SARS CoV 2 InfectionPhase 2/3NCT05279365
PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS
A Phase 2/3 study testing Pfizer/BioNTech (BNT162b2) and Moderna in people with SARS CoV 2 Infection and COVID-19, run by DHR Health Institute for Research and Development at 4 sites in United States.
Trial summary
The recent rise in infections with the Omicron variant of the SARS-CoV-2 is alarming. Equally disconcerting is the fact that individuals who were previously vaccinated (< 6 months) and have co-morbidities that are considered high risk, are getting re-infected...a process referred to as "breakthrough". Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection, COVID-19
- What is being tested?
- Pfizer/BioNTech (BNT162b2) and Moderna
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Jul 2021to 31 Aug 2023
- Phase
- Phase 2/3
- 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
- Adults 18 years and over that have been fully vaccinated (2 doses) with the Pfizer/BioNTech COVID-19 vaccine (BNT162b2) and with the 1st booster at least 90 days prior to the 2nd booster
- Healthcare workers employed by and/or affiliated with DHR Health, Renaissance Medical Foundation, DHR Partners, Starr County Memorial Hospital
- Any adult with any of the following risk factors for severe COVID-19 disease progression (as outlined by the CDC)
Who cannot join
- Previous history of allergic reaction to vaccination
- less than or equal to 3 months from last booster dose of vaccine
- active SARS-COV-2 infection
- less than or equal to 21 days of full recovery from SARS-CoV-2 infection
- less than or equal to 14 days of any vaccination
- vaccinated with any other available COVID-19 vaccine other than Pfizer/BioNTech or Moderna
- Healthcare workers not employed by and/or affiliated with DHR Health, Renaissance Medical Foundation, Star County Memorial Hospital or non DHR Partners
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Brownsville Independent School District
Brownsville, Texas, 78521
Sohail Rao, MD, MA, DPhil, 956-362-2387, s.rao@dhr-rgv.com
Monica Betancourt-Garcia, MD, 956-362-3223, m.betancourt@dhr-rgv.com
- Recruiting
DHR Health Institute for Research and Development
Edinburg, Texas, 78539
Sohail Rao, MD,MA,DPhil, 956-362-2387, s.rao@dhr-rgv.com
Monica Betancourt-Garcia, MD, 956-362-3223, m.betancourt@dhr-rgv.com
- Recruiting
Edinburg CISD School Based Health Center
Edinburg, Texas, 78542
Sohail Rao, MD,MA, DPhil, 956-362-2387, s.rao@dhr-rgv.com
Monica Betancourt-Garcia, MD, 956-362-3223, m.betancourt@dhr-rgv.com
- Recruiting
Starr County Memorial Hospital
Rio Grande City, Texas, 78582
Sohail Rao, MD, MA, DPhil, 956-362-2387, s.rao@dhr-rgv.com
Monica Betancourt-Garcia, MD, 956-362-3223, m.betancourt@dhr-rgv.com
About this study
The recent rise in infections with the Omicron variant of the SARS-CoV-2 is alarming. Equally disconcerting is the fact that individuals who were previously vaccinated (< 6 months) and have co-morbidities that are considered high risk, are getting re-infected...a process referred to as "breakthrough". There is some evidence that in these high risk individuals, the gradual decrease in immunity against the virus as depicted by a drop in anti-SARS-CoV-2 antibodies, is responsible (partially or wholly) for this reinfection. In this study, we intend to give a booster does Pfizer/BioNTech and/or Moderna and ascertain the levels of antibodies at various times pre and post vaccination. The incidence of infection with SARS-CoV-2 after booster vaccination will also be obtained.
- Conditions
- SARS CoV 2 Infection, COVID-19
- Being tested
- Pfizer/BioNTech (BNT162b2), Moderna
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pfizer/BioNTech (BNT162b2)Biological
participants will receive a booster dose (1st booster or 2nd booster) of vaccine
ModernaBiological
participants will receive a booster dose (1st booster or 2nd booster) of vaccine
| Study group | Role | What they receive |
|---|---|---|
| Administration of Booster Dose | Experimental | study participant will receive either 30ug in 0.3 ml of Pfizer/BioNTech (BNT162b2) or 0.25 ml of Moderna vaccine administered intramuscularly. Receives: Biological: Pfizer/BioNTech (BNT162b2); Biological: Moderna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants infected with SARS-CoV-2 after booster Dose
Determine effectiveness of booster dose in the prevention of SARS-CoV-2 Infection by assessing if subjects remain free from infections with SARS-CoV-2 after receiving booster dose.
