ImmunodeficienciesPERSISTNCT04852276
COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations
An observational study of Immunodeficiencies and Immune Dysregulations, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: The immune system defends the body against disease and infection. Immune deficiencies are health conditions that decrease the strength of this response. Vaccines stimulate the immune system to create a defense against a specific type of germ. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunodeficiencies, Immune Dysregulations
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to 31 Aug 2023
- Phase
- Observational
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Immunodeficient individuals will be recruited from NIAID protocols that evaluate primary or secondary immune deficiencies. Potential subjects will be identified by discussion between the study teams and review of medical and research records if necessary. They may also be referred from community practitioners who see this population.Healthy adult volunteers will be recruited through the NIH Clinical Research Volunteer Program, the Office of Patient Recruitment, MMG Patient Recruitment, ResearchMatch, or BuildClinical. Volunteers will also be recruited from existing NIH protocols. Healthy relatives of immunodeficient participants can be recruited for participation as controls if they meet enrollment criteria.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet the following criteria:
- Aged 3 years and older.
- Must be eligible to receive (based on official FDA authorization or approval) and scheduled to receive or have already received a COVID-19 vaccine outside of this facility.
- Must meet the definition of affected participant or control participant:
- Affected participants must have evidence of a primary or secondary immune deficiency or dysregulation under another NIAID protocol or as documented by an outside physician.
- Control participants are healthy volunteers that do not have evidence of a primary or secondary immune deficiency or dysregulation and may include unaffected relatives of affected participants.
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- Ability to provide informed consent.
- Willing to have blood samples stored for future research.
- Able to proficiently speak, read, and write English.
Who cannot join
- Individuals meeting any of the following criteria will be excluded from study participation:
- Receipt of any other vaccine within 14 days prior to screening.
- Planned non-COVID-19 vaccination within 28 days after COVID-19 vaccination(s).
- Any condition that, in the opinion of the investigator, contraindicates participation in this study (e.g. specific autoinflammatory diseases, interferonopathies).
- Self-reported history of HIV.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Analysis of the Immune Response to COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations
Background:
The immune system defends the body against disease and infection. Immune deficiencies are health conditions that decrease the strength of this response. Vaccines stimulate the immune system to create a defense against a specific type of germ. Researchers want to compare immune system responses to COVID-19 vaccines in people with and without immune deficiencies.
Read more
Objective:
To learn about how people with immune deficiencies respond to COVID-19 vaccines.
Eligibility:
People age 3 and older with an immune deficiency who plan to get a COVID-19 vaccine. Healthy volunteers are also needed.
Design:
Participants will be pre-screened for eligibility, including COVID-19 vaccination history and immune status.
Participants will give a blood sample before they get their first COVID-19 vaccine. Blood will be drawn from an arm vein using a needle. Blood can be drawn at the NIH, at a local doctor's office, or at a laboratory. It may also be drawn through a fingerstick at home. Participants will also complete 2 online surveys about their health and COVID-19 history. Additional surveys are optional.
Participants will give a second blood sample 2 to 4 weeks after they get the vaccine. They will complete 2 surveys about changes in their health and side effects from the vaccine.
If participants get another COVID-19 vaccine dose, they will repeat the blood draw and surveys 3 to 4 weeks later.
Participants may give 3 optional blood samples in the 24 months after their last vaccine. They may also give saliva samples every 2 weeks while they are in the study for 6 months following their last vaccine.
Participation will last from 1 month to 2 years after the participant's last vaccine.
