COVID-19Phase 4NCT05343871
Immunogenicity and Safety of Fractional Booster Dose of COVID-19 Vaccines Available for Use in Pakistan/Brazil: A Phase 4 Dose-optimizing Trial
A Phase 4 study testing Sinovac, AZD1222 and BNT162b2 in people with COVID-19, run by Albert B. Sabin Vaccine Institute at 2 sites in 2 countries.
Trial summary
Since the emergence of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pathogen in late 2019, millions of people around the world have fallen ill and died from coronavirus disease 2019 (COVID-19), with variant-fueled case spikes causing repeated cycles of morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Sinovac, AZD1222 and BNT162b2
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,354 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Jul 2022to 11 Jan 2024
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female individuals aged 18 years to 60 years
- Participant is willing and able to give written informed consent for participation in the trial
- Individuals who can comply with trial procedures and are available for the duration of follow-up.
- Brazil:
- ● Previous vaccination with a complete primary series of Sinovac (Priming Group 1), AZD1222 (Priming Group 2), or BNT162b2 (Priming Group 3-B) at least 6 months prior to screening
- Pakistan:
- ● Previous vaccination with a complete primary series of Sinovac (Priming Group 1) or AZD1222 (Priming Group 2) at least 6 months prior to screening, or PCR-confirmed natural infection (Priming Group 3-P) between February 2021 - 6 months prior to screening
Who cannot join
- Has a contraindication to BNT162b2, AZD1222 or Sinovac
- Has received an incomplete primary COVID-19 vaccination series
- Has received 3 doses of COVID-19 vaccine
- Has received heterologous primary COVID-19 vaccination series
- History of a solid organ or bone marrow transplant
- History of malignancy (other than non-melanoma skin cancer) within the past five years
Show all 21Show fewer
- Currently on hemodialysis
- Any confirmed or suspected immunosuppressive or immunodeficiency condition or diagnosis
- On chronic (>30 days) use of immunosuppressive medications at the time of enrollment (except topical steroids or short-term oral steroids, i.e., ≤14 days)
- Known diagnosis of HIV with CD4 count <200 cells/mm3 (in the past 6 months)
- Active or history of previous auto-immune neurological disorders (e.g., multiple sclerosis, Guillain-Barre syndrome, transverse myelitis) (excluding Bell's palsy)
- Has received anti-CD20 monoclonal antibodies for any reason in the past 12 months
- Has received monoclonal antibodies to treat a previous COVID-19 event
- Pregnant at screening
- Positive SARS-CoV-2 Antigen test in respiratory specimen at screening
- Planning to migrate out of the study area within 6 months of the enrollment
- Participants currently enrolled in any other COVID-19 vaccine research trial in which they are getting a COVID-19 vaccine during the study period
- Illiterate individuals (Brazil only)
- Has a severe and/or uncontrolled comorbidity
- Pakistan (natural infection Priming Group (Priming Group 3-P)):
- ● Prior vaccination with ANY vaccine against COVID-19
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Randomized Controlled Trial to Assess the Immunogenicity and Safety of Full Versus Fractional Dose of Pfizer/BioNTech, AstraZeneca, and Sinovac COVID-19 Vaccines Given as a Booster Dose at Least 6 Months After Primary Vaccination Series or PCR-confirmed Infection With SARS-CoV-2 in Healthy Adults
Since the emergence of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pathogen in late 2019, millions of people around the world have fallen ill and died from coronavirus disease 2019 (COVID-19), with variant-fueled case spikes causing repeated cycles of morbidity and mortality. The rapid development and emergency use authorization of vaccines against SARS-CoV-2 presents an enormous opportunity to protect populations, but bottlenecks in production have led to demand for vaccines that far outpaces supply. This project will investigate the immunogenicity of fractional doses of SARS-CoV-2 vaccines given a minimum of six months following an initial two-dose schedule or following natural immunity via documented infection. The consortium of research partners from the Sabin Vaccine Institute, Aga Khan University, Fundação Oswaldo Cruz (Fiocruz), and Stanford University will recruit volunteers to receive a full or fractional booster dose of BNT162b2, AZD1222 or Sinovac following receipt of their primary vaccination series or PCR-confirmed natural infection in Pakistan. The research team will follow participants for six months from boosting, with blood draws at baseline, 28 days, 3 months and 6 months, and measure sero-response rate (SRR) by anti-Spike immunoglobulin G (IgG) binding enzyme-linked immunosorbent assay (ELISA) with the ultimate aim of identifying whether fractional doses provide a similar immune response compared to full doses of vaccine.
