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| ID | Type | Description | Link |
|---|---|---|---|
| 2UG1CA189859-06 | U.S. NIH Grant/Contract | View source | |
| IRV-BC0004-22 | Other Grant/Funding Number | Leukemia & Lymphoma Society | |
| 3P30CA013330-49S3 | U.S. NIH Grant/Contract | View source |
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Due to decreased level of engagement and available funding, PI determined it appropriate to close the study prior to visit occurring. IRB approved.
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| Name | Class |
|---|---|
| Albert Einstein College of Medicine | OTHER |
| National Cancer Institute (NCI) | NIH |
| The Leukemia and Lymphoma Society | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Booster dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNT162b2 vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 4 weeks after administration of 2nd booster dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks after administration of 1st booster dose |
| Spike Antibody Titer |
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Inclusion Criteria (Cohort 1):
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.
Exclusion Criteria (Cohort 1):
Inclusion Criteria (Cohort 2):
Exclusion Criteria (Cohort 2):
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| Name | Affiliation | Role |
|---|---|---|
| Balazs Halmos, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36975207 | Derived | 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. |
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189 patients were assessed for eligibility to receive a booster COVID-19 vaccine after at least 28 days following completion of the standard COVID-19 vaccination series. Of the 189 patients, 56 patients declined to participate in the study, 2 patients did not meet eligibility criteria, and 25 participants were not enrolled due to 'Other reasons.' Accordingly, 106 patients were enrolled into the Booster Dose Trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Booster Dose |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Booster: 4 Week Follow up Visit |
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| 1st Booster: 4-6 Month Follow up Visit |
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| 2nd Booster: 4 Week Follow up Visit |
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| 2nd Booster: 4-6 Month Follow up Visit |
|
106 participants were enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Patients who have a negative SARS-CoV-2 spike IgG at least 14 days after 2 doses of the mRNA vaccines (BNT162b2 or mRNA-1273), or 28 days after the adenoviral based Ad26CoV2.S vaccine, received a third/booster mRNA vaccine (initially BNT162b2 per protocol, which was later amended to allow for third mRNA-1273 vaccine after the FDA authorized 'booster' doses in the fall of 2021). Patients then returned for follow-up at 4 weeks and 4-6 months after their third/booster dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 35 of 106 patients were seronegative after initial 2 dose vaccination series. At 4 weeks following receipt of the booster vaccine, 57% (20/35) of these patients seroconverted and had a detectable antibody response as demonstrated by anti-S antibody testing | Posted | Count of Participants | Participants | 4 weeks after administration of 1st booster dose |
|
Through study termination, up to 6 months. Patients were observed for a minimum of 15 minutes after their booster vaccinations to monitor for adverse events. Adverse event monitoring continued via administration of a questionnaire at 4 weeks (28 days), 3 months (90 days) and 6 months (180 days) following initial booster dose administration. Additional monitoring timepoints (i.e., 12 months (365 days), and 24 months (730 days)) were not reached as the study was terminated early.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Booster Dose | BNT162b2 vaccine: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | CTCAE (Unspecified) | Systematic Assessment | Verbatim Term: Persistent Fever. Hospitalized 3 days after booster. Listeria bacteremia unrelated to booster |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaccination Complication | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment | Verbatim Terms: Sore Arm, Muscle Aches |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Balazs Halmos | Montefiore Medical Center | 718-405-8404 | bahalmos@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2022 | Mar 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | ~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 | 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. | 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. | ~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. | ~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. | ~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. | 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. | ~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. | 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. | ~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. | 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. | ~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. | 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. | ~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 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Previous Vaccine Administered | Count of Participants | Participants |
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| Type of Booster Vaccine | Count of Participants | Participants |
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| Malignancy Category | Count of Participants | Participants |
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| Hematologic Malignancy | 40 patients had solid tumors. | Count of Participants | Participants |
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| Cancer Status | Count of Participants | Participants |
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| On Treatment at the Time of Booster | Count of Participants | Participants |
|
