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The purpose of this study is to evaluate the safety and efficacy of mRNA COVID-19 vaccines in:
• People with prior COVID-19 (SARS-CoV-2 infection) who were in the ACTIV-2/A5401 study.
And
• People who have never had COVID-19 (SARS-CoV-2 infection).
A5404 is a phase IV, open-label study. The objective of A5404 is to evaluate how prior investigational therapy for COVID-19 versus comparator (placebo or active comparator) affects vaccine response. The safety of mRNA COVID-19 vaccines is also explored.
Eligible A5404 participants include: Participants of ACTIV-2/A5401 at selected sites who received an investigational therapy or its comparator; and persons without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-A5401 participants). In line with our protocol, for outcome measures related to neutralizing antibodies and adverse events, we further break down the ACTIV-2/A5401 participants into two exposure groups: those who received an active therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV, BMS 096414+BMS 986413 subcutaneous) and those who received Camostat Oral or Placebo.
Participants of ACTIV-2/A5401 received study-provided standard dosing of the Moderna mRNA-1273 vaccine, or a community-provided mRNA-based COVID-19 vaccine (e.g., Moderna or Pfizer). Participants in ACTIV-2/A5401 received their mRNA-based COVID-19 vaccine 60-240 days after receiving their last dose of a select ACTIV-2/A5401 investigational therapy, or its comparator. Participants without prior COVID-19 received study-provided standard dosing of the Moderna mRNA-1273 vaccine.
The study closed early to accrual on February 25, 2022 due to slow enrollment. Clarification Memo #1 (dated January 11, 2023) reflects decisions to discontinue follow up at study Day 365 instead of following participants to Day 730 after the first dose of vaccine and to reallocate some secondary outcome measures to exploratory outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort: ACTIV-2/A5401 | Experimental | Participants of the ACTIV-2/A5401 randomized trial who received a select investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV, BMS 096414+BMS 986413 subcutaneous, Camostat Oral) or its corresponding comparator (Placebo). |
|
| Cohort: COVID-19 Naïve | Experimental | Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study-provided Moderna mRNA-1273 COVID-19 vaccine | Biological | Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing Antibody (NAb) Level | NAb level was measured by using both 50% neutralizing dilution titers (ND50) and 80% neutralizing titers (ND80). A higher NAb level corresponds to a stronger immune response. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000. We carry forward the Day 56 NAb measurement if the Day 140 measurement is not reported. | Measured 140 days after the first dose of the vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine | Relative change is defined as the ratio of post-vaccine NAb level/pre-vaccine NAb level. A ratio greater than one indicates an increase of NAb response. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000. |
| Measure | Description | Time Frame |
|---|---|---|
| CD4+ T Cell Response to SARS-CoV-2 Spike Protein | Team re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory. | At the visit 56 days after the first dose of the vaccine |
| CD8+ T Cell Response to SARS-CoV-2 Spike Protein |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Smith, MD, MAS | UCSD Antiviral Research Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA CARE Center CRS | Los Angeles | California | 90035-4709 | United States | ||
| UCSD Antiviral Research Center CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41700320 | Derived | Smith D, Weir IR, Ramirez S, Coelho CH, Manne-Goehler J, Aziz M, Benson CA, Wu X, Hyer R, Dhillon PK, Faraji F, Bloom N, Myers A, Ramezani-Rad P, Lopez PG, Parikh UM, Heaps AL, Javan AC, Bender Ignacio RA, Li JZ, Greninger AL, Daar ES, Wohl DA, Crotty S, Sieg SF, Chew KW. Impact of COVID-19 Monoclonal Antibody Therapy on Subsequent Vaccine-elicited SARS-CoV-2 Immune Responses. J Infect Dis. 2026 Feb 17:jiag091. doi: 10.1093/infdis/jiag091. Online ahead of print. |
| Label | URL |
|---|---|
| The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. | View source |
Not provided
Individual participant data that underlie results in the publication, after deidentification.
Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.
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For participant flow, ACTIV-2/A5401 participants regardless of the exposure (select active therapy or Camostat or placebo) are considered as one cohort, and COVID-naïve participants are considered as the second cohort.