- Conditions
- COVID-19
- Being tested
- Sinovac, AZD1222, BNT162b2
- Keywords
- Fractional dose, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SinovacBiological
Sinovac inactivated COVID-19 vaccine:
● Full dose (0.5 ml)
AZD1222Biological
AstraZeneca ChAdOx1-S recombinant AZD1222 vaccine:
- Full dose (0.5 ml)
- Half dose (0.25 ml)
BNT162b2Biological
Pfizer/BioNTech BNT162b2 mRNA vaccine:
- Full dose (30 micrograms)
- Half dose (15 micrograms)
- One-third dose (10 micrograms)
| Study group | Role | What they receive |
|---|---|---|
| Priming Group 1: Sinovac Prime, AZD1222 ½ dose (Brazil only) | Experimental | Not described Receives: Biological: AZD1222 |
| Priming Group 1: Sinovac Prime, AZD1222 full dose (Brazil only) | Active comparator | Not described Receives: Biological: AZD1222 |
| Priming Group 1: Sinovac Prime, BNT162b2 1/3 dose | Experimental | Not described Receives: Biological: BNT162b2 |
| Priming Group 1: Sinovac Prime, BNT162b2 1/2 dose | Experimental | Not described Receives: Biological: BNT162b2 |
| Priming Group 1: Sinovac Prime, BNT162b2 full dose | Active comparator | Not described Receives: Biological: BNT162b2 |
| Priming Group 1: Sinovac Prime, Sinovac full dose | Active comparator | Not described Receives: Biological: Sinovac |
| Priming Group 2: AZD1222 Prime, AZD1222 ½ dose (Brazil only) | Experimental | Not described Receives: Biological: AZD1222 |
| Priming Group 2: AZD1222 Prime, AZD1222 full dose (Brazil only) | Active comparator | Not described Receives: Biological: AZD1222 |
| Priming Group 2: AZD1222 Prime, BNT162b2 1/3 dose | Experimental | Not described Receives: Biological: BNT162b2 |
| Priming Group 2: AZD1222 Prime, BNT162b2 1/2 dose | Experimental | Not described Receives: Biological: BNT162b2 |
| Priming Group 2: AZD1222 Prime, BNT162b2 full dose | Active comparator | Not described Receives: Biological: BNT162b2 |
| Priming Group 3-B: BNT162b2 Prime, AZD1222 ½ dose (Brazil only) | Experimental | Not described Receives: Biological: AZD1222 |
| Priming Group 3-B: BNT162b2 Prime, AZD1222 full dose (Brazil only) | Active comparator | Not described Receives: Biological: AZD1222 |
| Priming Group 3-B: BNT162b2 Prime, BNT162b2 1/3 dose (Brazil only) | Experimental | Not described Receives: Biological: BNT162b2 |
| Priming Group 3-B: BNT162b2 Prime, BNT162b2 1/2 dose (Brazil only) | Experimental | Not described Receives: Biological: BNT162b2 |
| Priming Group 3-B: BNT162b2 Prime, BNT162b2 full dose (Brazil only) | Active comparator | Not described Receives: Biological: BNT162b2 |
| Priming Group 3-P: Natural Infection Prime, BNT162b2 1/3 dose (Pakistan only) | Experimental | Not described Receives: Biological: BNT162b2 |
| Priming Group 3-P: Natural Infection Prime, BNT162b2 1/2 dose (Pakistan only) | Experimental | Not described Receives: Biological: BNT162b2 |
| Priming Group 3-P: Natural Infection Prime, BNT162b2 full dose (Pakistan only) | Active comparator | Not described Receives: Biological: BNT162b2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sero-response rate by Spike IgG binding ELISA at 28 days post booster
Assess and compare humoral immune response from a fractional vs. full booster dose of BNT162b2 or AZD1222 in immunocompetent adults fully primed with BNT162b2, AZD1222, or Sinovac vaccines or natural infection, measured by anti-Spike IgG binding ELISA at 28 days post booster
