, MAS study chair

UCSD Antiviral Research Center

6 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 6 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Neutralizing Antibody (NAb) Level (time frame: Measured 140 days after the first dose of the vaccine). 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 NCT04952402, which also lists 1 linked publication.

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 24 May 2023.