COVID-19NVAERSNCT05095844
National Vaccine Adverse Event Reporting Survey and Etiology
An observational study of COVID-19 and Vaccine Adverse Reaction, run by Neuroganics LLC at 1 site in United States.
Trial summary
If your serious vaccine-induced adverse event has been entered in the CDC Vaccine Adverse Event Reporting System (VAERS) we are interested in enrolling you for this study in order to log your symptoms. Read more about this study
- Who is it for?
- Ages 5 to 99 years
- Conditions the study is for
- COVID-19, Vaccine Adverse Reaction, Vaccine Reaction
- What is being tested?
- vaccinated
- Type of treatment
- Vaccines
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: US citizens or permanent residents and their dependents who have been vaccinated in the past 3 years and experienced a documented adverse event within 60 days of vaccination
Who may be able to join
- Individuals who have received at least one vaccine dose of ANY of the following vaccines (below) and experienced adverse reaction within 60 days of vaccine administration:
- Pfizer-BioNTech COVID-19 Vaccine
- Moderna COVID-19 Vaccine
- J\&J/Janssen COVID-19 Vaccine
- Diphtheria (e.g., DTP, DTaP, Tdap, DT, Td, TT)
- Haemophilus influenza type b polysaccharide conjugate vaccines (e.g., Hib)
Show all 20Show fewer
- Hepatitis A (e.g., HAV)
- Hepatitis B (e.g., HBV)
- Human papillomavirus (e.g., HPV)
- Seasonal influenza (e.g., Flu)
- Measles (e.g., MMR)
- Mumps (e.g., MMR, MR, M)
- Meningococcal (e.g., MCV4, MPSV4, MenB-FHbp, MenB-4C)
- Pertussis (e.g., DTP, DTaP, Tdap)
- Pneumococcal conjugate (e.g., PCV)
- Polio (e.g., OPV or IPV)
- Rotavirus (e.g., RV)
- Rubella (e.g., MMR, MR, R)
- Tetanus (e.g., Td)
- Varicella (e.g., VAR).
Who cannot join
- Non citizens or permanent residents of the US
- Individuals who have not received at least one vaccine dose in the past 3 years.
- Individuals whose vaccine was administered more than 60 days before symptoms of the serious adverse event.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Neuroganics LLC
Northglenn, Colorado, 80265
Donald C Cooper, Ph.D., vaccinestudy@protonmail.com
Joseph P Ramos, MD,JD
About this study
Official title: National Vaccine Adverse Event Reporting Survey to Determine the Etiology of Vaccine-Induced Injury
If your serious vaccine-induced adverse event has been entered in the CDC Vaccine Adverse Event Reporting System (VAERS) we are interested in enrolling you for this study in order to log your symptoms.
The primary goal of this study is to create a national database and gather vaccine-associated serious adverse events/injury data from newly vaccinated individuals in the US in order to identify the possible underlying causal relationships and plausible underlying biological mechanisms. The project aims to identify the genetic determinants of vaccine-induced adverse response by studying host genetics. We plan to use whole genome sequencing to identify single nucleotide polymorphisms associated with cardiovascular, neurological, gastrointestinal, musculoskeletal and immunological symptoms induced by vaccine administration.
Read more
The secondary goal is to establish criteria that enable classification of vaccine-induced adverse events/injuries compare data from our database with the official Vaccine Injury Table National Vaccine Injury Compensation Program on or after March 21, 2017.
The tertiary goal is to establish a database to gather detailed long-term adverse reaction data from subjects enrolled in FDA Emergency Use Authorized vaccine clinical trials.
Read the detailed description
Vaccinations are typically administered to healthy persons and often are mandated by states or federal authorities as a condition for school attendance or military service in order to prevent the spread of infectious diseases. Because vaccines are either mandated or recommended for vulnerable groups, such as children or the elderly, vaccines are often held to a higher standard of safety by the FDA than other medical products.
Due to the vast numbers of vaccine doses administered in the US there is a need to gather quality information on serious vaccine-associated adverse events leading to serious injury. Vaccine-induced adverse events are typically reported in the CDC Vaccine Adverse Event Reporting System (VAERS) database, which contains information on unverified reports of adverse events (illnesses, health problems and/or symptoms) following immunization with US-licensed vaccines. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov.