Read the detailed description
Study Description:
This prospective cohort study will assess the pre- and post-vaccination immune responses in individuals with select immunodeficiencies and immune dysregulations compared to healthy volunteers who receive a coronavirus disease 2019 (COVID-19) vaccine, as well as any adverse events (AEs) experienced after vaccination. All required study visits for this protocol may be conducted remotely; in-person visits at the NIH are optional. Subjects who have not yet been vaccinated will undergo baseline blood sampling using finger stick microsampler kits and/or venous blood draw within 7 days prior to receiving the vaccine. Additional samples will be requested from participants approximately 14-21 days after dose 1 and 21-28 days after dose 2 (if applicable). Optional samples may be collected at 6, 12, and 24 months post-vaccination. If subsequent booster doses are received while a participant is still on study, blood samples will again be requested approximately 28 days after each booster dose, through the 5th COVID-19 vaccine dose received, and then participants may proceed with the optional 6-, 12-, and 24-month follow-up sample collection. Participants who are able to attend in-person visits at NIH will have optional on-site blood draws 1 and 3 days after doses 1 and 2 (as applicable). Research evaluations will include baseline severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) antibody titers to the spike (S), nucleocapsid (N), and receptor binding domain (RBD) proteins, to assess pre-vaccination SARS-CoV-2 exposure and evaluate responses to vaccination. Additional immune markers of interest may include presence of autoantibodies, transcriptomic profiling, T-cell receptor (TCR) repertoire, among others. Participants who only submit finger stick home microsampler kits at the timepoints listed above will be evaluated for SARS-CoV-2 antibody titers and autoantibodies only. All subjects will be asked at baseline about prior COVID-19 diagnosis, symptoms, and severity, and will be asked additional questions at follow-up timepoints (including after additional booster doses) about vaccine AEs using standardized questionnaires.
Primary Objective:
To characterize the immune response to COVID-19 vaccination among immunodeficient and immune dysregulated individuals compared to healthy volunteers.
Secondary Objectives:
To characterize the COVID-19 vaccine-associated AEs among immunodeficient and immune dysregulated individuals compared to healthy volunteers.
Exploratory Objectives:
Assess the relationship between prior SARS-CoV-2 infection and vaccine-induced immune response.
To characterize pre-vaccine COVID-19 disease prevalence and severity among immunodeficient and immune dysregulated individuals.
To assess induction, strength, and durability of T- and B-cell specific immune responses to SARS-CoV-2 (as measured by frequency and diversity of SARS-CoV-2 specific T and B cell clonotypes and titers of specific antibody responses), and their correlation to the underlying immune deficiency/dysregulation.
To characterize auto-antibodies present in immunodeficient and immune dysregulated individuals before and after COVID-19 vaccination.
To assess the incidence of post-vaccination breakthrough SARS-CoV-2 infection and to determine the SARS-CoV-2 virus genomic sequence in such cases.
Primary Endpoint:
Change in S and RBD immunoglobulin G (IgG) antibody titer from baseline to 14-21 days or 21-28 days (depending on vaccine manufacturer and platform) after vaccine dose 1, and 21-28 days after dose 2 and any subsequent doses (depending on vaccine manufacturer and platform).
Secondary Endpoints:
Incidence of vaccine-associated AEs experienced by immunodeficient individuals compared to healthy volunteers.
Exploratory Endpoints:
Characterization of post-vaccine immune response and AEs in patients with antibody evidence of prior SARS-CoV-2 infection
Pre- and post-vaccination incidence of COVID-19-associated symptoms experienced in individuals with immune deficiency/dysregulation who are positive for SARS-CoV-2 by serology or diagnostic polymerase chain reaction (PCR).
Characterize how various forms of immune deficiency or dysregulation impact generation, strength, and durability of T- and B-cell responses.
Incidence of autoantibodies pre- and post-COVID-19 vaccination comparing individuals with immune deficiency/dysregulation to healthy volunteers.
- Conditions
- Immunodeficiencies, Immune Dysregulations
- Keywords
- Adaptive immunity, clinical epidemiology, SARS-CoV-2, Coronavirus, Natural History
- Medical subject headings
- Immunologic Deficiency Syndromes, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control participants | Control participants will be healthy volunteers, and may include unaffected relatives of immunodeficient/dysregulated participants | |
| Patients with immunodeficiencies and immune dysregulations | Affected patients with evidence of a primary or secondary immune deficiency or dysregulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in S and Receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody Titer From Baseline Depending on Vaccine Manufacturer and Platform
To characterize the immune response to coronavirus disease 2019 (COVID-19) vaccination among immunodeficient and immune dysregulated individuals compared to healthy volunteers
Measured: Baseline, post dose 1 (14-21 days), and post dose 2 (21-28 days), depending on vaccine manufacturer and platform
Secondary outcomes (1)
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
To characterize the COVID-19 vaccine-associated adverse events among immunodeficient and immune dysregulated individuals compared to healthy volunteers.
