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Phase 2 Completed N=264 Randomized Quadruple-blind Other

A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age

Healthy
Source: ClinicalTrials.gov NCT05903183 ↗
Enrolled (actual)
264
Serious AEs
3.1%
Results posted
Dec 2025
Primary outcomePrimary: Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs — 46; 68; 5; 34 Participants

Summary

The primary purpose of the study is to assess the safety, tolerability and immunogenicity of a bivalent respiratory syncytial virus (RSV)/human metapneumovirus (hMPV) virus-like particle (VLP) candidate vaccine (IVX-A12) compared to placebo, when administered as a single-dose regimen in healthy older adults 60 to 85 years of age.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs
46; 68; 5; 34; 56; 19
PRIMARY
Number of Participants With Unsolicited Adverse Events
33; 38; 13
PRIMARY
Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb)
11980.96; 11167.48; 1944.00; 7787.22; 6560.64; 2205.65
PRIMARY
Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab)
1549.06; 1556.06; 393.03; 1707.15; 1856.88; 444.74
PRIMARY
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
35.9; 35.9; 6.7; 18.2; 21.6; 2.3
PRIMARY
Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration
45.8; 42.9; 0.0; 47.9; 52.0; 0.0
PRIMARY
Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers
5.86; 5.07; 0.95; 3.67; 3.11; 1.08
PRIMARY
Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
3.858; 3.465; 0.987; 4.008; 4.266; 0.896
SECONDARY
Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal
5; 3; 1; 54; 60; 21
SECONDARY
Number of Participants With Mild, Moderate, or Severe Lower Respiratory Tract Illness (LRTI) Caused by RSV and/or hMPV
4; 2; 0
SECONDARY
Number of Participants With Mild, Moderate, or Severe LRTI Cases Not Caused by RSV or hMPV
14; 11; 4
SECONDARY
Number of Participants With Clinically Significant Safety Laboratory Parameters
0; 0; 0
SECONDARY
Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb
6864.00; 7145.43; 2741.63; 4142.06; 3793.79; 1933.12
SECONDARY
Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
730.14; 739.32; 313.74; 781.54; 772.83; 406.42
SECONDARY
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
35.9; 35.9; 6.7; 18.2; 21.6; 2.3
SECONDARY
Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
12.9; 12.0; 0.0; 8.0; 10.2; 0.0
SECONDARY
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
39.6; 38.8; 0.0; 16.3; 20.7; 2.2
SECONDARY
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
3.21; 3.18; 1.34; 1.97; 1.68; 0.94
SECONDARY
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
1779.18; 2068.22; 1764.10; 12010.69; 10806.21; 1943.00

Eligibility Criteria

Inclusion Criteria

  • Male or female participants, who must be in stable health based on medical history, vital signs, physical examination, and laboratory evaluation prior to vaccination, in the investigator's clinical judgment
  • Participants may have ongoing chronic conditions (comorbidities such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism) who are, in the investigator's opinion, medically compensated and without recent exacerbation within the prior 3 months
  • Participants able to voluntarily give written informed consent and can comply with trial procedures including follow-up for approximately 12 months after vaccination
  • Body mass index 17 to less than ( =]4)
  • Prior receipt of any licensed or investigational RSV or hMPV vaccine within the past 12 months
  • Prior receipt of another investigational medicinal product (IMP; trial drug, biologic, or device) not authorized for use in the United States of America (USA) and European Union within the past 3 months
  • Laboratory-confirmed RSV or hMPV infection within 12 months prior to enrollment
  • Currently enrolled or plan to participate in another clinical trial with an investigational agent (including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) to be received during the trial period
  • History of malignancy within 5 years before screening not in the following categories: (i) participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator, (ii) participants with a history of malignancy within 5 years before screening, with minimal risk of recurrence per investigator's judgment, can be enrolled
  • Acute illness, with or without fever at the time of planned vaccination
  • History of hypersensitivity or serious adverse reactions to vaccines, such as anaphylaxis or angioedema, or any known allergies to any component of the IVX-121 and/or IVX-241 vaccine, or hypersensitivity to latex
  • Abnormal function of the immune system resulting from clinical conditions including chronic administration of systemic corticosteroids (oral/intravenous/IM at a daily dose equivalent of greater than (>) 20 milligram (mg) prednisone in a period of more than 14 days), or administration of immunosuppressive chemotherapy, biologics, or radiotherapy within the past 3 months prior to planned vaccination
  • Participants who have received treatment with immunoglobulins or other biologics, such as immunosuppressive therapies expected to modify immune response to vaccination (including monoclonal antibodies [MAbs] for chronic underlying conditions) within the past 3 months prior to planned vaccination
  • Trial personnel as an immediate family or household member
  • For licensed vaccines:
  • Receipt of licensed inactivated vaccines (including seasonal influenza vaccine) within 14 days prior to trial vaccine administration on Day 0, or licensed replicating vaccines such as ribonucleic acid (RNA) or live-attenuated virus vaccines within 30 days prior to Day 0
  • Receipt of licensed vaccines is permitted after completion of the Day 28 visit
  • Receipt of any licensed Coronavirus Disease-2019 (COVID-19) vaccines is permitted if dosing regimen completed within 21 days prior to Day 0 or after completion of the Day 28 visit.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05903183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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