The primary goal for this observational study is to establish an independent national database to classify vaccine-associated serious adverse events/injury data from vaccinated individuals. The plan is to gather survey data and health information from newly vaccinated individuals who have experienced serious adverse effects in order to help understand the possible causal relationships and plausible biological mechanisms underlying serious adverse events/injuries. The project aims to identify the genetic determinants of vaccine-induced adverse response by studying host genetics. We plan to use Nebula Genomics platform for whole genome sequencing to identify single nucleotide polymorphisms associated with cardiovascular, neurological, gastrointestinal, musculoskeletal and immunological symptoms induced by vaccine administration.
The secondary goal is to gather medical history and survey data from recently vaccinated individuals in order to develop a vaccine-injury risk assessment tool which may be used to predict individual vulnerability to vaccine adverse events/injury.
The tertiary goal is to establish a database to gather detailed long-term adverse reaction data from subjects enrolled in FDA Emergency Use Authorized vaccine clinical trials.
- Conditions
- COVID-19, Vaccine Adverse Reaction, Vaccine Reaction, Vaccine or Biological Substance, Unspecified Causing Adverse Effects in Therapeutic Use, Corona Virus Infection, Blood Clot
- Being tested
- vaccinated
- Keywords
- COVID-19, coronavirus, vaccine, influenza, injury, compensation, Pfizer, Moderna, BioNTech, Johnson and Johnson, Comirnaty, Flu Vaccination, Quadrivalent, Flucelvax, Flu Shots, Afluria Quadrivalent (Seqirus), Fluarix, FluLaval, Fluzone, Walgreens
- Medical subject headings
- COVID-19, Coronavirus Infections, Thrombosis, Thrombocytopenia, Neuritis, Vasculitis, Influenza, Human, Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccinatedBiological
Pfizer-BioNTech COVID-19 Vaccine, Moderna or J\&J/Janssen COVID-19 Vaccine, Diphtheria (e.g., DTP, DTaP, Tdap, DT, Td, TT) Haemophilus influenza type b polysaccharide conjugate vaccines (e.g., Hib) Hepatitis A (e.g., HAV) Hepatitis B (e.g., HBV) Human papillomavirus (e.g., HPV) Seasonal influenza (e.g., Flu) Measles (e.g., MMR) Mumps (e.g., MMR, MR, M) Meningococcal (e.g., MCV4, MPSV4, MenB-FHbp, MenB-4C) Pertussis (e.g., DTP, DTaP, Tdap) Pneumococcal conjugate (e.g., PCV) Polio (e.g., OPV or IPV) Rotavirus (e.g., RV) Rubella (e.g., MMR, MR, R) Tetanus (e.g., Td) Varicella (e.g., VAR)
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated | All individuals who have received a vaccine dose. Receives: Biological: vaccinated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Reported adverse event occurring less than 60 days after administration of vaccine.
Measured: 2 years
Secondary outcomes (1)
Vaccine manufacturer efficacy
Comparison of multiple vaccine manufacturers for adverse events.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start15 Mar 2022 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuroganics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ramos Injury Law Firm
- Responsible party
- Sponsor
- Investigators
- Donald C Cooper, Ph.D., Principal investigator, Chief Science Officer/ Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095844
- Sponsor's protocol ID
- NVAERS_1121
- Acronym
- NVAERS
- Status last verified
- Mar 2022
- First submitted
- 13 Oct 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Vaccine Adverse Event Reporting Survey to Determine the Etiology of Vaccine-Induced Injury
- ClinicalTrials.gov ID
- NCT05095844
- Acronym / sponsor ID
- NVAERS / NVAERS_1121
- Conditions
- COVID-19, Vaccine Adverse Reaction, Vaccine Reaction, Vaccine or Biological Substance, Unspecified Causing Adverse Effects in Therapeutic Use, Corona Virus Infection, Blood Clot
- Keywords
- COVID-19, coronavirus, vaccine, influenza, injury, compensation, Pfizer, Moderna
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Neuroganics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ramos Injury Law Firm
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
If your serious vaccine-induced adverse event has been entered in the CDC Vaccine Adverse Event Reporting System (VAERS) we are interested in enrolling you for this study in order to log your symptoms.
The primary goal of this study is to create a national database and gather vaccine-associated serious adverse events/injury data from newly vaccinated individuals in the US in order to identify the possible underlying causal relationships and plausible underlying biological mechanisms. The project aims to identify the genetic determinants of vaccine-induced adverse response by studying host genetics. We plan to use whole genome sequencing to identify single nucleotide polymorphisms associated with cardiovascular, neurological, gastrointestinal, musculoskeletal and immunological symptoms induced by vaccine administration.