Note on terminology: "No vaccine-associated side effects" means participants reported zero symptoms or reactions after vaccination. A "mild vaccine-associated side effect" means a participant reported any symptom/reaction and reported is as "mild" on the scale of "mild", "moderate", or "severe". A participant could have reported several mild symptom/reactions and several moderate or severe symptoms/reactions. Therefore, the number of mild, moderate, and severe vaccine-associated side effects will not sum to the total number of surveys completed.
Measured: Baseline up to a maximum of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start20 Apr 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 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 (3)Papers the sponsor has linked to this study.
- Other trials for ImmunodeficienciesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Emily E Ricotta, Ph.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852276
- Sponsor's protocol ID
- 10000384
- Other IDs
- 000384-I
- Acronym
- PERSIST
- Status last verified
- 6 Oct 2023
- First submitted
- 20 Apr 2021
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szczawinska-Poplonyk A, Breborowicz A, Samara H, Ossowska L, Dworacki G. Impaired Antigen-Specific Immune Response to Vaccines in Children with Antibody Production Defects. Clin Vaccine Immunol. 2015 Aug;22(8):875-82. doi: 10.1128/CVI.00148-15. Epub 2015 May 27.
PubMed 26018535Bonilla FA. Vaccines in Patients with Primary Immune Deficiency. Immunol Allergy Clin North Am. 2020 Aug;40(3):421-435. doi: 10.1016/j.iac.2020.03.004.
PubMed 32654690Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, McCullough MP, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott A, Flach B, Doria-Rose NA, Corbett KS, Morabito KM, O'Dell S, Schmidt SD, Swanson PA 2nd, Padilla M, Mascola JR, Neuzil KM, Bennett H, Sun W, Peters E, Makowski M, Albert J, Cross K, Buchanan W, Pikaart-Tautges R, Ledgerwood JE, Graham BS, Beigel JH; mRNA-1273 Study Group. An mRNA Vaccine against SARS-CoV-2 - Preliminary Report. N Engl J Med. 2020 Nov 12;383(20):1920-1931. doi: 10.1056/NEJMoa2022483. Epub 2020 Jul 14.
PubMed 32663912
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Immune Response to COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations
- ClinicalTrials.gov ID
- NCT04852276
- Acronym / sponsor ID
- PERSIST / 10000384
- Conditions
- Immunodeficiencies, Immune Dysregulations
- Keywords
- Adaptive immunity, clinical epidemiology, SARS-CoV-2, Coronavirus, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Posted 1 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
The immune system defends the body against disease and infection. Immune deficiencies are health conditions that decrease the strength of this response. Vaccines stimulate the immune system to create a defense against a specific type of germ. Researchers want to compare immune system responses to COVID-19 vaccines in people with and without immune deficiencies.
Objective:
To learn about how people with immune deficiencies respond to COVID-19 vaccines.
Eligibility:
People age 3 and older with an immune deficiency who plan to get a COVID-19 vaccine. Healthy volunteers are also needed.
Design:
Participants will be pre-screened for eligibility, including COVID-19 vaccination history and immune status.
Participants will give a blood sample before they get their first COVID-19 vaccine. Blood will be drawn from an arm vein using a needle. Blood can be drawn at the NIH, at a local doctor's office, or at a laboratory. It may also be drawn through a fingerstick at home. Participants will also complete 2 online surveys about their health and COVID-19 history. Additional surveys are optional.
Participants will give a second blood sample 2 to 4 weeks after they get the vaccine. They will complete 2 surveys about changes in their health and side effects from the vaccine.
If participants get another COVID-19 vaccine dose, they will repeat the blood draw and surveys 3 to 4 weeks later.