Measured: Day 28
Safety and reactogenicity profile of fractional and full dose of study vaccines at 28 days post-booster vaccination
Describe the safety and reactogenicity profile of fractional and full dose of study vaccines at 28 days post-booster vaccination through estimated incidence of solicited local and systemic adverse events, and incidence of unsolicited reported adverse events
- Occurrence of solicited local and systemic reactions within 7 days of booster
- Occurrence of unsolicited AEs within 28 days of booster
Measured: Day 28
Secondary outcomes (2)
Sero-response rate by anti-Spike IgG binding ELISA at 3m and 6m post booster
Assess the persistence of humoral immunity after a fractional vs. full booster dose of BNT162b2 or AZD1222 in immunocompetent adults fully primed with BNT162b2, AZD1222, or Sinovac vaccines or natural infection, measured by anti-Spike IgG binding ELISA at 3m and 6m post booster
Measured: Month 3 and Month 6
Safety and reactogenicity profile of fractional and full dose of study vaccines throughout the trial
Describe the safety and reactogenicity profile of fractional and full dose of study vaccines throughout the trial
- Occurrence of Medically attended adverse reactions within 3 months of booster
- Occurrence of adverse events (AE), Serious adverse events (SAE), and adverse events of special interest (AESI) within 28 days, 3 months, and 6 months of booster
Measured: Throughout study, 6 months per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start5 Jul 2022
- Primary completion28 Jul 2023
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert B. Sabin Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University, Oswaldo Cruz Foundation, Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343871
- Sponsor's protocol ID
- Sabin CoV 22
- Status last verified
- Jan 2024
- First submitted
- 20 Apr 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barros Verruck J, Moreira Puga MA, de Oliveira RD, Vieira da Silva P, Charu V, Hedlin H, Lu D, Zhang A, Ritter V, Shaw B, Rosser JI, Seidman JC, Carter AS, Qamar F, Luby S, Garret D, Croda J. Antispike IgG antibody decay after immunisation with fractional versus full booster doses of COVID-19 vaccines: a 6-month longitudinal analysis of the FRACT-COV trial in Brazil. BMJ Public Health. 2025 Jul 5;3(2):e002331. doi: 10.1136/bmjph-2024-002331. eCollection 2025.
PubMed 40620571
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Assess the Immunogenicity and Safety of Full Versus Fractional Dose of Pfizer/BioNTech, AstraZeneca, and Sinovac COVID-19 Vaccines Given as a Booster Dose at Least 6 Months After Primary Vaccination Series or PCR-confirmed Infection With SARS-CoV-2 in Healthy Adults
- ClinicalTrials.gov ID
- NCT05343871
- Acronym / sponsor ID
- Sabin CoV 22
- Conditions
- COVID-19
- Keywords
- Fractional dose, COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,354 participants (actual)
- Lead sponsor
- Albert B. Sabin Vaccine InstituteUniversity, hospital or other
- Collaborators
- Aga Khan University, Oswaldo Cruz Foundation, Stanford University
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 25 Apr 2022 (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.