The secondary goal is to establish criteria that enable classification of vaccine-induced adverse events/injuries compare data from our database with the official Vaccine Injury Table National Vaccine Injury Compensation Program on or after March 21, 2017.
The tertiary goal is to establish a database to gather detailed long-term adverse reaction data from subjects enrolled in FDA Emergency Use Authorized vaccine clinical trials.
Detailed description
Vaccinations are typically administered to healthy persons and often are mandated by states or federal authorities as a condition for school attendance or military service in order to prevent the spread of infectious diseases. Because vaccines are either mandated or recommended for vulnerable groups, such as children or the elderly, vaccines are often held to a higher standard of safety by the FDA than other medical products.
Due to the vast numbers of vaccine doses administered in the US there is a need to gather quality information on serious vaccine-associated adverse events leading to serious injury. Vaccine-induced adverse events are typically reported in the CDC Vaccine Adverse Event Reporting System (VAERS) database, which contains information on unverified reports of adverse events (illnesses, health problems and/or symptoms) following immunization with US-licensed vaccines. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov.
The primary goal for this observational study is to establish an independent national database to classify vaccine-associated serious adverse events/injury data from vaccinated individuals. The plan is to gather survey data and health information from newly vaccinated individuals who have experienced serious adverse effects in order to help understand the possible causal relationships and plausible biological mechanisms underlying serious adverse events/injuries. The project aims to identify the genetic determinants of vaccine-induced adverse response by studying host genetics. We plan to use Nebula Genomics platform for whole genome sequencing to identify single nucleotide polymorphisms associated with cardiovascular, neurological, gastrointestinal, musculoskeletal and immunological symptoms induced by vaccine administration.
The secondary goal is to gather medical history and survey data from recently vaccinated individuals in order to develop a vaccine-injury risk assessment tool which may be used to predict individual vulnerability to vaccine adverse events/injury.
The tertiary goal is to establish a database to gather detailed long-term adverse reaction data from subjects enrolled in FDA Emergency Use Authorized vaccine clinical trials.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccinated | – | Biological: vaccinatedAll individuals who have received a vaccine dose. |
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- US citizens or permanent residents and their dependents who have been vaccinated in the past 3 years and experienced a documented adverse event within 60 days of vaccination
Key inclusion criteria (20 listed)
- Individuals who have received at least one vaccine dose of ANY of the following vaccines (below) and experienced adverse reaction within 60 days of vaccine administration:
- Pfizer-BioNTech COVID-19 Vaccine
- Moderna COVID-19 Vaccine
- J\&J/Janssen COVID-19 Vaccine
- Diphtheria (e.g., DTP, DTaP, Tdap, DT, Td, TT)
Key exclusion criteria (4 listed)
- Non citizens or permanent residents of the US
- Individuals who have not received at least one vaccine dose in the past 3 years.
- Individuals whose vaccine was administered more than 60 days before symptoms of the serious adverse event.
- -
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 |
|---|---|---|
| vaccinatedPfizer-BioNTech COVID-19 Vaccine, Moderna or J\&J/Janssen COVID-19 Vaccine, Diphtheria (e.g., DTP, DTaP, Tdap, DT, Td, TT) Haemophilus influenza type b polysaccharide conjugate vaccines (e.g., Hib) Hepatitis A (e.g., HAV) Hepatitis B (e.g., HBV) Human papillomavirus (e.g., HPV) Seasonal influenza (e.g., Flu) Measles (e.g., MMR) Mumps (e.g., MMR, MR, M) Meningococcal (e.g., MCV4, MPSV4, MenB-FHbp, MenB-4C) Pertussis (e.g., DTP, DTaP, Tdap) Pneumococcal conjugate (e.g., PCV) Polio (e.g., OPV or IPV) Rotavirus (e.g., RV) Rubella (e.g., MMR, MR, R) Tetanus (e.g., Td) Varicella (e.g., VAR) | Biological | Vaccinated |
Primary outcome
Adverse Event
Time frame: 2 years
Reported adverse event occurring less than 60 days after administration of vaccine.
1 secondary outcome
Vaccine manufacturer efficacy
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Donald C Cooper, Ph.D. principal investigator
Chief Science Officer/ Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Vaccine Adverse Reaction, run by Neuroganics LLC 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 20 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: status not confirmed, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donald C Cooper, Ph.D. (303.733.6353, vaccinestudy@protonmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.