CancerPhase 2NCT05016622
Booster Dose Trial
A Phase 2 study testing BNT162b2 vaccine in people with Cancer, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The goal of this study is to assess the safety and effectiveness of COVID vaccine booster doses in patients with cancer who have not developed an antibody after the U.S. Food and Drug Administration (FDA) Emergency Use Authorized COVID primary vaccination series. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- BNT162b2 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2021to 21 May 2023
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above the age of 18
- Meet one of the sub-criteria below:
- Meet the CDC definition for immunocompromised status for cancer patients, i.e patients receiving active treatment for solid tumor or hematologic malignancy OR
- Be a recipient of stem cell transplant or CAR-T cell therapy in the last 2 years OR
- Have a negative SARS-CoV-2 spike IgG despite standard vaccination series, irrespective of active/inactive cancer status, on observation, or active therapy.
- Underwent an in-person encounter at a study facility during the study period
Show all 11Show fewer
- Have received the second of the mRNA-based vaccines BNT162b2 and mRNA-1273 (Pfizer/BioNTech or Moderna, respectively) or one dose of the adenoviral Ad26CoV2.S (Johnson \& Johnson) vaccine at least 28 days before the booster dose.
- Above the age of 18
- Have a diagnosis of prior or active malignancy, either hematological or solid tumor
- Have a negative or low-level SARS-CoV-2 spike IgG after 14 days of booster vaccination series irrespective of active/inactive cancer status, on observation, or active therapy.
- Have received an FDA-authorized booster dose of mRNA (BNT162b2 and mRNA-1273) vaccine at least 28 days before study enrollment.
Who cannot join
- Patients who have had a serious adverse reaction to any prior COVID-19 vaccines resulting in emergency room visit or hospitalization, had events related to myocarditis, thrombosis and thrombocytopenia syndrome or anaphylaxis to any prior dose of the COVID-19 vaccines.
- Patients who have had a documented COVID-19 infection in the 90 days prior to starting the study
- Patients who have had a serious adverse reaction to any prior COVID-19 vaccines resulting in emergency room visit or hospitalization, had events related to myocarditis, thrombosis and thrombocytopenia syndrome or anaphylaxis to any prior dose of the COVID-19 vaccines.
- Patients who have had a documented COVID-19 infection in the 90 days prior to study enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Safety and Efficacy of Booster Doses of COVID-19 Vaccine in Immunocompromised Patients With a Cancer Diagnosis
The goal of this study is to assess the safety and effectiveness of COVID vaccine booster doses in patients with cancer who have not developed an antibody after the U.S. Food and Drug Administration (FDA) Emergency Use Authorized COVID primary vaccination series.
Read the detailed description
Cancer patients show increased morbidity with COVID-19 and need effective immunization strategies. Many healthcare regulatory agencies recommend administering 'booster' doses of COVID-19 vaccines beyond the standard two-dose series, for this group of patients. Therefore, studying the efficacy of these additional vaccine doses against SARS-CoV-2 and variants of concern is of utmost importance in this immunocompromised patient population.
The investigator team designed a prospective single arm clinical trial for consenting patients with cancer who had received two doses of mRNA, or one dose of AD26.CoV2.S vaccine, and were administered a third dose of mRNA vaccine. Patients who had no or low responses to three mRNA COVID vaccines were administered a fourth dose of mRNA vaccine. Efficacy was assessed by changes in anti-spike antibody, T-cell activity, and neutralization activity, at baseline and 4 weeks.
First Booster Dose ("3rd dose") study:
Following the informed consent process patients are enrolled into the study. After drawing baseline laboratory samples that include spike antibody, a sample for T-cell assay, and a biobank sample, patients will receive a third mRNA vaccine (initially BNT162b2 per protocol, later amended to allow for a third mRNA-1273 vaccine after the Food and Drug Administration [FDA] authorized 'booster' doses in the fall of 2021). Patients who had received Ad26.CoV2.S vaccine will receive a BNT162b2 booster vaccine. Follow-up visits are scheduled at ~4 weeks and 4-6 months following the booster dose and laboratory sample collections will be repeated.
