NCT05765578

Brief Summary

The goal of this observational study is to analyze binding antibody levels in adults in the United States (US) after receiving coronavirus disease 2019 (COVID-19) bivalent boosters (original and omicron BA.4/5) and updated COVID-19 vaccines (XBB.1.5).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,713

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1.3 years

First QC Date

March 9, 2023

Last Update Submit

July 30, 2024

Conditions

COVID-19

Keywords

ImmunogenicityModernamRNA-1273OmicronVaccines

Outcome Measures

Primary Outcomes (6)

  • Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Binding Antibody Titers Against Omicron BA.4/5 at Day 29 Between MMMM Group and PPPP Group

    Day 29

  • GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 91 Between MMMM Group and PPPP Group

    Day 91

  • GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 181 Between MMMM Group and PPPP Group

    Day 181

  • Geometric Mean Ratio (GMR) of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 29 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)

    Day 29

  • GMR of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 91 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)

    Day 91

  • GMR of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 181 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)

    Day 181

Secondary Outcomes (2)

  • GMT Against All Other Omicron Variants and Subvariants Between MMMM Group and PPPP Group

    Day 29, Day 91, and Day 181

  • GMR of GMT Against All Other Omicron Variants and Subvariants Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)

    Day 29, Day 91, and Day 181

Study Arms (4)

Moderna-Only Vaccine/Booster Series (MMMM Group)

Individuals who previously received Moderna COVID-19 vaccines in both primary series and first booster and a bivalent booster against Omicron BA.4/5 as the second booster dose (Moderna mRNA1273.222).

Biological: Moderna COVID-19 VaccineBiological: Moderna mRNA1273.222 Booster

Pfizer-Only Vaccine/Booster Series (PPPP Group)

Individuals who previously received Pfizer COVID-19 vaccines in both primary series and first booster and a bivalent booster against Omicron BA.4/5 as the second booster dose (Pfizer-BNT 162b2 bivalent booster).

Biological: Pfizer COVID-19 Vaccine

Moderna mRNA COVID-19 updated vaccine (XBB.1.5): Comparison Group

Individuals who received Moderna 2023 updated COVID-19 vaccine (XBB.1.5).

Biological: Moderna 2023 Updated COVID-19 vaccine (XBB.1.5)

Pfizer-BioNTech COVID-19 updated vaccine (XBB.1.5): Reference Group

Individuals who received Pfizer 2023 updated COVID-19 vaccine (XBB.1.5).

Biological: Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)

Interventions

Moderna COVID-19 VaccineBIOLOGICAL

Sterile liquid for injection. Intervention not administered through this study.

Moderna-Only Vaccine/Booster Series (MMMM Group)
Moderna mRNA1273.222 BoosterBIOLOGICAL

Sterile liquid for injection. Intervention not administered through this study.

Moderna-Only Vaccine/Booster Series (MMMM Group)
Pfizer COVID-19 VaccineBIOLOGICAL

Sterile liquid for injection. Intervention not administered through this study.

Pfizer-Only Vaccine/Booster Series (PPPP Group)
Moderna 2023 Updated COVID-19 vaccine (XBB.1.5)BIOLOGICAL

Sterile liquid for injection. Intervention not administered through this study.

Moderna mRNA COVID-19 updated vaccine (XBB.1.5): Comparison Group
Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)BIOLOGICAL

Sterile liquid for injection. Intervention not administered through this study.

Pfizer-BioNTech COVID-19 updated vaccine (XBB.1.5): Reference Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who have received the COVID-19 vaccine(s) and booster.

You may qualify if:

  • Lives in the continental United States (US).
  • Speaks, reads, and understands English.
  • Is willing and able to submit vaccination card photo(s) or vaccination records.
  • Is willing and able to self-collect capillary blood during the study period via an at-home whole-blood collection device.
  • Is fully vaccinated against COVID-19 per protocol specified criteria.

You may not qualify if:

  • Has been diagnosed with significant cognitive impairment or dementia.
  • Is pregnant or planning to become pregnant during the study period.
  • Primary mailing address is a Post Office box, Army Post Office, Fleet Post Office, or Diplomatic Post Office address.
  • Currently lives in a US military base located overseas, or US territories (Puerto Rico, US Virgin Islands, Guam, Northern Mariana Island, or American Samoa).
  • Is currently participating in a COVID-19 vaccine clinical trial.
  • Is currently receiving chemotherapy or has received chemotherapy in the past 6 months.
  • Is currently taking steroids, such as prednisone, for any condition.
  • Has been diagnosed with and taking immunosuppressants for rheumatoid arthritis, lupus or multiple sclerosis.
  • Has received an organ transplant.
  • Is currently undergoing dialysis of any kind (for example, hemodialysis or chronic ambulatory dialysis) for kidney disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Science37

Culver City, California, 90230, United States

Location

Biospecimen

Retention: NONE RETAINED

Serum from blood samples will be used for binding antibody testing.

MeSH Terms

Conditions

COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA VaccinesNucleic Acid-Based VaccinesVaccines, SyntheticRecombinant ProteinsProteinsAmino Acids, Peptides, and ProteinsVaccinesBiological ProductsComplex MixturesCOVID-19 VaccinesViral VaccinesAntigensBiological Factors

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 13, 2023

Study Start

March 8, 2023

Primary Completion

June 17, 2024

Study Completion

June 17, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations

US(1)