| Median Titer after Primary Vaccination Series | The median titer at baseline after primary vaccination series | Median | Inter-Quartile Range | AU/mL |
|
| Positive Anti-spike IgG Titers among Patients with evaluable T-cell Results | The number of patients with evaluable T-cell immune responses at baseline was determined through a SARS-CoV-2 interferon-gamma release assay (IGRA). | At baseline (i.e. after primary vaccination) 88 patients had evaluable T-cell results | Count of Participants | Participants |
|
| Patients with evaluable positive T-cell immune responses who were seronegative for Anti-S antibody | 65 patients with evaluable T-cell immune responses demonstrated a positive T-cell response against SARS-CoV-2 | Count of Participants | Participants |
|
| Percentage of Patients Seropositive/Seronegative at Baseline (before 1st booster dose) | Percentage of patients seronegative at baseline following the standard 2 dose vaccination series as demonstrated by anti-S antibody testing. Biobanked samples were available for 103 patients. | Count of Participants | Participants |
|
| Patients with neutralizing antibodies (in seropositive patients) | 68 patients were seropositive at baseline following primary COVID-19 vaccination series. The GenScript surrogate virus neutralization assay was used to analyze samples for neutralizing antibodies. | Count of Participants | Participants |
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| Primary | 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) | 18 participants were enrolled into the 2nd booster dose cohort. All 18 patients in this cohort had hematologic malignancies. 15 patients received BNT162b2 as their 2nd booster vaccine and 3 patients received Ad26.CoV2.S as their 2nd booster vaccine. | Posted | Count of Participants | Participants | 4 weeks after administration of 2nd booster dose |
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| Secondary | 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. | 89 patients had evaluable T-cell results at 4 weeks following 1st booster dose of vaccine | Posted | Count of Participants | Participants | 4 weeks after administration of 1st booster dose |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | AU/mL | 4 weeks after administration of 1st booster dose |
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| Secondary | 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. | 66 patients had Hematologic malignancies | Posted | Median | Inter-Quartile Range | AU/mL | Baseline to 4 weeks after administration of 1st booster dose |
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| Secondary | 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. | 40 patients had Solid Tumor malignancies | Posted | Median | Inter-Quartile Range | AU/mL | Baseline to 4 weeks after administration of 1st booster dose |
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| Secondary | 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. | Of patients with Hematologic malignancies, 55 patients had Lymphoid malignancies and 11 patients had Myeloid malignancies | Posted | Median | Inter-Quartile Range | AU/mL | Baseline to 4 weeks after administration of 1st booster dose |
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| Secondary | 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. | 4 week samples were not collected/processed from 6 patients | Posted | Count of Participants | Participants | 4 weeks after administration of 1st booster dose |
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| Secondary | 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. | 85 patients were seropositive at 4 weeks. | Posted | Count of Participants | Participants | 4 weeks after administration of 1st booster dose |
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| Secondary | 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. | 15 patients had a negative anti-S antibody result at 4 weeks following booster dose administration. | Posted | Count of Participants | Participants | 4 weeks after administration of 1st booster dose |
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| Secondary | 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. | 21 patients demonstrated a negative T-cell response against SARS-CoV-2 at baseline | Posted | Count of Participants | Participants | 4 weeks after administration of 1st booster dose |
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| Secondary | 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. | 25 patients were on Anti-CD20 antibody therapy within 6 months of treatment | Posted | Median | Inter-Quartile Range | AU/mL | Within 6 months prior to treatment to 4 weeks after administration of 1st booster dose |
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| Secondary | 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. | 25 patients were on Anti-CD20 antibody therapy just prior to the study | Posted | Median | Inter-Quartile Range | AU/mL | Baseline to 4 weeks after administration of 1st booster dose |
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| Secondary | 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. | 81 patients were not on Anti-CD20 antibody therapy just prior to the study | Posted | Median | Inter-Quartile Range | AU/mL | Baseline to 4 weeks after administration of 1st booster dose |
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| Secondary | 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 | 81 patients were not on Anti-CD20 antibody therapy within 6 months prior to treatment | Posted | Median | Inter-Quartile Range | AU/mL | Within 6 months prior to treatment to 4 weeks after administration of 1st booster dose |
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| Secondary | 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. | 47 patients completed their 4-6 month follow-up visit following 1st booster dose. All 47 were seropositive at 4 weeks. 36 of these patients had hematologic malignancies and 11 of these patients had solid malignancies. Six patients had received anti-COVID monoclonal antibody therapy as per standard of care between the 4 week and 4-6 months' follow-up period. Nine patients had received a fourth dose of COVID-19 vaccine outside of the context of the study prior to the time of 4-6 months' follow-up. | Posted | Count of Participants | Participants | ~4-6 months after administration of 1st booster dose |