Second Booster Dose ("4th dose") study:
For patients who did not seroconvert after three doses or had low antibody response (<1000 AU/mL as determined by in-house Abbott assay), it was hypothesized that a 'mix and match' strategy with a 2nd booster dose ("4th dose") of COVID-19 vaccine would induce seroconversion and improve boosting of humoral antibody responses. To study this, a protocol was designed wherein patients who had received their 1st booster dose ("3rd dose") of mRNA vaccines and had undetectable anti-S antibody or had an anti-S antibody level of <1000 AU/mL measured at least 14 days after third dose would be randomized to an mRNA vs. adenoviral booster ("4th") vaccine dose. Responses would be then assessed at 4 weeks after the 2nd booster dose ("4th dose") through measurement of anti-S antibody results. Complete blood counts (CBC), quantitative immunoglobulin levels (IgG, IgA, and IgM), lymphocyte subsets, T-cell responses, and neutralization activity at baseline and 4 weeks will be assessed for each of these patients. Following the implementation of this protocol, the Centers for Disease Control (CDC) published a statement that advised that the mRNA vaccines should be preferentially administered over the adenoviral vaccines given concern over rare side effects such as thrombocytopenia and thrombosis syndrome. Given this advisory, the protocol was amended to allow recruitment in a cohort that would receive a fourth dose of the BNT162b2 vaccine to comply with CDC guidelines.
- Conditions
- Cancer
- Being tested
- BNT162b2 vaccine
- Keywords
- COVID-19, Booster
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2 vaccineBiological
Administer an additional dose of the BNT162b2 mRNA vaccine to patients with cancer who have a negative SARS-CoV-2 Spike IgG at least 14 days after 2 doses of the mRNA vaccines (BNT162b2/mRNA-1273) or 28 days after the adenoviral based Ad26CoV2.S vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Booster dose | Experimental | Not described Receives: Biological: BNT162b2 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Seroconversion for SARS-CoV-2 Spike Antibody Among Patients Who Were Seronegative After Primary Series of COVID-19 Vaccinations
Rate will be determined as the percentage of patients demonstrating booster-induced seroconversion, as evidenced by anti-Spike antibody testing, who were seronegative after the primary series of FDA authorized COVID-19 vaccinations.
Measured: 4 weeks after administration of 1st booster dose
Percentage of Patients Who Were 'Responders' After 2nd Booster Dose
A patient was classified as a responder if they either (1) had positive anti-S antibody at 4 weeks if seronegative at baseline (following 1st booster dose) or (2) if they achieved a titer of >1000 AU/mL at 4 weeks if they were sero-low at baseline (following 1st booster dose)
Measured: 4 weeks after administration of 2nd booster dose
Secondary outcomes (27)
Positive Anti-Spike Antibody (IgG) Titer
The number of patients with evaluable T-cell immune responses who demonstrated positive anti-S antibody (IgG) titers against SARS-CoV-2 after 1st booster dose of vaccine.
Measured: 4 weeks after administration of 1st booster dose
Spike Antibody Titer
The median SARS-CoV-2 spike antibody (IgG) titer among the entire cohort at 4 weeks after administration of the 1st booster dose of vaccine was determined.
Measured: 4 weeks after administration of 1st booster dose
Change in Anti-Spike Antibody Titer for Patients With Hematologic Malignancies
The median change in anti-S antibody titer for patients with Hematologic malignancies was determined.
Measured: Baseline to 4 weeks after administration of 1st booster dose
Change in Anti-Spike Antibody Titer for Patients With Solid Tumor Malignancies
The median change in anti-S antibody titer for patients with Solid tumor malignancies was determined.
Measured: Baseline to 4 weeks after administration of 1st booster dose
Change in Anti-Spike Antibody Titer Among Patients With Hematologic Malignancy by Type
Median change in Anti-S antibody titers was determined in patients who presented with Hematologic (either Lymphoid or Myeloid) malignancies.
Measured: Baseline to 4 weeks after administration of 1st booster dose
Percentage of Patients Seropositive/Seronegative Following 1st Booster Dose
Percentage of Patients who were either seropositive or seronegative following administration of 1st booster dose as demonstrated by anti-S antibody testing.
Measured: 4 weeks after administration of 1st booster dose
Neutralizing Antibodies Detected Among Seropositive Patients
The GenScript surrogate virus neutralization assay was used to analyze samples from seropositive patients to detect for the presence of neutralizing antibodies. The percentage of patients with neutralizing antibodies was determined.
Measured: 4 weeks after administration of 1st booster dose
Positive T-cell Response Among Patients With a Negative Anti-S Antibody
Percentage of patients with a negative anti-S antibody following 1st booster dose who demonstrated a Positive T-cell response.
