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Last Updated: April 29, 2025

CLINICAL TRIALS PROFILE FOR COVID-19 VACCINE, MRNA


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All Clinical Trials for covid-19 vaccine, mrna

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00000105 ↗ Vaccination With Tetanus and KLH to Assess Immune Responses. Terminated Masonic Cancer Center, University of Minnesota 2002-07-01 The purpose of this study is to learn how the immune system works in response to vaccines. We will give the vaccines to subjects who have cancer but have not had treatment, and to patients who have had chemotherapy or stem cell transplant. Some patients will get vaccines while they are on treatments which boost the immune system (like the immune stimulating drug interleukin-2 or IL-2). Although we have safely treated many patients with immune boosting drugs, we do not yet know if they improve the body's immune system to respond better to a vaccine. Some healthy volunteers will also be given the vaccines in order to serve as control subjects to get a good measure of the normal immune response. We will compare the patients and the healthy volunteers to study how their immune systems respond to the vaccines. There are several different types of white cells in the blood. We are interested in immune cells in the blood called T-cells. These T-cells detect foreign substances in the body (like viruses and cancer cells). We are trying to learn more about how the body fights these foreign substances. Our goal is to develop cancer vaccines which would teach T-cells to detect and kill cancer cells better. We know that in healthy people the immune system effectively protects against recurrent virus infection. For example, that is why people only get "mono" (mononucleosis) once under normal circumstances. When the body is infected with the "mono" virus, the immune system remembers and prevents further infection. We are trying to use the immune system to prevent cancer relapse. To test this, we will give two vaccines which have been used to measure these immune responses. Blood samples will be studied from cancer patients and will be compared to similar samples from normal subjects.
NCT00000755 ↗ A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3 Completed Genentech, Inc. Phase 1 1969-12-31 To examine the response of HIV-1 infected patients to vaccination with gp120/HIV-1MN antigen. To determine the effect of antiretroviral therapy on vaccine responsiveness. Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication. Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens.
NCT00000755 ↗ A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3 Completed Glaxo Wellcome Phase 1 1969-12-31 To examine the response of HIV-1 infected patients to vaccination with gp120/HIV-1MN antigen. To determine the effect of antiretroviral therapy on vaccine responsiveness. Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication. Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens.
NCT00000755 ↗ A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3 Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To examine the response of HIV-1 infected patients to vaccination with gp120/HIV-1MN antigen. To determine the effect of antiretroviral therapy on vaccine responsiveness. Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication. Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens.
NCT00000820 ↗ A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone. SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines. The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.
NCT00000822 ↗ A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells Completed Bristol-Myers Squibb Phase 1 1969-12-31 To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific antibody responses, and DTH reaction. To describe the durability of the immunogen in patients who respond to the first 7 injections when they are boosted every 8 weeks for an additional 6-12 months [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. To describe the ability of the immunogen to induce a response after an additional 6-12 months of injections among patients who did not respond to the first 7 injections [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for covid-19 vaccine, mrna

Condition Name

675445420010203040506070InfluenzaCOVID-19HIV InfectionsMelanoma[disabled in preview]
Condition Name for covid-19 vaccine, mrna
Intervention Trials
Influenza 67
COVID-19 54
HIV Infections 45
Melanoma 42
[disabled in preview] 0
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Condition MeSH

132116104710020406080100120140COVID-19Influenza, HumanMelanomaHIV Infections[disabled in preview]
Condition MeSH for covid-19 vaccine, mrna
Intervention Trials
COVID-19 132
Influenza, Human 116
Melanoma 104
HIV Infections 71
[disabled in preview] 0
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Clinical Trial Locations for covid-19 vaccine, mrna

Trials by Country

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Trials by Country for covid-19 vaccine, mrna
Location Trials
Spain 98
China 87
Italy 66
France 65
South Africa 58
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Trials by US State

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Trials by US State for covid-19 vaccine, mrna
Location Trials
Maryland 269
California 201
New York 192
Texas 188
Florida 147
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Clinical Trial Progress for covid-19 vaccine, mrna