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| Secondary | Percentage of Seronegative Patients Before 2nd Booster Dose | The percentage of patients determined to be seronegative before 2nd booster dose | 18 participants were enrolled into the second booster dose cohort. All 18 patients in this cohort had hematologic malignancies. 15 patients received BNT162b2 as their 2nd booster vaccine and 3 patients received Ad26.CoV2.S as their 2nd booster vaccine. | Posted | Count of Participants | Participants | Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months |
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| Secondary | 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. | 18 participants were enrolled into the second booster dose cohort. All 18 patients in this cohort had hematologic malignancies. 15 patients received BNT162b2 as their 2nd booster vaccine and 3 patients received Ad26.CoV2.S as their 2nd booster vaccine. | Posted | Count of Participants | Participants | Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months |
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| Secondary | 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. | 18 participants were enrolled into the second booster dose cohort. All 18 patients in this cohort had hematologic malignancies. 15 patients received BNT162b2 as their 2nd booster vaccine and 3 patients received Ad26.CoV2.S as their 2nd booster vaccine. | Posted | Count of Participants | Participants | ~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 |
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| Secondary | 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. | 7 patients remained seronegative following administration of Primary vaccination series and 1st booster dose | Posted | Count of Participants | Participants | ~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 |
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| Secondary | 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. | 11 patients were sero-low (IgG <1000 AU/mL) prior to administration of 2nd booster dose | Posted | Count of Participants | Participants | ~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 |
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| Secondary | 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. | 18 participants were enrolled into the 2nd booster dose cohort. All 18 patients in this cohort had hematologic malignancies. 15 patients received BNT162b2 as their 2nd booster vaccine and 3 patients received Ad26.CoV2.S as their 2nd booster vaccine. | Posted | Median | Inter-Quartile Range | AU/mL | Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months |
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| Secondary | 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. | 18 participants were enrolled into the 2nd booster dose cohort. All 18 patients in this cohort had hematologic malignancies. 15 patients received BNT162b2 as their 2nd booster vaccine and 3 patients received Ad26.CoV2.S as their 2nd booster vaccine. | Posted | Median | Inter-Quartile Range | AU/mL | ~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 |
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| Secondary | 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. | 14 patients in Cohort B had evaluable T-cell responses | Posted | Count of Participants | Participants | Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months |
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| Secondary | 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. | 18 participants were enrolled into the 2nd booster dose cohort. All 18 patients in this cohort had hematologic malignancies. 15 patients received BNT162b2 as their 2nd booster vaccine and 3 patients received Ad26.CoV2.S as their 2nd booster vaccine. | Posted | Count of Participants | Participants | ~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 |
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| Secondary | 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. | 18 participants were enrolled into the 2nd booster dose cohort. All 18 patients in this cohort had hematologic malignancies. 15 patients received BNT162b2 as their 2nd booster vaccine and 3 patients received Ad26.CoV2.S as their 2nd booster vaccine. | Posted | Count of Participants | Participants | Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months |
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| Secondary | 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. | 18 participants were enrolled into the 2nd booster dose cohort. All 18 patients in this cohort had hematologic malignancies. 15 patients received BNT162b2 as their 2nd booster vaccine and 3 patients received Ad26.CoV2.S as their 2nd booster vaccine. | Posted | Count of Participants | Participants | ~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 |
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| Secondary | 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. | 18 participants were enrolled into the 2nd booster dose cohort. All 18 patients in this cohort had hematologic malignancies. 15 patients received BNT162b2 as their 2nd booster vaccine and 3 patients received Ad26.CoV2.S as their 2nd booster vaccine. | Posted | Count of Participants | Participants | Prior to administration of 2nd booster dose, a minimum of 14-28 days following 1st booster dose, a median of approximately 5 months |
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| Secondary | 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. | 18 participants were enrolled into the 2nd booster dose cohort. All 18 patients in this cohort had hematologic malignancies. 15 patients received BNT162b2 as their 2nd booster vaccine and 3 patients received Ad26.CoV2.S as their 2nd booster vaccine. | Posted | Count of Participants | Participants | ~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 |