Participants may give 3 optional blood samples in the 24 months after their last vaccine. They may also give saliva samples every 2 weeks while they are in the study for 6 months following their last vaccine.
Participation will last from 1 month to 2 years after the participant's last vaccine.
Detailed description
Study Description:
This prospective cohort study will assess the pre- and post-vaccination immune responses in individuals with select immunodeficiencies and immune dysregulations compared to healthy volunteers who receive a coronavirus disease 2019 (COVID-19) vaccine, as well as any adverse events (AEs) experienced after vaccination. All required study visits for this protocol may be conducted remotely; in-person visits at the NIH are optional. Subjects who have not yet been vaccinated will undergo baseline blood sampling using finger stick microsampler kits and/or venous blood draw within 7 days prior to receiving the vaccine. Additional samples will be requested from participants approximately 14-21 days after dose 1 and 21-28 days after dose 2 (if applicable). Optional samples may be collected at 6, 12, and 24 months post-vaccination. If subsequent booster doses are received while a participant is still on study, blood samples will again be requested approximately 28 days after each booster dose, through the 5th COVID-19 vaccine dose received, and then participants may proceed with the optional 6-, 12-, and 24-month follow-up sample collection. Participants who are able to attend in-person visits at NIH will have optional on-site blood draws 1 and 3 days after doses 1 and 2 (as applicable). Research evaluations will include baseline severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) antibody titers to the spike (S), nucleocapsid (N), and receptor binding domain (RBD) proteins, to assess pre-vaccination SARS-CoV-2 exposure and evaluate responses to vaccination. Additional immune markers of interest may include presence of autoantibodies, transcriptomic profiling, T-cell receptor (TCR) repertoire, among others. Participants who only submit finger stick home microsampler kits at the timepoints listed above will be evaluated for SARS-CoV-2 antibody titers and autoantibodies only. All subjects will be asked at baseline about prior COVID-19 diagnosis, symptoms, and severity, and will be asked additional questions at follow-up timepoints (including after additional booster doses) about vaccine AEs using standardized questionnaires.
Primary Objective:
To characterize the immune response to COVID-19 vaccination among immunodeficient and immune dysregulated individuals compared to healthy volunteers.
Secondary Objectives:
To characterize the COVID-19 vaccine-associated AEs among immunodeficient and immune dysregulated individuals compared to healthy volunteers.
Exploratory Objectives:
Assess the relationship between prior SARS-CoV-2 infection and vaccine-induced immune response.
To characterize pre-vaccine COVID-19 disease prevalence and severity among immunodeficient and immune dysregulated individuals.
To assess induction, strength, and durability of T- and B-cell specific immune responses to SARS-CoV-2 (as measured by frequency and diversity of SARS-CoV-2 specific T and B cell clonotypes and titers of specific antibody responses), and their correlation to the underlying immune deficiency/dysregulation.
To characterize auto-antibodies present in immunodeficient and immune dysregulated individuals before and after COVID-19 vaccination.
To assess the incidence of post-vaccination breakthrough SARS-CoV-2 infection and to determine the SARS-CoV-2 virus genomic sequence in such cases.
Primary Endpoint:
Change in S and RBD immunoglobulin G (IgG) antibody titer from baseline to 14-21 days or 21-28 days (depending on vaccine manufacturer and platform) after vaccine dose 1, and 21-28 days after dose 2 and any subsequent doses (depending on vaccine manufacturer and platform).
Secondary Endpoints:
Incidence of vaccine-associated AEs experienced by immunodeficient individuals compared to healthy volunteers.
Exploratory Endpoints:
Characterization of post-vaccine immune response and AEs in patients with antibody evidence of prior SARS-CoV-2 infection
Pre- and post-vaccination incidence of COVID-19-associated symptoms experienced in individuals with immune deficiency/dysregulation who are positive for SARS-CoV-2 by serology or diagnostic polymerase chain reaction (PCR).
Characterize how various forms of immune deficiency or dysregulation impact generation, strength, and durability of T- and B-cell responses.