Measured: 4 weeks after administration of 1st booster dose
Positive T-cell Response Among Patients With a Negative T-cell Response at Baseline
Percentage of patients who demonstrated a Positive T-cell response among those who demonstrated a negative T-cell response at baseline.
Measured: 4 weeks after administration of 1st booster dose
Anti-spike Antibody Titers for Patients on Anti-CD20 Antibody Therapy Within 6 Months of Treatment
In order to determine association of specific cancer-directed therapies with the booster effect, median change in anti-S antibody titers were assessed for patients on anti-CD20 antibody therapy within 6 months of administration of 1st booster dose.
Measured: Within 6 months prior to treatment to 4 weeks after administration of 1st booster dose
Anti-spike Antibody Titers for Patients on Anti-CD20 Antibody Therapy
In order to determine association of specific cancer-directed therapies with the booster effect, median change in anti-S antibody titers were assessed for patients on anti-CD20 antibody therapy just prior to the study.
Measured: Baseline to 4 weeks after administration of 1st booster dose
Anti-spike Antibody Titers for Patients Not on Anti-CD20 Antibody Therapy
In order to determine association of specific cancer-directed therapies with the booster effect, median change in anti-S antibody titers were assessed for patients not on anti-CD20 antibody therapy just prior to the study.
Measured: Baseline to 4 weeks after administration of 1st booster dose
Anti-spike Antibody Titers for Patients Not on Anti-CD20 Antibody Therapy Within 6 Months of Treatment
In order to determine association of specific cancer-directed therapies with the booster effect, median change in anti-S antibody titers were assessed for patients not on anti-CD20 antibody therapy within 6 months of treatment
Measured: Within 6 months prior to treatment to 4 weeks after administration of 1st booster dose
Percentage of Patients Who Remained Seropositive Following 1st Booster Dose
Percentage of Patients who maintained a positive anti-S antibody (seropositive) following administration of 1st booster dose as demonstrated by anti-S antibody testing.
Measured: ~4-6 months after administration of 1st booster dose
Percentage of Seronegative Patients Before 2nd Booster Dose
The percentage of patients determined to be seronegative before 2nd booster dose
Measured: Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months
Percentage of Patients With Low (Anti-S Antibody) Serum Antibodies
The percentage of patients with low serum antibodies before administration of the 2nd booster dose was determined by assay. Patients with anti-S antibody titers of <1000 AU/mL were determined to have low serum antibodies.
Measured: Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months
Anti-spike IgG Responders After the 2nd Booster Dose
The percentage of patients who were classified as 'responders' after the 2nd Booster dose. A patient was classified as a responder if they: (1) had positive anti-S antibody at 4 weeks if seronegative after 1st booster dose or (2) if they achieved a titer of >1000 AU/mL at 4 weeks if they were sero-low after 1st booster dose.
Measured: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Rate of Seroconversion for SARS-CoV-2 Spike Antibody Among Patients Who Remained Seronegative Following 1st Booster Dose
Rate was determined as the percentage of patients demonstrating booster-induced seroconversion to positive anti-S antibody who had remained seronegative following administration of Primary Vaccination series and 1st Booster dose of BNT162b2, mRNA-1273, or AdCoV2.S COVID vaccine.
Measured: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Percentage of Patients With Low Anti-Spike Antibody Who Responded Following 2nd Booster Dose
The percentage of Patients with low anti-Spike antibody, determined to be IgG <1000 AU/mL by assay, who responded following administration of 2nd booster dose. Responses in this context were determined to be those patients with assay results of IgG > 1000 AU/mL.
Measured: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Anti-Spike Antibody Titer Following Administration of 1st Booster Dose
The median Anti-S antibody titer following administration of the primary vaccination series and 1st booster dose in Cohort B was determined.
Measured: Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months
Anti-Spike Antibody Titer Following Administration of 2nd Booster Dose
The median Anti-S antibody titer following administration of the 2nd booster dose (Cohort B) was determined.
Measured: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Positive Anti-Spike Antibody (IgG) Titer Prior to 2nd Booster Dose
The number of Cohort B patients with evaluable T-cell immune responses who demonstrated positive anti-S antibody (IgG) titers against SARS-CoV-2 following 1st booster dose and prior to 2nd booster dose of vaccine.