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| Post-Hoc | Anti-spike Antibody Titers for Patients on Bruton's Tyrosine Kinase (BTK) Inhibitors | In order to determine association of specific cancer-directed therapies with the booster effect, median change in anti-S antibody titers were determined for patients on BTK inhibitors prior to the study | 12 patients were on BTK inhibitors prior to the study | Posted | Median | Inter-Quartile Range | AU/mL | Baseline to 4 weeks after administration of 1st booster dose |
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| Post-Hoc | Anti-spike Antibody Titers for Patients Not on Bruton's Tyrosine Kinase (BTK) Inhibitors | In order to determine association of specific cancer-directed therapies with the booster effect, median change in anti-S antibody titers were determined for patients not on BTK inhibitors prior to the study | 94 patients were not on BTK inhibitors prior to the study | Posted | Median | Inter-Quartile Range | AU/mL | Baseline to 4 weeks after administration of 1st booster dose |
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| Post-Hoc | Change in Anti-Spike Antibody Titer by Prior SARS-CoV-2 (COVID-19) Infection Status | Median change in anti-S antibody titer was determined based on previous SARS-CoV-2 (COVID-19) infection status | 9 patients had prior COVID-19 infection, 96 patients did not have prior COVID-19 infection. Prior COVID-19 infection status was unknown for 1 patient. | Posted | Median | Inter-Quartile Range | AU/mL | Baseline to 4 weeks after administration of 1st booster dose |
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| Post-Hoc | Change in Anti-Spike Antibody Titer Based on Type of Booster Administered | Median change in anti-S antibody titer was determined based on the type of booster administered (BNT162b2 or mRNA-1273) | 78 patients were administered the BNT162b2 booster and 28 patients were administered the mRNA-1273 booster | Posted | Median | Inter-Quartile Range | AU/mL | Baseline to 4 weeks after administration of 1st booster dose |
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| Post-Hoc | Change in Anti-Spike Antibody Titer by Age | To investigate the association of age, median change in anti-S antibody titers were determined for the cohort of patients <65 years old as opposed to the cohort of patients >=65 years old. | 106 total patients analyzed. Breakdowns by age categories described with corresponding median antibody titer results. | Posted | Median | Inter-Quartile Range | AU/mL | Baseline to 4 weeks after administration of 1st booster dose |
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| Post-Hoc | Neutralization Against Wildtype (WT) SARS-CoV-2 Variant | Neutralization activity against the WT variant was assessed in the seronegative cohort using a neutralization activity assay. The percentage of patients with positive and negative results are reported. | 35 patients were found be seronegative after the 1st booster dose | Posted | Count of Participants | Participants | 4 weeks after administration of 1st booster dose |
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| Post-Hoc | Neutralization in Seronegative Cohort Against Omicron BA.1 Variant | Neutralization activity against the BA.1.1529 (Omicron BA.1) variant was assessed in the seronegative cohort using a neutralization activity assay. The percentage of patients with positive and negative results are reported. | 35 patients were found be seronegative after the 1st booster dose | Posted | Count of Participants | Participants | 4 weeks after administration of 1st booster dose |
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| Post-Hoc | Percentage of Patients With Breakthrough SARS-CoV-2 Infections | The percentage of patients with breakthrough SARS-CoV-2 infections was determined. | 47 patients completed their 4-6 month follow-up visit following 1st booster dose. All 47 were seropositive at 4 weeks. 36 of these patients had hematologic malignancies and 11 of these patients had solid malignancies. Six patients had received anti-COVID monoclonal antibody therapy as per standard of care between the 4 week and 4-6 months' follow-up period. Nine patients had received a fourth dose of COVID-19 vaccine outside of the context of the study prior to the time of 4-6 months' follow-up. | Posted | Count of Participants | Participants | ~4-6 months after administration of 1st booster dose |
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| Post-Hoc | Percentage of Patients Who Seroreverted | The percentage of patients who seroreverted (i.e., no longer had detectable serum antibody) was determined | 47 patients completed their 4-6 month follow-up visit following 1st booster dose. All 47 were seropositive at 4 weeks. 36 of these patients had hematologic malignancies and 11 of these patients had solid malignancies. Six patients had received anti-COVID monoclonal antibody therapy as per standard of care between the 4 week and 4-6 months' follow-up period. Nine patients had received a fourth dose of COVID-19 vaccine outside of the context of the study prior to the time of 4-6 months' follow-up. | Posted | Count of Participants | Participants | ~4-6 months after administration of 1st booster dose |
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| 0 |
| 106 |
| 1 |
| 106 |
| 63 |
| 106 |
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| Vaccination Site Lymphadenopathy | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Injection Site Reaction | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Fever | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Chills | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment | Verbatim Term: Lower Back Pain |
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| Dizziness | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Non-cardiac Chest Pain | General disorders | CTCAE (Unspecified) | Systematic Assessment | Verbatim Term: Chest Pain |
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Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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