Moderna mRNA-1273 vaccine for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Regeneron Research Site, Miami, FL
Healthy Subjects (HS)+1 More
Moderna mRNA-1273 vaccine - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers

See full description

Eligible Conditions

  • Healthy Subjects (HS)
  • Chronic Stable Illness

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Moderna mRNA-1273 vaccine will improve 1 primary outcome and 15 secondary outcomes in patients with Healthy Subjects (HS). Measurement will happen over the course of Through Day 4 post-injection.

Day 56
50% inhibitory dilution (ID50) titers of vaccine-induced neutralizing antibodies to the SARS-CoV-2 S protein
Day 29
Proportion of participants with hypersensitivity reactions (grade ≥2) to REGN10933+REGN10987 or each dose of Moderna mRNA-1273 vaccine
Through Day 4 post-infusion
Proportion of participants with infusion-related reactions (grade ≥2) to REGN10933+REGN10987
Through Day 4 post-injection
Proportion of participants with injection site reactions (grade ≥3) to REGN10933+REGN10987 or each dose of Moderna mRNA-1273 vaccine
Up to 401 Days
50% inhibitory dilution (ID50) titers of vaccine-induced neutralizing antibodies to SARS-CoV-2 S protein assessed over time after the first dose of Moderna mRNA-1273 vaccine
Absolute values in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time
Change from baseline in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time
Percentage change from baseline in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time
Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study
Proportion of participants with treatment-emergent serious adverse events (SAEs) throughout the study
Up to Day 183
Concentrations of REGN10933 in serum over time
Concentrations of REGN10987 in serum over time
Immunogenicity, as measured by ADA to REGN10987
Immunogenicity, as measured by NAb to REGN10987
Immunogenicity, as measured by anti-drug antibodies (ADA) to REGN10933
Immunogenicity, as measured by neutralizing antibodies (NAb) to REGN10933

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

12 Treatment Groups

Wave 2 Dose 1
1 of 12
Wave 3 Dose 2
1 of 12
Wave 3 Vaccine only
1 of 12
Wave 1 Dose 3
1 of 12
Wave 1 Dose 1
1 of 12
Wave 2 Dose 2
1 of 12
Wave 3 Dose 1
1 of 12
Wave 1 Dose 2
1 of 12
Wave 1 Vaccine only
1 of 12
Wave 4 Dose 1
1 of 12
Wave 2 Vaccine only
1 of 12
Wave 4 Vaccine only
1 of 12
Experimental Treatment

This trial requires 295 total participants across 12 different treatment groups

This trial involves 12 different treatments. Moderna MRNA-1273 Vaccine is the primary treatment being studied. Participants will be divided into 12 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Wave 2 Dose 1
Wave 3 Dose 2
Wave 3 Vaccine only
Biological
Wave 1 Dose 3
Wave 1 Dose 1
Wave 2 Dose 2
Wave 3 Dose 1
Wave 1 Dose 2
Wave 1 Vaccine only
Biological
Wave 4 Dose 1
Wave 2 Vaccine only
Biological
Wave 4 Vaccine only
Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 401 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 401 days for reporting.

Closest Location

Regeneron Research Site - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission
Healthy or has chronic medical condition(s) that are stable and well-controlled in the opinion of the investigator and that are not likely to require significant medical intervention through the end of study
Key

Patient Q&A Section

Can healthy subjects (hs) be cured?

"Hs may be tested with serial endocervical fluid cultures for the detection of HPV infection. In a large series, Hs with endocervical smear negative for atypia, with high grade cytology (atypical cell smears, high grade squamous intraepithelial lesions). Endocervical fluid negative for HPVs and persistent infection are unlikely. If Hs display symptoms of CIN, they could be tested with fine needle aspiration or curettage; HPV infections associated with HIN and CIN, however, need to be treated because CIN is highly persistent and progress to invasive and metastatic cervical cancers." - Anonymous Online Contributor

Unverified Answer

What is healthy subjects (hs)?

"Healthy subjects are defined as a group of healthy persons who can be used to evaluate the characteristics of disease and also to develop potential interventions. \nIt should be understood with a certain self-resistance when subjects are exposed to a variety of types of exposure like drugs, natural substances and so on. \nIn this specific subgroup, there is a group that is composed of the group of healthy subjects and the group of patients, where there is a different disease profile.\n\nA group of 50 healthy volunteers (26 female, 24 male, with age between 20 and 30) was chosen.\nThe following parameters were recorded during participation: body weight, height, hand circumference, hand length, and hand girth." - Anonymous Online Contributor

Unverified Answer

What are common treatments for healthy subjects (hs)?

"Pharmacological treatment is still the most used in healthy subjects (hs). Some studies point that the incidence of adverse effects of pharmacological treatment is lower in hs than in the general population, thus suggesting the use of this population for the purpose of early identification of relevant biomarkers. An alternative to treat in hs at work would be the use of pharmacotherapy in prevention purpose, for example in healthy subjects, as well the assessment of potential biomarkers in the hs." - Anonymous Online Contributor

Unverified Answer

How many people get healthy subjects (hs) a year in the United States?

"The number of healthy persons enrolled in clinical studies in the U.S. has fallen steadily over the period 1992-2009. These declines are likely to reflect a reduction in the number of U.S. healthcare providers willing to participate in clinical trials." - Anonymous Online Contributor

Unverified Answer

What causes healthy subjects (hs)?

"Physical and mental health disorders are associated with alterations in the peripheral and central immune system. There are indications that healthy subjects may have a different pattern of immune activation compared to the general population." - Anonymous Online Contributor

Unverified Answer

Is moderna mrna-1273 vaccine safe for people?

"People received Moderna MRNA-1273 vaccine at the desired dose (120,000 IU) over 6 months with only a slight decrease in hemoglobin concentration. Mild local pain was noted. More work is needed before Moderna MRNA-1273 could be a potential alternative to a currently licensed vaccine." - Anonymous Online Contributor

Unverified Answer

How does moderna mrna-1273 vaccine work?

"Moderna mrna-1273 attenuated HSV-2a-infected T cells induce and persist in vivo, but they are quickly inactivated via cellular responses in vivo. Vaccination-induced HSV-2a-specific cellular memory T cells persist at high levels in mice for up to 40 days post vaccination. A novel molecular response in infected human cervical cultures was detected. Data from a recent study may inform the development of a safe, effective, and novel gene therapy for the treatment of genital HSV-2 infections. © 2016 Wiley Periodicals, Inc." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of moderna mrna-1273 vaccine?

"We report side effects that we, when using vaccines, rarely consider and their prevalence should be kept in view when considering the role of moderna-1273 vaccine in a cohort of subjects already vaccinated against hepatitis viruses." - Anonymous Online Contributor

Unverified Answer

Does healthy subjects (hs) run in families?

"We conclude that it is unlikely that there exists a genetic factor responsible for the development of a positive family history. The fact that this group of patients was characterized by extreme genetic heterogeneity indicates that anosmia is not allelic to any of the ascertained genetic factors examined. Thus, the hypothesis that anosmia is genetically heterogeneous in the population is not corroborated by this family study." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in moderna mrna-1273 vaccine for therapeutic use?

"[A very new treatment method has been developed based on the molecular biology of mrna-1273 gene and it is the first therapeutic use of it]" - Anonymous Online Contributor

Unverified Answer

What is the primary cause of healthy subjects (hs)?

"If a healthy subjects (hs) is diagnosed with [neuropsychological, cognitive, or physiological] abnormalities, it is likely that the disease or disorder is not a psychiatric issue. Instead, it is more likely to be a physical problem.\n" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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