Measured: Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months
Positive Anti-Spike Antibody (IgG) Titer Following 2nd Booster Dose
The percentage of Cohort B patients who demonstrated positive anti-S antibody (IgG) titers against SARS-CoV-2 following administration of 2nd booster dose of vaccine.
Measured: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Neutralization Against Wildtype (WT) SARS-CoV-2 Variant Prior to 2nd Booster Dose
Neutralization activity against the WT variant was assessed using a neutralization activity assay. The percentage of patients with positive and negative T-cell results are reported.
Measured: Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months
Neutralization Against Wildtype (WT) SARS-CoV-2 Variant Following 2nd Booster Dose
Neutralization activity against the WT variant was assessed using a neutralization activity assay. The percentage of patients with positive and negative T-cell results are reported.
Measured: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Neutralization Against Omicron BA.1 SARS-CoV-2 Variant Prior to 2nd Booster Dose
Neutralization activity against the Omicron BA.1 variant was assessed using a neutralization activity assay. The percentage of patients with positive and negative T-cell results are reported.
Measured: Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months
Neutralization Against Omicron BA.1 SARS-CoV-2 Variant Following 2nd Booster Dose
Neutralization activity against the Omicron BA.1 variant was assessed using a neutralization activity assay. The percentage of patients with positive and negative T-cell results are reported.
Measured: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start10 Aug 2021
- Primary completion20 Apr 2022
- Study completion21 May 2023
Why it stopped: Due to decreased level of engagement and available funding, PI determined it appropriate to close the study prior to visit occurring. IRB approved.
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 CancerStudies 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine, National Cancer Institute (NCI), The Leukemia and Lymphoma Society
- Responsible party
- Sponsor
- Investigators
- Balazs Halmos, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016622
- Sponsor's protocol ID
- 2021-13204
- Other IDs
- 2UG1CA189859-06, IRV-BC0004-22, 3P30CA013330-49S3
- Status last verified
- Jul 2024
- First submitted
- 16 Aug 2021
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thakkar A, Pradhan K, Duva B, Carreno JM, Sahu S, Thiruthuvanathan V, Campbell S, Gallego S, Bhagat TD, Rivera J, Choudhary G, Olea R, Sabalza M, Shapiro LC, Lee M, Quinn R, Mantzaris I, Chu E, Will B, Pirofski LA, Krammer F, Verma A, Halmos B. Study of efficacy and longevity of immune response to third and fourth doses of COVID-19 vaccines in patients with cancer: A single arm clinical trial. Elife. 2023 Mar 28;12:e83694. doi: 10.7554/eLife.83694.
PubMed 36975207
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Booster Doses of COVID-19 Vaccine in Immunocompromised Patients With a Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT05016622
- Acronym / sponsor ID
- 2021-13204
- Conditions
- Cancer
- Keywords
- COVID-19, Booster
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to decreased level of engagement and available funding, PI determined it appropriate to close the study prior to visit occurring. IRB approved.
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine, National Cancer Institute (NCI), The Leukemia and Lymphoma Society
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 21 May 2023 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to assess the safety and effectiveness of COVID vaccine booster doses in patients with cancer who have not developed an antibody after the U.S. Food and Drug Administration (FDA) Emergency Use Authorized COVID primary vaccination series.
Detailed description
Cancer patients show increased morbidity with COVID-19 and need effective immunization strategies. Many healthcare regulatory agencies recommend administering 'booster' doses of COVID-19 vaccines beyond the standard two-dose series, for this group of patients. Therefore, studying the efficacy of these additional vaccine doses against SARS-CoV-2 and variants of concern is of utmost importance in this immunocompromised patient population.
The investigator team designed a prospective single arm clinical trial for consenting patients with cancer who had received two doses of mRNA, or one dose of AD26.CoV2.S vaccine, and were administered a third dose of mRNA vaccine. Patients who had no or low responses to three mRNA COVID vaccines were administered a fourth dose of mRNA vaccine. Efficacy was assessed by changes in anti-spike antibody, T-cell activity, and neutralization activity, at baseline and 4 weeks.
First Booster Dose ("3rd dose") study:
Following the informed consent process patients are enrolled into the study. After drawing baseline laboratory samples that include spike antibody, a sample for T-cell assay, and a biobank sample, patients will receive a third mRNA vaccine (initially BNT162b2 per protocol, later amended to allow for a third mRNA-1273 vaccine after the Food and Drug Administration [FDA] authorized 'booster' doses in the fall of 2021). Patients who had received Ad26.CoV2.S vaccine will receive a BNT162b2 booster vaccine. Follow-up visits are scheduled at ~4 weeks and 4-6 months following the booster dose and laboratory sample collections will be repeated.