Since the emergence of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pathogen in late 2019, millions of people around the world have fallen ill and died from coronavirus disease 2019 (COVID-19), with variant-fueled case spikes causing repeated cycles of morbidity and mortality. The rapid development and emergency use authorization of vaccines against SARS-CoV-2 presents an enormous opportunity to protect populations, but bottlenecks in production have led to demand for vaccines that far outpaces supply. This project will investigate the immunogenicity of fractional doses of SARS-CoV-2 vaccines given a minimum of six months following an initial two-dose schedule or following natural immunity via documented infection. The consortium of research partners from the Sabin Vaccine Institute, Aga Khan University, Fundação Oswaldo Cruz (Fiocruz), and Stanford University will recruit volunteers to receive a full or fractional booster dose of BNT162b2, AZD1222 or Sinovac following receipt of their primary vaccination series or PCR-confirmed natural infection in Pakistan. The research team will follow participants for six months from boosting, with blood draws at baseline, 28 days, 3 months and 6 months, and measure sero-response rate (SRR) by anti-Spike immunoglobulin G (IgG) binding enzyme-linked immunosorbent assay (ELISA) with the ultimate aim of identifying whether fractional doses provide a similar immune response compared to full doses of vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 19
| Arm | Type | Receives |
|---|---|---|
| Priming Group 1: Sinovac Prime, AZD1222 ½ dose (Brazil only) | Experimental | Biological: AZD1222 |
| Priming Group 1: Sinovac Prime, AZD1222 full dose (Brazil only) | Active comparator | Biological: AZD1222 |
| Priming Group 1: Sinovac Prime, BNT162b2 1/3 dose | Experimental | Biological: BNT162b2 |
| Priming Group 1: Sinovac Prime, BNT162b2 1/2 dose | Experimental | Biological: BNT162b2 |
| Priming Group 1: Sinovac Prime, BNT162b2 full dose | Active comparator | Biological: BNT162b2 |
| Priming Group 1: Sinovac Prime, Sinovac full dose | Active comparator | Biological: Sinovac |
| Priming Group 2: AZD1222 Prime, AZD1222 ½ dose (Brazil only) | Experimental | Biological: AZD1222 |
| Priming Group 2: AZD1222 Prime, AZD1222 full dose (Brazil only) | Active comparator | Biological: AZD1222 |
| Priming Group 2: AZD1222 Prime, BNT162b2 1/3 dose | Experimental | Biological: BNT162b2 |
| Priming Group 2: AZD1222 Prime, BNT162b2 1/2 dose | Experimental | Biological: BNT162b2 |
| Priming Group 2: AZD1222 Prime, BNT162b2 full dose | Active comparator | Biological: BNT162b2 |
| Priming Group 3-B: BNT162b2 Prime, AZD1222 ½ dose (Brazil only) | Experimental | Biological: AZD1222 |
| Priming Group 3-B: BNT162b2 Prime, AZD1222 full dose (Brazil only) | Active comparator | Biological: AZD1222 |
| Priming Group 3-B: BNT162b2 Prime, BNT162b2 1/3 dose (Brazil only) | Experimental | Biological: BNT162b2 |
| Priming Group 3-B: BNT162b2 Prime, BNT162b2 1/2 dose (Brazil only) | Experimental | Biological: BNT162b2 |
| Priming Group 3-B: BNT162b2 Prime, BNT162b2 full dose (Brazil only) | Active comparator | Biological: BNT162b2 |
| Priming Group 3-P: Natural Infection Prime, BNT162b2 1/3 dose (Pakistan only) | Experimental | Biological: BNT162b2 |
| Priming Group 3-P: Natural Infection Prime, BNT162b2 1/2 dose (Pakistan only) | Experimental | Biological: BNT162b2 |
| Priming Group 3-P: Natural Infection Prime, BNT162b2 full dose (Pakistan only) | Active comparator | Biological: BNT162b2 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male or female individuals aged 18 years to 60 years
- Participant is willing and able to give written informed consent for participation in the trial
- Individuals who can comply with trial procedures and are available for the duration of follow-up.
