NVAERS: National Vaccine Adverse Event Reporting Survey and Etiology

Sponsor
Neuroganics LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05095844
Collaborator
Ramos Injury Law Firm (Other)
100,000
1
24.6
4069.2

Study Details

Study Description

Brief 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.

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

Study Type:
Observational
Anticipated Enrollment :
100000 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
National Vaccine Adverse Event Reporting Survey to Determine the Etiology of Vaccine-Induced Injury
Anticipated Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Adverse Event [2 years]

    Reported adverse event occurring less than 60 days after administration of vaccine.

Secondary Outcome Measures

  1. Vaccine manufacturer efficacy [2 years]

    Comparison of multiple vaccine manufacturers for adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neuroganics LLC Northglenn Colorado United States 80265

Sponsors and Collaborators

  • Neuroganics LLC
  • Ramos Injury Law Firm

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Neuroganics LLC
ClinicalTrials.gov Identifier:
NCT05095844
Other Study ID Numbers:
  • NVAERS_1121
First Posted:
Oct 27, 2021
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Neuroganics LLC
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2022