Participants were enrolled from July 9, 2021 to December 16, 2021 at six clinical research sites in the U.S.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort: ACTIV-2/A5401 | Participants of the ACTIV-2/A5401 randomized trial who received a select investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV, BMS 096414+BMS 986413 subcutaneous, Camostat Oral) or its corresponding comparator (Placebo). Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series. Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Protocol Version 3.0 | Nov 30, 2022 |
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| Community-provided Moderna mRNA-1273 COVID-19 Vaccine | Biological | Participants received a two-dose series. |
|
| Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine | Biological | Participants received a two-dose series. |
|
| Measured before the first dose of the vaccine, and 56 days after the first dose of the vaccine |
| Proportion of Participants With New Grade 3 or Higher AE, or SAE, or AE Leading to Change or Discontinuation in Vaccine Receipt | An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. A serious adverse event (SAE) is defined as any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). | From first dose of the vaccine through 140 days after the first dose of the vaccine |
| Number of Participants With Grade 1 or Higher Allergic Reaction | Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). | From first dose of the vaccine through 56 days after the first dose of the vaccine |
| Proportion of Participants With Grade 2 or Higher Injection Site Reaction | Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). | From first dose of the vaccine through 56 days after the first dose of the vaccine |
| Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine by Received Vaccine | Relative change is defined as the ratio of post-vaccine NAb level/pre-vaccine NAb level by received vaccine, i.e., Moderna mRNA-1273 versus Pfizer-BioNTech BNT162b2. A ratio greater than one indicates an increase of NAb response for those on Moderna mRNA-1273 versus Pfizer-BioNTech BNT162b2. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000. | Measured before the first dose of the vaccine, and 56 days after the first dose of the vaccine |
Team re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory. |
| At the visit 56 days after the first dose of the vaccine |
| IgG Serologic Response to SARS-CoV-2 Spike Protein at Receptor Binding Domain (RBD) and N Terminal Domain (NTD) and Matrix (M) Protein. | Team re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory. | At the visit 56 days after the first dose of the vaccine |
| Flow Cytometry of PBMC for Markers of Exhaustion on B and T Cells | Team re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory. | At study entry/Day 0 and 56 days after the first vaccine dose. |
| IgM Serologic Response to SARS-CoV-2 Spike Protein at Receptor Binding Domain (RBD) and N Terminal Domain (NTD) and Matrix (M) Protein. | Team re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory. | At the visit 56 days after the first dose of the vaccine |
| San Diego |
| California |
| 92103 |
| United States |
| Rush University CRS (Site ID: 2702) | Chicago | Illinois | 60612 | United States |
| Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS | Boston | Massachusetts | 02115 | United States |
| Chapel Hill CRS (Site ID: 3201) | Chapel Hill | North Carolina | 27599 | United States |
| University of Washington AIDS CRS | Seattle | Washington | 98104-9929 | United States |
| Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010 | View source |
| FG001 | Cohort: COVID-19 Naïve | Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants). Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). |
| Completed Two-dose Vaccine Series |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All A5404 trial participants. For baseline characteristics, ACTIV-2/A5401 participants regardless of the exposure (select active therapy or Camostat or placebo) are considered as one cohort, and COVID-naïve participants are considered as the second cohort.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort: ACTIV-2/A5401 | Participants of the ACTIV-2/A5401 randomized trial who received a select investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV, BMS 096414+BMS 986413 subcutaneous, Camostat Oral) or its corresponding comparator (Placebo). Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series. Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series. |
| BG001 | Cohort: COVID-19 Naïve | Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants). Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index | 8 participants in the ACTV-2/A5401 cohort did not have BMI information collected. | Median | Inter-Quartile Range | kg/m^2 |
|
| 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 | Neutralizing Antibody (NAb) Level | NAb level was measured by using both 50% neutralizing dilution titers (ND50) and 80% neutralizing titers (ND80). A higher NAb level corresponds to a stronger immune response. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000. We carry forward the Day 56 NAb measurement if the Day 140 measurement is not reported. | The analysis population includes all participants who received at least the first dose of an mRNA-based COVID-19 vaccine and who provided a specimen sample at either Day 56 or Day 140 (One COVID-19 naïve participant who was not able to provide specimen at any study visits was excluded). | Posted | Geometric Mean | 95% Confidence Interval | titer | Measured 140 days after the first dose of the vaccine |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine | Relative change is defined as the ratio of post-vaccine NAb level/pre-vaccine NAb level. A ratio greater than one indicates an increase of NAb response. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000. | The analysis population includes all participants who received at least the first dose of an mRNA-based COVID-19 vaccine and who provided a specimen sample at both Day 0 and Day 56. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Measured before the first dose of the vaccine, and 56 days after the first dose of the vaccine |
| |||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With New Grade 3 or Higher AE, or SAE, or AE Leading to Change or Discontinuation in Vaccine Receipt | An adverse event (AE) is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. A serious adverse event (SAE) is defined as any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). | The analysis population includes all participants who received at least the first dose of an mRNA-based COVID-19 vaccine. | Posted | Number | 95% Confidence Interval | proportion of participants | From first dose of the vaccine through 140 days after the first dose of the vaccine |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 1 or Higher Allergic Reaction | Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). | The analysis population includes all participants who received at least the first dose of an mRNA-based COVID-19 vaccine. | Posted | Count of Participants | Participants | From first dose of the vaccine through 56 days after the first dose of the vaccine |
