National Vaccine Adverse Event Reporting Survey and Etiology (NVAERS)

March 3, 2022 updated by: Neuroganics LLC

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Northglenn, Colorado, United States, 80265
        • Recruiting
        • Neuroganics LLC
        • Contact:
        • Sub-Investigator:
          • Joseph P Ramos, MD,JD
        • Principal Investigator:
          • Donald C Cooper, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

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:

  1. Pfizer-BioNTech COVID-19 Vaccine
  2. Moderna COVID-19 Vaccine
  3. J&J/Janssen COVID-19 Vaccine
  4. Diphtheria (e.g., DTP, DTaP, Tdap, DT, Td, TT)
  5. Haemophilus influenza type b polysaccharide conjugate vaccines (e.g., Hib)
  6. Hepatitis A (e.g., HAV)
  7. Hepatitis B (e.g., HBV)
  8. Human papillomavirus (e.g., HPV)
  9. Seasonal influenza (e.g., Flu)
  10. Measles (e.g., MMR)
  11. Mumps (e.g., MMR, MR, M)
  12. Meningococcal (e.g., MCV4, MPSV4, MenB-FHbp, MenB-4C)
  13. Pertussis (e.g., DTP, DTaP, Tdap)
  14. Pneumococcal conjugate (e.g., PCV)
  15. Polio (e.g., OPV or IPV)
  16. Rotavirus (e.g., RV)
  17. Rubella (e.g., MMR, MR, R)
  18. Tetanus (e.g., Td)
  19. Varicella (e.g., VAR).

Exclusion Criteria:

  1. Non citizens or permanent residents of the US
  2. Individuals who have not received at least one vaccine dose in the past 3 years.

  3. Individuals whose vaccine was administered more than 60 days before symptoms of the serious adverse event.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaccinated
All individuals who have received a vaccine dose.
Biological: vaccinated
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event
Time Frame: 2 years
Reported adverse event occurring less than 60 days after administration of vaccine.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine manufacturer efficacy
Time Frame: 2 years
Comparison of multiple vaccine manufacturers for adverse events.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuroganics LLC

Collaborators

Ramos Injury Law Firm

Investigators

  • Principal Investigator: Donald C Cooper, Ph.D., Chief Science Officer/ Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2022

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVAERS_1121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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