Clinical Trial Phase

9.6%10.3%77.4%00100200300400500600700800900100011001200Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for covid-19 vaccine, mrna
Clinical Trial Phase Trials
Phase 4 141
Phase 3 152
Phase 2/Phase 3 40
[disabled in preview] 1139
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Clinical Trial Status

47.9%19.2%12.6%20.2%0150200250300350400450500550600650700750CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for covid-19 vaccine, mrna
Clinical Trial Phase Trials
Completed 732
Recruiting 294
Not yet recruiting 193
[disabled in preview] 309
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Clinical Trial Sponsors for covid-19 vaccine, mrna

Sponsor Name

trials020406080100120140160180200220National Cancer Institute (NCI)National Institute of Allergy and Infectious Diseases (NIAID)GlaxoSmithKline[disabled in preview]
Sponsor Name for covid-19 vaccine, mrna
Sponsor Trials
National Cancer Institute (NCI) 203
National Institute of Allergy and Infectious Diseases (NIAID) 181
GlaxoSmithKline 65
[disabled in preview] 112
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Sponsor Type

56.7%27.2%14.3%0020040060080010001200140016001800OtherIndustryNIH[disabled in preview]
Sponsor Type for covid-19 vaccine, mrna
Sponsor Trials
Other 1723
Industry 826
NIH 434
[disabled in preview] 58
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COVID-19 mRNA Vaccines: Clinical Trials, Market Analysis, and Projections

Introduction to mRNA COVID-19 Vaccines

mRNA (messenger RNA) COVID-19 vaccines have been a cornerstone in the global fight against the COVID-19 pandemic. These vaccines, developed by companies like Pfizer and Moderna, have undergone extensive clinical trials and have been approved for emergency use and full approval by regulatory bodies such as the U.S. Food and Drug Administration (FDA).

Clinical Trials and Development

The development of mRNA COVID-19 vaccines was accelerated through several initiatives:

  • Historical Foundation: More than 50 years of public and private laboratory research laid the groundwork for the rapid development of these vaccines. For instance, NIH and Moderna scientists planned for Phase 1 clinical trials to test the safety of mRNA vaccines for Nipah virus, which began in 2022[4].
  • Operation Warp Speed: Launched in May 2020, this initiative coordinated federal government efforts to speed up the approval and production of reliable COVID-19 diagnostics, vaccines, and treatments[4].
  • Clinical Trials: Large-scale Phase 3 clinical trials for the Moderna mRNA vaccine showed promising interim results as early as November 2020. These trials were supported by the NIH's COVID-19 Prevention Network (CoVPN)[4].

Updated mRNA COVID-19 Vaccines

Recently, the FDA approved and authorized updated mRNA COVID-19 vaccines for the 2024-2025 formula. These updates include a monovalent component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. This change is aimed at providing better protection against currently circulating variants and reducing the risk of serious consequences such as hospitalization and death[1].

Market Analysis

Current Market Size and Growth

The mRNA Vaccines and Therapeutics Market has seen significant growth driven by the COVID-19 pandemic:

  • Market Size: The market is estimated to reach USD 63.89 billion in 2025 and is projected to grow at a CAGR of 16.80% to reach USD 138.88 billion by 2030[2].
  • Regional Growth: North America is the largest market, while the Asia-Pacific region is expected to grow at the highest CAGR over the forecast period[2].

Key Players

Major companies operating in the mRNA Vaccines and Therapeutics Market include Pfizer Inc., Moderna, Inc., BioNTech SE, GlaxoSmithKline, and Daiichi Sankyo[2].

Segment Analysis

  • Infectious Diseases: This segment is expected to witness significant growth due to the increasing prevalence of diseases like Ebola, influenza, HIV, and COVID-19. The COVID-19 pandemic has particularly driven demand for mRNA vaccines and therapeutics[2].
  • Non-COVID-19 Vaccines: While COVID-19 vaccines currently dominate the market, vaccines and therapeutics for other indications, such as influenza and respiratory syncytial virus infection, are expected to see substantial growth in the coming years[3].