Measured: 24 months
Levels of anti-SARS-CoV-2 IgG antibody titers after booster
Determine the anti-SARS-CoV-2 IgG antibody titers using a semi quantitative method at various time points (Baseline/Day 0, Day 14, Week 12 and Week 24 after booster) to assess for sustained levels of relatively high titers of anti-SARS-CoV-2 IgG in the blood of the subjects
Measured: 24 months
Secondary outcomes (2)
Measure rate of decline of immune responses
Determine the rate of decline of immune responses in various cohort of recipients with similar co-morbidities by conducting cohort analysis
Measured: 24 months
Identify differences in immune responses based on comorbidity status
Identify differences in immune responses based on comorbidity status (e.g., Immune response in recipients with metabolic diseases vs. patients with immunosuppression) by using questionnaires
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start30 Jul 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DHR Health Institute for Research and Development
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohail Rao, DHR Health Institute for Research and Development
- Investigators
- Sohail Rao, MD,MA,DPhil, Principal investigator, DHR Health Institute for Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279365
- Sponsor's protocol ID
- 1789039
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS
- ClinicalTrials.gov ID
- NCT05279365
- Acronym / sponsor ID
- 1789039
- Conditions
- SARS CoV 2 Infection, COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- DHR Health Institute for Research and DevelopmentUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 15 Mar 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.
The recent rise in infections with the Omicron variant of the SARS-CoV-2 is alarming. Equally disconcerting is the fact that individuals who were previously vaccinated (< 6 months) and have co-morbidities that are considered high risk, are getting re-infected...a process referred to as "breakthrough". There is some evidence that in these high risk individuals, the gradual decrease in immunity against the virus as depicted by a drop in anti-SARS-CoV-2 antibodies, is responsible (partially or wholly) for this reinfection. In this study, we intend to give a booster does Pfizer/BioNTech and/or Moderna and ascertain the levels of antibodies at various times pre and post vaccination. The incidence of infection with SARS-CoV-2 after booster vaccination will also be obtained.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of Booster Dose | Experimental | Biological: Pfizer/BioNTech (BNT162b2), Biological: Modernastudy participant will receive either 30ug in 0.3 ml of Pfizer/BioNTech (BNT162b2) or 0.25 ml of Moderna vaccine administered intramuscularly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years and over that have been fully vaccinated (2 doses) with the Pfizer/BioNTech COVID-19 vaccine (BNT162b2) and with the 1st booster at least 90 days prior to the 2nd booster
- Healthcare workers employed by and/or affiliated with DHR Health, Renaissance Medical Foundation, DHR Partners, Starr County Memorial Hospital
- Any adult with any of the following risk factors for severe COVID-19 disease progression (as outlined by the CDC)
Key exclusion criteria (7 listed)
- Previous history of allergic reaction to vaccination
- less than or equal to 3 months from last booster dose of vaccine
- active SARS-COV-2 infection
- less than or equal to 21 days of full recovery from SARS-CoV-2 infection
- less than or equal to 14 days of any vaccination
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 |
|---|---|---|
| Pfizer/BioNTech (BNT162b2)participants will receive a booster dose (1st booster or 2nd booster) of vaccine | Biological | Administration of Booster Dose |
| Modernaparticipants will receive a booster dose (1st booster or 2nd booster) of vaccine | Biological | Administration of Booster Dose |
Primary outcome
Number of participants infected with SARS-CoV-2 after booster Dose
Time frame: 24 months
Determine effectiveness of booster dose in the prevention of SARS-CoV-2 Infection by assessing if subjects remain free from infections with SARS-CoV-2 after receiving booster dose.
Levels of anti-SARS-CoV-2 IgG antibody titers after booster
Time frame: 24 months
Determine the anti-SARS-CoV-2 IgG antibody titers using a semi quantitative method at various time points (Baseline/Day 0, Day 14, Week 12 and Week 24 after booster) to assess for sustained levels of relatively high titers of anti-SARS-CoV-2 IgG in the blood of the subjects
2 secondary outcomes
Measure rate of decline of immune responses
Time frame: 24 months
Identify differences in immune responses based on comorbidity status
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- 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.
Sohail Rao, MD,MA,DPhil principal investigator
DHR Health Institute for Research and Development
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pfizer/BioNTech (BNT162b2) and Moderna in people with SARS CoV 2 Infection and COVID-19, run by DHR Health Institute for Research and Development at 4 sites 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 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 4 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sohail Rao, MD,MA,DPhil (956-362-2387, s.rao@dhr-rgv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants infected with SARS-CoV-2 after booster Dose (time frame: 24 months). 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?
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 29 Mar 2022.