Second Booster Dose ("4th dose") study:
For patients who did not seroconvert after three doses or had low antibody response (<1000 AU/mL as determined by in-house Abbott assay), it was hypothesized that a 'mix and match' strategy with a 2nd booster dose ("4th dose") of COVID-19 vaccine would induce seroconversion and improve boosting of humoral antibody responses. To study this, a protocol was designed wherein patients who had received their 1st booster dose ("3rd dose") of mRNA vaccines and had undetectable anti-S antibody or had an anti-S antibody level of <1000 AU/mL measured at least 14 days after third dose would be randomized to an mRNA vs. adenoviral booster ("4th") vaccine dose. Responses would be then assessed at 4 weeks after the 2nd booster dose ("4th dose") through measurement of anti-S antibody results. Complete blood counts (CBC), quantitative immunoglobulin levels (IgG, IgA, and IgM), lymphocyte subsets, T-cell responses, and neutralization activity at baseline and 4 weeks will be assessed for each of these patients. Following the implementation of this protocol, the Centers for Disease Control (CDC) published a statement that advised that the mRNA vaccines should be preferentially administered over the adenoviral vaccines given concern over rare side effects such as thrombocytopenia and thrombosis syndrome. Given this advisory, the protocol was amended to allow recruitment in a cohort that would receive a fourth dose of the BNT162b2 vaccine to comply with CDC guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Booster dose | Experimental | Biological: BNT162b2 vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Above the age of 18
- Meet one of the sub-criteria below:
- Underwent an in-person encounter at a study facility during the study period
- Have received the second of the mRNA-based vaccines BNT162b2 and mRNA-1273 (Pfizer/BioNTech or Moderna, respectively) or one dose of the adenoviral Ad26CoV2.S (Johnson \& Johnson) vaccine at least 28 days before the booster dose.
- Above the age of 18
Key exclusion criteria (4 listed)
- Patients who have had a serious adverse reaction to any prior COVID-19 vaccines resulting in emergency room visit or hospitalization, had events related to myocarditis, thrombosis and thrombocytopenia syndrome or anaphylaxis to any prior dose of the COVID-19 vaccines.
- Patients who have had a documented COVID-19 infection in the 90 days prior to starting the study
- Patients who have had a serious adverse reaction to any prior COVID-19 vaccines resulting in emergency room visit or hospitalization, had events related to myocarditis, thrombosis and thrombocytopenia syndrome or anaphylaxis to any prior dose of the COVID-19 vaccines.
- Patients who have had a documented COVID-19 infection in the 90 days prior to study enrollment
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 |
|---|---|---|
| BNT162b2 vaccineAdminister an additional dose of the BNT162b2 mRNA vaccine to patients with cancer who have a negative SARS-CoV-2 Spike IgG at least 14 days after 2 doses of the mRNA vaccines (BNT162b2/mRNA-1273) or 28 days after the adenoviral based Ad26CoV2.S vaccine. | Biological | Booster dose |
Primary outcome
Rate of Seroconversion for SARS-CoV-2 Spike Antibody Among Patients Who Were Seronegative After Primary Series of COVID-19 Vaccinations
Time frame: 4 weeks after administration of 1st booster dose
Rate will be determined as the percentage of patients demonstrating booster-induced seroconversion, as evidenced by anti-Spike antibody testing, who were seronegative after the primary series of FDA authorized COVID-19 vaccinations.