- ● Previous vaccination with a complete primary series of Sinovac (Priming Group 1), AZD1222 (Priming Group 2), or BNT162b2 (Priming Group 3-B) at least 6 months prior to screening
- ● Previous vaccination with a complete primary series of Sinovac (Priming Group 1) or AZD1222 (Priming Group 2) at least 6 months prior to screening, or PCR-confirmed natural infection (Priming Group 3-P) between February 2021 - 6 months prior to screening
Key exclusion criteria (21 listed)
- Has a contraindication to BNT162b2, AZD1222 or Sinovac
- Has received an incomplete primary COVID-19 vaccination series
- Has received 3 doses of COVID-19 vaccine
- Has received heterologous primary COVID-19 vaccination series
- History of a solid organ or bone marrow transplant
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 |
|---|---|---|
| SinovacSinovac inactivated COVID-19 vaccine: ● Full dose (0.5 ml) | Biological | Priming Group 1: Sinovac Prime, Sinovac full dose |
| AZD1222AstraZeneca ChAdOx1-S recombinant AZD1222 vaccine: * Full dose (0.5 ml) * Half dose (0.25 ml) | Biological | Priming Group 1: Sinovac Prime, AZD1222 full dose (Brazil only), Priming Group 1: Sinovac Prime, AZD1222 ½ dose (Brazil only), Priming Group 2: AZD1222 Prime, AZD1222 full dose (Brazil only), Priming Group 2: AZD1222 Prime, AZD1222 ½ dose (Brazil only), Priming Group 3-B: BNT162b2 Prime, AZD1222 full dose (Brazil only), Priming Group 3-B: BNT162b2 Prime, AZD1222 ½ dose (Brazil only) |
| BNT162b2Pfizer/BioNTech BNT162b2 mRNA vaccine: * Full dose (30 micrograms) * Half dose (15 micrograms) * One-third dose (10 micrograms) | Biological | Priming Group 1: Sinovac Prime, BNT162b2 1/2 dose, Priming Group 1: Sinovac Prime, BNT162b2 1/3 dose, Priming Group 1: Sinovac Prime, BNT162b2 full dose, Priming Group 2: AZD1222 Prime, BNT162b2 1/2 dose, Priming Group 2: AZD1222 Prime, BNT162b2 1/3 dose, Priming Group 2: AZD1222 Prime, BNT162b2 full dose, Priming Group 3-B: BNT162b2 Prime, BNT162b2 1/2 dose (Brazil only), Priming Group 3-B: BNT162b2 Prime, BNT162b2 1/3 dose (Brazil only), Priming Group 3-B: BNT162b2 Prime, BNT162b2 full dose (Brazil only), Priming Group 3-P: Natural Infection Prime, BNT162b2 1/2 dose (Pakistan only), Priming Group 3-P: Natural Infection Prime, BNT162b2 1/3 dose (Pakistan only), Priming Group 3-P: Natural Infection Prime, BNT162b2 full dose (Pakistan only) |
Primary outcome
Sero-response rate by Spike IgG binding ELISA at 28 days post booster
Time frame: Day 28
Assess and compare humoral immune response from a fractional vs. full booster dose of BNT162b2 or AZD1222 in immunocompetent adults fully primed with BNT162b2, AZD1222, or Sinovac vaccines or natural infection, measured by anti-Spike IgG binding ELISA at 28 days post booster
Safety and reactogenicity profile of fractional and full dose of study vaccines at 28 days post-booster vaccination
Time frame: Day 28
Describe the safety and reactogenicity profile of fractional and full dose of study vaccines at 28 days post-booster vaccination through estimated incidence of solicited local and systemic adverse events, and incidence of unsolicited reported adverse events 1. Occurrence of solicited local and systemic reactions within 7 days of booster 2. Occurrence of unsolicited AEs within 28 days of booster
2 secondary outcomes
Sero-response rate by anti-Spike IgG binding ELISA at 3m and 6m post booster
Time frame: Month 3 and Month 6
Safety and reactogenicity profile of fractional and full dose of study vaccines throughout the trial
Time frame: Throughout study, 6 months per participant
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 30 Jan 2024.
- Derived from this study: PubMed 40620571Barros Verruck J, Moreira Puga MA, de Oliveira RD, Vieira da Silva P, Charu V, Hedlin H, Lu D, Zhang A, Ritter V, Shaw B, Rosser JI, Seidman JC, Carter AS, Qamar F, Luby S, Garret D, Croda J. Antispike IgG antibody decay after immunisation with fractional versus full booster doses of COVID-19 vaccines: a 6-month longitudinal analysis of the FRACT-COV trial in Brazil. BMJ Public Health. 2025 Jul 5;3(2):e002331. doi: 10.1136/bmjph-2024-002331. eCollection 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sinovac, AZD1222 and BNT162b2 in people with COVID-19, run by Albert B. Sabin Vaccine Institute at 2 sites in 2 countries.
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 7 inclusion and 21 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil, Pakistan. 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?
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?
Sero-response rate by Spike IgG binding ELISA at 28 days post booster (time frame: Day 28). 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 NCT05343871, 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 30 Jan 2024.