Market Projections

Future Growth

Despite the subsidence of the COVID-19 pandemic, the mRNA vaccines and therapeutics market is expected to continue growing:

  • Expansion Beyond COVID-19: The market is anticipated to expand as research and development focus on various infectious and chronic diseases. For example, vaccines and therapeutics for influenza are expected to drive significant growth due to increased investment and awareness[3].
  • Clinical Trials and Pipeline: The number of clinical trials for mRNA-based products has increased at a compounded annual growth rate (CAGR) of more than 60% since 2017. This growth is driven by the development of COVID-19 vaccines and the entry of new mRNA therapeutics and vaccines into the clinical phase[3].

Regional Dynamics

  • North America: This region remains the largest market for mRNA vaccines and therapeutics. However, the Asia-Pacific region is expected to grow rapidly due to increasing demand and investment in healthcare infrastructure[2].
  • Global Initiatives: Programs supported by organizations like the World Bank, which approved operations to support vaccine rollout in 78 countries amounting to USD 10.1 billion, have significantly impacted the market's growth[2].

Impact of COVID-19 Pandemic

The COVID-19 pandemic has had a profound impact on the mRNA vaccines and therapeutics market:

  • Demand Surge: The pandemic led to a sharp rise in demand for mRNA vaccines due to their potent protection against various strains of the SARS-CoV-2 virus[2].
  • Economic Impact: The U.S. COVID-19 vaccination program is estimated to have prevented 2 million deaths, 17 million hospitalizations, and 66 million infections through March 2022, saving nearly $900 billion in health care costs[4].

Future Outlook

Emerging Trends

  • Next-Generation Therapeutics: The success of mRNA-based therapies and vaccines has increased research activity in novel RNA therapeutics. This includes the development of vaccines and therapeutics for diseases like HIV, where lessons learned from COVID-19 vaccine development are being applied[3].
  • Contract Manufacturing: The rich pipeline of mRNA-based therapeutics and vaccines is driving growth in the mRNA synthesis and manufacturing market, as drug developers seek contract services to scale up production[3].

Key Takeaways

  • Updated Vaccines: The FDA has approved updated mRNA COVID-19 vaccines for the 2024-2025 formula to better target currently circulating variants.
  • Market Growth: The mRNA Vaccines and Therapeutics Market is projected to reach USD 138.88 billion by 2030, driven by the COVID-19 pandemic and expanding research into other infectious and chronic diseases.
  • Regional Dynamics: North America is the largest market, but the Asia-Pacific region is expected to grow at the highest CAGR.
  • Clinical Trials: The number of clinical trials for mRNA-based products has significantly increased, driving market growth.

FAQs

What are the key updates in the 2024-2025 mRNA COVID-19 vaccines?

The 2024-2025 mRNA COVID-19 vaccines have been updated to include a monovalent component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2, aimed at providing better protection against currently circulating variants[1].

How big is the mRNA Vaccines and Therapeutics Market expected to be in 2025?

The mRNA Vaccines and Therapeutics Market is expected to reach USD 63.89 billion in 2025[2].

Which region is expected to grow the fastest in the mRNA Vaccines and Therapeutics Market?

The Asia-Pacific region is estimated to grow at the highest CAGR over the forecast period (2025-2030)[2].

What are the major driving factors for the infectious diseases segment in the mRNA Vaccines and Therapeutics Market?

The increasing prevalence of diseases like Ebola, influenza, HIV, and COVID-19 are major driving factors for this segment[2].

How have global initiatives impacted the mRNA Vaccines and Therapeutics Market?

Global initiatives, such as the World Bank's operations to support vaccine rollout, have significantly impacted the market's growth by providing substantial funding and support for vaccine development and distribution[2].

Sources

  1. FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines. FDA, August 22, 2024.
  2. mRNA Vaccine and Therapeutics Market Size & Share Analysis. Mordor Intelligence.
  3. mRNA Vaccine and Therapeutics Market Size & Share 2035. Roots Analysis.
  4. Decades in the Making: mRNA COVID-19 Vaccines. NIAID, April 4, 2024.
  5. Global mRNA Vaccines and Therapeutics Market. Bis Research.

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