| ||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Grade 2 or Higher Injection Site Reaction | Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1). | The analysis population includes all participants who received at least the first dose of an mRNA-based COVID-19 vaccine. | Posted | Number | 95% Confidence Interval | proportion of participants | From first dose of the vaccine through 56 days after the first dose of the vaccine |
| |||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine by Received Vaccine | Relative change is defined as the ratio of post-vaccine NAb level/pre-vaccine NAb level by received vaccine, i.e., Moderna mRNA-1273 versus Pfizer-BioNTech BNT162b2. A ratio greater than one indicates an increase of NAb response for those on Moderna mRNA-1273 versus Pfizer-BioNTech BNT162b2. For ND50 values less than lower limit of quantification (LLQ), we impute with 10 (which is ½ LLQ of 20). For ND50 values exceeding the upper limit of quantification (ULQ), we impute with 20,000 (a value suggested by the immunology lab, which is 2 times the ULQ of 10,000). For ND80, we impute similarly with 10 and 20,000. | The analysis population includes all participants who received at least the first dose of an mRNA-based COVID-19 vaccine and who provided a specimen sample at both Day 0 and Day 56. None of the participants who received Pfizer-BioNTech BNT162b2 COVID-19 vaccine provided a specimen sample at both Day 0 and Day 56. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Measured before the first dose of the vaccine, and 56 days after the first dose of the vaccine |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | CD4+ T Cell Response to SARS-CoV-2 Spike Protein | Team re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory. | Not Posted | At the visit 56 days after the first dose of the vaccine | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | CD8+ T Cell Response to SARS-CoV-2 Spike Protein | Team re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory. | Not Posted | At the visit 56 days after the first dose of the vaccine | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | IgG Serologic Response to SARS-CoV-2 Spike Protein at Receptor Binding Domain (RBD) and N Terminal Domain (NTD) and Matrix (M) Protein. | Team re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory. | Not Posted | At the visit 56 days after the first dose of the vaccine | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Flow Cytometry of PBMC for Markers of Exhaustion on B and T Cells | Team re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory. | Not Posted | At study entry/Day 0 and 56 days after the first vaccine dose. | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | IgM Serologic Response to SARS-CoV-2 Spike Protein at Receptor Binding Domain (RBD) and N Terminal Domain (NTD) and Matrix (M) Protein. | Team re-prioritized the analysis of secondary objectives due to limited accrual and moved this outcome to exploratory. | Not Posted | At the visit 56 days after the first dose of the vaccine | Participants |
From study entry through 1 year after receiving the first dose of vaccine.
Any unfavorable/unintended sign/lab finding/symptom/dx during the study REGARDLESS of attribution inc. any occurrence new in onset/aggravated in severity/frequency from baseline. SAE/EAEs should also be entered into the DAIDS Adverse Experience Reporting System. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (V2.1).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACTIV-2/A5401 Investigational Therapy Except Camostat | Participants of ACTIV-2/A5401 who received an investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV or BMS 096414+BMS 986413 subcutaneous). Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series. Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG001 | ACTIV-2/A5401 Placebo or Camostat | Participants of ACTIV-2/A5401 who received placebo or Camostat. Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series. Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series. | 0 | 10 | 0 | 10 | 8 | 10 |
| EG002 | COVID-19 Naïve | Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants) Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). | 0 | 25 | 0 | 25 | 7 | 25 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rhinitis perennial | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Alopecia areata | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
The study closed early to accrual due to difficulty enrolling participants. Therefore the sample size is very small and precision is limited.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ACTG Clinicaltrials.gov Coordinator | ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company | (301) 628-3348 | ACTGCT.gov@fstrf.org |
| Feb 3, 2023 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Clarification Memo | Jan 11, 2023 | Feb 16, 2023 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Letter of Amendment #1 | Jul 12, 2021 | Feb 16, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 27, 2023 | Jan 31, 2023 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 30, 2022 | Feb 22, 2023 | ICF_004.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
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| Gender Queer |
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| Male |
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| 80% neutralizing dilution titers (ND80) |
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| ACTIV-2/A5401 Placebo or Camostat |
Participants of ACTIV-2/A5401 who received placebo or Camostat. Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series. Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series. |
| OG002 | COVID-19 Naïve | Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants) Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). |
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| OG001 | ACTIV-2/A5401 Placebo or Camostat | Participants of ACTIV-2/A5401 who received placebo or Camostat. Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). Community-provided Moderna mRNA-1273 COVID-19 Vaccine: Participants received a two-dose series. Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series. |
| OG002 | COVID-19 Naïve | Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants) Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). |
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| OG002 | COVID-19 Naïve | Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants) Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). |
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| OG002 | COVID-19 Naïve | Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants) Study-provided Moderna mRNA-1273 COVID-19 vaccine: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28). |
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| OG001 | Participants Who Received Community-provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine | Participants from the ACTIV-2/A5404 cohort. Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine: Participants received a two-dose series. |
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