Incidence of autoantibodies pre- and post-COVID-19 vaccination comparing individuals with immune deficiency/dysregulation to healthy volunteers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control participants | – | –Control participants will be healthy volunteers, and may include unaffected relatives of immunodeficient/dysregulated participants |
| Patients with immunodeficiencies and immune dysregulations | – | –Affected patients with evidence of a primary or secondary immune deficiency or dysregulation |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Immunodeficient individuals will be recruited from NIAID protocols that evaluate primary or secondary immune deficiencies. Potential subjects will be identified by discussion between the study teams and review of medical and research records if necessary. They may also be referred from community practitioners who see this population.Healthy adult volunteers will be recruited through the NIH Clinical Research Volunteer Program, the Office of Patient Recruitment, MMG Patient Recruitment, ResearchMatch, or BuildClinical. Volunteers will also be recruited from existing NIH protocols. Healthy relatives of immunodeficient participants can be recruited for participation as controls if they meet enrollment criteria.
Key inclusion criteria (9 listed)
- In order to be eligible to participate in this study, an individual must meet the following criteria:
- Aged 3 years and older.
- Must be eligible to receive (based on official FDA authorization or approval) and scheduled to receive or have already received a COVID-19 vaccine outside of this facility.
- Must meet the definition of affected participant or control participant:
- Ability to provide informed consent.
Key exclusion criteria (5 listed)
- Individuals meeting any of the following criteria will be excluded from study participation:
- Receipt of any other vaccine within 14 days prior to screening.
- Planned non-COVID-19 vaccination within 28 days after COVID-19 vaccination(s).
- Any condition that, in the opinion of the investigator, contraindicates participation in this study (e.g. specific autoinflammatory diseases, interferonopathies).
- Self-reported history of HIV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in S and Receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody Titer From Baseline Depending on Vaccine Manufacturer and Platform
Time frame: Baseline, post dose 1 (14-21 days), and post dose 2 (21-28 days), depending on vaccine manufacturer and platform
To characterize the immune response to coronavirus disease 2019 (COVID-19) vaccination among immunodeficient and immune dysregulated individuals compared to healthy volunteers
1 secondary outcome
Incidence of Vaccine-associated Adverse Events (AE) Experienced by Immunodeficient Individuals Compared to Healthy Volunteers
Time frame: Baseline up to a maximum of 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26018535Szczawinska-Poplonyk A, Breborowicz A, Samara H, Ossowska L, Dworacki G. Impaired Antigen-Specific Immune Response to Vaccines in Children with Antibody Production Defects. Clin Vaccine Immunol. 2015 Aug;22(8):875-82. doi: 10.1128/CVI.00148-15. Epub 2015 May 27.
- Background: PubMed 32654690Bonilla FA. Vaccines in Patients with Primary Immune Deficiency. Immunol Allergy Clin North Am. 2020 Aug;40(3):421-435. doi: 10.1016/j.iac.2020.03.004.
- Background: PubMed 32663912Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, McCullough MP, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott A, Flach B, Doria-Rose NA, Corbett KS, Morabito KM, O'Dell S, Schmidt SD, Swanson PA 2nd, Padilla M, Mascola JR, Neuzil KM, Bennett H, Sun W, Peters E, Makowski M, Albert J, Cross K, Buchanan W, Pikaart-Tautges R, Ledgerwood JE, Graham BS, Beigel JH; mRNA-1273 Study Group. An mRNA Vaccine against SARS-CoV-2 - Preliminary Report. N Engl J Med. 2020 Nov 12;383(20):1920-1931. doi: 10.1056/NEJMoa2022483. Epub 2020 Jul 14.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Emily E Ricotta, Ph.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunodeficiencies and Immune Dysregulations, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 9 inclusion and 5 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2024). 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?
Change in S and Receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody Titer From Baseline Depending on Vaccine Manufacturer and Platform (time frame: Baseline, post dose 1 (14-21 days), and post dose 2 (21-28 days), depending on vaccine manufacturer and platform). 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 NCT04852276, which also lists 3 linked publications.
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 1 Oct 2024.