Percentage of Patients Who Were 'Responders' After 2nd Booster Dose
Time frame: 4 weeks after administration of 2nd booster dose
A patient was classified as a responder if they either (1) had positive anti-S antibody at 4 weeks if seronegative at baseline (following 1st booster dose) or (2) if they achieved a titer of >1000 AU/mL at 4 weeks if they were sero-low at baseline (following 1st booster dose)
27 secondary outcomes
Positive Anti-Spike Antibody (IgG) Titer
Time frame: 4 weeks after administration of 1st booster dose
Spike Antibody Titer
Time frame: 4 weeks after administration of 1st booster dose
Change in Anti-Spike Antibody Titer for Patients With Hematologic Malignancies
Time frame: Baseline to 4 weeks after administration of 1st booster dose
Change in Anti-Spike Antibody Titer for Patients With Solid Tumor Malignancies
Time frame: Baseline to 4 weeks after administration of 1st booster dose
Change in Anti-Spike Antibody Titer Among Patients With Hematologic Malignancy by Type
Time frame: Baseline to 4 weeks after administration of 1st booster dose
Percentage of Patients Seropositive/Seronegative Following 1st Booster Dose
Time frame: 4 weeks after administration of 1st booster dose
Neutralizing Antibodies Detected Among Seropositive Patients
Time frame: 4 weeks after administration of 1st booster dose
Positive T-cell Response Among Patients With a Negative Anti-S Antibody
Time frame: 4 weeks after administration of 1st booster dose
Positive T-cell Response Among Patients With a Negative T-cell Response at Baseline
Time frame: 4 weeks after administration of 1st booster dose
Anti-spike Antibody Titers for Patients on Anti-CD20 Antibody Therapy Within 6 Months of Treatment
Time frame: Within 6 months prior to treatment to 4 weeks after administration of 1st booster dose
Anti-spike Antibody Titers for Patients on Anti-CD20 Antibody Therapy
Time frame: Baseline to 4 weeks after administration of 1st booster dose
Anti-spike Antibody Titers for Patients Not on Anti-CD20 Antibody Therapy
Time frame: Baseline to 4 weeks after administration of 1st booster dose
Anti-spike Antibody Titers for Patients Not on Anti-CD20 Antibody Therapy Within 6 Months of Treatment
Time frame: Within 6 months prior to treatment to 4 weeks after administration of 1st booster dose
Percentage of Patients Who Remained Seropositive Following 1st Booster Dose
Time frame: ~4-6 months after administration of 1st booster dose
Percentage of Seronegative Patients Before 2nd Booster Dose
Time frame: Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months
Percentage of Patients With Low (Anti-S Antibody) Serum Antibodies
Time frame: Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months
Anti-spike IgG Responders After the 2nd Booster Dose
Time frame: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Rate of Seroconversion for SARS-CoV-2 Spike Antibody Among Patients Who Remained Seronegative Following 1st Booster Dose
Time frame: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Percentage of Patients With Low Anti-Spike Antibody Who Responded Following 2nd Booster Dose
Time frame: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Anti-Spike Antibody Titer Following Administration of 1st Booster Dose
Time frame: Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months
Anti-Spike Antibody Titer Following Administration of 2nd Booster Dose
Time frame: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Positive Anti-Spike Antibody (IgG) Titer Prior to 2nd Booster Dose
Time frame: Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months
Positive Anti-Spike Antibody (IgG) Titer Following 2nd Booster Dose
Time frame: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Neutralization Against Wildtype (WT) SARS-CoV-2 Variant Prior to 2nd Booster Dose
Time frame: Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months
Neutralization Against Wildtype (WT) SARS-CoV-2 Variant Following 2nd Booster Dose
Time frame: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Neutralization Against Omicron BA.1 SARS-CoV-2 Variant Prior to 2nd Booster Dose
Time frame: Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months
Neutralization Against Omicron BA.1 SARS-CoV-2 Variant Following 2nd Booster Dose
Time frame: ~4 weeks after administration of 2nd booster dose, a minimum of 4-6 weeks following 1st booster dose, a median of approximately 6.0-6.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36975207Thakkar A, Pradhan K, Duva B, Carreno JM, Sahu S, Thiruthuvanathan V, Campbell S, Gallego S, Bhagat TD, Rivera J, Choudhary G, Olea R, Sabalza M, Shapiro LC, Lee M, Quinn R, Mantzaris I, Chu E, Will B, Pirofski LA, Krammer F, Verma A, Halmos B. Study of efficacy and longevity of immune response to third and fourth doses of COVID-19 vaccines in patients with cancer: A single arm clinical trial. Elife. 2023 Mar 28;12:e83694. doi: 10.7554/eLife.83694.
- 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.
Balazs Halmos, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BNT162b2 vaccine in people with Cancer, run by Montefiore Medical Center 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 11 inclusion and 4 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: stopped early, as of the sponsor's last update on 31 Jul 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.
What does this 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.
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 31 Jul 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?
Rate of Seroconversion for SARS-CoV-2 Spike Antibody Among Patients Who Were Seronegative After Primary Series of COVID-19 Vaccinations (time frame: 4 weeks after administration of 1st booster dose). 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 NCT05016622, 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 31 Jul 2024.